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A. E. <I>e,n;OTOB
OCHOBbI
GMP
IIpOH3BO}];CTBO
JIeKapCTBeHHbIX Cpe}];CTB
ACHUKOM
MOCKBA

-
cDelIOTOB A. E.
OCHOBbl GMP. M.. ACI1HKOM, 2012 r., 576 C., HJl.
Fedotov A. E.
Basics of GMP. Moscow, ASENMCO, 2012, 576 p.
ISBN 978-5-9903456-1-4
127299, POCCHSI, MocKBa, YJl. K.UeTKHH, 4
TeJI./<!:>aKc: (495) 777-72-31, (499) 156-28-98
E-mail: invar@mai1.cnt.rll
info.asincom@mail.ru
www.invar-project.rll
www.asincom.info
OTne'laTaHO B THnorpacjmH «Otavan Kiljapaino Oy», <t>HH1l5lH.D.H5I

--
3
TIPE)J:HCJIOBHE
(])e.D.OTOB AJ1eKcaHlIp EBreHbeBH4
nOCJle OKOH4aHHSI acnHpaHTY-
pbl B 1977 r. 3aHHMaJ1 PYKOBO-
.D.SlIllHe .D.OmKHOCTH B HaYKe H
Ha npOMbllllJIeHHblX npelInpHSI-
THSlX, BbmYCKaBlllHX BbICOKOOT-
BeTCTBeHHYIO npO.D.YKUHIO.
B 1986 r. 3alllHTHJl .D.OKTOpCKYIO
.D.HCCepTaUHIO B 06JIaCTH aBTOMa-
TH4eCKHX CHCTeM ynpaBJleHHSI H
perYJlHpOBaHHSI.
MHOro JIeT 3aHHMaeTCSI npo-
6JIeMaMH 4HCTblX nOMellleHHH,
opraHH3aUHH npOH3BO.D.CTBa H
npaBHJIaMH GMP.
B 1991 r. Y4pe.D.HJI <!:>HPMY «I1HBap» (B HaCTOSllllee BpeMSI 000
«I1HBap-npoeKT»). OCHOBHaSi c<!:>epa .D.eSlTeJIbHOCTH - npOeKTHpOBaHHe H
aTTeCTaUHSI npOH3BO.D.CTB JleKapCTBeHHblX Cpe.D.CTB comaCHO Tpe60BaHH-
SlM G M P H .D.Pymx 06"beKTOB, HCnOJIb3YIOIllHX 4HCTble TeXHOJIOrHH.
Ope3HlIeHT AccoUHaUHH HH)I(eHepOB no KOHTpOJlIO MHKp03arp13He-
HHH (ACJ.1HKOM), maBHblH pe.D.aKTOp )l(ypHaJIa «TeXHOJlOrHSI 4HCTO-
Tbl», npe.D.Ce.D.aTeJlb TeXHH4eCKHX KOMHTeTOB no CTaH.D.apTH3aUHH TK 184
«06ecne4eHHe npOMblWJleHHOH 4HCTOTbl» H TK 458 «npOH3BO.D.CTBO H
KOHTpOJIb Ka4eCTBa JIeKapCTBeHHblX Cpe.D.CTB». npe.D.CTaBJl5leT POCCHIO B
Me)I(.D.YHapO.D.HOM TeXHH'leCKOM KOMHTeTe I1CO TK 209 «4HCTble nOMe-
w.eHHSI H CBSl3aHHbie C HHMH KOHTpOJlHpyeMble Cpe.D.bl».
nO.D. ero pe.D.aKUHeH BblWJla KHHra «4HCTble nOMellleHHSI» (H3.D.aHH1
1998, 1999 H 2003 r.r.). ABTop MHorHX CTaTeH H .D.OKJIa.D.OB Ha Me)I(.D.YHa-
PO.D.HbIX KOH<!:>epeHuHSlx.
B Te4eHHe 20 JleT .D.06HBaeTcSI BBelIeHHSI B POCCHH npaBHJ1 G M P
EBponeHcKoro COlO3a B KalleCTBe 06513aTellbHoro .D.OKYMeHTa. nO.D. ero
PYKOBOlICTBOM B 1996 r. 6blJl BbInOJlHeH nepeBOlI npaBHJI GMP EC Ha
PYCCKHH Sl3blK H H3.D.aH OT.D.eJlbHol'1 KHHroH (nSlTb THpa)l(eH). B 2004 r.
nepeBO.D. npaBHJl G M P EC 6blJ1 npHHSlT B Ka4eCTBe fOCTa P 52249-
2004 H nepeH31IaH B 2009 r. B KalleCTBe fOCTa P 52249-2009.
KHHra S1BJl5leTC5I HTOroM MHoroJIeTHeH pa60Tbl B HaYKe H npOMblW-
JleHHOCTH, H3Y4eHHSI opraHH3aUHH H TeXHOJIOrHH npOH3BO.D.CTBa lleKap-
CTBeHHblX cpelICTB 1a py6e)l(OM, pa60Tbl C Be.D.YIllHMH CneUHaJlHCTaMH.
B Hei1 06061lleH onblT npaKTJ1LlecKoro BHe.D.peHHSI npaBHJl GMP.

...
'-....
(
U
....

4
BBe,lJ,eHHe
f Jlasa I
1.I
1.2
1.3
1.4
1.5
1.6
1.7
fJIaBa 2
2.1
2.2
2.3
2.4
2.5
2.6
2.7
2.8
2.9
OfJIABJIEHHE
OCHOSHOH 3aKOH npOH3BO,lJ,CTBa JIeKapCTBeHHbIx cpelIcTB
YTO TaKoe GMP?
Dopb6a 3a Ka4eCTBO: <!:>aKTbl HCTOpHH
CTaHOBJleHHe npaBHJI GMP
E.D.HHble npaBHJla HJlH HaUHOHaJIbHaSi cneUH<!:>HKa?
I1cTOpHSI GMP B POCCHH
HopMaTHBHble 1I0KYMeHTbl no GMP
HOBbIe np06JleMbl
npHHu,unbl pa60Tbl no G MP
UeJIb - Ka4eCTBO
YCJ10BHSI 06ecne4eHHSI Ka4eCTBa
fOCT P 52249 - npaBHJIa GMP EC
GMP B CiliA: OCHOBHble OTJIH4HSI OT EBponbl
TepMHHbl
fOpbl 6YMar H 6H3Hec Ha GMP
TpY.D.HOCTH OCBoeHHSI GMP
UeHa - 6e30nacHocTb H Ka4eCTBO
Eme pa3 0 npHHUHnax
fJlasa 3 MaTepH3Jlbl
3.1 BHlIbl MaTepHaJlOB
3.2 AKTHBHble <!:>apMaueBTH4ecKHe cy6CTaHuHH
3.3 BcnoMOraTeJIbHble BellleCTBa
3.4 Bbl60p nOCTaBIllHKOB
3.5 nepBH4Hble ynaKoB04Hble MaTepHaJIbl
3.6 DHOTeXHOJIOrHSI
3.7 Oc06eHHocTH MaTepHaJIOB lIJlSl BaKUHH
f JlaBa 4
4.1
4.2
4.3
4.4
4.5
4.5.1
4.5.2
4.5.3
n pOH3BO,lJ,CTSO
CxeMa npOH3BO.D.CTBa
06pallleHHe C MaTepHaJIaMH .D.O nepe.D.a4H B npOH3BO.D.CTBO
OT60p H aHaJIH3 np06 MaTepHaJIOB
3THKeTKH H MapKHpOBKa
npOH3BOlICTBO npOlIYKUHH
npHeM MaTepHaJIOB B npOH3BOlICTBO
TeXHOJIOrl14eCKHe npoueCCbl npOH3BOlICTBa
BHyrpHnpoH3BOlICTBeHHblH KOHTpOllb
-
CTp.
10
17
17
19
23
29
30
36
38
39
39
41
45
45
50
54
57
60
61
63
63
64
74
77
79
84
85
87
87
88
92
96
99
99
99
101

02.l106JleHue 5
4.5.4 YnaKOBKa npOlIYKUHH 102
4.5.5 ConOCTaBJleHHe 104
4.5.6 fOTOBaSl np0.D.YKUHSI 104
4.5.7 npOTOKOJl Ha cepHIO npO.D.YKUHH 105
4.6 CepHSI npOlIYKUHH 109
4.7 3alllHTa OT 3arpSl3HeHHH H nepeKpeCTHblX 3arpSl3HeHHH 113
4.8 OTKJlOHeHHble, nOBTopHO HCnOJlb30BaHHble H B03Bpa- 117
llleHHble MaTepHaJIbl H np0.D.YKUHSI
4.9 Pa60Ta no KOHTpaKTaM 118
4.10 BbInYCK no napaMeTpaM 119
fJlaBa 5 .lI.oKYMeHTaI\HH 120
5.1 Ha3Ha4eHHe .D.OKYMeHTaUHH 120
5.2 CnJlOlllHOe .D.OKYMeHTHpOBaHHe -OCHOBHOH npHHUHn GMP 121
5.3 Tpe60BaHHSI K .D.OKYMeHTaUHH 122
5.3.1 061llHe nOJlO)l(eH HSI 122
5.3.2 513b1K .D.OKYMeHTa 123
5.3.3 CTHJIb .D.OKYMeHTa 124
5.4 nOpSl.D.OK pa3pa60TKH .D.OKYMeHTOB 126
5.5 OCHoBHble BHlIbl .D.OKYMeHTOB 129
5.6 I1H<!:>0pMauHSI 0 npelInpHSlTHH 131
5.7 CneUH<!:>HKauHH 133
5.8 n pOMbllllJIeHHble perJlaMeHTbl, TeXHOJIOrH4eCKHe 134
HHCTPYKUHH H HHCTPYKUHH no ynaKoBKe
5.9 I1HcTPYKuHH H MeTO.D.HKH 135
5.10 Be.D.eHHe .D.OKYMeHTaUHH H BHeceHHe H3MeHeHHH 140
5.11 Oc06eHHOCTH .D.OKYMeHTaUHH B CiliA 142
5.12 .lI.oKYMeHTaUHSI B 3JIeKTpOHHOH <!:>opMe 144
5.13 THnH4Hble He.D.OCTaTKH B 1I0KYMeHTaUHH 145
fJlaBa 6 nO.ll.fOTOBKa npOH3BO,lJ,CTBa 147
6.1 OCHOBa npOH3BO.D.CTBa 147
6.2 Ha4HHaTb HY)I(HO C npoeKTa 149
6.3 CTa.D.HH pa3pa60TKH H COCTaB npoeKTa 150
6.4 TexHoJlorH4eCKHH pa3.D.eJI - OCHOBa npoeKTa 153
6.5 Y KOro 3aKa3aTb npoeKT? 155
6.6 ATTecTauHSI H 3KcnepTH3a npoeKTa 155
6.7 UeHa npoeKTa H ueHa 06"beKTa 158
6.8 THnH4Hble OWH6KH npH npoeKTHpOBaHHH 159
6.9 Bbl60p 060PYlIoBaHHSI 167
6.10 CTpOHTeJlbCTBO H MOHTa)l( 168
r JlaBa 7 3,lJ,aHHH H nOMemeHHH 172
7.1 31IaHHSI H npOH3BOlICTBeHH,UI nJIOIlla.D.Ka 172
7.2 Tpe60BaHHSI TeXHOJlOrHH 177

6
7.3 TexHoJIorH4eCKHH npouecc 180
7.4 YHcTble nOMellleHHSI 184
7.5 CHcTeMbl BeHTHJlSlUHH H KOHlIHUHOHHpOBaHHSI 189
fJlasa 8 06oPY,lJ,OBaHHe H CHCTeMbl 191
8.1 TexHoJIorH4ecKoe 060PY.D.OBaHHe 191
8.2 KOHTpOJIb napaMeTpOB 193
8.3 nOKa3aTeJIH Ha3Ha4eHHSI H HcnblTaHHSI (aTTecTauHSI) 195
8.4 060PY.D.OBaHHe .D.JlSl npOH3BOD.CTBa TBep.D.blX <!:>OpM 196
8.5 Oc06eHHocTH 060PY.D.OBaHl1S1 .D.J1S1 npOH3BO.D.CTBa 202
CTepHJIbHOH npO.D.YKUHH
8.6 Tpe60BaHHSI K BO.D.e 203
8.7 fa3bl H C)I(aTblH B03.D.YX 211
8.8 YTHJIH3aUHSI OTXO.D.OB 214
8.9 THnH4Hble HeCOOTBeTCTBHSI Tpe60BaHHSlM GMP 215
fJlaBa 9 IIcnblTaHHH H aTTeCTaWtH 216
9.1 BH.D.bl HCnblTaHHH (aTTecTaUHH) 216
9.2 I1cnbITaHHSI npH pa3pa60TKe H nOCTaHOBKe H3.D.eJIHSI 221
Ha npOH3BO.D.CTBO
9.3 I1CnbITaHHSI cepHHHoH npO.D.YKUHH Ha 3aBO.D.e-H3roToBHTelle 222
9.4 I1cnbITaHHSI Ha MeCTe 3KCnJlyaTaUHH 223
9.5 KpHTH4ecKoe 060PY.D.OBaHHe 224
9.6 nporpaMMa HCnblTaHHH 226
9.7 ATTecTaUHSI CHCTeM nO.D.roToBKH BO.D.bl 227
9.8 ATTeCTaUHSI Ta6JIeT04HblX npeCCOB 229
9.9 ATTecTaUHSI npOH3BOlICTB 6HOJIOrH4eCKH aKTHBHblX 230
cy6cTaHUHH
9.10 06LUHH CJlY4aH 232
9.11 CTaH.D.apT ASTM E2500 233
9.12 PYKOBO.D.CTBO FDA 234
9.13 BMeCTO 3aKJIlO4eHHSI 235
fJlaBa 10 ATTecTaHH npoeCCOB OlfHCTKH 06oPY,lJ,OBaHHH 238
10.1 np06JICMa 04HCTKH 060pY.D.OBaHHSI 238
10.2 HopMaTHBHble Tpe60BaHHSI K 04HCTKe 060pYlIoBaHHSI 240
10.3 CneUHaJIH3aUHSI 060PYlIoBaHHSI 242
10.4 MeTO.D.bl 04HCTKH 060PY.D.OBaHHSI 243
10.4.1 PY4Hble MeTO.D.bl 243
10.4.2 MeTO.D.bl 04HCTKH Ha MeCTe 245
10.4.3 3alllHTa OT MHKp06HblX 3arpSl3HeHHH 248
10.4.4 I1HcTPYKuHSI no 04HCTKe 249
10.5 Cyrb aTTeCTaUHH npoueCCOB 04HCTKH 250
10.6 MeTolIbl oueHKH 4HCTOTbl nOBepxHocTeH 255
10.7 ATTeCTaUH npOUCCCOB 04HCTKH C nOMOlllblO oT60pa np06 261

O2Jla6JleHue 7
10.7.1 3Tanbl aTTeCTaUHH 261
10.7.2 KpHTepHH 4HCTOTbl (oCTaTKH npe.D.bl.D.Ylllero npo.D.YKTa) 261
10.7.3 ATTecTaUHSI MeTOlIOB 04HCTKH OT lIPYrHX 3arpSl3HeHHH 266
10.7.4 Koma CJle.D.yeT npOBOlIHTb aTTecTaUHIO? 266
10.8 AHaJIH3 np06 267
10.9 npOTOKOJI aTTeCTaUHH npouecca 04HCTKH 268
fJIaBa II An3JIHTHlfeCKHe MeTOJ],b1 270
11.1 06JIaCTb npHMeHeHHSI 270
11.2 npHHUHnbl aTTeCTaUHH H npOBepKa 271
pa60Tocnoc06HoCTH MeTO.D.OB
11.3 npOBepKa pa60Tocnoc06HocTH aHaJlHTH4eCKHX MeTO.D.OB 276
11.4 ATTecTauHSI aHaJIHTH4eCKHX MeTO.D.OB 276
11.5 XapaKTepHcTHKH aHaJIHTH4eCKHX MeTO.D.OB 278
11.6 Tpe60BaHHSI K aHaJIHTH4eCKHM MeTO.D.aM 287
11.7 ATTecTaUHSI npH60poB 288
11.8 KaTeropHH npH60poB 296
fJlaBa 12 nepCOH3JI 297
12.1 061llHe nOJIO)l(eHHSI 297
12.2 HeMHoro nCHXOJlOrHH 299
12.3 CTHMYJIHpOBaHHe 300
12.4 nO.D.60p nepCOHaJIa 304
12.5 OTHoweHHe K pa60Te 307
12.6 nOBelIeHHe nepCOHaJIa 311
12.7 YHcToTa H rHrHeHa 313
12.8 TexHoJlorH4ecKaSi O.D.e)l(1la 316
12.9 COCTOSlHHe 3.D.OpOBbSi 318
fJlaBa 13 06Y1feHUe nepCOH3Jla 319
13.1 Koro H 4eMY HY)I(HO Y4HTb? 319
13.2 f.D.e Y4HTb? 326
13.3 KTO MO)l(eT H 1I0J1)1(eH Y4HTb? 327
13.4 TexHHKa BblcTynJleHHSI H KYJlbTypa pe4H 330
13.5 CTpyt<Typa 3aHSlTHH 335
13.6 Cpe.D.CTBa 06Y4eHHSI 337
fJlaBa 14 06ecnelfeHHe KalfeCTBa 339
14.1 CTaH.D.apTbl B 06JlaCTH Ka4eCTBa 339
14.2 YTO TaKoe Ka'leCTBO? 340
]4.3 06ecne4eHHe, ynpaBJleHHe, MeHelI)I(MeHT 342
]4.4 GMP, CHCTeMbl Ka4eCTBa H CTaHlIapTbl I1CO 9000 344
]4.5 npHHuHnbl 06ecne4eHHSI Ka4eCTBa 349
]4.6 npH4HHbl HH3KOro Ka4eCTBa 350
]4.7 3Tanbl C031IaHH1 CHCTeMbl 06ecne ' leHHH Ka'leCTBa 351

--
8
--
14.8 OTKJlOHeHHSI OT cneUH<!:>HKaUHH 352
14.9 TeXHOJlOrHSI aHaJIH3a npouecca (PAT) 357
14.10 KOHTpOJlbHble Jla60paTopHH 359
fJlaBa 15 ADMH3 PUCKOB 361
15.1 4TO TaKoe aHaJIH3 pHCKOB? 361
15.2 AHaJIH3 pHCKOB no rOCT P 52249-2009 365
15.3 npaBHJla GMP EC H PYKOBO.D.CTBO ICH Q9 365
15.4 «OCHOBHble» MeTO.D.bl aHaJIH3a pHCKOB 367
15.5 «D.pyrHe» MeTOlIbl aHaJIH3a pHCKOB 370
15.6 npHMepbl npHMeHeHHSI aHaJIH3a pHCKOB 374
15.6.1 Ta6JIeT04Hoe npOH3BO.D.CTBO 374
15.6.2 npOeKTHpOBaHHe <!:>apMaueBTH4ecKHx npOH3BO.D.CTB 377
15.6.3 npHMep npHMeHeHHSI MeTO.D.a HACCP 378
15.7 MHHa 3aMelIJleHHoro lIeHcTBHSI 378
15.8 YTO B CiliA? 381
15.9 PaUHOHaJIbHblH CMblCJI B aHaJIH3e pHCKOB 382
15.9.1 D.eHcTBYIOIllHe npOH3BO.D.CTBa 383
15.9.2 HOBbIe npOH3BO.D.CTBa 387
15.9.3 npaKTH4eCKHe npHMepbl 387
15.10 HeCKOJIbKO 061llHX COBeTOB 390
15.11 BepHeMcSI K HCTOpHH 392
15.12 B 4eM KOpHH nyraHHUbl? 396
15.13 3aKJIlO4eHHe 400
fJlaBa 16 YnOJIHOMOlfeHHbIe JIHa 402
fJlaBa 17 YnpaBJIeHHe npOH3BO,lJ,CTBOM 409
17.1 YnpaBJleHHe npOH3BO.D.CTBOM: TeopHSI HJlH npaKTHKa? 409
17.2 061llHe Tpe60BaHHSI K CJIO)l(HblM CHCTeMaM 411
17.3 OpraHH3auHoHHaSi CTpYKTypa npe.D.npHSITHSI 419
17.4 HarpY3Ka Ha PYKoBO.D.HTeJIeH H HCnOJIHHTeJIeH 419
17.5 3JleMeHTapHaSl opraHH3aUHSI pa60Tbl 420
17.6 I1HHuHaTHBa H HCnOJlHHTeJlbCKaSi .D.HCUHnJlHHa 422
17.7 3TH Ka H 3CTeTH Ka 426
17.8 3aKJIlO4eHHe 429
fJlaBa 18 GLP - GCP - GMP . . . 431
18.1 KOMnJIeKC .D.OKYMeHTOB GxP 431
18.2 I1CnblTaHHSI B Jla60paTOpHH - GLP 432
18.3 KllHHI14eCKHe HcnblTaHHSI - GCP 432
18.4 OmoBaSl TOproBJlSl - GO P 433
18.5 TeXHOJlOrHH KJleTOK H TKaHeH - GTP 436
18.6 GMP lIllH npOH3BOlICTBa npOlIYKTOB nHT<lHHSI 437
H KocMeTwlecKoH npOMblWJleHHOCTH

O2JIa6JleHUe 9
fJlaBa 19 "HcneKlI.HH H aY,lJ,HT 439
19.1 npoBepKa COOTBeTCTBHSI Tpe60BaHHSlM GMP 439
19.2 I1HcneKuHH 442
19.3 npoBelIeHHe HHcneKUHH 447
19.4 nOCJle HHcneKUHH 455
19.5 I1HcneKUHH FDA CiliA 456
19.6 I1HcneKuHH B EBpone 459
19.7 AY.D.HT 462
19.8 npHMepbl THnH4HblX HapyweHHH Tpe60BaHHH GMP 465
19.8.1 3aKoHoMepHocTH H3MeHeHHSI 3aMe4aHHH 465
noGMPBCiliA
19.8.2 3aMe4aHHSI HHcneKUHH EC 469
19.8.3 THnH4Hble He.D.OCTaTKH B POCCHH 472
19.9 Ka4ecTBo pa60Tbl HHcneKUHH 475
fJlaBa 20 0630p nHceM-npeJ],ynpeJK,ll,eHHH FDA CIlIA 477
20.1 061llaSi xapaKTepHCTHKa 477
20.2 npOH3BO.D.CTBO JIeKapCTBeHHblX Cpe.D.CTB .D.J1S1 4eJlOBeKa 478
20.3 J10)I(HaSI peKJIaMa H BblnyCK 6e3 pa3pellleHHSI Ha npHMeHeHHe 490
20.4 npOH3BO.D.CTBO aKTHBHblX <!:>apMaueBTH4eCKHx cy6cTaHUHH 490
20.5 npOH3BO.D.CTBO npO.D.YKTOB nHTaHHSI 494
20.6 npOH3BO.D.CTBO KOpMOB H CO.D.ep)l(aHHe )l(HBOTHbIX 495
fJlaBa 21 <I>apMaKoneH H GMP 497
fJlaBa 22 CTaH,lJ,apTbI H npaBHJla 504
fJlaBa 23 OpraHH3all.HH, pa60TalOIlI.He B 06J1aCTH GMP 513
3aKJIlOlfeHHe 517
npHJlo}J{eHHe I PeKOMeH1laUHH no COCTaBJleHl11O 519
I1H4>opMaUHH 0 npelInpl1S1THI1 (EC)
npHJlo}J{eHHe 2 Me)l(1lYHapolIHble rapMOHH3HpOBaHHble 527
Tpe60BaHHSI K cepTH4>HKaUHH cepHH
"pHJIo}J{eHHe 3 Ha1le)l(HOCTb CHCTeM H 060pYlIoBaHHSI 529
"pHJIo}J{eHHe 4 CI1CTeMbl Ka4eCTBa H Mca 9000 537
llpHJlo}J{eHHe 5 MeT01lbl aHaJlH3a pHCKOB 544
npHJIo}J{eHHe 6 nOpSllIOK npOBe1leHHSI HHcneKUHH 549
H 06MeHa HH4>opMauHei1 (EC)
llpHJlo}J{eHHe 7 CepTl14>HKaT COOTBeTCTBHH GMP (EC) 556
npHJIo}J{eHHe 8 Or'leT 0 npOBelIeHI1H HHcneKUHH G M P EC 559
npHJlo}J{eHHe 9 npHMep 3aMe4aHHH no 4>opMe 4G 563
npHJlo}J{eHHe to nHCbMO-npe1lynpe>K1leHl1e FDA (npHMep) 564
11 HTepaTypa 569
nepe1.JeHb cOKpaweHI1H 572
Contents (English) 573

10
BBE)J:EHIIE
Bbl XOTHTe, nOJIb3YSlCb JIH<!:>TOM, ynacTb C HHM C lIBalIuaToro 3Ta)l(a
BHH3 H3-3a .D.e<!:>eKTa B CHCTeMe 6JIOKHpOBKH?
Bbl COfJIaCHbl C TeM, 4T06bl OTKa3aJIH TopM03a B aBTOM06HJle HJIH
B30pBaJICSI KOTeJl Ha COCe.D.HeM npe.D.npHSITHH?
BaM .D.a)l(e npe.D.CTaBHTb CTpaWHO, 4TO npoH30i1.D.eT, eCJIH H3-3a
OWH6KH B CHCTeMe aBTOMaTHKH 6Y.D.eT HCnOJIHeHa JIO)l(HaSi KOMaH.D.a Ha
nepeBO.D. CTpeJIKH no.D. .D.BH)I(YIllHMCSI nOe3.D.OM, B KOTOpOM Bbl M4HTeCb co
CKOpOCTblO 150 KM/4.
06ecne4eHHe 6e30nacHocmu BO Bcex 3THX CJIY4aSlX perJlaMeHTHpyeT-
C}l 06H3ameJlbHbLMU iJoKYMeHmllMU, HX BbInOJIHeHHe 3aKJIa.D.blBaeTCSI B H3-
.D.eJIHe Ha CTa.D.HSlX pa3pa60TKH H npOH3BO.D.CTBa. 3a BceM 3THM CJIelISiT
Ha.D.30pHble OpraHbl.
HHKTO He cnpalllHBaeT npOH3BO.D.HTeJISI, comaceH OH C HopMaMH no
06ecne4eHHIO 6e30naCHOCTH HJlH HeT. npOH3BO.D.HTeJIb 06maH HX Bbl-
nOJlHSlTb. 3TO 06S13aTeJIbCTBO OH 6epeT Ha ce6S1, pelllHB 3aHSlTbCSI .D.aH-
HblM BH.D.OM 6H3Heca.
A pa3Be YIllep6 OT JleKapCTBeHHoro Cpe.D.CTBa, H3roTOBJ1eHHoro H3
nJIOXHX MaTepHaJIOB, nepenyraHHblx, oWH604HO MapKHpOBaHHblX HJlH
Hcnop4eHHblX npH xpaHeHHH, MeHbwe?
Pa3Be cHTyaUHSI JlY4111e, eCJIH BMeCTe C HH"beKUHeH 4eJlOBeKY BBO-
.D.SlTCSI MHKpoopraHH3Mbl, cO.D.ep)l(alllHeCSI B paCTBope, KOTOpblH .D.OJI)I(eH
6bITb CTepHJlbHbIM, HJlH BMeCTe C Ta6JIeTKOH npHHHMalOTCSI OCTaTKH .D.e-
TepreHTOB HJlH .D.pyroro nOCTopoHHero BellleCTBa H3-3a nJIOxoro MbITbSl
060PY.D.OBaHHSI?
HeT, cHTyaUHSI He JIY4we. OHa MO)l(eT 6bITb .D.a)l(e xY)l(e BBH.D.Y Mac-
COBOro, KpynHocepHHHoro npOMblWJIeHHoro npOH3BO.D.CTBa JIeKapCTBeH-
HblX Cpe.D.CTB.
n04eMY )l(e HHKTO He ocnapHBaeT BBe.D.eHHe 06S13aTeJIbHb1X HOpM
6e30naCHOCTH .D.JlSl JIH<l:>TOB, KOTJIOB H CaMOJleTOB, a B OTHoweHHH JIeKap-
CTBeHHblX Cpe.D.CTB npOlIOJI)I(alOTCSI paCCY)I(.D.eHHSI H BBe.D.eHHe G M P 3aTSI-
HyrO Ha 20 JIeT?
n04eMY Be.D.yrcSi pa3roBopbl, HY)l(Hbl JlH HaM GMP C 2014 ro.D.a HJIH
HX JIY4we OTO.D.BHHyrb KYlIa-HH6Y.D.b nO.D.aJIbwe? A TopM03a Hy)I(Hbl KO-
r.n.a? Ha4HHaSl C 2014 ro.D.a HJlH B MOMeHT npH06peTeHHSI aBTOM06HJlSl?
Cyrb B TOM, 4TO npOH3BO.D.CTBeHHbIH .D.e<!:>eKT CaMOJleTa, KOTJla, TOp-
M030B npHBO.D.HT K H6HbLM, 3pHMblM nOCJle.D.CTBHSlM. npH na.D.eHHH caMO-
JIeTa, KpyweHHH nOe3.D.a HJlH B3pblBC KOTJla npH.D.eTCSI OTBe4aTb nepe.D.
npOKYPopOM. 3TOro He X04eT HHKTO: HH npOH3BOlIHTeJlH, HH 4HHOBHHKH.
OTJlH4He JleKapCm6eHHOlO cpeiJcm6a COCTOHT B TOM, lITO ero lIe<!:>eKT
SlBJlSleTC}l, KaK npaBHJlO, CKpblmbLM. OH MO)l(eT 6blTb He YCTaHOBJleH BO-

B6eoeHue
11
Bce, ero nOCJle.D.CTBHSI MorYT 6blTb He 3a<!:>HKCHpOBaHbl, JlH60 npHnHcaHbl
4eMY-TO lIPyrOMY.
3Ta npocTaSi HCTHHa 6blJIa nOHSITa Ha 3ana.D.e .D.aBHO. TaM 061lleCTBO
HaY4HJIOCb 3alllHIllaTb ce6S1 OT .D.e<!:>eKTOB B npOH3BO.D.CTBe JIeKapCTBeHHblx
Cpe.D.CTB, npHHSlB 06S13aTeJIbHble npaBMJIa, KOTopble 6blJIH Ha3BaHbl 06-
pa3HO OpaBHJIaMH GMP (Good Manufacturing Practice, dOCJ/06HbIU nepe-
60d - flpa6uJ/a xopoUle20 npou360dcm6a). 3Ta 06pa3HocTb 6blJIa npH.D.aHa
npaBHJlaM HaMepeHHo, .D.J1S1 KOHTpacTa C CYllleCTBOBaBlllHMH Tor.aa nJIO-
XHMH npOH3BO.D.CTBaMM. KOppeKTHblH nepeBO.D. Ha PYCCKHH Sl3blK 3ByYHT
KaK «/Ipa6UJla npou3600cm6a JleKapCm6eHHblX cpeocm6».
Ellle O.D.HOH Ba)l(HOH oc06eHHocTbIO JIeKapCTBeHHblX Cpe.D.CTB SlBJlSl-
eTCSI TO, 4TO HX CnJIOlllHOH, 100%-H KOHTpOJlb Hepa3PywalOIllHMH MeTO-
.D.aMH HeB03MO)l(eH. OpOBepeHHaSi e.D.HHHua npO.D.YKUHH (paCTBopeHHaSi
Ta6JIeTKa, BCKpblTblH <!:>JIaKOH) Y)I(e He Moryr HCnOJIb30BaTbCSI. n03TOMY
KOHTpOJIb cepHH JIeKapCTBeHHblX Cpe.D.CTB BelIeTCSI no orpaHH4eHHOH Bbl-
60pKe H3 BceH cepHH.
PaCCMOTpHM BbmYCK CTepHJIbHbIX npenapaTOB, HanpHMep, BaKUHHbl
.D.JlSl .D.eTei1, C pa3MepOM cepHH 10000 <!:>JIaKOHOB. npOBepKe Ha CTepMJIb-
HOCTb nO.D.Jle))(aT 20 <!:>JIaKOHOB H3 Ka)I(.D.OH cepHH. ECJIH B cepMH 6Y.D.eT
100 HeCTepHJlbHblX <!:>JIaKOHOB, TO BepOSITHOCTb 06Hapy)l(HTb HeCTepHJIb-
HblH <!:>JIaKOH paBHa 0,18, a He 06Hapy)l(HTb - 0,82. OpH BbmYCKe CTa
TaKHX cepMH CTepHJIbHblMH 6y.D.yr npM3HaHbl 82 cepHH, HeCMOTpSl Ha
HaJIH4He B Ka)I(.D.OH M3 HHX 100 HeCTepHJlbHblX <!:>JIaKOHoB. B HTore 6y.D.yr
BbmYllleHbl B 060POT 8200 HeCTepHJIbHblX <!:>JlaKOHOB, H 8200 lIeTSIM (B
TOM 4MCJIe HOBOpO)I(.D.eHHbIM) 6y.D.yr BBe.D.eHbl HeCTepMJlbHble npenapaTbI,
npM4eM Ha Ka)I(.D.OM <!:>JIaKOHe 6Y.D.eT Ha.D.nMCb «CTepHJlbHO».
ECJIH 3TH UH<!:>Pbl nepeHeCTH Ha B03.D.YlllHbIH TpaHcnoPT, TO B 30He
a3ponopTOB MOCKBbl npOMCXO.D.HJIH 6bl 2-3 KaTacTp0<!:>bl B .D.eHb.
Bac ellle Y1lHBJlSlIOT BblCOKl1e nOKa3aTeJII1 CMepTHOCTI1 B POCCI1I1?
OHI1 Y>KaCalOlllH!
no np01l0Jl>KHTeJlbHOCTI1 )l(H3HI1 POCCI1S1 3aHHMaeT 129-e MeCTO B Ml1pe
H3 192 CTpaH nocJle 60JlI1BHH, faHaHbI H BbeTHaMa. Y Hac MY>K1.JI1Hbl >KI1BYT
Ha 1611eT, a )l(eHllll1Hbl Ha 9 JIeT MeHbwe, 1.JeM B CiliA. Bo <t>paHUI1I1 cpe1l-
HSISI np01l011>KI1TeJIbHOCTb >K113HI1 MY>K1.JHH COCTaBJlSleT 78 JIeT, B nOllbwe 74
ro1la, a B POCCI1I1 59 JIeT. MJla1leH1.JeCKaSl CMepTHOCTb (1lem OT 0 110 I r01la)
B POCCHI1 B 5,8 pa3a Bblwe Cpe1lHeMHpoBoH.
BepHeMCSI K npHMepy co CTepHJlbHOH npO.D.YKUHeH. MO)l(HO YBeJIH-
'lHBaTb npoueHT npoBepSieMblx e.D.HHHU npO.D.YKUHH, HO 3TO He MeHSIeT
.D.eJIa B npHHUHne: Bce paBHO onaCHOCTb BbInYCKa Ha pblHOK .D.e<!:>eKTHOH
npO.D.YKUHH 6Y.D.eT BeJlHKa. ECJIH opraHH30BaTb CnJIOWHOH, 100%-H KOH-
TpOJIb, TO Bce npe.D.npHSITHSI 6y.D.yr pa60TaTb TOJlbKO Ha KOHTpOJlb, 6e3
peaJIH3aUHH npOlIYKUHH.
ECTb TOJIbKO OlIHO peweHHe: nOCTpOHTb npOH3BO.D.CTBO TaK, 4T06bl
BbInYCK lIe<!:>eKTHoi1 npOlIYKUI1H 6blJl UClCJllOlteH.

12
B6edeHue
.uOJI)I(Hbl 6bITb HCKJlI04eHbl nepenyrblBaHHe MaTepHaJIOB H npOlIYK-
UHH, nOna.D.aHHe B HHX nOCTopOHHHX BellleCTB, HCnOJlb30BaHHe Hero.D.-
HblX MaTepHaJIOB H T. .D.. 3TY 3a.D.a4Y pewalOT npaBHJIa GMP.
UeJlb GMP - nOCTpOHTb npOH3BOlICTBO TaK, 4T06bl 6blJIa rapaHTHSI:
- COOTBeTCTBHSI COCTaBa JIeKapCTBeHHoro cpelICTBa YCTaHOBJleHHblM
Tpe60BaHHSlM;
- OTcyrCTBHSI B HeM 3arpSl3HeHHH;
- npaBHJlbHOCTH MapKHpOBKH;
- HeH3MeHHOCTH CBOHCTB npOlIYKUHH B Te4eHHe cpOKa ro.D.HOCTH.
D.nSl CTepHJIbHOH npO.D.YKUHH He06xo.D.HMbl BbICOK03<!:><!:>eKTHBHble
npoueCCbl CTepHJlH3aUHH H 06ecne4eHHe 4 HCTOTbl, npH KOTOpblX lapaH-
mupyemcH CTepHJlbHOCTb BceH cepHH npO.D.YKUHH, H HH O.D.HH H3 nOTpe-
6HTeJIeH He nOJIY4HT C HH"beKUHeH .D.03Y MHKpoopraHH3MOB.
3TH Tpe60BaHHSI pacnpOCTpaHSIIOTcSI Ha npOH3BO.D.CTBO neKapCTBeH-
HblX Cpe.D.CTB KaK .D.J1S1 4eJIOBeKa, TaK 11 .D.J1S1 )l(HBOTHbIX.
K HaCTOSlllleMY BpeMeHH npaBHJla GMP, OTHOCSlIllHecSi K HHM
CTaH.D.apTbl H PYKOBolICTBa 06pa3YIOT KOMnJleKC HopMaTHBHOH
.D.OKYMeHTaUHH, n03BOJISIIOIllHH C031IaBaTb H 3KCnJIyaTHpoBaTb
npOH3BO.D.CTBa, 06ecne4HBaSi 6e30naCHOCTb JIeKapCTBeHHblx Cpe.D.CTB H
COOTBeTCTBHe HX CBoeMY Ha3Ha4eHHIO.
Ho He Bce TaK npocTO. K CO)l(aJIeHHfO, GMP 3acopeHbI
YCJIO)l(HeHHSlMH H nyraHHueH H3 06JIaCTH BaJIH.D.aUHH, MeHe.D.)J(MeHTa H
aHaJIH3a pHCKOB. 3TO HCKYcCTBeHHO C03.D.aHHbIH 6H3Hec Ha GMP H nOlI
<!:>JlaroM GMP, HeHY)J(HbIH H Bpe.D.HblH .D.JlSl .D.eJIa. OH CJIy)I(HT TOJlbKO
KOHCYJIbTaHTaM H BaJIH.D.aTOpaM, HX JlH4HblM HHTepecaM. 3TO HY)I(HO
nOHHMaTb, nOCKOJIbKY OH YBO.D.HT B CTOPOHY H .D.HCKpelIHTHpyeT GMP B
rJIa3aX npOH3BO.D.CTBeHHHKOB. 3TOT Bonpoc paCCMOTpeH B rJlaBe 2 H
.D.Pymx pa3.D.eJIaX KHHm.
flpa6UJla GMP - KOHKpemHblii u iJeJl060ii iJoKYMeHm
ABTop CTaBHJI ueJIb .D.OHeCTH CMblCJl npaBHJI .D.O 4HTaTeJISI, HCnOJIb3YSI
CCblJIKH Ha .D.OKYMeHTbl EBponbl, POCCHH H CiliA, H nOKa3aTb, 4TO GMP
- 3TO He Ha60p 061llHX <!:>pa3, a KOHKpeTHoe PYKOBO.D.CTBO K .D.eHCTBHIO
no 06ecne4eHHIO 6e30nacHocTH JleKapCTBeHHblx Cpe.D.CTB Ha CTa.D.HH npo-
H3BO.D.CTBa.
ABTop CTaBHJI nepell C060H 3a.D.a4Y Ha3BaTb BelllH CBOHMH HMeHaMH,
y6paTb Bce HCKyccTBeHHoe, HeHY)I(HOe, 3aTpYlIHSlIOIllee BocnpHSlTHe
npaBHJI GMP H HX BHe.D.peHHe, H H3JlO)l(HTb npelIMeT PYCCKHM Sl3bIKOM.
B npaBHJIaX GMP HeT HJ1Llero HOBOro. OHH He TaK CTpaWHbl, KaK
HX HenpaBHJIbHOe, caMOYBepeHHoe H HeKOMneTeHTHoe TOJlKOBaHHe.
111IeSl G M P - 1aJIO)l(l1Tb Ka4eCTBO npOlIYKUH 11 Ha 3Tane pa3pa60TKH
H npOH3BOlICTBa, TaK OpraHI130BaTb npouecc, 4T06bl BbInYCK
HelI06pOKa4ecmeHHOH npOlIYKUHH 6blJl HCKJlI04eH - He HOBa. 60Jlee 100
neT Ha3a.D., B ::moxy 6YPHOro CTpOHTeJlbCTBa )l(eJle3Hb1X 1I0por, B03HHKJla
np06JleMa KalleCTBa H3rOTOBJlCHH1 peJlbCOI3. MeTOlIbl 06HapY)l(eHH1

B6eoeHue
13
CKpblTblX lIe<!:>eKTOB peJIbCOB (YJlbTpa3BYKOBaSi lIe<!:>eKTOCKonHSI paKOBHH,
MHKpOTpelllHH H np.) OTCYTCTBOBaJIH. A 3TH .D.e<!:>eKTbl MOrJlH npHBeCTH K
H3JlOMY peJIbCa nOlI lIBH)I(YIllHMCSI nOe3.D.OM H TSI)I(eJlblM nOCJIe.D.CTBHSlM.
PeWHTb np06JIeMY YlIaJIOCb 3a C4eT TeXHOJIorHH npOH3BOlICTBa,
HCKJlI04alOIlleH nOSlBJleHHe .D.e<!:>eKTOB. EblJl pa3pa60TaH CneUHaJIbHblH
CTaH.D.apT, nepBblH CTaHlIapT AMepHKaHcKoro 06weCTBa no HCnblTaHHSlM
H MaTepHaJIaM - ASTM (American Society for Testing and Materials),
KOTOpblH nOJImKHJI Ha4aJIO 60JIbWOH pa60Te B pa3HblX OTpaCJISIx.
B MaCCOBOM MacwTa6e HlIeSl GMP, HO no.D. .D.PYrHMH Ha3BaHHSlMH,
CTaJIa peaJIH30BbIBaTbcSI B 50-e ro.D.bl .D.Ba.D.uaToro BeKa B 3JIeKTpOHHOH,
npH60pocTpOHTeJlbHOH, aBHaUHoHHoH, KocMH4ecKoH H .D.PYrHX OTpaCJISIX
npOMbllllJIeHHOCTH. EblJIH oTpa60TaHbl TeXHOJIOrHH H cxeMbl opraHH3a-
UHH npOH3BO.D.CTBa, HCKJlI04aBWHe BbmYCK npO.D.YKUHH C OTKJlOHeHHSlMH
OT 3a.D.aHHbIX Tpe60BaHHH.
OHH nOJIO)l(HJIH Ha4aJIO MaccoBoMY .D.BH)I(eHHIO BO Bcex OTpaCJISlX,
3aHSlTblX BbInYCKOM OTBeTCTBeHHoH npolIYKUHH. ABTop HMeJl 4eCTb
J1H4HO, Ha npaKTHKe, Y4acTBoBaTb B 3TOM, 3aHHMaSi PYKOBO.D.SlIllHe
.D.OJI)l(HOCTH B HaYKe H Ha npOH3BO.D.CTBe .D.O 1991 r.
B Ha4aJIe 90-x ro.D.OB, Koma HayYHblH H TeXHHLJeCKHH nporpecc B
CTpaHe 6bIJI HCKYCCTBeHHO OCTaHOBJleH, OCHOBHOH npOH3BO.D.CTBeHHbIH
<!:>OH.D. .D.erpa.D.HpOBaJI, a CneUHaJIHCTbl OKa3aJIHCb He Y.D.eJI, Mbl nOCTaBHJIH
ueJIb npHMeHHTb CBOH 3HaHHSI B Be4HOH c<!:>epe 4eJlOBe4eCKOH
.D.eSlTeJIbHOCTH -3.D.paBOOXpaHeHHH.
ACJ.1HKOM 6blJla C031laHa B 1991 r. KaK He3aBI1CI1MOe HeKOMMep1.Je-
CKoe 06111ecTBo npo4>eccHOHaJlOB, CB0601lHbIX OT BJlI1S1HI1S1 6lOpoKpaTI1I1. B
S11lPO ACJ.1HKOM BOWllI1 11 101l11 , Opl1eHTl1pOSaHHbIe Ha Me>K1lYHap01lHbIH
ypOBeHb, CMOTpSlllll1e Bnepe1l H nOCTaBHBWHe ueJIb n01l"bCMa HaUHOHaJlbHOH
npOMbIWlleHHOCTI1.
CHa1.JaJla Mbl orpaHH1.Jl1JII1Cb BHe1lpeHl1eM 1.Jl1CTblX nOMellleHI1H, nOJIa-
raSl, 4TO eCTb KOMY 3aHI1MaTbCSI cneuH4>I11.JeCKI1MI1 np06J1eMaMI1 npOH3B01l-
CTBa JleKapCTBeHHblX Cpe1lCTB, 1.JTO B 3TOM 1leJle eCTb CBOI1 KOpl14>el1, KOTO-
pblM MO>KHO 1l0BepSlTb. OKa3aJlOCb, 1.JTO 3TO OWI16Ka. 11l1ua, B3S1BWl1eCSI 3a
pa3pa60TKY HOpMaTI1BHblX 1l0KYMeHTOB no np0I13B01lCTBY JIeKapCTBeHHblX
Cpe1lCTB, He I1MeJlI1 HI1 npaKTl11.JeCKoro OnbITa pa60Tbl, HI1 3HaHHH COBpe-
MeHHoro npoI13B01lCTBa 11 He opHeHTHpOBaJlHCb Ha OCHOBHYIO UeJIb - BblBe-
CTI1 OTe1.JeCTBeHHble npe1lnpl1S1TI151 Ha Ml1pOBOH ypOBeHb.
3TH Jll1ua CTPa1laJIH 60Jle3HbIO MHOrHX HaWI1X I1HCTI1TYTOB - Be1.JHO
nJleCTI1Cb B XBOCTe 3ana1lHOH HaYKI1 11 TeXHI1KI1, 1.JTO-TO nepeHI1MaSl Y HI1X, a
1.JTO-TO OCTaRJISlSl Ha «nOTOM') 11 1l06aBJlillI cBOe, HCKYCCTBeHHoe 11 HI1KOMY
He HY>KHoe. rOCY1lapcTBO 3£1 3TO nnaTI1JIO 6101l>KeTHbIe Cpe1lCTBa, 3£1 KOTopble
OTLII1TblBaJlHCb Ylllep6HblMI1 1l0KYMeHTaMI1, 3allll1111aJll1 1lI1CCepTaUI1I1, a npo-
MblWJIeHHOCTb 6blJIa 1le30pl1eHTl1pOBaHa OCTaMI1, PD, 11 MY, 0 KOTOpblX
HY>KHO 3a6bITb.
Mbl 3TO nOHSllll1. J.1 nOCTaBHJlI1 3a1la1.JY npSlMoro BBelleHI1S1 B POCCI1I1
npaBHJI GMP EBponeHcKoro COlO3a - GMP EC.

14
B6edeHue
E,lJ,HHCTBeHHbIH BapHaHT nOlI"bCMa HaweH <!:>apMaueBTH4ecKoH npo-
MblWJIeHHOCTH .D.O COBpeMeHHoro YPOBHSI - 3TO npSlMoe BBelIeHHe B
CTpaHe npH3HaHHblX B MHpe H XopOWO oTpa60TaHHblX npaBHJI npOH3-
BO.D.CTBa JIeKapCTBeHHblX Cpe.D.CTB - npaBHJl GMP.
3TO He CJlenoe KonHpoBaHHe TOro, 4TO eCTb Ha 3ana.D.e. 3TO OCO-
3HaHHaSi n03HUHSI BblXOlIHTb cpa3Y Ha .D.OCTHrHyrbIH B MHpe Py6e)l(, OT-
6POCHB Bce HeHY)I(HOe, H C 3TOH CTyneHH .D.BHraTbCSI .D.aJIbWe, cTpeMSlcb
6b1Tb Bnepe.D.H. He4ero 6ecKoHe4Ho H306peTaTb BeJlOCHne,lJ,. 11M HY)I(HO
nOJIb30BaTbCSI.
BBelIeHHIO npaBHJl GMP B POCCHH OKa3bIBaeTCSI )l(eCTKOe conpo-
THBJIeHHe.
TaK Ha3bIBaeMaSi «HaYKa» nO.D.MeHSIeT SlCHble H 4eTKHe 1I0KYMeHTbl
cypporaTaMH C «HaUHOHaJIbHOH» cneUH<!:>HKOH. B 4eM OHa COCTOHT, HH-
KTO 06"bSlCHHTb He MO)l(eT. Pa3Be B POCCHH acnHpHH .D.pyroH, 4eM B
nOJlbWe, a BHPYC rpHnna npH nepece4eHHH pOCCHHCKOH rpaHHUbl CTa-
HOBHTCSI .D.PYrHM H .D.J1S1 60pb6bl C HHM HY)I(Hbl .D.PYrHe npaBHJIa?
He Bce npe.D.npHSITHSI CTpeMSlTCSI pa60TaTb Ha.D. Ka4eCTBOM JIeKap-
CTBCHHblX Cpe.D.CTB no CYllleCTBY. Koe-KTo X04eT nOLlBeCTH lIeJIO no.D.
CBOH, 04eHb OTCTaJIblH ypOBeHb. He Bce B Ha.D.30pHbIX opraHax XOTSIT ne-
pelIOBblX HOpM, HM JIer4e oueHHBaTb pa60TY no 06"beMY 6YMar, 4eM pa3-
6HpaTbcSI B GMP.
Mbl nO-npe)l(HeMY CJlbIWHM, 4TO GMP - He .D.J1S1 Hac, 4TO OHH no-
ry6S1T Hawy npOMbllllJIeHHOCTb, KOTopaSi H TaK .D.bIWHT Ha JIa.D.aH. A KOro,
C06CTBeHHO, ry6HTb? B POCCHH HMnopTHble npenapaTbl COCTaBJlSlIOT 80%
pblHKa. OHH npOH3Be.D.eHbl no GMP HJIH HeT? HHKTO He 3HaeT.
OTcyrcTBHe npaBHJI GMP B CTpaHe H OTcyrcTBHe KOHTpOJIH 3apy-
6e)l(HblX npOH3BO.D.CTB Ha COOTBeTCTBHe G M P C03.D.aJIO n04BY .D.J1 BbIC-
weH CTeneHH BblrolIHOro 6H3Heca: B POCCHIO MO)l(HO no xopoweH ueHe
nOlI BH.D.OM JIeKapCTBeHHblX Cpe.D.CTB nOCTaBJlSlTb 4TO yro.D.HO H npOH3Be-
.rreHHoe B KaKHX yro.D.HO YCJlOBHSlX.
POCCHHCKHM npOH3BOlIHTeJISlM npHHMJle)l(aT 20% pblHKa. MHorHe
HX HHX pa60TalOT XopOWO. A TeM, KTO nJIOXO - OlIHa 1I0pora - B He6bl-
THe. PSI.D. npelInpHSlTHH KynJIeH HHOCTpaHHblMH <!:>HpMaMH C O.D.HOH ue-
JIblO: Bbl)l(aTb MaKcHMYM npH MHHHMYMe 3aTpaT, nOJlb3YSlCb oTcyrcTBHeM
06S13aTeJIbHb1X GMP.
HaM He HY)l(Ha npOlIYKUHSI npe.D.npHSITHH, .D.bIWaIllHX Ha JIa.D.aH, H He
Hy)I(Hbl npelInpHSlTI1S1, nOJIY'IaIOIllHe CBepxnpH6blJlb, ry6S1 Hawe 3.D.OpOBbe.
Mbl, ACI1HKOM, 20 JIeT nHweM H roBOpHM 0 GMP, roTOBHM CBSI-
3aHHble C HHMH CTaHlIapTbl. To, 4TO 06S13aTeJIbHble npaBHJIa GMP -
06"beKTHBHaSi He06xolIHMOCTb, 6blJIO SlCHO lIaBHO. BpeMeHH Ha nO.D.roToB-
KY 6blJIO .D.OCTaTO'IHO.

B6edeHue
15
CllMoe mpYOHoe - 6 :JJleMeHmapHoM
GMP 03Ha4a1OT, 4TO HY)I(HO:
- HCnOJlb30BaTb TOJIbKO xopOWHe MaTepHaJlbl;
- 4eTKO BbInOJlHSlTb CBOH 06S13aHHOCTH;
- HMeTb HC4epnblBalOIllYIO CHCTeMY .D.OKYMeHTaUHH, me HanHcaHO,
4TO H KaK .D.eJIaTb, H O<!:>0PMJISlTb <!:>aKT BbInOJlHeHHSI pa60Tbl;
- npHMeHSlTb TeXHOJIOrHlO, rapaHTHpYlOlllYIO BbInYCK npO.D.YKUHH B
COOTBeTCTBHH C .D.OKYMeHTaUHeH;
- HCKJlI04aTb nepenyrblBaHHe H nepeKpeCTHble 3arpSl3HeHHSI;
- C06JlIO.D.aTb 4HCTOTY H rHrHeHY.
B 3TOM Cyrb GMP.
He TaK CTpaWHbl GMP, KaK KOMMeHTapHH K HHM, KaK .D.OMbICJIbl
JIlOlIeH, KOTopble caMH HHKoma He pa60TaJIH Ha npOH3BO.D.CTBe, HO
KaTeropH4Ho CY.D.S1T 060 BceM, npHBHOCSI CBoe, He HMelOlllee OTHoweHHSI
K .D.eJlY nOHHMaHHe. OHO npOHHKaeT B HopMaTHBHble .D.0KYMeHTbl,
nO.D.aeTCSI OT HMeHH Ha.D.30pHbIX opraHOB pa3Horo pO.D.a KOMMeHTaTopaMH
H BBO.D.HT B 3a6JIY)l(.D.eHHe npe.D.npHSITHSI.
D.nSl npOH3BO.D.CTBeHHHKa eCTb TOJlbKO O.D.HH BbIXO.D.: CllMOMY
pa306pambCH 6 cymu 60npoca, nOHSlTb OCHOBOnOJlaralOlllHe Tpe60BaHHSI H
npHMeHHTb I1X Y ce6S1, YMeTb OTMeCTH Bce HeHY)I(Hoe. 3a Bce Ilecem
om6emcm6eHHocmb CllM npOU3600cm6eHHUK: H 3a Ka4eCTBO CBoeH
npO.D.YKUHH, H 3a 3KOHOMHKY cBoero npelInpHSITHSI. 3a OWH6KH H
nOCJle.D.CTBHSI nJIOXHX COBeTOB OH paCnJIa4HBaeTCSI caM. OH .D.OJI)J(eH
OC03HaHHO opHeHTHpOBaTbCSI B OKpy)l(alOllleM MHpe, YMeTb OTCTaHBaTb
CBOfO n03HUHIO.
KHHra OCHOBaHa Ha JIH4HOM OnblTe aBTopa, onblTe pa3pa60TKH
CTaH.D.apTOB, MHoroJIeTHeM 4TeHHH JIeKUHH no .D.aHHOH TeMe,
npoeKTHpOBaHHH, C03.D.aHHH H aTTeCTaUHH npOH3BO.D.CTB Ha COOTBeTCTBHe
Tpe60BaHHSlM GMP. Pa60Ta B HaUHOHaJIbHblX H Me)I(.D.YHap0.D.HbIX
TeXHH4eCKHX KOMHTeTax no CTaH.D.apTH3aUHH, BblcTynJIeHHSI Ha
KOH<!:>epeHUHSlX, 061lleHHe C pOCCHHCKHMH H 3apy6e)l(HblMH KOJlJleraMH,
aHaJIH3 npOH3BOlICTB JleKapCTBeHHblX Cpe.D.CTB B pa3HblX CTpaHax
n03BOJlHJIH C<!:>OpMHpOBaTb CHCTeMHoe nOHHMaHHe np06JleMbl GMP.
B KHHre BelllH Ha3BaHbl CBOHMH HMeHaMH, 6e3 peBepaHCOB. TOJIbKO
TaK MO)l(HO 1I06HTbCSI HCTHHbl H BblBeCTH npOMbllllJIeHHOCTb H3 60JIOTa,
KY.D.a ee 3arHaJIH H H3 KOTOpOro ynopHo He lIalOT Bb16paTbCSI.
BeJIHKHH PYCCKHH 4eJIOBeK MHXaHJI BaCHJIbeBH'1 JlOMOHOCOB nHCaJI:
«Be:JICJ1U60cmb U KOMnJ/UMeHmbl HUl.{e20 He cmoflm 6 oeJ/ax, Komopble
KaCQlOmCfl 6J/a2a 20cydapcm6a, U oc06eHHO, K02da Hecnpa6edJ/U60cmb 6epem
6epx» .
3TH CJlOBa KaK HeJlb3S1 60Jlee cOBpeMeHHbI.

16
B6edeHue
MHoroe H3 G MP He Tpe6yeT Cpe.D.CTB Ha peKOHCTpYKUHIO H 1I0Jl)l(HO
6blTb ClIeJlaHO cpa3Y. 3TO opraHH3aUHSI .D.eJIa, BelIeHHe .D.OKYMeHTaUHH,
pa60Ta C nepCOHaJIOM, KOHTpOJIb Ka4eCTBa Ha COBpeMeHHOM ypOBHe.
CaMoe CJlO)l(HOe - 3JIeMeHTapHoe HaBelIeHHe nOpSl.D.Ka, TaKaSi opraHH3a-
UHSI pa60Tbl, Koma Ka)l(1lblH 4eTKO 3HaeT CBOH 06S13aHHOCTH, YMeeT HX
BbInOJlHSlTb H BbInOJlHSleT T04HO B COOTBeTCTBHH C .D.OKYMeHTaUHeH, BOBpe-
MSI 06Hapy)l(HBaeT OTKJlOHeHHSI H npHHHMaeT Mepbl K HX YCTpaHeHHIO.
3TO - OCHOBa .D.eJla. Ho OlIHOH opraHH3aUHH MaJIO. D.nSl BbInYCKa Ta-
KOH OTBeTCTBeHHOH H MaCCOBOH npOlIYKUHH KaK JIeKapCTBCHHble cpe.D.-
CTBa Hy)I(Hbl COBpeMeHHble npoueCCbl, 060PY.D.OBaHHe H nOMellleHHSI.
KHHra He npeTeH.D.yeT Ha nOJIHory H3JlO)l(eHHSI Bcex Tpe60BaHHH H
He SlBJlSleTCSI HC4epnbIBalOIllHM PYKOBO.D.CTBOM. OHa JIHWb .D.aeT OCHOBY
.D.J1S1 <!:>OpMHpOBaHHSI c06CTBeHHOH n03HUHH H CO.D.ep)l(HT npaKTH4eCKHe
peKOMeHlIaUHH no OCHOBHblM COCTaBJlSllOlllHM npaBHJI GMP. B HeH He
paCCMaTpHBaeTCSI cneUH<!:>HKa CTepHJIbHblX JIeKapCTBeHHblX Cpe.D.CTB, KO-
TOpOH nOCBSlllleHa OT.D.eJIbHaSi KHHra «npOH3BO.D.CTBO CTepHJlbHblX
JIeKapCTBeHHblX Cpe.D.CTB» 110].
Hy)I(HO HMeTb B BH.D.Y fJIaBHoe: 6e30naCHOCTb H Ka4eCTBO
Ha4HHalOTCSI C Kallecm6a HopMamU6HblX iJOKjJMeHmoe. B 3TOM nJlaHe MHO-
roe He 6JIaronOJlY4HO H HY)I(HO MeHSlTb cxeMY pa60Tbl B npHHUHne.
fpaMOTHble HopMbllIalOT npaBHJlbHblH KypC lIBH)I(eHHSI. be3 HHX ueJIb
- 6e30nacHOCTb H Ka4eCTBO - He.D.OCTH)I(HMa.
)J,peBHepHMCKHH <!:>HJlOCO<!:> CeHeKa nHCaJI: «Kopo6.111O, He 3HaIOUI,eMY, 6
KaKYIO 2aeOHb I1.IIbleem, Hem nonymH020 6empa».
ABTOp .D.aJIeK OT MbICJlH, 4TO Bce HaWH 6e.D.bl - OT OTCyrCTBHSI GMP.
Ho TO, 4TO BOJlOKHTa H nyraHHua C GMP 6bfOT no 3.D.OpOBblO HaCeJIeHHSI
04eHb CHJIbHO, 04eBH.D.HO. C TeMOH GMP conpHKacaeTCSI MHO)l(eCTBO
JIlOlIetl. Ka)l(.D.OMY H3 HHX CJIe.D.yeT 3HaTb npocTYIO HCTHHY:
Mbl CllMU nUUleM ucmopulO C60elO iJeJla U CllMU 6bl6upaeM Jlull,a, C
KOmOpblMU 6 Hee 60iiiJeM.
Hawa pa60Ta H3BeCTHa 3a Py6e)l(OM (KHHrH, CTaTbH H BblcTynJleHHSI
Ha aBTopHTeTHblX Me)I(.D.YHap0.D.HbIX KOH<!:>epeHUHSlX). B 2008 r. aBTOp 6blJl
Y.D.OCTOeH npeCTH)I(HOH Harpa.D.bl - npeMHH )J,)I(0p.D.)I(a CaHKca (George
Sykes Award) HaY4Horo 061lleCTBa B 06JlaCTH <!:>apMauHH H
3.D.paBOOxpaHeHHSI BeJlHK06pHTaHHH (The Pharmaceutical and Healthcare
Sciences Society - PHSS) 3a ny6JIHKaUHIO 0 pa3pa60TKe fOCT P 52539-
2006 «YHcToTa B031Iyxa B JIe4e6Hblx Y4pe)I(.D.eHHSlX. 061llHe Tpe60BaHHSI».
3Ta npeMHSI npHCY)l(.D.aeTCSI OlIHH pa3 B roll 3a JIY'IWYIO pa60TY B .D.aHHOH
06JIaCTH. OCTaHoBKa 3a MaJIblM - npHMeHHTb CBOH OnbIT Y ce6S1 .D.OMa.
ABTop 6JIarolIapeH COTPYlIHHKaM 000 «I1HBap-npoeKT» H 4JleHaM
ACI1 H KOM 3a nOMOlllb npH nO.D.rOTOBKe KHHrH.

17
f JIaBa 1
OCHOBHOH 3AKOH
npOH3BO,aCTBA JIEKAPCTBEHHbIX CPE)J:CTB
1.1 qTO TaKoe GMP?
B COBpeMeHHOM MHpe npa6UJla GMP - npaBHJla npOH3BO.D.CTBa Jle-
KapCTBeHHblX cpelICTB, 06S13aTeJlbHbl .D.J1S1 HCnOJlHeHHSI. PeaJIH3aUHSI npo-
.D.YKUHH, npOH3Be.D.eHHOH C OTKJlOHeHHeM OT 3THX Tpe60BaHHH, 3anpellleHa.
D.nSl .D.OnYCKa Ha pblHOK HelIOCTaT04HO npOBepHTb npO.D.YKT HJIH ce-
pHIO npO.D.YKUHH. He06xo.D.HMO .D.OKa3aTb, 4TO npou360iJcm60 coom6em-
cm6yem npa6UJlllM GMP. 3TH npaBHJla S1BJlSlIOTCSI 06S13aTeJIbHbIMH. no-
nbITKH 060HTH HX BJleKYT 3a C060H OTBeTcTBeHHOCTb, BnJIOTb.D.O yroJIOB-
HOH.
nepBble npaBHJIa GMP (.D.)I(H-3M-nH) - Good Manufacturing Prac-
tice, nOSlBHJIHCb B Ha4aJIe 60-x ro.D.OB XX-ro BeKa B AMepHKe, a 3aTeM B
EBpone. C Tex nop BO MHomx CTpaHax COOTBeTCTBHe npaBHJIaM GMP
51BJlSleTCSI YCJIOBHeM .D.J1S1 nOJIY4eHHSI JlHueH3HH Ha npOH3BO.D.CTBO JIeKap-
CTBeHHblX Cpe.D.CTB.
B OCHOBe npaBHJI GMP JIe)l(HT CJIe.D.YlOlllaSi <!:>YH.D.aMeHTaJIbHaSi H.D.eSl:
JleKapCm6eHHbie cpeiJcm6a - 3mo OC06blii 6UiJ npoiJYKu.UU. He.D.OCTaT04Ho
YCTaHOBHTb Tpe60BaHHSI K caMOH npOlIYKUHH H MeTOlIaM ee KOHTpOJlSl.
He06xo.D.HMO YCTaHOBHTb Tpe60BaHHSI K np0u.eccy npou360iJcm6a H Bbl-
nOJIHSlTb HX.
n04eMY?
J1eKapcTBeHHble Cpe.D.CTBa HMelOT TPH CYllleCTBeHHble oc06eHHocTH,
OTllH4alOIllHe HX OT .D.PyrHx BH.D.OB npO.D.YKUHH:
I) OHH .D.OJl)l(Hbl Ha 100 % coom6emcm606amb C60eMY Ha3HalleHUIO,
6bITb 6e30nacHblMH H 3<!:><!:>eKTHBHbIMH. J11060e OTKJlOHeHHe OT 3Toro
YCJlOBHSI 03Ha4aeT Bpe.D. .D.J1S1 nOTpe6HTeJlSl, HHor.aa Bpe.D. HenonpaBHMblH;
2) I1x lIe<!:>eKTbl S1BJlSlIOTCSI CKpblmblMU, OHH MorYT 6bITb 06HapY)I(e-
Hbl CJlHWKOM n03.D.HO HJlH He 06HapY)I(eHbl Bo061lle;
3) J1eKapcTBeHHble cpelICTBa HeJlb3H np06epumb Hepa3pYUlalOlU,UMU
MemoiJllMU KOHmpOJlH. npoBepHTb MO)l(HO TOJIbKO omiJeJlbHble 06pa3ubl
HJIH np06bl H3 cepHH npO.D.YKUHH. CnJIOWHOH KOHTpOJlb HeB03MO)l(eH. B
3TOM COCTOHT npHHUHnHaJIbHOe OTJIH4He <!:>apMaueBTH4ecKoH npOMblW-
JleHHOCTH OT npOH3BOlICTBa aBTOM06HJIeH, MHKpocxeM H MHO)l(eCTBa .D.PY-
rHX BHlIOB npOlIYKUHH, r.ae Ka)l(1l0e H31IeJlHe MO)l(HO npOBCpHTb, a Hero.D.-
Hble - oT6paKoBaTb.

-
/8
IJw6a 1
o Ka'leCTBe cepHH JleKapCTBeHHoro cpelICTBa MO)l(HO CYlIHTb TOJlbKO
no OT.D.eJIbHbIM 06pa3uaM. 3T0 CY)I(1leHHe 6YlIeT npaBHJIbHblM, eCJlH:
O,lJ,HH 06pa3el\ H3 cepHH npOJ],yKI\HH
Ha 100 % nOBTopHeT CBODCTBa BceD cepHH
OTCIO.D.a BbITeKaeT ueJIb GMP: npoiJYKm iJoA:JICeH 6celiJa npOU360-
iJumbcH oiJuHaK060 U C oiJuHaK06blMU, 3apallee 3aiJallllblMU c60iicm6llMu.
KOHTpOJIb roTOBOro npO.D.YKTa He SlBJlSleTCSI rapaHTHeH Ka4eCTBa.
Ka4eCTBO 06ecne4HBaeTCSI meXlloJlolueii U oplallu3au.ueii npou36oiJcm6a.
npHHUHn G M P YHHBepCaJIeH. Ha.D.e)l(HOe, a6COJllOTHO nOBTopSieMoe
npOH3BO.D.CTBO, me HeT MeCTa CJIy<IaHHOCTSlM, oWH6KaM H CKpblTblM ,lJ,e-
<!:>eKTaM, HY)I(HO BO MHomx OTBeTCTBeHHblX OTpaCJlSlX.
OHO .D.OCTHraeTCSI 3a C4eT BblCOKOro TeXHH4ecKoro ypOBHSI, Ka4eCTBa
H Hane)l(HOCTH Bcex 3JIeMeHTOB npOH3BO.D.CTBa: CblpbSl H MaTepHaJIOB,
nOMellleHHH H 060PY.D.OBaHHSI, TeXHOJIOrHH, opraHH3aUHH pa60Tbl, CH-
CTeMbl ynpaBJ1eHHSI npelInpHSITHeM, 1I0KYMeHTaUHH, KBaJIH<!:>HKaUHH H
HCnOJIHHTeJIbCKOH LlHCUHnJIHHbl nepCOHaJIa H np.
PeaJIH3aUHSI 3THX Tpe60BaHHH rapaHTHpyeT 6e30naCIlocmb JIeKap-
CTBeHHblX Cpe.D.CTB H coom6emcm6ue UX C60eMY Ha3HalleHUIO.
3TH YCJIOBHSI eCTeCTBeHHbl H nOHSlTHbl, HO BbInOJIHHTb HX HeJIerKO.
Cyrb GMP COCTOHT B HX rapaHTHpOBaHHOM BbInOJlHeHHH, 3TO Tpe6yeT
CneUHaJIbHblX opraHH3aUHOHHbIX, TeXHH4eCKHX H TeXHOJIOrH4eCKHX Mep.
TOJIbKO TaK MO)l(HO 06ecne4HTb 6e30naCHOCTb JleKapCTBeHHblx Cpe.D.CTB H
3aJIO)l(eHHYIO B HHX 3<!:><!:>eKTHBHOCTb.
3a npowelIlllHe 50 JIeT BO MHorHX CTpaHax HaKOnJleH 60raTblH on bIT
pa60Tbl no npaBHJIaM GMP. l1.D.eoJIorHSi GMP pacnpOCTpaHHJIaCb Ha
KOCMeTH4eCKYIO H nHllleBYfO npOMblWJIeHHOCTb (rJlaBa 18).
lJmo iJaiJym npa6UJla GMP Poccuu?
OHH .D.a.D.yr rJIaBHOe - 6e30naCHOCTb H Ka'leCTBO JleKapCTBeHHblX
Cpe.D.CTB Ha ypOBHe MHpOBblX CTaHlIapTOB.
3TO n03BOJIHT:
- rapaHTHpoBaTb HaCeJleHHIO 6e30nacHocTb npO.D.YKUHH;
- peaJIH30BbIBaTb ee Ha 3apy6e)l(HblX pblHKax;
- 06ecne4HTb KOHKypeHTocnoc06HoCTb OTe'leCTBeHHbIX npenapaTOB;
- YCTaHOBHTb 3aCJlOH HMnopTY HelI06poKa ' lecTBeHHoH np0,lJ,YKUHH;
- YCTpaHHTb TeXHH4eCKHe 6apbepbl B ToproBJle.
nOJIO)l(eHHe, Koma Bce OTCTaJIO, He TaK Y)I( nJIOXO, MO)l(eT 6blTb .D.a-
)l(e XopOWO. ECJlH Bce OTCTaJIO JIeT Ha 50 HJIH HaBcema, TO 3TO Bce HY)I(-
HO y6paTb H nOCTpOHTb HOBoe. fJIaBHOe, '1T06bl OHO 6blJIO .D.eHCTBHTeJlb-
HO HOBbIM, a He cypporaTOM H3 MOpaJIbHO YCTapeBWHX peweHHH H 060-
PYlIOBaHHI, HOBOro TOJIbKO Ha BHll. 11 CTpaHa CH\HeT nepelIoBoH B C4H-
TaHHbie ro.D.bI. He06xo.D.HMOe YCJlOBHe 3TOMY - npaBHJIbHml HopMaTHB-
HaSi 6a3a.

OCH06HOU 3aKoH npou.J60dcm6a .leKapcm6eHHblX cpedcm6
19
1.2 EopL6a 3a KalfeCTBO: 4JaKTbI HCropHH
Eopb6a 3a Ka4eCTBO H CTpeMJIeHHe OT.D.eJIbHbIX JIHU nOJIY4aTb CBepx-
npH6blJIb 3a C4eT <!:>aJIbcH<!:>HKaUHH np0,lI,YKUHH - BC4HaSl np06JIeMa, KaK
caMa 6H6JleHCKaSl np06JleMa 60pb6bl 1I06pa H 3Jla.
JI.pe6Huii MUP
Eopb6a 3a Ka'leCTBO npO.D.YKTOB .D.J1S1 'leJlOBeKa Ha4aJIaCb ellle H3 3ape
UHBHJIH3aUHH, ee HCTOpHSI YXO.D.HT Bmy6b BeKOB. 3aKoHbi .D.peBHHX HY.D.e-
eB H erHnTSIH pemaMeHTHpOBaJIH nOpSI.D.OK 06pallleHHSI C MSICOM. Y rpe-
KOB H pHMJISIH 6blJIO 3anpellleHo pa36aBJlSlTb BHHO BOlIOH H 06BewHBaTb
nOKynaTeJIeH npH npo.D.a)l(e 3CpHa H MaCl1a.
CpeiJllue 6eKa
B XII1 BeKe KOpOJIb AHmHH 110aHH H3.D.aJl BeJIHKyIO XapTHfO BOl1b-
HocTeH (Magna Charta), B KOTOpOH, B 4HCJIe np04ero, 6blJlH YCTaHOBJle-
Hbl Tpe60BaHHSI K MepaM H BecaM. 3TO nOJIO)l(H110 Ha4aJIO e.D.HHCTBY H3-
MepeHHH, He06xo.D.HMOMY B pa3HblX 06JIaCTSIX ,lJ,eSlTeJlbHOCTH, B TOM 4HC-
JIe .D.J1S1 H3roTOBJleHHSI JIeKapCTBeHHblX Cpe.D.CTB.
B cpelIHHe BeKa anTeKapH o6De.D.HHSlJIHCb B rMJIb.D.HH - c06CTBeHHble
npo<!:>eCCHOHaJIbHble opraHH3aUHH. O.D.HOH H3 3a.D.a4 rHl1b.D.HH 6blJIO npo-
THBOCTOSlTb <!:>aJIbCH<!:>HKaUHH JleKapCTB H OTMe))(eBaTbCSI OT Hee.
rHJIb.D.HH HMeJIH CBOH npaBHJla, H CJle.D.OBaHHe HM 06ecne4HBaJIO .D.J1S1
TOro HH,lJ,HBH.D.YaJIbHO-KYCTapHoro xapaKTepa npHroTOBJleHHSI JIeKap-
CTBeHHblX cpelICTB H TOH HOMeHKJlarypbl npHeMJIeMblH ypOBeHb Ka4e-
CTBa.
nepBble Tpe60BaHHSI K Ka4eCTBY cy6cTaHuHH nOSlBHJlHCb B AHrJIHH B
1316 r. B .D.OKYMeHTe O.D.HOM H3 rHJlblIHH «Ordinances of the Guild of
Peppers of Soper Lane», KOTopblH YCTaHOBHJI nOpSl.D.OK 06pallleHHSI C HM-
nOPTHpyeMblMH paCTHTeJIbHblMH MaTepHaJIaMH, HCnOJIb3yeMblMH ,lI,JlSl
npHroTOBJleHHSI JleKapCTBeHHblX Cpe,lI,CTB.
B nOCJIe.D.CTBHH B AHrJIHH nOSlBHJlHCb .D.PYrHe .D.OKYMe, HTbl pema-
MeHTHPYlOlllHe Tpe60BaHHSI K Ka4eCTBY HCXO.D.HbIX MaTepHaJlOB H roTOBblX
JleKapCTBeHHblx Cpe.D.CTB 1531.
H060e 6peMH
nepBaSi <!:>apMaKoneSi 6blJIa H3lI.aHa B 1618 r B AHmHH H Ha3bIBaJIaCb
<JloHlIoHcKaSi <1>apMaKoneSl» (London Pharmacopoeia). 3aTeM BblWJla 3.D.HH-
6yprcKaSi <!:>apMaKoneSl (1699 r.) H D,y6JlHHCKaSi <!:>apMaKoneSi (1807 r.). B
1864 r. nOSlBHJlaCb opHTaHcKaSl <!:>apMaKoneSi .D.J1S1 BceH CTpaHbl. B CiliA
nepBoe H31IaHHe <!:>apMaKoneH BblWJIO B 1820 r. (maBa 21 KHHrH).
B POCCHH B XVII - Ha'laJIe XVIII BeKa no Mepe pa3BHTHSI anTeKap-
CKHX oroPOlIOB nOSlBHllHCb Tpe60BaHH1 K pa60Te 6011bHH'IHbIX anTeK,
npHroTOBJleHl11O H OTnYCKY JlCKapCTBeHHblX cpelICTB.

-
20
rfla6a 1
I1CTOpHSI anTeKapcKoro lIeJIa B AMepHKe CBH.D.eTeJlbCTByeT 0 pacnpo-
cTpaHeHHH <!:>aJIbcH<!:>HKaUHH JleKapCTBeHHblX cpelICTB. nOCJIe OTKpblTHSI
::nOH 4aCTH CBeTa TY.D.a YCTpeMHJlHCb MHOrHe CMeJIble H npelInpHHM4HBble
JIIO.D.H. He Bce H3 HHX YBa)I(aJIH 3aKOH H HOpMbl MOpaJIH. Ellle B 1630 r. B
KOJIOHHH Macca4yceTc HeKHH TOproBeu 6blJI npHroBopeH K wTpa<!:>y H
HaKa3aHHIO nJIeTbMH 3a npOlIa)l(Y npoCToH BO.D.bl B Ka4eCTBe JleKapCTBa OT
UHHrH.
TaKHx npHMepOB MHOro, 0 HHX roBOpSiT CBHlIeTeJIbCTBa H3 HCTOpHH
pa3HblX CTpaH.
I1cTopHSI npOWJlblX CTOJIeTHH CBH.D.eTeJlbCTByeT 0 nOnblTKaX 60pb6bl
061lleCTBa C 3THM 3JlOM. <1>aJIbcH<!:>HKaTopoB HaKa3blBaJIH, HO C06JIa3H
JIerKoro 3apa60TKa Ha 6e.D.ax JlIO.D.eH BcerlIa npHBJleKaJI H npHBJleKaeT )l(Y-
JIHKOB pa3Horo KaJIH6pa. D.eJIo YCyry6JISlJIOCb TeM, 4TO Bpe.D., nOCJIe.D.CTBHSI
OT nO.D..D.eJIOK HJlH npOCTO onaCHblX npenapaTOB .D.aJIeKO He Bcer.aa npo-
CJIe)l(HBaJIHCb, oc06eHHO B npOlliJIble CTOJleTHSI. 061lleCTBO He cpa3Y
HaY4HJlOCb 60pOTbCSI C 3THM, TeM 60Jlee, 4TO <!:>aJIbCH<!:>HKaTopbl XOpOlllO
OnJIa4HBaJIH peKJIaMY H YMeJIH HaXO.D.HTb KJlI04H K BJlaCTH.
ClllA - HallaJlO oplaHU306alllloii 60Pb6bl 3a 6e30naCHbie npoiJYKmbl
bYPHoe pa3BHTHe npe.D.npHHHMaTeJIbCTBa B CiliA B XIX BeKe co-
npOBO)I(.D.aJIOCb MOIllHblM BCnJIeCKOM <!:>aJIbcH<!:>HKaUHH B c<!:>epe npOH3-
BO.D.CTBa npO.D.yt<TOB nHTaHHSI H JIeKapCTBeHHblX Cpe.D.CTB. 3TO SlBJleHHe
6blCTpO npH06peJlo MaccoBblH H opraHH30BaHHblH xapaKTep.
OTBeTHoH peaKuHeH 061lleCTBa CTaJI nOCTeneHHblH nepeXO.D. OT pa30-
BblX CTbl4eK K CHCTeMaTH4eCKOH 60pb6e C nO.D..D.eJIKaMH. B 3TOM .D.eJle no-
HBHJIHCb CBOH JIH.D.epbl H 3HTY3HaCTbl.
Eoiiu.bl npomU6 HiJa
B AMepHKe <!:>HrYPoH HOMep O.D.HH B 60pb6e 3a Ka4eCTBO npO.D.YKTOB
nHTaHHSI H JIeKapCTBeHHblx Cpe.D.CTB CTaJI .D.OKTOp YaHJIH (Harwey W.
Wiley), nOCBSlTHBWHH eH )l(H3Hb. B 1883 r. OH OCTaBHJI YHHBepCHTeT-
CKYIO Ka<!:>e.D.PY H CTaJI PYKOBOlIHTb XHMH4eCKHM 61Opo D.enapTaMeHTa
CeJIbCKoro X03S1HCTBa CiliA.
B TO BpeMSI KOHTpOJIb npO.D.YKUHH 6blJI npHMHTHBeH HJlH OTCyrCTBO-
BaJI BOBce. TOKCH4HOCTb XHMH4eCKHX KOHcepBaHTOB H KpaCHTeJIeH He
KOHTpOJlHpOBaJIaCb HHKeM. PblHOK 6blJl HaBO.D.HeH «naTeHTOBaHHbIMH Jle-
KapCTBaMH OT Bcex 60Jle3HeH», «3JIHKCHpaMH >KH3HH», «6aJIb3aMaMH MO-
JIO.D.OCTH» KaKoro-JIH60 HHlIeHcKoro nJleMeHH, cpelICTBaMH 06HOBJleHHSI
BHYTpeHHHX opraHOB, H36aBJleHHSI OT .D.Ha6eTa, Cep.D.e4HOH He.D.OCTaT04-
HOCTH H np.
3alllHTa HHTepeCOB H 6e30naCHOCTH nOTpe6HTeJlSl 6blJla .D.eJIOM caMO-
ro nOTpe6HTeJISI.
D.OKTOp YaHJlH B Te4eHHe MHOrHX JleT ynopHo paCCJle.D.OBaJI CJlY4aH
<!:>aJIbCHQJHKaUHH, npHlIaBaSi HM WHPOKYIO omaCKY. OH HaWe]] OTKJlHK B
3MOUHOHaJIbHOH H Bne'IaTJIHTeJIbHOH cpelle - Y npelICTaBHTeJlbHHU «cJla60-

OCH06HOU 3aKOH npOU360dcm6a fleKapcm6eHHbiX cpedcm6
21
ro» nOJla. Ero nonYJISlpHble BblcTynJleHHSI B )l(eHCKHX KJly6ax npHBJleKJIH
BHHMaHHe nHCaTeJleH H )l(ypHaJIHCTOB H Bbl3BaJ1H 061lleCTBeHHblH pe30HaHC.
AMepHKa pe3KO H BHSlTHO OTpearHpOBaJIa Ha 6YM <!:>aJIbCH<!:>HKaUHH.
B 1903 r. 1I0KTOp YaHJlH opraHH30BaJI «rpynny 60HUOB npOTHB SllIa». B
ee COCTaB BOWJIH .D.06pOBOJlbUbl - MOJIOlIble JIIO.D.H, Ha ce6e HCnblTbIBaB-
WHe .D.eHCTBHe XHMH4eCKHX KOHcepBaHTOB. OHH lIaJIH COrJIaCHe nHTaTbCSI
TOJIbKO npOlIYKTaMH, COlIep)l(alllHMH XHMHKaTbl, 4T06bl .D.eMOHCTpHpOBaTb
HX BJlHSlHHe Ha CBoe 31I0pOBbe.
Pe3YJlbTaTbl WHpOKO OCBelllaJIHCb B ne4aTH. 3T0 6blCTpO npHBJleKJIO
BHHMaHHe 061lleCTBeHHOCTH H BJlaCTeH.
3aKOH ClllA 1906l. U omKam Ha3aiJ
AMepHKa - 3TO He TOJIbKO CTpaHa peWHTeJlbHblX .D.OKTOpOB H 60H-
UOB npoTHB SI.D.a. 3TO cTpaHa, B KOTOpOH 4HHOBHH4eCTBO nOHHMaeT, 4TO
OHO HaXO.D.HTCSI Ha cO.D.ep)l(aHHH 061lleCTBa .D.JlSl TOro, 4T06bl BbInOJlHSlTb
B03JlO)l(eHHble Ha Hero <!:>YHKUHH, B 4aCTHOCTH, no oxpaHe 3.D.OpOBbSi
rpa)I(.D.aH. B npOTHBHOM CJIyYae nJIaTHTb eMY .D.eHbrH He3a4eM.
11 npaBHTeJlbCTBO CiliA 6blCTpO OTpearHpOBaJIO Ha KPHTHKY. Y)I(e B
1906 r. 6blJIa opraHH30BaHa JIa60paTopHSI, Ha 6a3e KOTOpOH BTIOCJIe.D.-
CTBHH 6blJIa C03.D.aHa FDA - Food and Drug Administration (YnpaBJleHHe
no KOHTpOJIIO npO.D.YKTOB nHTaHHSI H JIeKapCTBeHHblX Cpe.D.CTB).
He.D.aBHO 3Ta CHJIbHaSi H aBTopHTeTHaSi rocY.D.apCTBeHHaSl CTpYKTypa,
HaC4HTblBalOIllaSi 60JIee 10 TbIC. COTPY.D.HHKOB, OTMeTHJIa CBOH CTOJIeTHHH
106HJIeH.
B 1906 r. B CiliA 6blJI npHHSlT 3aKoH 0 npO.D.YKTax nHTaHHSI H JIe-
KapCTBeHHblX cpelICTBax (The Pure Food and Drugs Act). OH nOJIO)l(HJI
Ha4aJIO rOCY.D.apCTBeHHOMY KOHTpOJIIO B 3TOH c<!:>epe. EblJIH 3aJIO)l(eHbl
OCHOBbl aHaJIH3a Ka4eCTBa, oTpa60TaHbl IOpH.D.H4eCKHe npOue.D.ypbl,
HaKOnJIeH onblT.
O.D.HaKO, B03MO)l(HOCTH 3TOro 3aKOHa 6blJlH orpaHH4eHbi. cDaJIbCH-
<!:>HKaTopbl npHHSlJIH Bce Mepbl, 4T06bl HeHTpaJIH30BaTb HJIH OCJla6HTb
3aKOH. EblJIa npHHSlTa nonpaBKa K 3aKOHY, KOTopaSi CBeJla ero .D.eHCTBHe
n04TH K HYJlIO. D.nSl npHBJle4eHHSI <!:>aJIbCH<!:>HKaTopa K OTBeTCTBeHHOCTH
Tpe60BaJIOCb .D.OKa3aTb B cY.D.e, 4TO OH HaMepeHHO 06MaHbIBaJI nOTpe6H-
TeJleH. 3TO Y.D.aBaJIOCb .D.aJIeKO He Bcer.aa.
npOH30WeJl OTKaT Ha3a.D., .D.J1HBlllHHCSI npHMepHO 30 JIeT.
cDaJIbcH<!:>HKaTOpbl pa3Horo KaJIH6pa npOUBeTaJIH, rocnO.D.CTBOBaJIH
Ha pblHKe, HX nO.D..D.ep)l(HBaJIH .D.eJlbUbl OT peKJIaMbl. Ha3peBaJI KOH<!:>JlHKT
Me)I(.D.Y HHMH H 4eCTHblMH npe.D.npHHHMaTeJISlMH, ce6eCTOHMOCTb npo-
.D.YKUHH KOTOpblX 6blJIa Bblwe no OnpelIeJleHHIO. YecTHoMY 6H3Hecy 6blJlO
TPY.D.HO BblCTOSlTb 3KOHOMH4eCKH B KOHKypeHTHoH 60pb6e npOTHB <!:>aJIb-
cH<!:>HKaTOpoB.

22
Ffla6a 1
Kpymoii n060pom
B3pbIB npOH30WeJI B 1937 r., Koma HeKaSi <!:>HpMa BbInYCTHJla Ha
pblHOK «3JIHKCHp cYJIb<!JaHHJIaMH.D.». ComaCHO peKJIaMe OH npe.D.Ha3Ha-
4aJICSI .D.J1S1 lIeTeH H 3aMeHSlJI Ta6JIeTKH npOTHB CTpenTOKOKKOBOH HH<!:>eK-
UHH, KOTopble OHH npHHHMaTb He XOTeJIH. Ll..rISi nOJIY4eHHSI )l(H.D.KOH
<!:>OpMbl aKTHBHblH HHrpe.D.MeHT paCTBOpHJIH B .D.H3THJleHrJIHKOJIe H roTO-
BblM npO.D.YKT He npOBepHJIH Ha TOKCH4HOCTb.
HHKOMY He npHlllJIO B roJlOBY, LJTO ,LJ,H3THJleHmHKOJIb BXOlIHT B Ka-
LJeCTBe OCHOBHOro KOMnOHeHTa B COCTaB aHTH<!:>pH3a H He MO)l(eT npH-
HMMaTbCSI BHyrpb. YnoTpe6JIeHHe 3JIMKCMpa-aHTH<!:>pH3a npHBeJIO K
CMepTH 107 4eJIOBeK.
3Ta Tpare.D.MSI Bbl3BaJIa 6YPHYIO peaKUHIO 061lleCTBa H npHHY.D.HJla
BJlaCTb npHHSlTb B 1938 r. cDe.D.epaJIbHblH aKT CiliA B 06JIaCTH npO.D.YKTOB
nHTaHHSI, JIeKapCTBeHHblX H KOCMeTH4eCKHX Cpe.D.CTB - US Federal Food,
Drug and Cosmetic Act, ,LJ,eHcTBYIOIllHH H B HaCTOSllllee BpeMSI.
AKT, B 4MCJIe npOLJero:
- BBeJI Tpe60BaHHe iJoKa3bl6amb 6e30nacHocmb HOBblX JIeKapCTBeH-
HbIX Cpe.D.CTB.D.O HX BbIXO.D.a Ha pbIHOK;
- onpe.D.eJIHJl, 4TO CllM tjJaKm nOR6JleHUH <!:>aJIbCH<!:>HUHpoBaHHoro
npO.D.yKTa y)l(e 03Ha4aeT 6UHY npou360iJumeJlH; OTnMa He06xo.D.HMOCTb
c06MpaTb .D.OKa3aTeJIbCTBa npe.D.HaMepeHHOCTH BBe.D.eHHSI nOTpe6HTeJISI B
3a6Jly)I(.D.eHHe 0 JIe4e6HOM .D.eMCTBHM npenapaTa, T.e. 06MaHa;
- YCTaHOBHJl Tpe60BaHHSI YKa3bIBaTb Ha 3THKeTKax nOpSI.D.OK 6e3-
onacHoro npHMeHeHHSI npenapaTa;
- BBeJI UHcneKmup06aHue npou36oiJcm6 H nOpSl.D.OK npHBJle4eHHSI K
cyiJe61l0ii om6emcm6eHHocmu.
- pacnpoCTpaHHJI Tpe60BaHHSI Ha KOCMemUlleCKue Cpe.D.CTBa.
B 50-e ro.D.bl K 3TOMY 3aKOHY 6blJIa npHHSlTa nonpaBKa, YCTaHaBJlH-
BalOIllaSi nOpSI.D.OK npOBe.D.eHHSI HHcneKUHH, npe.D.CTaBJleHHSI OT4eTOB HH-
cneKTopOB H pe3YJIbTaTOB aHaJIH30B, npOBO.D.HMbIX FDA. npOH3BO.D.HTeJIH
npO.D.YKTOB nHTaHHSI .D.OJI)I(Hbl 6bIJIH iJoKa3bl6amb 6e30nacHocmb Jl1060l0
6elU,ecm6a, BXO,LJ,SlIlJ,ero B COCTaB npO.D.YKTOB.
06H3aHHocmb iJoKa3bl6amb 6e30nacHocTb npO.D.YKUHH 6blJIa B03JlO-
)I(eHa Ha CllMUX npou36oiJumeJleii.
POJIb opraHOB rocY.D.apcTBeHHoro Ha.D.30pa B CiliA (FDA) H3MeHH-
JIaCb Pa.D.HKaJIbHO. BMecTo paCCJle.D.OBaHHH C0061lleHHH OT nOTepneBWHX,
KOTopble nOCTpa.D.aJIH OT Y:JICe nocmynu6Uleii Ha pblHOK npOlIYKUHH,
Ha.D.30pHble opraHbl CTaJIH BbInOJlHSlTb npeiJynpeiJumeJlbllYIO tjJYHKU.UIO.
BnOCJIe.D.CTBHH 3TH Tpe60BaHHSI 6blJIH pacnpOCTpaHeHbl Ha Me.D.H-
UHHCKHe H3.D.eJIHSI. B 1962 r. KOHrpecc CiliA npHHSlJl peweHHe 0 npo-
H3BO.D.CTBe JIeKapCTBeHHblX Cpe.D.CTB B COOTBeTCTBHH C npaBHJlaMH GMP H
,LJ,aJI COOTBeTCTBYlOlllee nopY4eHHe FDA.

OCH06HOU 3aKOH npOU3600Cm6a JleKapCm6eHHbiX cpedcm6
23
BeJlUK06pumaHUH - OC03HaHue onaCHocmu
061lleCTBeHHOCTb H npaBHTeJIbCTBO 06paTHJlH BHHMaHHe Ha npOH3-
BO.D.CTBO JleKapCTBeHHblX cpelICTB B Ha4aJIe 60-x ro.D.OB nOCJIe TparelIHH C
TaJIH.D.OMH.D.OM. 3TOT npenapaT npOnHCbIBaJICSI 6epeMeHHblM )l(eHIllHHaM
KaK Cpe.D.CTBO OT yrpeHHero He.D.OMOraHHSI H SlBHJICSI npH4HHOH TSI)I(eJIblX
Bp0)l(1leHHbIX ypO.D.CTB Y 10000 MJla.D.eHueB.
B 1963 r. B BeJIHK06pHTaHHH npelICTaBHTeJIb onn03HUHH, CTaBWHH
BnOCJIe.lJ,CTBHH MHHHCTpOM 3.D.paBOOXpaHeHHSI, 3aSlBHJl:
«flpa6UmeJlbCm60 U 06U(ecm60 6blJlU 6He3anHO pQ36YJlCeHbl meM rjJaK-
mOM, '1mo Jl/o60u npou360dUmeJlb MOJICem 6bmycmumb Ha pblHOK Jl/o60U npo-
dYKm, Henpa6UJlbHO np06epeHHbiu U onacHblu, 6e3 KOHmpOJlJ/ e203rjJrjJeKmu6-
Hocmu UJlU 6e30nacHocmu CO cmopOHbl He3a6UCUM020 op2aHa».
061lleCTBO C y)l(aCOM Y3HaJIO, 'ITO JII060H MO)KeT CTaTb «npOH3BO.D.H-
TeJIeM JIeKapCTBeHHoro Cpe.D.CTBa» H BbInYCKaTb ero me yro.D.HO H B JIIO-
6blX YCJlOBHSlX, He nOJIY4HB JIHueH3HIO Ha npOH3BO.D.CTBO.
nepBOH peaKUHeH 6blJIO C03.D.aHHe B 1963 r. .D.06POBOJIbHOH CHCTeMbl
oueHKH Bcex HOBblX cy6cTaHUHH H roTOBblX <!:>OpM Ha HX OCHOBe, KOTO-
PYID BbInOJIHSlJlH CneUHaJIbHble 3KcnepTbl, yrBep)I(.D.eHHble roCY.D.apCTBOM.
06S13aTeJIbHOe JIHUeH3HpOBaHHe npOH3BOlICTB 6blJI0 BBe.D.eHO He-
CKOJIbKO n03)Ke, B 1968 r., H pacnpOCTpaHeHO Ha Bce JIeKapCTBeHHble
Cpe.D.CTBa, BKJlI04aSl .D.aBHO nOCTaBJIeHHble Ha npOH3BO.D.CTBO. DblJIO BBe-
.D.eHO Tpe60BaHHe HHcneKTHpOBaHHSI npOH3BO.D.CTBeHHbIX nOMellleHHH.
C TOH nopbl B BeJlHK06pHTaHHH CYIlleCTBYfOT .D.Ba BH.D.a JIHueH3HH:
- JIHueH3HH Ha npOH3BO.D.CTBO - Manufacturers Licences (B TepMH-
HOJIOrHH EBpocolO3a - «Manufacturing Authorisations»);
- JIHueH3HH Ha peaJIH3aUHIO - Product Licences (B TepMHHOJIOrHH
EBpocolO3a - «Marketing Authorisations»).
1.3 CTaHOBJIeHHe npaBHJI G MP
flepe.llOM B OTHoweHHH K npOH3BO.D.CTBY H KOHTpOJIIO Ka4eCTBa JIe-
KapcTBeHHblx cpelICTB HacTynHJI B KOHue 50-x - Ha4aJIe 60-x ro.D.OB.
ECJIH .D.O 3TOro BpeMeHH OCTpHe 60pb6bl 3a Ka4eCTBO 6blJlO HanpaBJle-
HO npOTHB <!:>aJIbcH<!:>HKauHH, H BHHMaHHe 06palllaJIH Ha KOHTpOJlb Ka4e-
CTBa lom060U npoiJYKu.uu, TO 3aTeM CTaJIH .D.eJlaTb ynop Ha npoU360iJcm60.
Tpe60BaHHSI K npOH3BOlICTBY 6blJIH Ha3BaHbl npaBHJlaMH GMP, KO-
Topble lIaJIH KpHTepHH KOHTpOJlSl .D.J1S1 Ha1I30pHblX opraHOB. a npOH3BOlIH-
TeJlSlM - YKa3aHHSI, KaK HY)l(HO BeCTH npOH3BO.D.CTBO.
'Imo 6 iJpYlUX ompacJlHX?
111IeSl G M P He HOBa. BnepBble, HO nOlI Ha3BaHHSlMH «cucmeMa
06ecnelleHuH Ka.,ecm6a npoiJYKu.uu» H lIP., OHa nOSlBHJlaCb B 060POHHblX
OTpaCJISIX (B aBHaUHH, paKeTOCTpoeHHH, KocMH4ecKoH H 3JIeKTpOHHOM

24
F.na6a 1
npOMbIWJleHHOCTH), npWleM B CCCP 3Ta CHCTeMa nOSlBHJlaCb He n03)1(e,
4eM Ha 3analle. AKueHT Ha 06ecne4eHHe Ha.D.e)l(HOCTH H HeO)l(HlIaHHbie
TaJIaHTJIHBble TeXHH4eCKHe peweHHSI B paKeTOCTpoeHHH H KOCMH4eCK0l1
npOMbIWJleHHOCTH, B 4HCJIe .D.PYrHX Mep, 3aJIO)l(HJIH OCHOBY J1H.D.epCTBa
CCC P B Te rollbl.
B 50-e - 60-e rolIbl CHCTeMbl 06ecne4eHHSI Ka4eCTBa 6blJIH BHe.D.pe-
Hbl B CiliA H .D.PYrHX 3analIHblX CTpaHax. MOIllHblM TOJl4KOM nOCJlY)I(HJIa
peaJIH3aUHSI KOCMH4eCKOH nporpaMMbl «AnoJlJloH».
K TOMY BpeMeHH Ha 3ana.D.e 6blJlH 3aJIO)l(eHbl OCH06bl meXHOJlOlUU IIU-
cmombl. YHcTble nOMellleHHSI Ha4aJIH B MaCCOBOM nopSilIKe npHMeHSlTbcSI B
KOCMHLJeCKOH, 3JleKTpOHHOH H lIPymx HHTeHCHBHO pa3BHBaBWHXCSI OTpac-
JISiX npOMbllllJleHHOCTH. 3T0 pe3KO YMeHbWaJIO HJlH HCKJlI04aJIO nOna.D.aHHe
3arpSl3HeHHH Ha 060PY.D.OBaHHe H B np0.D.YKUHIO npH H3roTOBJleHHH H yna-
KOBKe, 4TO rapaHTHpOBaJIO OTcYTCTBHe .D.e<!:>eKTOB H3-3a 3arpSl3HeHHH.
HeJlb3Jl 6bl:6pamb xopOUlee U3iJeAue U3 11JlOXOU cepuu. HY:JICHO maK no-
cmpoumb mexHOJlOlUIO U OplilHU3aqUIO npoU36oiJcm6a, npUMellJUllb Cbtpbe U
MamepU/Ltlbl maKOlO Ka.,eCm6a, lIm06bl iJetjJeKmbl npoiJyKIl,uu 6blJlU UClCJlIOlleHbl.
B 3TOM npHHUHnHaJIbHOe OTJlH4He HOBOro nO.D.XO.D.a OT CTapblX cxeM.
HeB03MO)l(HO 06ecne4HTb Ka4eCTBO 3a C4eT KOHTpOJlSl roTOBOH npO.D.YK-
IJ,HH, HY)I(HO 3aJIO)l(HTb rapaHTHIO Ka4eCTBa B caMO npOH3BO.D.CTBO.
I1MeHHo B 3TOM H 3aKJIlO4aeTCSI CYTb H.D.eOJIOrHH GMP.
lIpolpecc 6 meXHOJlOlUU U omCmaJlOCmb npOU3600cm6
nepBble npaBHJIa GMP nOSlBHJlHCb B 60-e ro.D.bl.
3TO 6blJIO npO.D.HKTOBaHO )l(H3HblO. .lJ.0 XX-ro BeKa JleKapCTBeHHble
Cpe,lJ,CTBa H3rOTaBJlHBaJIHCb, KaK npaBHJIO, B anTeKax HJlH Ha MaJIblX
npe.D.npHSlTHSIX no npOCTOH TeXHOJIOrHH He60JlbWHMH cepHSlMH HJlH B
Ka4eCTBe e.QHHH4HbIX 06pa3UOB, npe.D.Ha3Ha4eHHblX .D.JlSl KOHKpeTHoro
60JIbHOro. OWH6Ka B npOH3BO.D.CTBe Moma nOBpe.D.HTb TOJlbKO 3TOMY 4e-
JIOBeKY. CblpbeM CJlY)I(HJlH MaTepHaJIbl paCTHTeJIbHoro, )l(HBOTHOro HJlH
MHHepaJIbHoro npOHCXO)I(.D.eHHSI.
K Cepe.D.HHe XX-ro BeKa CHTYaUHSI H3MeHHJIaCb. npOH3BO.D.CTBO Jle-
KapCTBCHHblX Cpe.D.CTB 6blJIO nOCTaBJJeHO Ha npOMblWJIeHHYIO OCHOBY.
iliHpOKoe npHMeHeHHe nOJlY4HJlH MeTO.D.bl mOIlKOlO XUMUlleCKOlO CUHme3a,
TeXHOJIOrH4eCKHe npoueCCbl YCJlO)l(HHJlHCb, caMO npOH3BO.D.CTBO npH06pe-
JIO KpynllocepuUHblU xapaKmep. OWH6Ka npH npOH3BOlICTBe cepHH Moma
HaHeCTH Bpe.D. MHO)l(eCTBY JlIO.D.eH. nOSlBHJlHCb npHHUHnHaJIbHO HOBbIe BH-
.D.bl BbICOK03<!:><!:>eKTHBHbIX JIeKapCTBeHHblX cpelICTB: aHTH6HOTHKH H lIpyrHe
npenapaTbl, COBepWHBWHe nOHCTHHe mepane6mUlleCKYlO pe60JlIOu.ulO B
3.D.paBOOXpaHeHHH.
Ho npaBHJla opraHH3aUHH npOH3BOlICTBa OTCyrCTBOBaJIH. 3TO npH-
BeJIO K TOMY, 4TO JleKapCTBeHHble cpelICTBa 3a4aCTYlO npOH3BOlIHllHCb B
a6COJllOTHO HenpHeMJleMblX YCJlOBHSlX. 1131IaTeJlb npaHI111 G MP BeJIHKO-
6pHnlHHH )])KOH iliapn (John ShQ/p) H OlIHH HJ nepBblX HHcneKTOpOI3
GMP, npHBOlIHT lIBa npHMepa H3 C130eH npaKTHKH [13].

OCH06HOU 3aKOH npou360dcmea J1eKapcmeeHHbiX cpedcm6
25
npHMep I
J.1HcneKTI1PYSI 01lHO 113 npellnpl1S1TI1M, OH 06paTHJI BHI1MaHl1e Ha xa-
paKTepHYIO nOJlocy Ha CTeHe np0I13B01lCTBeHHoro 31laHI1S1 Ha HeKOTopOM
paCCTOSlHl111 OT ypoBHSI 3eMJII1. OKa3aJlOCb, 1.JTO 3£1 npe1leJlaMI1 npe1lnpl1S1TI1S1
6blJl oroP01l, BbIX01lI1BWI1H K peKe. Bo BpeMSI naBOllKa ypoBeHb B01lbl B peKe
nOBbIWaJlCSI, BOlla 3aJll1BaJla orop01l 11 nepBblH 3Ta>K, OCTaBJlSISI OTMeTKY Ha
CTeHax. B pe3YJIbTaTe 31laHl1e 6blJll1 nOpa>KeHO nJleCeHblO. K KaKOH 3arpSl3-
HeHHOCTI1 B031lyxa 11 06oPY1l0BaHI1S1 3TO npI1BOlll1J10, He 3HaJl HHKTO, no-
CKOJlbKY He 6blJlO HI1 HOpM, HI1 MeT01l0B KOHTpOllSl.
npHMep 2
nOJlbl OllHOro H3 np0l13BOllCTB TBepllblX 4>oPM 6blJII1 nOKpblTbl TOJl-
CTblM CJlOeM nbllll1. nblJlb 6blJla Ha CTeHax 11 060PYlloBaHI1I1. Ha 3TO 6b1J1o
06pallleHo BHI1MaHl1e RJla1leJlbua npellnpmlTI1S1. TOT 01.JeHb paCCTpOI1JICSI H
noo6elllaJl HaBeCTI1 nopSllloK. K CJIe1lYlOllleMY npl1e31lY I1HcneKTopa Be31le
6blJII1 YJlO>KeHbl KOBpbI.
3TO MO)l(eT BocnpHHHMaTbCSI KaK 4epHblH IOMOp, HO 3TO He IOMOp,
3TO npaB.D.a. ABTOp HMeeT 4eCTb 6blTb JIH4HO 3HaKOM C ll)l(OHOM iliap-
nOM, He3aypSl.D.HblM 'leJIOBeKOM, <!:>aMHJIHSI KOTOpOro COOTBeTcTByeT ero
xapaKTepy «<sharp» 03Ha4aeT «OCTpbIH»).
HHKaKOH HaYKH H HHKaKHX BblCOKHX MaTepHH B OCHOBe npaBHJl
GMP He 6blJI0 H HeT. DblJIO O.D.HO - )l(eJIaHHe HaBeCTH 3JleMeHTapHblH no-
pSI.D.OK, 3aKpenHB ero HopMaTHBHblM 1I0KYMeHToM. CY.D.SI no BbICKa3blBaHH-
SlM LbKOHa UJapna, COCTOSlHHe MHorHX npe.D.npHSlTHH-H3rOTOBHTeJleH Jle-
KapcTBeHHblx Cpe.D.CTB B EBpone 6blJlO Y)l(aCHbIM. He JIyYwe 06CTOSlJIO lIe-
JIO H B CiliA, HeCMOTpSl Ha rp03HYlO penyraUHIO FDA.
TaKYIO opraHH3aUHIO .D.eJIa MO)l(HO 6blJIO 06pa3Ho Ha3BaTb BMP -
Bad Manufacturing Practice. B npoTHBoBec eH 6blJIH nO.D.rOTOBJleHbl npa-
BHJIa GMP - Good Manufacturing Practice. 3T0 06pa3Hoe Ha3BaHHe, 3£1
KOTOpblM HeT HHKaKoro <!:>HJIOCO<!:>CKOro KaMHSI. npOCTO C03.D.aTeJlH npa-
BHJI GMP peWHJlH npHBJle4b BHHMaHHe K np06JIeMe 11 HamSl.D.HO npOBe-
CTH 4epTY Me)l(1ly nJlOXHM H XOpOWHM.
B 50-60-e ro.D.bl pe3KO npOSlBHJlOCb npomu60pellue 6 pa36umuu npo-
u3600cm6, npOTHBope4He Me)l(1ly H06blM coiJep:JICallUeM npOH3BOlICTBa H
omcmaJlOU ljJOpMOU - ero opraHH3aUHeH H TexHoJlorHeH.
3TO npoTHBope4He 6blJIO pa3peweHo BBe.D.eHHeM npaBHJI GMP.
XpOHOJlOrHSI 60pb6bl 3a Ka4eCTBO JIeKapCTBCHHblX cpelIcTB Ha 3ana.D.e
nOKa3aHa Ha pHC. 1.1, 1.2 H B Ta6JIHUe 1.1.
AMepUKa
nepBblH .D.OKYMeHT, B KOTOpOM YCTaHaBJlHBaJIHCb Tpe60BaHHSI K
npOH3BO.D.CTBY JIeKapCTBeHHblX cpelICTB, nOSlBHJICSI B KaHcllle B 1957 r. OH
Ha3blBaJICSI «Manufacwre, Control and Distribution of DrtI[{s» - «npOH3-
BOlICTBO, KOHTpOJlb H peaJIH3aUHSI JleKapCTBeHHblX cpelIcTB». TaM He 6bl-
JIO cOKpawcHHoro 060JHa'leHH1 GMP. HO no COlIep)l(aHHIO JTO 6blJII1
nepBblc 04eHb KpaTKI1C npaBHJla B 1lYxc GMP.

26
IJw6a I
B 1962 r. BnepBble nOSlBHJ10Cb nepBoe YKa3aHHe Ha npaBHJ1a GMP B
.D.OnOJlHeHHH K <DelIepaJIbHoMY aKTY CiliA B 06JIaCTH JIeKapCTBeHHblX H
KOCMeTH4eCKHX cpelICTB 1938 r. 3TO 6blJIO 04eHb KpaTKoe H 061llee PY-
KOBO.D.CTBO, 3aHHMaBwee He 60Jlee lIBYX CTpaHHU TeKCTa. B CiliA 6blJIO
npHHSlTO HaHMeHOBaHHe «The Current Good Manufacturing Practice» HJlH
npocTo cGMP - «TeKYIllHe npaBHJIa GMP». OHO cOXpaHHJIOCb .D.O
HacToSllllero BpeMeHH.
npaBHJla cGMP YCTaHOBJleHbl KOlIeKcoM <!:>elIepaJIbHblX npaBHJl
CiliA - Code of Federal Regulations, Vol. 21, Ch. I, Part 2/0, Current good
manufacturing practice in manufacturing, processing, packaging or holding of
drugs, general u CFR Vol. 21 Ch 1, Part 211 Current good manufacturing
practice for finished pharmaceuticals.
COBpeMeHHblH TeKCT npaBHJI GMP CiliA 6blJI yrBep)I(.D.eH B 1976 r,
nOCJle.D.HHe H3MeHeHHSI BHeceHbl B 2009 r.
Ta6/luu,a 1.1
XpOHOJlOrHSi 60pb6bl 3a Ka4eCTBO JIeKapCTBeHHblX Cpe.D.CTB
no Ha1.JaJla 1906 - 1940 1940 - 1960 1960 - 1980 C 1980 r. C 2000 r.
xx BeKa r.r. r.r. r.r.
KYCTapHblH POCT npo- CTaHORJIe- TeXHH1.Je- Pa3BHTI1e MI1- nOHI1Ma-
xapaKTep lla>K JleKap- Hl1e Kpyn- CKHH npo- pOBOro pblHKa Hl1e Heo6-
npOI13B01l- CTBeHHblX HOCepI1HHO- rpecc, nOSlB- JIeKapCTBeH- X01lI1MOCTI1
CTBa. Cpe1lCTB. ro npoMblW- JIeHl1e '111- HblX Cpe1lCTB. pacnpo-
OTCYTCTBl1e MaCCOBblH JleHHoro CTblX TeXHO- CTpaHeHI1S1
np0113BOll- JlOrHH. TeXHl11.JeCKl1e Tpe60Ba-
CI1CTeMbl BbInYCK CTBa JIeKap- 6apbepbl - HI1H GMP
60pb6blC 4>aJlbCl14>H- CTBeHHbIX npOTl1BOpe- TOpM03 TOp- Ha cy6-
4>aJl bC 114> 11- Ul1poBaHHblX cpellCTB. 1.111 e M e>K1lY roBJlI1. CTaHUI1I1.
KaUl1ei1 npenapaTOB. HOBblM CO- E1lI1Hble npa-
CWA- KOHTpoJlb 1lep)l(aHHeM BI1J1a GMP PYKOB01l-
cepl1i-i 110 npOI13B01l- EC. CTBO ICH,
nepBblC op- BbInYCKa, a CTBa 11 YCTa- npl1J10>Ke-
raHI130BaH- He peampo- peBweH op- Kypc Ha rap- Hl1e 18, a
Hble Mepbl BaHl1e Ha raHI13aUl1ei-i. MOHI13aUI11O B 3aTeM pa3-
60pb6blC nOCJlellCTBI1S1 Ml1pOBOM 1lell II B
4>aJl bC 114> 11- HaUl1oHaJlb- MacwTa6e GMP EC
KaUl1eH Hble npaBI1-
Jla GMP B
pa3HbiX
CTpaHax.

OCH06HOii 3aKOH /lpou.J60dcm6a JleKapcm6eHHbiX cpedcm6
27
t:JpeBHUU MUP
CpeOHue BeKa
HOBoe BpeMfi
Espana: eunwuu anmsKapeu
CL=0
XIX \ XX 20002
6YM cpanbcu-
cpuxaljuu,
6opb6a C Hejj
----I-
Ezunem. 0
l1yoeR.
.peljUR
I
X
I
XVI
____ I
XVII/ I
/
I AMepuxa, CWA:
npo6neMbl C
K8L1eCmeOM
PHC. 1.1. EOpb6a 3a Ka4eCTBO JIeKapCTBeHHblX Cpe.aCTB .D.O XX BeKa
CiliA
I
1906
I
T epaneBmUl/eCKafi peBonlOUfI
c6 I - I
1937 1938 1950 1953 1960 20002
\  \ 
MaCC080e A1<m 0 npoiJ}'Kmax Tpe60saHuR nSpsble GMP
ompasnSHue numaHUR. x A<1JC CWA
3neKcupOM neKapcmeeHHblX
cynbCpaHun- U KOCMemU4eCKUX
BMU(J cpe(JcmeBx
E5YM cpanbCUcpUKaUU
I I
60Pb6a
xm f!J2!!_ 1900 _ 1903
Yajjnu .pynna
60jjljOS
npomU8 IfcJa
Yaiinu
I I
3aKOH 0
npooyxmax
numBHUR U
nc
PHC. 1.2. Eopb6a 3a Ka4eCTBO JIeKapCTBeHHblX cpelICTB B XX BeKe
BeJlUK06pumallUH
B 1970 r. B BeJIHK06pHTaHHH Ha4aJIa .D.eHCTBOBaTb I1HCneKUHSI no
GMP. Ha Ha4aJIbHOM 3Tane Bee COCTaB BXO.D.HJIH fJlaBHblH HHcneKTOp H
.D.Ba BelIYIllHX HHcneKTopa. OCHOBblBaSiCb Ha c06CTBeHHOM on bITe, 3TH
JIIO.aH C03.D.aJIH nepBble npaBHJla G M P BeJlHK06pHTaHHH 06"beMOM 23
CTp., KOTopble 6blJIH H3.D.aHbl B 1971 r. B 06JlO)l(Ke OpaH)I(eBoro UBeTa H
nOJIY4HJIH HaHMeHOBaHHe (Ora/lge Guide» - OpaH)I(eBOe PYKOBO.D.CTBO.
B 1975 r. 6blJI0 npHHSlTO peweHHe 0 nepeCMOTpe npaBHJl GMP. B
::nOH pa60Te Y4aCTBOBaJIH Bce 4JIeHbi HHcneKUHH GM P. PYKOBO.D.HTeJIeM
pa60Tbl 6blJl Ha3Ha4eH H3BeCTHblH CneUHaJIHCT LbKOPlI)K CaHKc (George
Sykes). nOcJle ero CMepTH 3TOT noCT 3aHSlJI LI.)I(OH iliapn, aBTOp KHHr H
MHorHX cTaTeH, MaTepHaJIbl KOTOpblX ny6JlHKOBaJIHCb B )l(ypHaJIe «TexHo-
JIOrHSI 4HCTOTbl», a TaK)l(e HCnOJlb30BaHbi B .D.aHHOH KHHre.
nOCJle .D.J1HTeJIbHbIX .D.HcKYCCHH C npOMblWJIeHHOCTblO B 1977 r. 6bl-
JIO yrBep)l(1leHO BTopoe H31IaHHe GMP 06"beMOM Y)I(e 52 CTp. no cpaBHe-
HHIO C nepBblM H31IaHHeM OHO I1MeJlO 60JIee JIOrH4HYIO CTPYKTYPY.
TpeTbe H31IaHHe npaBHJl GMP BCJlHK06pHTaHHH BblWJIO B 1983 r. H
no 06"beMY CHOBa 131IBoe npeBOCXOlIHJ10 npe.D.bllIYlllee H3LI.aHHe - 110 CTp.

28
rl/a6a I
E6poneUCKUU COlO3
K KOHUY 70-x rolIOB B pSilIe eBponeHCKHX CTpaH lIeHCTBOBaJIH npa-
BHJla GMP. nOSlBHJIHCb npaBHJla GMP B03 - BceMHpHoH opraHH3a-
UHH 311paBOOXpaHeHHSI. B 4eTbipex CTpaHax 6blJlH ony6JlHKOBaHbl c06-
CTBeHHble npaBHJla GMP - B BeJlHK06pHTaHHH, <1>paHuHH, I1TaJIHH H
naHHH. 113 HHX nOlIp06HblMH npaBHJlaMH 6blJIH TOJlbKO GMP BeJIHKO-
6pHTaHHH H <1>paHUHH.
CYllleCTBOBaHHe pa3JlH4HblX npaBHJl SlBJlSlJlOCb TeXHH4eCKHM 6apbe-
pOM B ToproBJle, laTpY.D.HSlBWHM pa60TY, npenSlTcTBoBaBwHM pa3BHTHIO
H Tpe60BaBlllHM HeOnpaB.D.aHHO BblCOKHX 3aTpaT Ha HHCneKTHpOBaHHe.
BbIXO.D.OM H3 nOJIO)l(eHHSI S1BHJlOCb npHHSlTHe pellleHHSI 0 nOlIroToBKe
e.D.HHbIX npaBHJl GMP EBponeHcKoro COlO3a (GMP EC). B 1989 r. Bbl-
lllJIH nepBble npaBHJla G M P EC. 3TOT .D.OKYMeHT BO MHOroM nOBTOpSlJl
npaBHJIa GMP BeJlHK06pHTaHHH 1983 r.
B EBpone H CiliA Ha4aJIH pa3pa6aTbIBaTbCSI HopMaTHBHble .D.OKY-
MeHTbl H peKOMeH.D.aUHH no pa3JlH4HblM aCneKTaM npaBHJI GMP, B TOM
4HCJIe npo<!:>eCCHOHaJIbHbIMH opraHH3aUHSlMH.
HallWlO 63aUMHblX ullcneKu.uu
B 70-e ro.D.bI y)l(e .D.eHCTBOBaJIH CHCTeMbl GMP B CTpaHax EBponbl 11
B CiliA. D.nSl .D.OnYCKa Ha eBponeHCKHH pblHOK JleKapCTBeHHblX Cpe.D.CTB,
npOH3Be.D.eHHbIX B AMepHKe, nOTpe60BaJIOCb HHcneKTHpOBaHHe npe.D.-
npHSlTHH B CiliA npe.D.CTaBHTeJISlMH EBponbl H Ha060poT.
Ha4aJIOCb BCTpe4Hoe HHcneKTHpOBaHHe. EBponeHcKHe HHcneKTopa
06HapY)I(HBaJIH HH3KHH ypOBeHb npOH3BO.D.CTB B CiliA, a HHcneKUHH
aMepHKaHueB B EBpone HanOMHHaJIH HaweCTBHSI rYHHOB.
HecMoTpSl Ha 3MOUHOHaJIbHblH OTTeHOK, 3TH BCTpe4Hble HHcneKUHH
C.D.eJIaJIH .D.06poe .D.eJlo: HHKTO H3 npOH3BO.D.HTeJleH He nO)l(eJlaJI 6blTb B
4epHOM cnHCKe. Bce 3aHSlJIHCb HaBe.D.eHHeM nOpSl.D.Ka H MO.D.epHH3aUHeH
npOH3BOlICTB. Ha4aJIOCb 4TO-TO BpOlle 3.D.OpOBOro copeBHOBaHHSI 3a Bbl-
COKHH ypOBCHb npOH3BO.D.Cma.
HeCJlY4aHHo MHorHe npelInpHSITHSI B EBpone 3Ha4HTeJlbHO npeBOC-
XO.D.SlT Tpe60BaHHSI GMP H S1BJlSlIOTCSI 06pa3uaMH KYJIbTYPbl H 3CTeTHKH
npOH3BOlICTBa.
C06emCKUU COlO3
Hallo npH3HaTb 1I0Jl)l(HOe nOJIHblH rocYlIapcTBeHHblH KOHTpOJlb H
rocY.D.apCTBeHHaSi c06cTBeHHocTb 06eCne4HBaJIH 3alllHTY OT nO.D..D.eJlOK.
CHcTeMa KOHTpOJlSl 6blJla HalIe)l(HoH.
Ho B YCJlOBHSlX 3aKpblTOCTH CTpaHbl H OTCyrCTBHSI Y npOH3BOlIHTe-
JleH CTHMYJlOB pa3BHBaTb 3KcnopT H caMOCTOSlTeJlbHO lIeHcTBoBaTb Ha
BHeWHeM pblHKe HHTcpeca K npaBHJlaM GMP, y)l(e npHHSlTblM Ha 3ana-
.D.e, He 6bIJlO.
CKa3blB<UlaCb 061lla51 OTCTaJIOCTb H HH3KHH YPUI3CHb 060PY.D.0I3aHH1.

OCH06HOU 3aKOH npou360dcm6a JleKapcm6eHHbiX cpeocme
29
B onpe.D.eJIeHHoH CTeneHH pa3BHBaJIaCb CHCTeMa HopMaTHBHblX .D.O-
KYMeHTOB no opraHH3aUHH npOH3BOlICTBa. OHa BO MHOroM KOnHpOBaJIa
3ana.aHble .D.OKYMeHTbl, HO .D.eJlaJIOCb 3TO C On03.D.aHHeM, C BHeceHHeM
c06CTBeHHblX nonpaBOK, nopoH HeonpaBlIaHHO YCJIO)l(HSIIOIllHX H YlIOPO-
)l(aIOIllHX npoH3BolICTBO.
1.4 E,lJ,HHble npaBMa HJlH HaU,HOH3JlbH3H cnel{H(I)HKa?
Ha nepBOM 3Tane npaBHJIa GMP pa3pa6aTbIBaJIHCb B Ka)l(1l0H
CTpaHe OT.D.eJlbHO. JlH.D.epaMH SlBJlSlJIHCb BeJIHK06pHTaHHSI H CiliA. iliH-
pOKoe pacnpOCTpaHeHHe nOJIY4HJIH npaBHJIa G M P BeJlHK06pHTaHHH.
Co BpeMeHeM 06HapY)I(HJIOCb HeY.D.06cTBO TaKaro HaUHOHaJIbHO
opHeHTHpoBaHHoro nO.D.XO.D.a, npH KOTOpOM Bce npOBepSlJlH Bcex. 3TO
OTHHMaJIO CJIHWKOM MHOro BpeMeHH H Cpe.D.CTB H 6blJIO nOMeXOH pa3BH-
THIO Me)I(.D.YHapolIHoH TOproBJlH. PeweHHeM np06JIeMbl 6blJIO B3aHMHoe
npH3HaHHe pe3YJIbTaTOB HHcneKUHH H 06MeH OT4eTaMH 06 HHcneKTHpo-
BaHHH. 3Ta HlleSi 6blJIa peaJIH30BaHa B EBpone B 1970 r. nyreM 3aKJI104e-
HHSI KOHBeHuHH no HHCneKTHpOBaHHIO <!:>apMaUeBTH4eCKHx npelInpHSI-
THH - Pharmaceutical Inspection Convention (PIC). B .D.aJlbHeHWeM, B
CBSl3H C paCWHpeHHeM rpaHHU EBpocof03a, 6blJIa C03.D.aHa opraHH3auHSI
PIC/S C HeCKOJIbKO HHblMH <!:>YHKUHSlMH (maBa 23).
B 1987 r. B EC 6blJla nOCTaBJleHa 3a.D.a4a pa3pa60TKH e.D.HHbIX Tpe60Ba-
HHH K npOH3BO.D.CTBY H B 1989 r. 6blJlH npHHSlTbl npaBHJla GMP E6poneu-
CKOlO COlO3a (GMP EC) - Guide to Good Manufacturing Practice for medici-
nal products «<npaBHJIa npOH3BO.D.CTBa JIeKapCTBeHHblX Cpe.D.CTB»). 3TH npa-
BHJla K HaCTOSlllleMY BpeMeHH BbllllJIH .D.aJIeKO 3a npelIeJlbl EBponbl.
XopOWO oTpa60TaHHblM H aBTopHTeTHblM .D.OKYMeHTOM SlBJlSlIOTCSI
npaBHJIa GMP CiliA. AHaJIorH4Hble HOpMbl JleHCTBYIOT H B .D.PYrHX
CTpaHax. B nOCJIe.D.Hee BpeMSI SlCHO 0603Ha4HJlaCb TeH.D.eHUH5I C6JlH)I(eHHSI
Tpe60BaHHH GMP pa3Hblx perHOHOB C nepcneKTHBoH C03.D.aHHSI MHpO-
BblX GMP. B 3TOM HanpaBJleHHH pa60TalOT EBpona, CiliA H 51noHHSI.
B 2010 r. KHTaH npHHSIJI npaBHJIa GMP, OCHOBaHHble Ha GMP EC H
B03, C .D.06aBJleHHeM pa3.D.eJIa no KHTaHCKOH TPa.D.HUHOHHOH Me.D.HUHHe.
B CTpaHax BOCT04HOH EBponbl, B TOM 4HCJIe B 6bIBWHX pecny6JIH-
Kax npH6aJITHKH, B Ha4aJIe 90-x ro.D.OB 6blJIO npHH5ITO peweHHe 0 BBe-
.D.eHHH eBponeHcKHx HOpM. lLrISI 06JIer4eHHSI nepeXO.D.a HeKOTopble CTpa-
Hbl BBeJlH CHCTeMY iJ60UIlbiX cmaHiJapm06: BHa4aJIe lIeHCTBOBaJIH KaK CTa-
pble CTaHlIapTbl, TaK H eBponeHCKHe, HO B CJlY4ae KOH<!:>JIHKTa npHopHTeT
OT.D.aBaJICSI eBponeHcKHM HopMaM. CnYCTSI HeKOTopoe BpeMSI eBponeH-
CKHe HOpMbl CTaJIH 06S13aTeJIbHbIMH.
Pe3YJIbTaT .D.aJI 0 ce6e 3HaTb 6bICTpO. Y)I(e K KOHUY 90-x rO.D.OB TaM
6blJIa <!:>apMaueBTH'leCKaSi npOMbIWJIeHHOCTb, B 3Ha ' IHTeJIbHoH CTeneHH

30
F.fla6a I
npowelIwaSi peKOHCTpYKUHIO, C 06Y4eHHblMH Ka.D.paMH H HaJIa)l(eHHOH
CHCTeMOH Ka4eCTBa.
Ho 3TO He Bce. TaM 6blJIa C03.D.aHa HH<!:>pacTPYKTypa GMP B BHlle
<!:>HPM, 3aHHMalOIllHXCSI 06CJIY)I(HBaHHeM 3aBOlIOB no BceMY cneKTpy 3a-
,lJ,a4 GMP - npoeKTHpoBaHHeM, aTTecTauHeH. 06Y4eHHeM, OT4aCTH Bbl-
nycKoM MaTepHaJIOB H 060PY.D.OBaHHSI.
nporpecc Tpe6yeT rpaMOTHblx H peWHTeJIbHblX .D.eHCTBHH. TOT, KTO
Ha HHX He cnoc06eH, 06pe4eH Ha 3acToH H nOTeplO BpeMeHH Ha 6ecKo-
He4Hble nycTble .D.HCKYCCHH.
1.5 I1cTopHH G MP B POCCHH
R06aR pOJIb HopMamU6HblX iJoKYMeHm06
I1cTopHSI GMP B POCCHH aHaJIOrH4Ha pa3BHTHIO CTaH.D.apTH3aUHH B
ueJIOM. 11.0 1991 r. 3KOHOMHKa POCCHH npHHUHnHaJIbHO OTJlH4aJIaCb OT
3KOHOMHKH 3ana.D.Horo MHpa. BcSI C06CTBCHHOCTb npHHa.lJ,.Jle)l(aJIa rocy-
.D.apCTBY.
npe.D.npHSITHSI nOJIY4aJIH nJIaHbl H 3aKa3bl Ha npOH3BO.D.CTBO npo-
.D.YKUHH OT roCY.D.apCTBa. CHa6)J(eHHe BceMH MaTepHaJIaMH 6blJIO ueHTpa-
JlH30BaHHblM H KOHTpOJIHpOBaJIOCb roCY.D.apCTBOM. PYKOBO.D.CTBO npe.D.-
npHSlTHH He 3a60THJIOCb 0 pblHKe H peWaJIO TOJIbKO O.D.HY 3a.D.a4Y: Bbl-
nOJIHHTb roCY.D.apCTBeHHbIH nJlaH. DOJlee TOro, HHKTO He HMeJI npaBa
npOH3BOlIHTb 4TO-JIH60 nyreM HenocpelICTBeHHblX neperoBopoB C nOTpe-
6HTeJlSlMH 6e3 BKJlI04eHHSI B nJIaH. rOCY.D.apCTBO nOJIHOCTblO KOHTpOJlH-
pOBaJIO HCnOJIb30BaHHe MOIllHOCTeH npe.D.npHSITHH. OHO TaK)l(e pa3pa6a-
TbIBaJIO CTaH.D.apTbl, KOTopble 6blJlH 06S13aTeJIbHbIMH.
B TaKHX YCJIOBHSlX npe.D.npHSITHSI 6blJIH 3aHHTepeCOBaHbl TOJIbKO B
TOM, '1TO roBOpHJIO roCY.D.apCTBO, a He B nOTpe6HOCTSlX pblHKa. ECJIH ro-
BOpHTb npSlMO, TO pblHOK OTCyrCTBOBaJI COBceM. rOCYlIapCTBO 6bIJlO:
- e.D.HHCTBCHHbIM 3aKa34HKOM,
- e.D.HHCTBeHHbIM nOCTaBIllHKOM,
- c06CTBeHHHKOM Bcex npe.D.npHSITHH,
- Ha.D.30pHb1M opraHOM.
D.nSl ynpaBJleHHSI BceH 3TOH TOTaJIbHOH CHCTeMOH 6blJI C03.D.aH rHraHT-
CKHH 61OpOKpaTH4eCKHH annapaT CO MHOrHMH HHCTH"ryraMH, KOTopble He
CJlHWKOM HHTepeCOBaJIHCb BbInYCKOM npOlIYKUHH MHpOBOro YPOBHSI.
3Ta CHCTeMa nOpO.D.HJIa MHO)l(eCTBO JlIO.D.eH, KOTopble C03.D.aBaJIH
CTaH.D.apTbl TOJlbKO Ha OCHOBe c06CTBeHHoro nOHHMaHHSI. nOSlBHJIaCb
opHeHTaUHSI Ha CTaHlIapTbl C TaK Ha3bIBaeMblMH «HaUHOHaJIbHbIMH OCO-
6eHHOCTSlMH». B .D.eHCTBHTeJlbHOCTH 3TOT no.D.XO.D. He OTpa)l(aJI HHKaKHX
HaUHOHaJIbHblX oc06eHHOCTeH H CJlY)I(HJI JIHWb HHTepecaM nceBlIOHaY4-
HOH 61OpOKpaTHH H OTCTaJIblX npelInpHITHH.
BHelIpeHl1e Me)l(1lYHapOlIHblX HOpM H npaBHJl Tpc60BaJIO 3aTpaT Ha
peKOHCTPYKUHIO npOH3BOlICTB 11 OCBoeHHH HOl3blX TeXHOllOrHH. 11.eHer Ha

OCH06HOU 3aKOH npOU360()Cm6a J1eKapcm6eHHbiX cpedcm6
31
3TO Bcer.aa He XBaTaJIO, oc06eHHO .D.JlSl npe.D.npHSlTHH He060poHHOro
npo<!:>HJISI. n03TOMY CTaH.D.apTbl nOlIroHSlJIHCb nOlI CYllleCTBYlOlllHe B03-
MO)l(HOCTH npOH3BOlICTB. 3Ta KOHcepBaUHSI OTCTaJIOCTH H SlBHJIaCb
HaweH «HaUHOHaJIbHOH cneUH<!:>HKOH».
B Ha4aJIe 90-x ro.D.OB CH"ryaUHSI H3MeHHJIaCb KopeHHblM 06pa30M.
nepBble TPH <!:>YHKUHH roCY.D.apCTBa 6blJIH ynpa3.D.HeHbl. 3a roCYlIapCTBOM
OCTaJIHCb TOJlbKO npHHSlTHe 3aKOHOB H HopMaTHBHblX .D.OKYMeHTOB H
KOHTpOJIb HX BbInOJIHeHHSI. npOH3BOlIHTeJlH nOnaJIH B pblH04HYIO cpe.D.Y.
Bbl60p CTaH.D.apTOB, 06ecne4HBalOIllHX ycnex Ha pblHKe, OKa3aJICSI .D.JlSl
HHX )l(H3HeHHO Ba)l(HbIM. He Bce 3TO nOHSIJlH cpa3Y.
3KoHoMH4ecKaSi CHCTeMa H3MeHHJlaCb 6bICTpO, HO OCTaJIOCb MHO)l(e-
CTBO CTapbIX HHCTHTyrOB H JIHU, He H3MeHHBwHX CBoeH n03HUHH. OHH
OKa3bIBaJIH H OKa3bIBalOT conpOTHBJleHHe BHe.D.peHHIO HOBOH H.D.eOJIOrHH
CTaH.D.apTH3aUHH.
He Bce nOHHMaIOT, 4TO nepe.D.OBble CTaH.D.apTbl Hy)I(Hbl TOJIbKO npo-
H3BO.D.HTeJlSlM H nOTpe6HTeJISIM. TpeTbSl CTopOHa - locyiJapcm60 - npH-
HHMaeT CTaH.D.apTbl, HO HU 3a limo He om6ellaem. OTBe4alOT TOJIbKO npo-
u360iJumeJlU - C60eu 3KOHOMUKOU, U nompe6umeJlu - C60UM 3iJOP06beM.
J.13MeHeHHe COUHaJIbHOro CTpOSI B POCCHH H nepeXO.D. Ha pblH04HYIO
3KOHOMHKY BHeCJIH H .D.PYrHe H3MeHeHHSI. PblHOK BbInYCTHJI Ha BOJlIO
Bce: npe.D.npHHM4HBOCTb, HHHUHaTHBY H )l(YJIbHH4eCTBO, C KOTOpblM 06-
llleCTBO .ao CHX nop 60POTbCSI He HaY4HJIOCb. Mbl OKa3aJIHCb 6e33a1llHT-
HblMH He TOJIbKO OT BHyrpeHHHx <!:>aJIbCH<!:>HKaTOpOB.
3apy6e)l(Hble KOMnaHHH .D.a)l(e pecneKTa6eJIbHblX CTpaH, He BH.D.SI Y
POCCHH 3aCJIOHOB npOTHB 6paKa B BH.D.e GMP, He Bcer.aa cnoc06Hbl
YCTOSlTb npOTHB C06JIa3Ha nOCTaBJlSlTb HaM 4TO-HH6Y.D.b noxY)I(e, C HH3-
KOH ce6eCTOHMOCTblO, T. e. .D.J1S1 ce6S1 - no G M p, a .D.J1S1 POCCHH - TO,
4TO MO)l(HO eH c6blTb. nOCKOJlbKY pe4b H.D.eT 0 MHJIJIHap.D.aX .D.OJIJlapOB, TO
TaKOH C06JIa3H 6blCTpO npeBpalllaeTcSI B peaJIbHOcTb.
OTcyrcTBHe npaBHJI GMP, a 3aTeM nOSlBJleHl1e pa3Horo pO.D.a «nceB-
.D.o-GMP» .D.e30pHeHTHpOBaJIH npOMbllllJIeHHOCTb. OHa KaK He Morna
paHbwe npe.D."bSlBHTb npOH3BO.D.CTBa, npHro.D.Hble .D.JlSl BbInYCKa npO.D.YKUHH
Ha 3KcnopT, TaK He MO)l(eT H ceH4ac.
HaM KaK B03.D.YX HY)I(Hbl npaBHJla G M P He TOJlbKO 4T06bl 3alllHTHTbCSI
OT MoweHHHKOB BHyTpH CTpaHbl, HO H OT JIOBKa'leH 3apy6e)l(Horo nOKpoSI.
«Na 3anaiJ Hac He nYCmHm!»
nOpOH npHXO.D.HTCSI 3TO CJIbIWaTb.
A Y Koro, c06cTBeHHo, HY)I(HO cnpaWHBaTb pa3peweHHe? Y)I(e .aBa-
.D.uaTb JleT Ha3alI B ueHTpe JloH.D.OHa npO.D.aBaJIHCb CYBeHHpbl C HaUHO-
HaJIbHOH aHrnHHCKOH CHMBOJlHKOH, Bce 6e3 I1CKJlI04eHHSI H3roTOBJleH-
Hble B KHTae. CeH4ac 60JlbWHHCTBO nOTpe6HTeJIbCKHX TOBapOB B EBpone
H CiliA - KHTaHcKoro npOH3BOlICTBa.
Y KOro KHTatiUbl cnpaWHBaJIH pa3peweHHe?

32
F;W6a I
Ha pblHOK lleKapCTBeHHblX CpelICTB EBpOnbl Y)I(e BOWJlH EeJIapYCb H
YKpaHHa, OMaH H 3aM6HSI. nOKa3aTeJleM aKTHBHOCTH S1BJlSleTCSI 4HCJIO
HHcneKUHH, npOBelIeHHblX EC B .D.aHHOH CTpaHe.
B nOCJlelIHHe ro.D.bl eBponeHCKHe HHcneKUHH npHmawalOT An)l(HP,
ApreHTHHa, EOTCBaHa, 3HM6a6Be, I1paH, MeKCHKa, HHrepHSI, TYHHC H
.D.PyrHe CTpaHbl. npe.D.CTaBHTeJISlMH EC npOBe.D.eHbl HHcneKUHH H Ha He-
KOTOpblX pOCCHHCKHX npelInpHSlTHSlX.
BbIXO.D. Ha 3apy6e)l(Hble pblHKH peaJIeH.
ABTop 3TO 3HaeT no c06CTBeHHOMY OnbITY, BbInYCKaSl np0.D.YKUHIO
Ha 3KcnopT B 80-e ro.D.bl. EOJIee TOro, npelInpHSITHe, KOTopoe He CTaBHT
ueJIb pa60TaTb no MHpOBblM CTaHllapTaM H 3KcnopTHpOBaTb npOlIYKUHIO,
6ecnepcneKTHBHO.
npHHUHnbl 06ecne4eHHSI Ka4eCTBa HCnOJlb30BaJIHCb H B <!:>apMaueB-
TH4eCKOH npOMblWJIeHHOCTH CCCP. Ho OTcyrcTBOBaJIa .D.OJI)J(HaSi CHCTe-
Ma, 6bIJlH CYllleCTBeHHble OTJIH4HSI OT MHpOBblX CTaH.D.apTOB, 3Ha4HTeJIb-
HO OTCTaBaJIO 06ecne4eHHe 4 HCTOTbl nOMellleHHH, Ka4eCTBO 060PY.D.OBa-
HHSI He COOTBeTCTBOBaJIO COBpeMeHHblM KpHTepHSlM, KYJIbrypa npOH3BO.D.-
CTBa HaXO.D.HJIaCb Ha HH3KOM ypOBHe.
CaMa H.D.eSl TOro, 4TO Ka4eCTBO .D.OJl)l(HO 06ecne4HBaTbCSI He TOJIbKO 3Q
clfem ICOHmpOJlH MamepUQJl06 U npoOyKu.uu, HO, B OCHOBHOM, 3a C4eT mexHOJlO-
lUU U oplaHU3aquu npoU36oiJcm6a, BocnpHHHMaJIaCb C TpY.D.OM H He cpa3Y.
O<!:>HUHaJIbHble JIHua MHH3.D.paBa POCCHH B Cepe.D.HHe 90-x rO.D.OB 3a-
S1BllSillH, 4TO Y POCCHH - CBOH nyrb, 4TO Y Hac eCTb CBOSI ro.D.aMH OTpa-
60TaHHaSi CHCTeMa KOHTpOJISI, H 3ana.D.HblH onblT HaM He HY)I(eH. 3Ta no-
3HUHSI .D.Oporo 06XOlIHTCSI CTpaHe.
D.BH)I(eHHe no BBe.D.eHHIO B POCCHH npaBHJI GMP Ha4aJIOCb B Ha4aJIe
90-x ro.D.OB. 04eHb CKOpO nOSlBHJlHCb .D.Be npOTHBOnOJIO)l(Hble T04K11 3peHHSI:
- nepBaSl T04Ka 3peHHSI 3aKJIlO4aJIaCb B npSlMOM BBe.D.eHHH npaBHJl
GMP EC B POCCHH 6e3 KaKHX-JlH60 H3MeHeHHH. OHa npHHa.D.Jle)l(aJIa
ACI1HKOM;
- BTopaSi COCTOSlJIa B C03.D.aHHH 4ero-To «HaUHOHaJIbHO cneUH<!:>H4e-
CKOro». OHa npHHa.D.Jle)l(aJIa 61OpOKpaTHH H «HHCTHT)'TaM».
l1ep6blu nymb - npSlMoe BBe.D.eHHe npaBHJI GMP EC - OTKpbIBaeT
.D.BH)I(eHHe Bnepe.D. Ha OCHOBe XopOWO oTpa60TaHHblX 3apy6e)l(HblX HOp-
MaTHBHblX .D.OKYMeHTOB. OHO 03Ha4aeT noiJbeM omellecm6eHHOU npOMblUl-
JleHHOCmu iJo MUp060l0 yp061lH, 06ecne4eHHe KOHKypeHTocnoc06HOCTH
npO.D.YKUHH, coxpaHeHHe CYllleCTBYlOlllHX H OCBoeHHe HOBblX pbIHKOB.
3TOT nOlIXO.D. OTBe4aeT HHTepecaM npOMbIWJIeHHOCTH, HaCeJleHHSI H
CTpaHbl B ueJlOM. D.nSl ero npeTBOpeHI151 B )l(H3Hb Tpe6yeTcSI BbInOJIHHTb
YCJIOBHe - BBeCTH B .D.eHCTBHe npaBHJla GMP EC B Ka4eCTBe 06S13aTeJIb-
HOro 1I0KYMeHTa.
nYTb 3TOT peaJIeH.

OCH06HOU 3aKOH npOU360dcm6a JleKapcm6eHHbiX cpedcm6
33
KOHe4HO, OH Tpe6yeT BpeMeHH H 4eTKoro nOHHMaHHSI TOro, KaKaSl
4aCTb 3a.D.a4H G M P H Ha KaKOM 3Tane MO)l(eT 6bITb pellleHa .D.J1S1 .D.aHHOrO
npelInpHSITHSI. OH Tpe6yeT npHBJle4eHHSI KOMneTeHTHblX CneUHaJIHCTOB H
<!:>HPM, pe3YJIbTaT pa60Tbl KOTOpblX npH3HaeTCSI 3a py6e)l(OM.
Bmopou nymb - pa36umue no HOpMllM C «llau.UOllaJlbHOU» cneu.U(jJu-
KOU. OH 03Ha4aeT CTarHaUHIO H TynHK .D.JlSl OTe4eCTBeHHOH npOMbIWJIeH-
HOCTH. OH Ha .D.J1HTeJIbHYIO nepCneKTHBY 3aKJIa.D.bIBaeT OTCTaJIOCTb CTpa-
Hbl. PeKOHCTPYKUHSI H HOBoe CTpOHTeJIbCTBO npe.D.npHSlTHH BelIyrcSi no
HopMaTHBHblM .D.OKYMeHTaM C OTJIH4HSlMH OT MHpOBbIX. 3T0 JIHlllaeT
CTpaHY.D.a)l(e 6JIH3Jle)l(alllHX pbIHKOB.
B ueJIOM, 4T06bl HaWH TOBapbl MomH npO.D.aBaTbCSI 3a Py6e)l(OM, a
HaWH HHcneKUHH H npOBepKH npH3HaBaJIHCb B MHpe, HY)I(HO BbInOJI-
HHTb TPH YCJIOBHSI:
- pa60TaTb H BbInYCKaTb np0.D.YKUHIO no O.D.HHM H TeM )l(e HopMa-
THBHblM 1I0KYMeHTaM;
- npOBO.D.HTb OueHKY no O.D.HHM H TeM )l(e MeTO.D.HKaM;
- npHBJleKaTb K aTTeCTaUHH opraHH3aUHH H CneUHaJIHCTOB, OTBe4alO-
IllHX .D.BYM 06S13aTeJlbHb1M YCJlOBHSlM: KOMncreHTHoCTH H .D.06POCOBeCTHOCTH.
FapMollu3au.UH
ECTb ellle O.D.HH nyrb, TaK Ha3bIBaeMaSl «rapMOHH3aUHSI» CTaHllapTOB
H npaBH]] C 3apy6e)l(HblMH. 3TO onaCHblU nymb.
«rapMOHH3HpOBaHHble» .D.OKYMeHTbl, T. e. .D.OKYMeHTbl, B 4eM-TO
COBna.D.afOIllHe C Me)I(.D.YHapO.D.HbIM aHaJIoroM, a B 4eM-TO OTJIH4alOIllHecSi
OT Hero, .D.OJI)I(Hbl CO.D.ep)l(aTb nOJlHblU nepelleHb OmAUIIUU B BH.D.e Ta6JIHUbl,
B KOTOpOH 6blJIa 6bl npHBelIeHa pelIaKUHSI 3apy6e)l(Horo .D.OKYMeHTa H
«rapMOHH3HpoBaHHoro» OTe4eCTBeHHoro .D.OKYMeHTa.
06S13aTeJIbHO .D.OJI)J(HO 6blTb 060CHOBaHHe, 4eM Bbl3BaHO 3TO OTJlH-
l!He, 4TO OHO .D.aeT OTe4eCTBeHHOMY npOH3BO.D.HTeJIIO (noTpe6HTeJlIO) H BO
4TO OHO 060H.D.eTCSI. HHKTO H3 pa3pa60T4HKOB HopMaTHBHblX .D.OKYMeH-
TOB B 06JIaCTH JleKapCTBeHHblX Cpe.D.CTB 3TOro He C.D.eJIaJI.
HY)J(HO CJIOMaTb nop04HYIO npaKTHKY 6ecKoHe4Horo «YJlY4weHHSI»
OTe4eCTBeHHblX OTCTaJIblX .D.OKYMeHToB no.D. BH.D.OM HX rapMoHH3aUHH C
Me)I(.D.YHapO.D.HbIMH Tpe60BaHHSlMH. HY)I(HO npocTo BBeCTH 3TH Me)l(1lYHa-
pOlIHble Tpe60BaHHSI.
HaM )l(H3HeHHO He06xo.D.HMO npSlMoe BBe.D.eHHe H lIPYrHX Me)l(1lYHa-
pO.D.HbIX 1I0KYMeHToB. ECJIH B03HHKaeT MbICJIb, 4TO KaKOe-JIH60 nOJIO)l(e-
HHe Me)l(1lYHapO.D.Horo .D.OKYMeHTa HaM He nO.D.XO.D.HT, TO 3TO HY)I(HO
060CHOBaTb. ECJlH BHOCHTCSI H3MeHeHHe, TO HY)J(HO nOKa3aTb, 4eM OHO
Bbl3BaHO H K KaKHM nOCJIe.D.CTBHM npHBe.D.eT.

34
1Q6a I
llOlleMY GMP EC?
K HaCTOSlllleMY BpeMeHH B MHpe CYllleCTBYIOT .D.Be OCHOBHble CHCTe-
Mbl GMP: GMP EBponeHcKoro COlO3a (GMP EC) H cGMP CiliA, B
OCHOBHOM, CXO)l(He Me)l(1lY C060H, HO GMP EC nO.D.p06Hee paCCMaTpH-
BalOT MHOrHe KJlI04eBble np06JleMbl. CHbIMH, KOHKpeTHblMH H XOPOWO
oTpa60TaHHblMH S1BJlSlIOTCSI npaBHlla cGMP CiliA. Cyrb HX Ta )l(e, 4TO H
B EBpone, HO eCTb H OTJIH4HSI (rJIaBa 2, n. 2.4).
CYllleCTBYIOT TaK)l(e GMP B03 H GMP PIC. YTO 3TO 3a 1I0KYMeH-
Tbl? 06a OHH npe.D.CTaBJlSlIOT C060H OlIHY H3 nepBblX pe.D.aKUHH G M P EC
C He3Ha4HTeJIbHOH npaBKOH. 3a npowelIlllHe 10 JIeT npaBHJIa GMP EC
6blJIH ,lJ,OnOJlHeHbl MHoro4HCJleHHblMH npHJIO)l(eHHSlMH, OCHOBHOH TeKCT
HX HeOlIHOKpaTHO KoppeKTHpOBaJICSI. B pe3YJIbTaTe TPH TeKCTa GMP:
EC, B03 H PIC, CTaJIH rjJaKmUlleCKU HeuiJellmUIIHblMU.
LlOKYMeHTbl B03 H PIC SlBJlSlIOTCSI 4HCTO HH<!:>opMaUHOHHbIMH.
CBHlleTeJIbCTBO 0 COOTBeTCTBHH HM He S1BJlSleTCSI nponYCKOM Ha KaKoH-
JIH60 pbIHOK.
C npaBHJIaMH GMP EC - .D.eJIO .D.Pyroe. ECJlH B YCTaHOBJleHHOM no-
pSI.D.Ke nO.D.TBep)l(1leHO COOTBeTCTBHe npOH3BO.D.CTBa 3THM npaBHJIaM, TO
pblHOK EBponbl (H He TOJIbKO ee) OTKpblT .LI.JUI npO.D.YKUHH, BbInYllleHHOH
Ha 3TOM npOH3BO.D.CTBe.
lJopb6a 3a 66edeHue GMP EC
ACI1HKOM ellle B 1993 r. nOCTaBHJIa 3a.D.a4Y npSlMoro BBe.D.eHHSI
npaBHJl GMP EC B POCCHH. nepBblH nepeBOlI npaBHJl GMP EC Ha PYC-
CKHH Sl3blK 6blJI BbInOJTHeH ACI1HKOM B 1996 r. npHMepHo B TOT )l(e
nepHO.D. 6blJI BbInOJlHeH nepeBOlI YKpaHHCKHMH KOJIJIeraMH. 06MeH MHe-
HHSlMH H COBMeCTHaSl pa60Ta n03BOJTHJlH CHSlTb MHOrHe BOnpOCbl. Hc-
CKOJIbKO n03)1(e 6blJT BbInOJlHeH nepeBO.D. B 6eJlOPYCCHH.
B 1996 r. nepeBO.D. npaBHJl GMP EC 6blJI H3.D.aH HaMH B BH.D.e OT-
,lJ,eJIbHOH KHHrH. 3aTeM OH nOCTOSlHHO COBepweHCTBOBaJICSI H HeO.D.HO-
KpaTHO nepeH31IaBaJICSI. Bcero 3a nepHO.D. 1997-2001 r.r. BblWJIO nSlTb TH-
pa)l(eH nepeBOlIa npaBHJl GMP EC (H3.D.aHHe H nepeBO.D. ACI1HKOM)
061llHM 06"beMOM 60JIee 1500 3K3.
KOH<!:>epeHuHH ACI1HKOM TPH)l(.D.bl (1996, 1997 H 1998 ro.D.bl) 06-
palllaJIHCb B opraHbl BJlaCTH C peKoMeHlIauHeH npHHSlTb GMP EC B Poc-
CHH. nepBblM 3TY HlIelO nO.D..D.ep)l(aJI rOCCTaH.D.apT POCCHH B 1997 r. no-
CTeneHHO MblCJIb 0 6ecnepcneKTHBHoCTH HaUHoHaJIbHOH H30JlSlUHH 6blJIa
nO.D..D.ep)l(aHa H npelInpHSlTHSlMH. nepBblMH Cpe.D.H HHX 6blJIH OAO
«Y<!:>HMcKHH BHTaMHHHblH 3aBOlI» H OAO «TIOMeHCKHH xHM<!:>apM3aBO.D.'),
O.D.HaKO PYKOBOlICTBO MHH31IpaBa P<D nO.D..D.ep)l(HBaJIO H.D.elO HaUHOHaJIb-
HOH cneuH<!:>HKH POCCHH H HaUHOHaJIbHO 060c06JleHHblX HOpM.
n pe3HlleHT AC 11 H KO M HeOlIHOKpaTHO 06pawaJIcSi K PYKOBOlIHTe-
JISIM MHH31IpaBa P<D H B npaBHTeJIbCTBO P<D C 060CHOBaHHeM He06xo-
lIHMOCTH BBelIeHH1 G M P EC B POCCHH.

OCH06HOU 1aKOH npOU360dcm6a JleKapcm6eHHblX cpedcm6
35
Mbl 3anaBaJIH npOCTble BonpOCbl:
- B 4eM HMeHHO COCTOSIT HaUHOHaJIbHble OTJlHllHSI POCCHH, He .D.O-
nYCKalOlllHe npSlMoro BBe.D.eHHSI GMP EC?
- 4eM onpaBlIaHbl 60JIee BblCOKHe 3aTpaTbl Ha BHelIpeHHe OCT a 42-
510-98 no cpaBHeHHIO C BBe.D.eHHeM GMP EC?
- pacnpOCTpaHSleTCSI JIH OCT Ha Bcex npOH3BO.D.HTeJIeH JIeKapCTBCH-
HblX cpelICTB: KaK OTe4eCTBeHHbIX, TaK H 3apy6e)l(HblX, HJIH TOJIbKO Ha
oTe4ecTBeHHblx? ECJlH HeT, TO HaWH npelInpHSITHSI CTaBSlTCSI B 60JIee
)l(eCTKHe YCJIOBHSI. KOMY H 3a4eM 3TO HY)I(HO?
BHSlTHOro OTBeTa He nOCTynHJIO.
B 90-e ro.D.bl YCHJIHSI ACI1HKOM ycnexa He HMeJIH. B 1991 H 1998
ro.D.ax B POCCHH 6blJIH npHHSlTbl .D.Ea OTpaCJleBblX «HaUHOHaJIbHO opHeH-
THpOBaHHbIX» .D.OKYMeHTa. B .D.eHCTBHTeJIbHOCTH OHH npe.D.CTaBJlSlJlH C060H
KOMnHJISlUHIO TeKCTa GMP EC C HCKJlI04eHHeM 4aCTH MaTepHaJIa, ero
nepeMeWHBaHHeM, H3MeHeHHeM H .D.06aBJleHHeM HeHY)I(HblX Tpe60BaHHH,
KOTopble HOCHJlH ellle 60JIee )l(eCTKHH xapaKTep, 4eM GMP EC.
B Te4eHHe 10 JIeT ACI1HKOM JJOKa3b1BaJIa, 4TO 3TOT nyrb He HMeeT
6YlIYlllero, 4TO OH BpelIeH .D.J1S1 061lleCTBa H npOMbIWJIeHHOCTH. D.o 2002
r. Mbl HcnblTblBaJIH )l(eCTKOe COnpOTHBJleHHe co CTOpOHbl llHHOBHHKOB H
m06HTeJIeH «HaUHOHaJIbHOH» cneuH<!:>HKH. 3T0 6bIJI TPY,lJ,HbIH nepHO.D..
nOCTeneHHo cHTyaUHSI MeHSlJIaCb. npe.D.npHSITHSI Ha4aJIH nOHHMaTb,
4TO npHH5ITHe Me)I(.D.YHap0.D.HbIX HOpM CJlY)I(HT HX HHTepecaM. DpOH30-
ruJIH HeKOTopble H3MeHeHHSI B roCY.D.apCTBeHHbIX opraHax, B HHX nOSlBH-
JIHCb HOBbIe JlIO.D.H. B MHH3.D.paBe POCCHH B Ha4aJIe 2000-x ro.D.OB <!:>ap-
MaueBTH4ecKoH npOMblWJleHHOCTblO 3aHHMaJIHCb MOJlOlIble, cnoc06Hble
BH.D.eTb nepcneKTHBY JllOlIH. I1MH 6blJla nO.D..D.ep)l(aHa H.D.eSl npSlMoro BBe-
.D.eHHSI B POCCHH npaBHJI GMP EC.
ACI1HKOM no 3a.D.aHHIO MHH3.D.paBa POCCHH H npH nO.D..D.ep)J(Ke
rOCCTaH.D.apTa POCCHH npHcTynHJIa K nO.D.roToBKe COOTBeTCTBYlOlllero
TeXHH'lecKoro pernaMeHTa. K 3TOH pa60Te nO.D.KJlIO'IHJIHCb .D.eCSlTKH Be-
.D.YUJ.HX CneUHaJIHCTOB.
B 2003 r. BCTynHJl B CHJIY <1>e.D.epaJIbHbIH 3aKOH «0 TeXHH4eCKOM pe-
ryJIHpOBaHHH», KOTOpblM 6blJI YCTaHOBJleH npHopHTeT Me)I(.D.YHap0.D.HbIX
HOpM (CT. 12 3aKoHa).
B SlHBape 2004 r. rOCcTaHllapToM POCCHH 6blJI YTBep)I(.D.eH TexHH4e-
CKHH KOMHTeT no CTaHlIap-rH3aUHH TK 458 «npOH3BOlICTBO H KOHTpOJlb
Ka4eCTBa lleKapCTBeHHblX Cpe.D.CTB», npe.D.Ce.D.aTeJIeM KOTOpOro 6blJI
Ha3Ha4eH aBTOp KHHrH.
nepBblH pe3YJIbTaT 6blJI nOJlY4eH Y)I(e B 2004 r. npaBHJla GMP EC
6blJIH npHHSlTbl B Ka4eCTBe HaUHOHaJIbHOro CTaH.D.apTa POCCHH rOCT P
52249-2004 «npaBHJla npOH3BO,lJ,CTBa H KOHTpOJIH K3lfeCTBa JleKapcTBeH-
HblX Cpe,lJ,CTB». 3TOT CTaHllapT 6blJI H.D.eHTH4eH GMP EC co BceMH 18
npHJIO)l(eHHSlMH.

36
IJw6a 1
3mo 6bLil, iJeiicm6UmeJlbll0, npopbl6 6nepeo. EOJIee TOro. rOCT P
52249- 2004 SlBHJICSI nepBblM pOCCHHCKHM CTaHlIapTOM, KOTopblH .D.J1S1
BceH OTpaCJlH YCTaHOBHJI npaBHJla, H.D.eHTH'IHble eBponeHcKHM HopMaM.
MHorHe CTaHlIapTbl I1CO H CEN (eBponeHcKHe cTaHlIapTbl) 6bIJIH npH-
HSlTbl B POCCHH paHee, HO G M P SlBHJlHCb nepBblM KJlI04eBblM CTaH.D.ap-
TOM .D.JlSl ueJlOH OTpaCllH npOMbIWJleHHOCTH.
HeCKOJlbKO J1em Ha3ad odHa U3 3anaOHbiX rjJUpM paCCMOmpeJIQ mpu 6apu-
aHma nepe60da GM P EC Ha PYCCKUU R3bIK: YKpaUHCKUU, 6eJlOpYCCKUU U
HaUl POCCUUCKUU rOCT 5bIJi cOeJlOH odH03Ha'1Hb1U 6b1600: pa60mamb
HYJlCHO no rOCTy, maK KaK OH nOJlHOCmblO UOeHmU'1eH GMP EC, HYMe-
pau,uR nYHKm06 U pa30eJ/06 6 HeM ma JlCe, '1mo U 6 GMP EC. 3mo -
06R3ameJ/bHoe YCJ106ue OJIR conocma6um(!';lbHOi!O aHaJlU3a, CCblJlOK U np.
JIAR mOi!O, '1m06bl 3mo nOHRmb, HYJlCHO xomR 6bl OOUH pQ3 npUHRmb Y'1a-
cmue e ou,eHKe Jl1060i!0 u3deJlUR UJIU npou360dcm6a Ha coom6emcm6ue
ome'1eCmeeHHblM U MeJICoYHapooHblM HopMaM odH06peMeHHo.
CnycTSI nSlTb JleT, B Mae 2009 r., 6blJI yrBep)l(1leH rOCT P 52249-
2009 «npOH3BO.D.CTBO H KOHTpOJlb Ka4eCTBa JIeKapCTBCHHblX cpelICTB». OH
HlIeHTH4eH npaBHJlaM GMP EC, HO B Hero He BKJlI04eHO npHJIO)l(eHHe
20 no aHaJIH3Y pHCKOB BBH.D.Y ero HeKOHKpeTHOCTH H HenpHro.D.HOCTH K
npaKTH4eCKOMY HCnOJIb30BaHHIO (CM. rJlaBY 15).
1.6 HopMaTHBHble ,lJ,OKYMeHTbl no GMP
npHHSlTHe CTaH.D.apTa, Ka3aJIOCb 6bl, nOlIBeJIO 4epTY nOlI MHoroJleT-
HeH 60pb60H H .D.HcKyccHeH 0 TOM, KaKHMH .D.OJDKHbl 6bITb npaBHJIa
GMP B POCCHH.
Ho He Bce TaK npOCTO. Ha Ha4aJIO 2012 r. He 6blJI pellleH maBHblH
Bonpoc - Bonpoc 06 06S13aTeJlbHOCTH npaBHJI GMP. ECTb pa3Hble BapH-
aHTbl pellleHHSI 3TOH np06JleMbl, np06JIeMbl 3anyraHHoH B CBSl3H .D.eH-
CTBHeM 3aKOHa «0 TeXHH4eCKOM peryJlHpOBaHHH» (maBa 23). 06S13a-
TeJIbHblH .D.OKYMeHT MO)l(eT HMeTb <!:>OPMY TeXHH4ecKoro perJlaMeHTa, JlI1-
60 HenocpelICTBeHHO 6blTb yrBep)I(.D.eHHblM nOCTaHOBJleHHeM npaBHTeJIb-
CTBa PocCHHCKOH (})elIepaUHH (4TO J1Y4we).
He Ba)l(HO, KaK Ha3BaTb 06S13aTeJIbHbIHlIoKYMeHT no GMP, Ba)l(HO,
4T06bl OH 6blJI npHHSlT H 6blJI HlIeHTH4eH GMP, a He SlBHJICSI CHOBa BH-
HerpeTOM, npHnpaBJleHHblM COYCOM pa3roBopoB 0 «rapMOHH3aUHH». B
POCCI1H lIeHcTByeT 3aKOH «0 JleKapCTBeHHblX cpelICTBax». 3TO 061llHH 3a-
KOH, KOTOpblH COlIep)l(HT JIHWb ynoMHHaHHe 0 npOH3BO.D.CTBC JIeKap-
CTBeHHblX cpelICTB. Ba)l(HO, '!T06bl lIeHCTBOBaJI KOMnJleKC .D.OKYMeHTOB no
GMP, 1I0nOJIHSlIOWHX lIpyr .D.pyra (Ta6JlHUa 1.2).

OCH06HOU 3aKOH np01l3600cm6a .leKapcm6eHHblX cpeocm6
37
Ta6J/uu,a 1.2
CHCTeMa 1I0KYMeHTOB no GMP B pa3JlH4HblX CTpaHax
,lI,oKYMeHT CIlIA EC POccHMcKaH
<l>e.u.e p aUHH
06H3aTeJlb- 21 CFR (Code of D.l1peKTI1Ba Ha MOMeHT nepe1la1.J11
HbIM Federal regula- 2003j94jEC KHl1rH B ne1.JaTb 06S13a-
tions) - Part 211 YCTaHaRJI 11 BalO- TeJlbHblH 1l0KYMeHT OT-
«Current Good lllaSl npl1HUl1nbl CYTCTBOBaJl.
Manufacturing 11 npaBI1J1a G M P
Practice for Fin-
ished Pharmaceuti- U
cals» (GMP)
PeKOMeH1la- PYKoB01lCma FDA, npaBI1J1a GMP faCT P 52249 «npa-
TeJlbHblH, HO HaUI10HaJlbHbie EC, CTaH1lapTbl BI1J1a np0I13B01lCTBa 11
YTBep>K.lI.eH- CTaH1lapTbl, CTaH- MCa, CEN 11 KOHTpOJlSl Ka1.JeCTBa lle-
HblM rocy.u.ap- 1lapTbl M ca 1lp., 1l0KYMeHTbl KapCTBeHHblX cpellCTB»,
CTBeHHbIM op- PIC 1lpyme CTaH1laPTbI, B T.
raHOM U 4. MCa 11 CEN
PeKOMeH1la- PeKOMeH1laUI1I1 11 PeKOMeHllaUI111 PeKOMeHllaUl111 11 py-
UHH npoec- PYKOBOllCTBa ISPE, 11 PYKOB01lCTBa KOBOllCTBa ISPE, PDA,
CHOHaJlbHbIX PDA, I EST H 1lp. ISPE, PDA, 1 EST 11 IIp.
06mecTB H up. I EST H 1lp.
B 2003 r. ACI1HKOM npe.D.J10)/(HJIa npOCTOe pellleHHe - npHHSlTb
pOCCHHCKYIO BepCHIO D.HpeKTHBbl EBponeHcKoH KOMHCCHH 2003/94/EC
OT 8 OKTSl6pSl 2003 r., YCTaHaBJlHBalOllleH «npHHUHnbl H npaBHJla npOH3-
BOlICTBa JIeKapCTBeHHblX cpelICTB .D.J1S1 HCnOJIb30BaHHSI 4eJIOBeKOM, B TOM
4HCJle JIeKapCTBCHHblX Cpe.D.CTB, npelIHa3Ha4eHHblX .D.JlSl HCCJIe.D.OBaHHH»
(laying down the principles and guidelines of good manufacturing practice in
respect of medicinal products for human use and investigational medicinal
products for human use).
HaMH 6blJI nO.D.roTOBJleH H npe.D.CTaBJleH Ha O<!:>HUHaJIbHOe 06cY)l(.D.e-
HHe npoeKT COOTBCTcTBYlOlllero TeXHH4ecKoro pemaMeHTa. ACI1HKOM
6blJIa npe.D.J10)l(eHa e6poneiicKaH MoiJeJlb TeXHH4ecKoro peryJIHpOBaHHSI B
06JIaCTH npOH3BO.D.CTBa JleKapCTBeHHblx Cpe.D.CTB.
HecMoTpSl Ha TO, 4TO HaUHOHaJIbHblH CTaHlIapT no GMP 6blJI npH-
HIT, yrBep.D.HTb TeXHH4eCKHH pemaMeHT no GMP He YlIaJIOCb. npoeKT
6blJI npOBaJIeH Ha 3acelIaHHH KOMHCCHH rOCYlIapCTBeHHOH D.YMbl B <!:>eB-
PaJIe 2004 r. B pe3YJlbTaTe XopOWO opraHH30BaHHoH H nOCTbI.D.HOH HH-
TpHrH. HHKTO He OTBeTHJl Ha npoCToH Bonpoc: nO'leMY HX He YCTpaHBaeT
e6poneiicKaH MoiJeJlb, B3ITaSl 3a OCHOBY npoeKTa'?
4eM nllOXH «MMHHHCTpaTHBHble 6apbepbl», KOTopble EBpona no-
CTaBHJIa Ha nyrH JlCKapCTBeHHblX cpelICTB, He om6ellalOU(UX mpe606allUHM
6e30naCHocmu U Kallecm6a'?

38
f/la6a I
1.7 HOBbie np06J1eMbl
)J(H3Hb He CTOHT Ha \1eCTe. Mbl ellle He pa306paJIHCb B GMP, a K
HaM B ,lJ,Bepb Y)I(e BOpBaJIHCb HOBbIe onaCHOCTH.
PblHOK HaBOlIHeH peKJIaMOH «KJleTOlIHbIX TeXHOJlorHH», «CTBOJlOBbIX
KJleTOK» H np. B 60JIbWHHCTBC CJlyYaeB, KpOMe 06ewaHHH JllOlISiM nOMOIllH
«B 6Y.D.YllleM», OHH He .D.alOT HH4ero. 3aTo .D.alOT B03MO)l(HOCTb nOJlY'JaTb Be-
COMYIO npH6blJIb, HH 3a 4TO He OTBe4aSl. 06IlleCTBO.D.O CHX nop He Bblpa60-
TaJIO Cpe.D.CTB 3alllHTbl OT B03MO)l(HOM <!:>aJIbCH<!:>HKaUHH B :nOH c<!:>epe.
60JIee TOro, HeT npOBepeHHblX BpeMeHeM .D.OKa3aTeJIbCTB 6e30naCHO-
CTH H 3<!:><!:>eKTHBHOCTH KJleT04HblX TeXHOJlOrHH, 4eTKoro pa3rpaHH4eHHSI,
'-ITO MO)l(HO .D.eJlaTb, a 4ero HeJlb3S1. rp03HOH onaCHOCTblO SlBJlSleTCSI He-
KOHTpOJlHpyeMaSl nepeCa.D.Ka opraHOB H KpHMHHaJIbHaSi Me.D.HUHHa. HY)I(-
HO 3aHHMaTbCSI CHHTe30M TKaHeH H BHyrpeHHHx opraHOB 4eJIOBeKa Bce-
pbe3, 4T06bl n06e.D.HTb 3TY 4YMY. B nJIaHe Tpe60BaHHH K npOH3BO,lJ,CTBY
3ana.D. npO,lJ,BHHYJICSI Bnepe.D.: nOSlBHJIHCb npaBHJIa GTP - Good Tissue
Practice - npaBHJIa npOH3BO,lJ,CTBa TKaHeH (maBa 18).
He peweH Bonpoc C npaBHJIaMH npOH3BO.D.CTBa Meouu.uHcKUX U30e-
Jluii. O.D.HHX npaBHJI G M P .D.J1S1 npOH3BO,lJ,CTBa JIeKapCTBeHHblX Cpe.D.CTB
MaJIO. He.D.OCTaT04Ho BbInYCTHTb 6e30naCHblH npenapaT .D.JlSl HH"beKUHH.
ilinpHUbl, <!:>HJIbTpbl .D.J1S1 KpOBH, 1ll0BHble MaTepHaJIbl, Cep.D.e4Hble KJlana-
Hbl, HCKYCCTBeHHble CYCTaBbl - Bee .D.OJI)l(HO BbInYCKaTbCSI C rapaHTHeH
6e30nacHocTH H COOTBeTCTBHSI CBoeMY Ha3Ha4eHHIO. HeKOHTpOJIHPyeMble
npOH3BO.D.CTBa no BbInYCKY 3THX H3.D.eJlHH COUHaJIbHO OnaCHbl.
HY)I(Hbl CneUHaJIH3HpOBaHHble GMP .D.JlSl 3TOH OTpaCJlH.
(/)apMaKoneH
D,ocTaT04Ho JIH BBe.D.eHHSI npaBHJl G M P .D.J1S1 nO.D."beMa OTe4eCTBeH-
HOH npOMbllllJIeHHocTH? HeT, He.D.OCTaT04HO. npaBHJIa GMP - Ba)l(HbIH,
HO He e,lJ,HHCTBeHHbIH HopMaTHBHblH .D.OKYMeHT. OHH roBOpSlT, KaK opla-
HU306amb npOU3600cm60, H KaKue mpe606aHUH npe.D."bSlBJ1S1IOTCSI K TeXHO-
JIOrHH H 060PY.D.OBaHHIO. Ho 3TO TOJlbKO O.D.Ha CTopOHa .D.eJIa.
D,PyraSl CTopOHa - KaKUM iJOJl:JICHO 6blmb JleKapCTBeHHoe cpelICTBO,
KaK ero KOHmpOJlUp06amb, KaKHMH .D.OJl)l(Hbl 6bITb TeXHOJlOrH4eCKHe cpe-
.D.bl (BOlla, C)I(aTblH B03.D.YX H np.) - SlBJlSleTCSI npe.D.MeTOM (/)apMaKoneu.
OT nepe.D.OBblX npaBHJl G M P npH OTCTaJIOH <!:>apMaKonee nOJlb3bl MaJIO.
KpaHHe Ba)l(HblM BonpOCOM SlBJlSleTCSI C031IaHHe I1HcneKuHH no
GMP. 31Iecb TO)l(e He4ero H306peTaTb. J1Y4waSl HHcneKUHSI - 3TO FDA
CiliA C 4eTKoH cHcTeMoH KOHTpOJISI, OTKpblTOCTblO H rpaMOTHblMH Ka,lJ,-
paMH (maBbl 19 H20).
3TO peaJIbHO H He OlleHb TPYlIHO. HY)I(Hbl JlHWb npaBHJlbHble opra-
HI13aUHOHHblC MCpbl, nOHHMaSl, 4TO nepe.D. HaMH CTOHT elIHHCTBCHHaSl
3alIa4a - 06ccnC4eHHC 6C30naCHOCTH 11 Ka4eCTBeHHblX Cpe.D.CTB, a He
JIJ1LIHble HllH KopnopaTHRHblC HHTepeCbl.

39
f JIaBa 2
IIPHHIUIHbI PAEOTbI IIO GMP
2.1 IJ,eJlb - KalfeCTBO
nO.D.p06HO 3Ta np06JIeMa paCCMaTpHBaeTCSI B maBe 14. 3.D.eCb JIHWb
OTMeTHM, 4TO npOH3BO.D.CTBO pewaeT O.D.HY H TOJIbKO O.D.HY 3a.D.a4Y - Bbl-
nYCK npOlIYKUHH B COOTBeTCTBHH C 3a.D.aHHbIMH Tpe60BaHHSlMH. CJIe.D.o-
BaTeJIbHO, .D.J1S1 npOH3BO.D.HTeJlSl Kallecm60 npoiJYKu.uu - 3mo ee coom6em-
cm6ue 3aiJallllblM mpe606aHUHM.
Ha BbInOJlHeHHe 3TOro YCJlOBHSI H HanpaBJleHbl npaBHJIa GMP.
HHKaKHx npHHUHnHaJIbHblX pa3JlH4HH GMP CiliA H GMP EC He
HMeIOT. GMP B03, PIC H .D.PyrHe npe.D.CTaBJlSlIOT C060H KOMnHJlSlUHIO
npaBHJI GMP EC, npaB.D.a, C pSilIOM OTJIH4HH. 0630p GMP CiliA H
cpaBHeHHe HX C GMP EC .D.aHbl B n. 2.4.
He3aBHcHMo OT HCnOJIHeHHSI, Bce BapHaHTbl GMP nOCTpoeHbl no
O.D.HHM H TeM )l(e npHHUHnaM H OTpa)l(alOT OCHOBHble Tpe60BaHHSI K npo-
H3BO.D.CTBY. I1x 06"belIHHSleT OlIHO 061llee Ha4aJIO: CHCTeMHOCTb H OXBaT
np06JIeMbl B UeJlOM.
npaBHJla .D.alOT OCHOBHble Tpe60BaH, HSI HO Cpe.D.CTBa BbInOJlHeHHSI
3THX Tpe60BaHHH MOryr 6blTb pa3JIH4HbIMH. npOH3BO.D.CTBeHHHK HJlH npo-
eKTHpOBIllHK B OT.D.eJlbHbIX CJlY4aSlX BnpaBe npHHHMaTb rH6KHe peweHHSI,
HO OH .D.OJl)l(eH nOKa3aTb, 4TO YCTaHOBJleHHble Tpe60BaHHSI BbInOJIHSlIOTCSI.
BcSI pa60Ta npe.D.npHSITHSI HanpaBJleHa Ha 06ecne4eHHe Ka4eCTBa.
CucmeMa 06ecnelleHUH Kallecm6a - 3TO KOMnJleKC opraHH3aUHOHHblX
H TeXHH4eCKHX Mep, 06ecne4HBalOIllHx BbInYCK JleKapCTBeHHblX Cpe.D.CTB
B COOTBeTCTBHH C 3anaHHblMH Tpe60BaHHSlMH.
K 3TOMY TepMHHY HY)I(HO nOllXOlIHTb OC03HaHHO H OCTOpO)l(HO. Mo-
)l(eT CJlO)l(HTbCSI MHeHHe, 4TO CHCTeMa 06ecne4eHHSI Ka4eCTBa - 3TO 4TO-
TO .D.OnOJlHHTeJlbHOe K npOH3BOlICTBY, 4TO HY)I(HO pa3pa6aTbIBaTb, npH-
CTpaHBaTb HJIH BCTpaHBaTb B npOH3BO.D.CTBO. HeT, 3TO He TaK. HHKaKOH
«CHCTeMbl 06ecne4eHHSI Ka4eCTBa» 1I0nOJIHHTeJIbHO K npOH3BO.D.CTBY H
npaBHJIaM GMP C03)],aBaTb He HY)I(HO. 3TO - 6eCCMbICJlHua. HY)I(HO opra-
HH30BbIBaTb npOH3BO.D.CTBO H Bce ero 3JleMeHTbl TaK, 4T06bl np0.D.YKUHSI
HeH3MeHHO BbInYCKaJIaCb B COOTBeTCTBHH C 3anaHHblMH Tpe60BaHHSlMH.
ECJlH :noro HeT, TO HHKaKHe KOCMeTH4eCKHe npHeMbl, HHKaKHe «CH-
CTeMbl MeHelI)I(MeHTa Ka4eCTBa», I1CO 9000 H aHaJIH3bl pHCKOB He nOMO-
rYT. HY)I(HO peKoHcTpYHpoBaTb npoH3BolICTBO (HJIH CTpOHTb 3aHOBO) B CO-
oTBeTcTBHH C GMP.

40
(flaRa 2
Mbl npHMeHSIeM TepMHH «CHCTeMa 06ecne4eHHSI Ka4eCTBa», nOCKOJIbKY
OH eCTb B npaBHJlaX GMP EC H nepeHeceH B rOCT P 52249. B TO >Ke BpeMSI
3TOT repMHH npelICTaBJlSICTCSI 4eM-TO HJIJllOCTpaTHBHblM H HCKYCCTBeHHbIM.
B 3TOM JlerKO y6e.D.HTbCSI, eCJIH 3anHcaTb B O.D.HH cToJI6eu COCTaBJlSl-
IOIllHe GMP, a pSlllOM, B .D.PyroH - CHCTeMbl 06ecne4eHHSI Ka4eCTBa. 5y-
.D.yr .D.Ba OlIHHaKOBblX cToJl6ua. nOBTopeHHe OlIHoro H TOro )l(e pa3HblMH
CJIOBaMH B HopMaTHBHOM 1I0KYMeHTe - npaKTHKa He BblcweH np06bl.
ABTOpbl npaBHJI GMP EC peWHJlH n01I4epKHYTb 3Ha4HMOCTb Ka4e-
CTBa, BBe.D.SI TepMHH «CHCTeMa 06ecne4eHHSI Ka4eCTBa», a B .D.eHCTBHTeJIb-
HOCTH BHeCJlH nyraHHUY.
I1HrepecHo, 4TO B npaBHJIaX cGMP CiliA [16] pa31leJla no CHCTeMe Ka-
4eCTBa HeT, TeKCT 60Jlee .D.eJloBoH H TepMHH «Ka4eCTBO» ynoMHHaeTcSI YMecT-
HO. 061llaSi cxeMa opraHH3aUHH JII060ro npoH3BolIcTBa H 06ecne4eHHSI
Ka4eCTBa nOKa3aHa (pHC. 2.1).
06ecne'leHHe npOHJBOJ\CTBa B 3KcllJlyaTIIIIHH:
.nonroTOHK.1 nepCOHalla:
'KynbTypa npOH3BOnCTBa:
'KOHTpOJlL napaMeTj)OB:
-TCXHH(ICCKOe o6CJlY>KIHJ3HHe Ii pe\fOHT.
T
HCXOJ\Hble H
noc- ynaKOBO'IHble f- "POu36o(Jcm6o f- KOHTponL - nOTpe6H-
TIlBUIIIKH - MaTepHaJlbl .. rOTOBOH TeJlb
h npOIlYKUHH
KOHT)lOJlL BHyrpHnpoH3BOllCTBeHHbJi1
KOHTpOJlb I
t I I I
 I I
nO,/J,l'OTOBKa npoHJBOJ\CTBa: I I
AIIanHJ OTIUIOHCHHH OT f4--_.I I
.npOCKTllpOnaHHC: cnclIHIjIHKaIlHH
-C1pOJ.1TCRbCTBO 11 MOHTi.J)K:  -______I
-ArreCTaUlUI (HcnblTlIl1nl)
no\tClUCHltlt. npoueCCOB II
o6opynoBaHIfH: nnaH McponpHHTHH no
.P..upaGoTKa J10....} MCHlalUtIt o6CCne'lCHHHI Ka'lCCTBa
PHC. 2.1 CxeMa 06ecne4eHHSI Ka4eCTBa
D.nSl TOro, 4T06bl BbInYCKaTb npOlIYKUHIO Tpe6yeMoro Ka4eCTBa,
HY)l(Hbl:
- xopOWHe HCXOlIHble MamepUaJlbl;
- noOlom06AellHoe npOU3600cm60 (nOMellleHHSI, 060PYlIOBaHHe, npo-
ueCCbl), KOTopble rapaHTHpOBaHHO npOH3BOlIHJlH 6bl H3 xopowero CblpbSl
npOlIYKUHIO B COOTBCTCTBHH C 3a1laHHbIMH Tpe60BaHHSlMH;
- KnaJlHQJHUl1ponaHHblH H llHCUHnJlHHHpOBC1HHblH nepCOHaJl, rpa-
MOTHO 11 TO'IHO nLInOlllHIIOIllHi-i CBOH 06l3aHHOCTH;

flpUHlI,Unb/ pa60mb/ no GM P
41
- KOHmpO.llb Kallecm6a:
- oplaHu3au.UH U ynpa6.1lellUH, KOTopble 06eCne411BaJII1 6bl Bce B3aH-
MOCBSl3H B npOH3BOlICTBeHHOM opraHH3Me;
- 061llaSi KYJlbmypa,
- nOHUMaHue BceMH pa60THHKaMH npe.D.npHSlTHSI, B nepBYIO 04epellb
ero PYKOBOlIHTeJISlMH, cymu pa60mbl no GMP.
Bce 3TH BonpOCbl nOlIp06HO paCCMOTpeHbl B KHHre. 31IeCb OTMeTHM
JIHWb OCHOBHble nOJIO)l(eHHSI.
2.2 YCJlOBHH 06ecnelfeHHjJ K3lfeCTB3
06ecne4eHHe Ka'leCTBa SlBJlSleTCSI KOMnJleKCHOH JalIa4eH, B KOTOpOH
HeT BTopoCTeneHHblx 3JleMeHTOB.
HCXOOHble U ynaKo60llHbie MamepUaJlbl
Ka4ecTBo roTOBOH npO.D.YKUHI1 Ha4HHaeTCSI C Ka4eCTBa CblpbSl, MaTe-
pHaJIOB, KOMnJ1eKTyIOIllHx, T. e. Bcero, H3 4ero npOH3BO.D.HTCSI npolIYKuHSI.
Pa60Ta C MaTepHaJIaMH BKJlI04aeT B ce6S1:
- Bbl60p nOCTaBIllHKOB, rapaHTHpoBaHHo nOCTaBJlSlfOlllHX MaTepHaJIbl
Tpe6yeMoro Ka4eCTBa;
- nJIaHHpOBaHHe cHa6)1(eHHSI TaK, 4T06bl npOH3BOlICTBO pa60TaJIO
pHTMH4HO H CpOKH rolIHOCTH He BbIXO.D.HJIH 3a .D.OnYCTHMble npe.D.eJlbl;
- Be.D.eHHe .D.OKYMeHTaUHH H Y4eT MaTepHaJIOB;
- opraHH3aUHIO xpaHeHHSI MaTepHaJIOB;
- nopSlllOK oT60pa np06 H KapaHTHHHoro xpaHeHHSI,
H OXBaTblBaeT BCIO uenb OT 3aKJIlO4eHHSI .D.OroBOpOB Ha nOCTaBKY .D.O Bbl-
}la4H MaTepHaJIOB B npOH3BOlICTBO.
nO.D.p06HO pa60Ta C MaTepHaJIaMH paCCMOTpeHa B maBe 3.
D.o 2003 r. npaBHJIa GMP pacnpOCTpaHSlJlHCb TOJlbKO Ha lom06YlO
npooYKU. UIO .
Bonpoc: «KaKoH CMblCJl pemaMeHTHpOBaTb npOHJBO.D.CTBO rOTOBOH
npO.D.YKUHH, eCJlH OTCyrCTBYIOT Tpe60BaHHSI K npOHJBO.D.CTBY HCXOlIHblX Ma-
TepHaJIOB?» - 06cY)l(.D.aJICSI .D.aBHO. Bonpoc HenpocTOH, nOCKOJlbKY 06ecne-
4HTb 4HCTOTy HCXOlIHblX MaTepHaJIOB TPYlIHO. 3Ta np06J1eMa 3aTparHBaeT
HHTepecbl nOCTaBIllHKOB, MHorHe H3 KOTOpblX lIaJIeKH OT nOHHMaHHSI 3ana4
GMP. nepCneKTHBa HHBeCTHpOBaTb B peKOHCTpYKUHIO npOH3BO.D.CTB HC-
XOlIHblX MaTepHaJIOB no GMP MaccoBoro 3HTy3Ha3Ma He Bbl3bIBaJIa.
Ha060pOT, H3BeCTeH cJlyYaH, Koma 6e3YKopH3HeHHo pa60TalOIllaSI
KpynHaSl Me)l(1lYHapolIH<lSI <!:>HpMa, CneUHaJIH3HpYIOIllaSicSI Ha XHMH4eCKOM
CHHTe3e, y6paJIa H3 CBoeH 1I0KYMeHTaUHH ynoMHHaHHSI 06 aKmU6HblX ljJap-
Mau.e6mullecKUX cy6cmallu.UJlX (AC/JC), 4T06bl H36e)l(aTb BH3HTOB HHcneKTO-
POB GMP. B 1I3HHOM CJlY4ae, KaK roBOpHTCSI, «y CTpaxa ma3a BeJlHKH,). 3Ta
CPHpMa C 3anaCOM coomeTCTByeT Tpe60naHHHM GMP, HO npHMep nOKa3bl-
BaeT HaCTOpO)l(eHHOCTb npoH3BoJIHTeJleH cy6cTaHuHH K I1paBI1J1aM G M P.

42
FJw6a 2
nepHO.D. .D.HCKYCCHH 6blJl 3aBepweH C npHHSlTHeM PYKOBOlICTBa ICH
Q7 1361, KOTopoe B 2003 r. nOJlHOCTblO BOWJIO B COCTaB npaBHJI GMP
EC B Ka4eCTBe npHJlO)l(eHHSI 18. C :noro BpeMeHH Tpe60BaHHSI GMP K
npoH3BolICTBY aKTHBHblX <!:>apMaueBTH4ecKHx cy6cTaHuHH (A<1>C) CTaJIH
B EBpone 06S13aTeJIbHbIMH. C 2008 r. OHH BOWJlH B npaBHJIa GMP B Ka-
4eCTBe YaCTH II, a JaTeM B rOCT P 52249-2009.
B CiliA Tpe60BaHHSI G M P .D.eHCTBYIOT H .D.J1S1 npOH3BOlIcma 6cnOMO-
lameJlbHblX 6ew,ecm6-
flOOlom06Ka npou3600cm6a
nO.D. nOlIroToBKoH npOH3BO.D.CTBa nOHHMaeTCSI C03.D.aHHe npOH3BO.D.-
cTBeHHoH Cpe.D.bl (31IaHHH, nOMellleHHH, 30H H np.), OCHallleHHe 060PY.D.0-
BaHHeM C 06ecne4eHHeM TeXHH4ecKoro 06CJlY)I(HBaHHSI H peMOHTa, opra-
HH3aUHSI TeXHOJIOrH4eCKHX npoueCCOB, BKJlI04aSl nOlIroToBKY TeXHOJlOrH-
4eCKHX cpe.D. (BO.D.a, C)I(aTblH B03.D.YX, ra3bl, BaKYYM H T. 11.). Ee3 3TOro n.y-
MaTb 0 BbInYCKe npO.D.YKUHH Ha.D.Jle)l(alllero Ka4eCTBa - 3aHSITHe nYCToe.
HY)I(HO CTpOHTb nOMelU,ellUH H npelIYCMaTpHBaTb 060pyiJ06aHue, KO-
Topble n03BOJISIT BbInOJIHHTb Tpe60BaHHSI HopMaTHBHblX .D.OKYMeHTOB H
3a.D.a4H, KOTopble CTaBSlTCSI nepe.D. npOH3BO.D.CTBOM. Bce 3TO onpe.D.eJlSleTCSI
npoeKmOM. npoeKT - KJlI04eBOH .D.OKYMeHT pa3BHTH npOH3BO.D.CTBa. no-
.D.P06HO 3TOT Bonpoc paCCMOTpeH B rnaBax 6 11 7.
npOH3BO.D.CTBO Hy)I(HO nO.D.roToBHTb. D:YMaTb, 4TO Ha KaKOM yro.D.HO
060PY.D.OBaHHH H B JII06blX nOMellleHHSlX MO)l(HO BbInYCKaTb XOPOWHH
npO.D.YKT, )l(OHrJlHpySI TepMHHaMH THna «MeHe.D.)l(MeHT Ka4eCTBa», 3Ha4HT
He nOHHMaTb CyrH n.eJIa, JlH60 KPHBHTb .D.YWOH, 4TO ellle xY)I(e.
flpOU3600cm60
npOH3BO.D.CTBO pa60TaeT B peaJIbHOM BpeMeHH. HeKOTopble nOKa3a-
TeJIH OCTalOTCSI nOCTOSlHHblMH Bcer.aa, a HeKoTopble MeHSIIOTCSI B 3aBHCH-
MOCTH OT BbInYCKaeMoH npO.D.YKUHH, CTalIHH npOH3BO.D.CTBa, BJlHSlHHSI
CJIy<IaHHbIX <!:>aKTOpOB H np. BceM 3TH HY)I(HO ynpaBJlSlTb. npOH3BO.D.CTBO
- ueHTp Bcero, B HeM Bce B3aHMOCBSl3aHO. D:JlSl ero 4eTKOH pa60Tbl
HY)I(Ha CHCTeMa .D.OKYMeHTaUHH.
j.(OKYMeHmau.UH
D:oKYMeHTaJIbHOMY o<!:>opMlleHHIO nOlIJle)l(aT Bce npoueCCbl npOH3-
BOlICTBa, KOHTpOJISI Ka4eCTBa, TeXHH4ecKoro 06CJlY)I(H, BaHHSI 3KCnJIyaTa-
UHH H np. 31-0 1I0Jl)l(HO 6blTb C.D.eJIaHO B npoCToH H KOHKpeTHOH q)OpMe,
CHbIM S13bIKOM, He .D.OnYCKaIOIllHM lIBYCMblCJleHHOCTH H JIHWHeH HH-
Q)OpMaUHH, nepenHcaHHoH H3 lIPyrHx 1I0KYMeHTOB.
D:oKYMeHTaUHSI 4eTKO pernaMeHTHpyeT, KTO, 4TO, Koma H KaK 1I0JI-
)l(eH .D.eJIaTb, YCTaHaBJlHBaeT Tpc60BaHHSI K MaTepHaJIaM, roToBoH npo-
lIYKUHH, 060PYlIOBaHHIO H T. 11. OHa .D.OJI)I(Ha npelIYCMaTpHBaTb perH-
CTpaUHIO BbInOJIHeHHblX onepauHH H nOJIY'ICHHbIX pe3YJlbTaTOB.

flpUHlI,Unbl pa60mbl no GM P
43
Jl1060e lIeHCTBHe 1I0JI)I(HO BbInOJIHSlTbCSI B COOTBeTCTBHH C 1I0KYMeH-
TOM. HeJIb3S1 pa60TaTb no YCTHblM paCnOpSl)l(eHHSlM, no naMSlTH HllH c06-
CTBeHHblM 1I0MbICJlaM.
YeTKaSl CHCTeMa .D.OKYMCHTaUHH n03BOJISleT 06ecne4HTb CKB03HYIO
npOCJle:JICU6aeJHOClnb Bcero npouecca npOH3BOlICTBa OT npHeMa MaTepHa-
JlOB .D.O BbInycKa npolIYKUHH.
Ba)l(HblM YCJlOBHeM S1BJlSleTCSI lIemKoe onpeiJeJlellue 06R3allllocmeii u
om6emcm6eHHocmu. 06S13aHHocTH H OTBeTCTBeHHOCTb Bcex PYKoBolIHTe-
JleH H Bcex COTPY.D.HHKOB npe.D.npHSlTHSI .D.OJI)I(Hbl 6bITb lleTKO OnpelIeJleHbl
H H3JlO)l(eHbl B .D.OJl)l(HOCTHbIX UHcmpYKu.uRX.
ECJIH 6bl <!:>aKTopoB, H3-3a KOTOpblX B03MO)l(Hbi OTKJlOHeHHSI npo-
uecca npOH3BO.D.CTBa OT Tpe60BaHHH .D.OKYMeHTaUHH He 6bIJlO, ynpaBJle-
HHe CTaJIO 6bl npocTblM .D.eJIOM. Ho )l(H3Hb CJlO)l(Hee. B03MO)l(Hbi 01llH6KH
nepCOHaJIa, C60H B pa60Te 060PYlIOBaHHSI, HepHTMH4HOCTb cHa6)1(eHHSI H
np. He Bce CJIY4aH MO)l(HO npe.D.YCMOTpeTb B .D.OKYMeHTax. ECJlH BbInOJl-
HeHHe OT.D.eJlbHbIX onepaUHH H npoueCCOB MO)l(HO H HY)I(HO pemaMeHTH-
pOBaTb 0.D.H03Ha4HO, TO pa60Ta npe.D.npHSITHSI B ueJlOM nO.D.Bep)l(eHa B03-
.D.eHCTBHIO MHorHX <!:>aKTopOB. Bce npe.D.YCMOTpeTb HeB03MO)l(HO. 3JleMeH-
Tbl CJlY4aHHocTH, Henpe.D.BH.D.eHHOCTH H HepaBHOMepHOCTH Moryr 6blTb
Be3.D.e. 3a.D.a4a opraHH3aUHH H ynpaBJleHHSI COCTOHT B TOM, 4T06bl CHCTe-
Ma pa60TaJIa YCTOH4HBO H npH BJlHSlHHH 3THX <!:>aKTOpOB (maBa 17).
llepCOHaJl
Jl106ble 3aTpaTbl Ha pa3BHTHe npOH3BO.D.CTBa 6eCnOJIe3Hbl, eCJIH nep-
COHaJI npe,lJ,npHSITHSI 6e3rpaMOTeH, 6e30TBeTCTBeHeH, JleHHB H He .D.HCUH-
nJIHHHpOBaH, eCJIH OH He YBa)l(aeT CBOIO pa60TY, PYKOBO.D.HTeJleH H ce6S1.
nO.D.60p, pacCTaHoBKa, 06Y4eHHe H KOHTpOJIb nepCOHaJIa - KJlI04eBble
<!:>aKTOpbl B 06ecne4eHHH Ka4eCTBa npO.D.YKUHH (maBbl 12 H 13).
Ha npelInpHSlTHH .D.OJl)l(Ha 6blTb 4eTKaSl UCnOJlHUmeJlbCKaH iJucU.UTl.llU-
Ha H KOHTpOJIb HCnOJIHeHHSI. JllOlIH .D.OJl)l(Hbl 3HaTb CBOH 06S13aHHocTH,
4eTKO BbInOJIHSlTb nopY4eHHYIO pa60TY H HeMelIJleHHO .D.OKJIa.D.blBaTb, ec-
JIH 4TO-JIH60 3TOMY MewaeT.
KYJlbmypa
KYJIbTypa npOH3BO.D.CTBa MHororpaHHa.
31-0061llaSl KYJIbTypa Ha npe.D.npHSITHH: 4HCTOTa H nOpSl.D.OK Ha TeppH-
TOpHH, B npOH3BOlICTBCHHbIX, CKJla.D.CKHX, 6blTOBblX H BcnOMOraTeJlbHblX
nOMellleHHSlX. 3TO JIH4HaSl rHmeHa, II, HCTOTa onpSlTHOCTb H HCnOJlHH-
TeJIbHOCTb nepCOHaJIa. 3TO KYJIbT)'pa B3aHMOOTHoweHHH: KoppeKTHaSl pa-
60Ta PYKoBolIHTeJleH, 6JlaronpHSITHblH nCHXOJlOrH4eCKHH MHKpOKJIHMaT Ha
Bcex ypOBHSlX, HO B TO )l(e BpeMSI 4eTKaSl cy60plIHHaUHSI.
KYJIbTypa B3aHMooTHoweHHH CTOHMOCTHOH oueHKe He n01l.D.aeTCSI.
OHa He Tpe6yeT CpClICTB. Ho CCJlI1 ec HeT, TO HHKaKHe BJlO)l(eHHSI He no-
Moryr. Ka'leCTBa npOlIYKUI1H He 6YlIeT npH OTCYTCTBHH 311eMeHTapHOH
KYJIbTYPbl Ha npOI1JB01lCTBC.

44
1J106a 2
KOHmpOJlb Kallecm6a
KOHTpOJIIO nO.D.J1e)l(aT HCXOlIHble H ynaKoBo'IHble MaTepHaJIbl, npo-
Me)l(yr04HaSl H roToBaSi npOlIYKUHSI, napaMeTpbl TeXHOJIOrH4ecKoro npo-
uecca H oKPY)I(alOllleH CpelIbI. naccHBHblH KOHTpOJlb, T. e. TOJIbKO KOH-
CTaTaUHSI <!:>aKTa COOTBeTCTBHSI HJlH HeCOOTBeTCTBHSI nOKa3aTeJlSl YCTaHOB-
JIeHHblM Tpe60BaHHSlM, HelIOCTaT04eH H nOJlb3bl OT Hero MaJIO.
HY)I(Ha aKmU61laH n03uu.UH: rJIaBHOe - YCTaHOBHTb npUIIUHbl omlCJlo-
HeHuii H YCTpaHSlTb HX. D.nSl 3TOro Tpe6yeTcSI cHcTeMaTH4ecKHH aHaJIH3
OTKJlOHeHHH OT Tpe60BaHHH cneUH<!:>HKaUHH, aHaJIH3 OTKa30B 060PYlIO-
BaHHSI H c60eB B TeXHOJIOrH4eCKOM npouecce, aHaJIH3 pHCKOB B KPHTH-
4eCKHX KOHTpOJlbHblX T04Kax. CJIe.D.yeT npOBO.D.HTb caMOHHcneKUHH
(BHyrpeHHHH aY.D.HT), H3Y4aTb pbIHOK, npH4HHbi peKJIaMaUHH H OT3bIBOB
npO.D.YKUHH H Bo061lle JII06ble OTpHuaTeJlbHble <!:>aKTbI.
HY)I(HO pa3pa60TaTb nJlaH opraHH3aUHOHHO-TeXHH4eCKHX MeponpH-
SlTHH no 06ecne4eHHIO Ka4eCTBa H KOHTpOJlHpOBaTb ero BbInOJIHeHHe.
CJIelIYlOlllHH war - oueHKa 3<!:><!:>eKTHBHOCTH MepOnpHSlTHH, HX .D.OCTa-
T04HOCTH, H nOHCK .D.aJIbHeHWHX peweHHH no nOBblweHHIO YCTOH4HBO-
CTH npOH3BO.D.CTBa.
[JOHUMaHue cymu pa60mbl no GMP
BCTpe4aeTCSI OTHoweHHe K npaBHJlaM GMP KaK K 4eMY-TO HCKYC-
CTBCHHOMY H BpeMeHHOMY, KaK K KaKOH-TO KaMnaHHH. Ellle xy)I(e, Koma
peaJIbHaSi pa60Ta nO.D.MeHSleTCSI <!:>OpMaJIH3MOM, ropaMH 6YMarH H He
HMelOlllHM OTHoweHHSI K .D.eJlY «MeHeD,)I(MeHTOM Ka4eCTBa». K CO)l(aJIe-
HHIO, HenOHHMaHHe CyrH GMP CBOHCTBeHHO pSl.D.Y PYKoBO.D.HTeJleH.
D.nSl TOro, 4T06bl 6bmYCKamb XOPOUlYIO npoiJYKu.UIO, HY)I(HO:
- HCnOJIb30BaTb TOJlbKO xopOUlue MamepUaJlbl;
- pa60TaTb Ha XOpOUle.M 060pyiJ06aHuu, HCKJlI04alOIlleM 6paK;
- 06ecne4HTb Tpe6yeMYIO lIucmomy nOMelU,eHUii U 060pyiJ06aHUH;
- J1MeTb nOJIHblH KOMTl.IleKm iJoKYMeHmau.uu;
- HaY4HTb nepCOHaJl pa60TaTb cmpOlO no iJoKYMeHmau.uu;
- opraHH30BaTb KOHmpOJlb UCnOJlHeHUH;
- onupambCH Ha nepeiJ06YlO HopMamU6HYlO 6a3Y.
YaCTo 3a.D.a1OT Bonpoc: C l.fei!O Hal.famb. i!Om06RCb K pa60me no GMP?
C KJ/accurjJuKau.lIU 30H no I.fucmome. nplli!/IatlieHUR KOHcYJlbmaHm06?
HeT, B nepBYIO 04epellb HY)I(HO:
- npHBeCTH npOXOlIHble H T)'aJIeTbl B UHBHJIH30BaHHblH BH1l;
- .D.06HTbCSI, 4T06bl nepCOHaJI MblJI PYKH nOCJle nocellleHHSI TYaJIeTa
H Bo061lle C06JllOlIaJI npaBHJla rHrHeHbl;
- HCKopeHHTb 6paHb, rpy60CTb, xaMCTBO;
- 1I06HTbCSI a6COJIIOTHoro BbInOJlHeHHSI Tpe60BaHHH HHCTPYKW1H H
.D.PYrHX 1I0KYMeHTOB, C03.llaTb He06xolIHMblH KOMnJleKC 1I0KYMeHTaUHH;
- BBeCTH CHCTeMY KOHTpOJISI HCnOJlHeHHSI, .D.06HTbC1 BblCOKOH HC-
nOJIHHTeJIbCKOHlIHCUHnJIHHbl H 'leTKOCTH B pa60Te.

flpUHlI,Unbl pa60mbl no GM P
45
2.3 rOCT P 52249 - npaBHJla GMP EC
rOCT P 52249-2009 SlBJlSleTCSI l1.D.eHTH4HbIM nepeBOlIOM npaBHJl
G M P EBponeHcKoro COlO3a (G M P EC) «Good Manufacturing Practice for
Medicinal Products for Human and Veterinary Use» 2009 r.
B 2010-2011 r. B GMP EC BHeceH pSl.D. H3MeHeHHH H .D.OnOJlHeHHH:
- ClIeJIaHbl yr04HeHHSI B pa31IeJIe «lloKYMeHTauHSI» (YacTb I), Kaca-
IOIllHecSi TepMHHOJIOrHH H npOTOKOJlOB cepHH; OHH He MeHSlIOT cyrH H
paCCMOTpeHbl B maBe 5 KHHrH;
- nOSlBHJlaCb YaCTb III, KOTOpblH npelICTaBJlSleT C060H C60PHHK H3
lleTblpex OTlIeJIbHblX 1I0KYMeHTOB:
. nOSlCHeHHSI K pa3pa60TKe .D.OKYMeHTa «I1H<!:>opMaUHSI 0 npe.D.-
npHSlTHH» - Explanatory Notes on the preparation of a Site Mas-
ter File (CM. rJlaBY 5 KHHrH, npHJIO)l(eHHe I);
. ICH Q9 «AHaJII13 pHCKOB.D.J1f1 Ka4eCTBa» [38];
. ICH QIO «nOSlcHeHHSI K PYKOBOlICTBY no CHCTeMaM Ka4eCTBa
.D.J1S1 <!:>apMaUHH» [39];
. «Me)I(.D.YHapolIHble rapMOHH3HpOBaHHble Tpe60BaHHSI K cep-
TH<!:>HKauHH cepHH» (npHJIO)l(eHHe 2 K KHHre).
npHJIO)l(eHHe 20 no aHaJIH3Y pHCKOB B npe.D.bl.D.YllleH pe.D.aKUHH
GMP EC nepeHeceHO B YaCTb III. KaK nOKa3aHO B maBe 15, 3TOT TeKCT
H3JlO:>KeH HeKOHKpeTHO H HenpHrolIeH lIJlSl npaKTHKH.
BHeceHbl HeKOTopble H3MeHeHHSI B npHJIO)l(eHHe II no CHCTeMaM C
KOMnblOTepHblM ynpaBJleHHeM H KOHTpOJIeM H B npHJIO)l(eHHe 14 no
npOH3BO.D.CTBY JIeKapCTBeHHblX Cpe.D.CTB H3 KpOBH HJIH nJIa3Mbl 4eJIOBeKa.
2.4 GMP B CIlIA: OCUOBUble OTJlHIfHH OT EBPOUbI
B CiliA .D.eHCTByeT KO.D.eKC <!:>e.D.epaJIbHbIX npaBI1JI CFR 210-211 -
Current Good Manufacturing Practice for Finished Pharmaceuticals -
cGMP. EYKBa «c» (current - TeKYIllHH) .D.06aBJleHa, 4T06bl nO.D.llepKHyrb:
GMP - He 3aCTbIBWHH 1l0KYMeHT, OH pa3BHBaeTCSI. 3TH npaBHJIa HMelOT
CHJIY 3aKOHa. B .D.OnOJIHeHHe K HHM FDA yrBeplIHJIa pSilI PYKOBO.D.CTB:
- Guideline on Sterile Drug Products Produced by Aseptic Processing -
PYKOBOlICTBO no acenTWleCKOMY npOH3BO.D.CTBY CTepHJIbHblX JIeKapCTBeH-
H blX cpelICTB;
- Guideline on General Principles of Process ValidaTion - 061llHe
npHHUHnbl aTTeCTaUHH npoueCCOB;
- Guidelinesfor Drug Master Files (DMFs) - PYKOBO.D.CTBO no COCTaB-
JIeHHIO perHCTpaUHoHHoro 1I0Cbe Ha JleKapCTBeHHoe Cpe.D.CTBO;
- Good Automated Laboratory Practice - npaBHJIa no pa60Te aBTOMa-
TH3HpoBaHHoro 060PYlIoBaHHSI B Jla60paTopHSlx;
- STabiliTy TesTing of BioTechnological Products - KOHTpOJlb cTa6HJlb-
HOCTH 6HOllorWIeCKHX JleKapCTBeHHblX cpelICTB;

46
IJw6a 2
C01lepJKaHHe rOCT P 52249-2009
0611aCTb npl1MeHeHI1S1
4acTb I OCHoBHble Tpe60BaHI1S1
I OpraHl13aUI1S1 pa60Tbl no 06eCne1.JeHHIO Ka'leCTBa
2 nepCOHaJI
3 nOMellleHI1S1 11 o60pY1loBaHl1e
4 LloKYMeHTaul1S1
5 np0I13B01lCTBO
6 KOHTpoJlb Ka1.JeCTBa
7 Pa60Ta no KOHTpaKTaM Ha npoI13B01lCTBO npo1lYKUI1I1 11 npOBe1le-
Hl1e aHaJlI130B
8 PeKJIaMaUl111 11 OT3blB npo1lYKUI1I1
9 CaMOI1HCneKUI1H
4aCTb II OCHOBHble Tpe60BaHI1S1 K aKTI1BHblM ct>apMaUeBTI11.JeCKI1M cy6cTaH-
UI1S1M (A<DC), HCnOJlb3yeMbIM B Ka1.JeCTBe I1CX01lHbIX MaTepl1aJ10B
np0l13BOllCTBO CTepl1JlbHblX JleKapCTBeHHbIX Cpe1lCTB
np0I13B01lCTBO 6110JIOrl11.JeCKI1X JIeKapCTBeHHblX cpellCTB
n p0l13BOllCTBO pa1lI-104>apMaueBTI11.JeCKI1X npenapaTOB
OpOH3B01lCTBO JleKapCTBeHHblX Cpe1lCTB 1lJISI >KI1BOTHbIX
(KpoMe I1MMYHHblX JIeKapCTBeHHblX Cpe1lCTB)
Op0I13B01lCTBO I1MMYHHblX JIeKapCTBeHHblX Cpe1lCTB LUISI
>KI1BOTHbIX
np0I13B01lCTBO Melll1UI1HCKI1X ra30B
np0I13B01lCTBO JleKapCTBeHHblX Cpe1lCTB
113 paCTI1TeJIbHoro CblpbSl
OT60p npo6 I1CX01lHbIX 11 ynaKOB01.JHblX MaTepl1aJlOB
np0I13B01lCTBO >K111lKOCTeH, KpeMOBI1 Ma3eH
np0I13B01lCTBO a3po30JleH LUI I1HraJlSlUI1H
CI1CTeMbl C KOMnblOTepHblM ynpaRJIeHl1eM 11 KOHTpoJleM
(;(cnOJlb30BaHl1e 110HI1311pYlOlllero 113J1Y ' leHI1S1
B npoI13B01lCTBe JleKapCTBeHHblX Cpe1lCTB
npl1J10>KeHHe 13 np0l13BOllCTBO JleKapCTBeHHblX Cpe1lCTB
LUISI KJlI1Hl11.JeCKI1X I1CCJle1l0BaHI1H
npl1110>KeHHe 14 np0I13B01lCTBO JleKapCTBeHHblX Cpe1lCTB 113 KpoBI1
11J111 nJla3Mbl 4eJIOBeKa
npl1J10>KeHl1e 15 ATTecTaUI1S1 npoueCCOB 11 060pYlloBaHI1S1
npl1JIO>KeHl1e 16 n01lTBep>K1leHl1e ynoJlHOM01.JeHHblM JlI1UOM
COOTBeTCTBI1S1 cepl1l1 npOllYKUl111 C tieJlblO ee BbInYCKa
npl1J10)KeHl1e 17 BbInYCK no napaMeTpaM
npl1J10>KCHHe 18* (nepeHcceHo nOJIHOCTblO B 4aCTb II)
npl1J10>KeHl1e 19 KOHTpoJIbHble 11 apXHBHble 06pa3Ubl
06111l1e TepMI1Hbl 11 onpe1leJleHI1S1
npl1JIO>KeHl1e I
n pl1JIO>KeHl1e 2
npl1J10>KeHl1e 3
npl1J10>KeHl1e 4
npl1JIO>KeHl1e 5
npl1JIO>KeHl1e 6
npl1J10>KeHI1C 7
npl1J10>KeHHe 8
n pl1JlO>KeHl1e 9
n pl1JIO>KeHl1e 10
n pl1JlO>KeHl1e II
n pl1J10)l(eHl1e 12

flpUHlI,Unbl pa60mbl no GM P
47
- General Principles of Software Validation - 061llHe npHHUHnbl aTTe-
CTaUHH nporpaMMHoro 06ecne4eHHSI;
- Manufacture, Processing, or Holding of Active Pharmaceuticallngredi-
ents - npOH3BOlICTBO, TeXHOJIOrH4eCKHe npoueCCbl H 06pallleHHc C aK-
THBHblMH <!:>apMaueBTH'lecKHMH cy6cTaHUH}lMH;
ECTb pSl.D. PYKOBO.D.CTB no HHcneKTHpoBaHHIO npOH3BO.D.CTB, KOTopble
OTKpblTbl .D.J1S1 nOJlb30BaHHSI BceM )l(eJIaIOIllHM.
CO,lJ,ep*aHHe cGMP, CFR 211, ClllA
Subpart A - General Provisions A. 06mHe nOJlO>KeHHH
211.1* Scooe 06J1aCTb nOHMeHeHHH
21 1.3* Definitions OnoelleJ1eHHH
Suboart B - Or!!:anization and Personnel B. OoraHH3al\HH H neOCOH3JI
211.22 Responsibilily of quality control OTBeTcTBeHHocTb OTlleJ1a KOH-
unit Tooml Ka'leCTBa
211.25 Personnel qualifications KmulHdmKaUHSI neDCOHaJla
211.28 Personnel resDonsibilities OTBeTcTBeH HOCTb neDCOHaJla
211.34 Consultants KOHCVJ1bTaHTbl
Subpart C - Buildings and Facilities C. 3.llaHHH H nOMemeHHH
211.42 Design and construction features npOeKTl1pOBaHl1e 11 CTpOI1TeJ1bCTBO
2.11.44 Lighting OCBeWeHl1e
211.46 Ventilation, air filtration, air heat- BeHTHJ1S1UI1I, I}JI1J1bTpaUHSI, nOllO-
ing and cooling rpeB 11 OXJ1a)!(lJeHl1e B0311yxa
211.48 Plumbing BOllonpoBoll 11 KaHaJlI13aUHSI
211.50 Sewage and refuse CTOKI1 11 OTXOllbl
211.52. Washing and toilet facilities YMblBaJlbHble 11 T}'aJleTbl
211.56 Sanitation Y60DKa 11 CaHI1Tapl1S1
211.58 Maintenance TexHH'JecKoe 06CJ1Y)l(I1BaHl1e
Subpart D - Equipment D. 06oPY1l0BaHHe
211.63 Equipment design, size and loca- ilHJaMH, paJMepbl 11 pacnOJ1O)l(e-
tion Hl1e 060OVllOBaHI1H
211.65 Equipment construction KOHCTPYKUHH 06opYlloBaHmi
211.67 Equipment cleaning and mainte- O'lHcTKa H TeXHI1'JeCKOe o6cJ1Y)l(I1-
nance BaHle 06oPYlloBaHI1H
211.68 Automatic, mechanical, and elec- ABToMaTl1'lecKoe, MeXaHl1'leCKOe 11
tronic equioment 3J1eKTOOHHoe 060pYlloBaHI1e
211.72 Filters <DHJlbTPbl
Subpart E - Control of Components and E. 06pameHHe C HCXOllHblMH H
Drug Product Containers and Closures ynaKoBo'lHblMH MaTepH3JlaMH, B
TOM '1HCJle )I,JIH YKynopKH
211.80 General requirements 06WHe TDe60BaHI1H
211.82 Receipt and storage of untested npHeM H XpaHeHl1e HenponepeH-
components, drug product con- HblX HCXOllHblX H ynaKoBo'lHblX
tainers, and closures MaTepHaJ10B, B TOM 'II1CJ1e llJ1H
VKvnOOKH
211.84 Testing and approval or rejection KOHTPOJ1b, paJpeWeHl1e Ha npl1-
of components, drug product MeHeHHe Hml OTKJlOHeHl1e UCXOll-
containers. and closures HblX H yn<lKouo'lHblX M<lTCpH<lJIOU,
II TOM 'IHCJ1e 1lJ1H VKvnOOKU

48
1J106a 2
211.86 Use of approved components, I1cnOIlbJOBaHHe paJpeWeHHblX HC-
dmg product containers. and clo- XOllHblX 11 ynaKoBo'lHbIX MaTepl1a-
sures IIOB, B TOM 'II1CJ1e LUISI YKynooKI1
211.87 Retesting of approved compo- nOBTOpHblH KOHTpOIlb pa3peweH-
nents, dmg product containers, HblX I1CXOllHblX H ynaKoBo'lHblX
and closures MaTepHaIlOB, B TOM '1HCJ1e llIlSl
YKynoOKH
211.89 Rejecting components, drug OTKJlOHeHHble HCXOllHble H ynaKo-
product containers, and closures BO'lHble MaTepI11U1bl, B TOM '!HcIle
LUISI YKynopKH
211.94 Dmg product containers, and clo- YnaKoBo'lHble MaTepHaJlbl llJlSl Jle-
sures KapCTBeHHblX cpellCTB, B TOM 'nIC-
IIe llIlSl YKynopKH
Subpart F - Production F. npOH3BOllCTBO H npol(eccbI
and Process Controls
21 I. 100 Written procedures; deviations I1HCTPYKUHI1 H OTKJlOHeHHSI
211.101 Charge-in of components Pa60Ta c MaTeOHaJlaMH
211.203 Calculation of yield PaC1.JeT BblXOlla nOOllYKUHH
21 I. 105 Equipment identification 0603Ha'leHHe 060ovlloBaHHSI
211.110 Sampling and testing of in- OT60p npo6 H BHYTpl1npoH3Boll-
process materials and drug prod- CTBeHHblH KOHTpOJlb MaTepHaJlOB H
ucts npOllYKUHH
211.111 Time limitations on production OrpaHH'leHHSI Ha BpeMSI npOHJ-
BOllCTBa
211.113 Control of microbiological con- KOHTPOIlb MI1Kp06HblX 3arpSlJHe-
tamination HHH
211.115 Reprocessing nepepa60TKa
Subpart G - Packing and Labeling Control G. YnaKoBKa H MapKHpoBKa
211.122 Materials examination and usage KOHTPOIlb MaTepHaJIOB H KpHTe-
criteria PHH 1lIISI HCnOJlb30BaHHSI
211.125 Labeling assurance 06paweHHe c 3THKeTKaMH
211.130 Packing and labeling operations OnepauHH no ynaKoBKe 11 MapKH-
pOBKe
211.132 Tamper-evident packing require- Tpe60BaHHSI K HeBOCCTaHaBJ1HBae-
ments for over-the-counter MOH 01lHopa30BoH ynaKoBKe (noJ-
(OTC) human drug products BOIlSllOweH 06HaPY)KHTb Hapywe-
HHe ee ueIlocTHoCTH) LUISI IIeKap-
CTBeHHblX cpellCTB, npellHaJHa-
'1eHHbIX llIlSl '1eIlOBeKa, peaJlHJye-
MbIX B 003HHUV
211.134 Drug product insoection KOHTOOJlb IIeKaOCTBeHHblX coellCTB
211.137 Expiralion dating YKa3aHHe cpOKa rollHOCTH
Subpart H - Holding and Distribution H. 06pameHHe H peaJIH3al(HJI
211.142 Warehousing procedures CKJI aLl bl
2 11.150 Distribution procedures PeaJlHJaUHSI
Subpart I - Laboratorv Controls I. KOHTDOJIb B JIa600aTooHH
211.160 General requirements 06WHe Tpe60BaHHSI
211.165 Testing and release for distribution KOHTPOIlb H BbmVCK B oeaJlHJaUHIO
211.166 Stabil ity testing KOHTpOJlb cTa6HIIbHoCTH
211.167 Special testing requirements CneUl1aJlbHble Tpe60BaHHSI K KOH-
TDOIlIO

flpUHlI,Unbl pa60mbl no GM P
49
211.170 Reserve samoles KOHTOoflbHble 06oa3Ubl
211.173 Laboratory animals Jla6opaTopHbie )l(H BOTHble
211.176 Penicillin contamination 3aroH3HeHHe neHHUHflJlHHOM
Subpart J - Records and Reports J. npOTOKOJlbl H OT'IeTbl
211.180 General requirements 06ume Toe6oBaHHSI
211.182 Equipment cleaning and use log O'lHcTKa 06oPYlloBaHHH H )l(ypHa-
flbl TeXHl1 l lecKoro 06CflY)l(I1BaHI1S1
211. 184 Component, drug product con- npOTOKOflbl Ha I1CXOllHble 11 yna-
tainer. closure, and labeling rec- KOB04Hble MaTepHMbl, B TOM 'IHC-
ords Jle llJlSl YKynOPKH, H 3TH KeTKI1
211.186 Master production and control 3TMOHHble npoToKoflbl Ha npOl13-
records BOllCTBO 11 KOHTOOflb
211.188 Batch production and control npOTOKOflbl Ha npOI1JBOllCTBO 11
records KOHTpOflb CepHI1
211.192 Production record review PaccMOTpeHl1e npOTOKOJlOB Ha
npOl13BOllCTBO
211.194 Laboratorv records npOTOKOflbl fla60paToPHH
211.196 Distribution records LlOKYMeHTaUI1S1 Ha peMI13aUI11O
211. 198 Complaint files LloKYMeHTaul1S1 0 peKJIaMaUl1f1X
Subpart K - Returned and Salvaged Drug K. B03BpameHHaH
Products H VTHJJH3HPOBaHHaH np01lYKUHH
2 I 1.204 Returned drug products B03BpaUleHHbie JleKapCTBeHHble
cpellCTBa
211.208 Drug product salvaging YTl1fl113aUI1S1 JleKapCTBeHHblx
coellCTB
*HYMepau,UR nYHKmo6 uoem He noopRO, 0 C nponYCKaMU, KaK pe3ep6 HO 6y-
oYL«ee. To, Lfmo nOCJle 92//./ uoem CP03Y 92//.3, He 03HOLfaem OUlu6KY.
UeJlb H CMblCJl npaBHJI GMP B EBpone H CiliA O.D.HHaKOBbl, HO
eCTb H OTJlH4HSI.
B EBpone OCHOBHble TPe60BaHHSI GMP .D.aHbl B KpaTKHX .D.OKYMeHTax:
- llHpeKTHBe 2003/94/EC OT 8 OKTSl6pSl 2003 r., YCTaHaBJlHBalOllleH
npHHUHnbl H npaBHJIa npOH3BOlICTBa JIeKapCTBeHHblX Cpe.D.CTB .D.J1S1 4eJIO-
BeKa, B TOM 4HCJle JIeKapCTBeHHblX cpelICTB .D.J1S1 KJlHHH4eCKHX HCCJle.D.O-
BaHHH (Commission Directive 2003/94/EC laying down the principles and
guidelines of good manufacturing practice in respect of medicinal products for
human use and investigational medicinal products for human use), Ha 5 C.;
- llHpeKTHBe 1991/42/EEC OT 23 HIOJlSl 1991 r., YCTaHaBJlHBalOllleH
npHHUHnbl H npaBHJla npOH3BOlICTBa JleKapCTBeHHblX Cpe.D.CTB .D.J1S1 )l(HBOT-
HblX (Commission Directive 91/412/EEC laying down the principles and guide-
lines of good manufacturing practice veterinary medicinal products), Ha 4 c.;
llHpeKTHBbl HMelOT CHJIY 3aKOHa. I1x Tpe60BaHHSI KOHKpeTH3H-
PYIOTCSI B OmeJlbHOM 06"beMHOM 1I0KYMeHTe - npaBHJlaX G MP EC,
KOTopble pacnpOCTpaHSIIOTCSI Ha JleKapCTBeHHble cpelICTBa KaK .D.JISI 4e-
JIOBeKa, TaK H .llJlSl )l(HBOTHbIX. 3TH npaBHJIa .D.eTaJIH3HpYIOT Tpe60Ba-
HHSI 1J.HpeKTHB H OTpa)l(alOT n03HUHIO Ha1I30pHblX opraHoB. TeopeTH-

50
[,106a 2
4eCKH MO)l(HO OTKJlOHSlTbCSI OT npaBHJl GMP EC, .D.OKa3aB 3TO HH-
cneKUHH H nOJlY4HB Ha TO pa3peweHHe.
B CiliA BeCb TeKCT cGMP 1I0CTaT04HO nOlIp06eH H HMeeT CHJlY
3aKOHa. LleTaJIH3auHSI HX .D.aHa B pSllIe PYKOBO.D.CTB. CYlllecTBeHHble OT-
JIH4HSI OT G M P EC 3aKJIlO4alOTCSI B Tpe60BaHHSlx K acenTH4eCKOMY
npoH3BolICTBY H 4HCTblM nOMellleHHSlM. 3TH OTJlH4HSI pacCMOTpeHbl B
KHHre 110]. ECTb H .D.PyrHe OTJIH4HSI, HanpHMep, B OTHoweHHH aHaJIH-
3a pHCKOB (rnaBa 15).
2.5 TepMHHbl
AHrJlHHcKHH TeKCT npaBHJI GMP COlIep)l(HT pSl.D. TepMHHOB, Bbl3bl-
BalOlllHX nyraHHUY H HeOlIH03Ha4Hoe nOHHMaHHe, B TOM 4HCJIe H B aH-
rnOSl3bl4HOH cpe.D.e. Bo H36e)l(aHHe 3TOH nyraHHUbl npH no.arOTOBKe PYC-
CKOro TeKCTa npaBHJl GMP H nOCJle.D.YIOIllHX CTaH.D.apTOB npe.D.J1araeTCSI
HMeTb B BH.D.Y CJle,lJ,YfOlllee:
I. TepMHH .D.OJl)l(eH HMeTb SlCHoe H, no B03MO)l(HOCTH, npOCToe
onpe.D.eJIeHHe. OH .D.OmKeH BOCnpHHI1MaTbCSI 0.D.H03Ha4HO H He ,lJ,OnYCKaTb
.D.B05lKOro TOJIKOBaHHSI.
2. ECJIH TepMHH COCTOHT H3 HeCKOJIbKHX CJIOB, TO Ka)l(.D.Oe CJIOBO
.D.OJl)l(HO 6bITb OCMbICJIeHO.
3. He .D.OnYCKaeTCSI BKJla.D.blBaTb B TepMHH 3MOUHOHaJIbHblH HJIH HH-
TYHTHBHblH OTTeHOK. TepMHH CJly)l(HT .D.J1S1 pa60Tbl, a He SlBJlSleTCSI JIHPH-
4eCKHM aTpH6yroM.
4. npH HaJIH4HH pa3Hblx TepMHHOB Ha O.D.HH H Te )l(e npe.D.MeTbl,
CJle.ayeT LJeTKO onpe.D.eJlSlTb pa3HHUY Me)I(.D.Y HHMH.
5. ECJlI1 TaKOH pa3HHUbl HeT, TO TepMHHbl SlBJlSlIOTCSI CHHOHHMaMH.
B 3TOM CJlYLJae B pa3,lJ,eJIe «TepMHHbl H onpe.D.eJIeHHSI» CTaH.D.apTa nepBblM
YKa3blBaeTC5I HaH60Jlee pacnpOCTpaHeHHblH (peKOMeH.D.yeMbIH K HCnOJlb-
30BaHHIO) TepMHH, a BTOpblM YKa3blBaeTCSI CHHOHHM. LlaJIee B TeKCTe
CTaH.D.aPTa MO)!(eT HCnOJIb30BaTbCSI TOJIbKO OCHOBHOH TepMHH.
6. ECJIH CYlllecTByeT 061llenpHHSlTblH B PYCCKOM Sl3blKe TepMHH,
aHaJIOrH4HblH HHOCTpaHHOMY, TO CJIelIyeT OT.D.aTb npe.D.n04TeHHe PYCCKO-
MY TepMHHY.
7. npH pa60Te c nepeBO.D.aMH CJle.D.yeT HMeTb B BH.D.Y pa3JlH4He Me)l(-
.D.Y TPa.D.HUHOHHbIMH OC06eHHOCTSlMH CneUHaJIbHblX TeKCTOB Ha aHrJlHH-
CKOM H PYCCKOM Sl3blKax. AHrJlHHCKHH TeKCT .D.OnYCKaeT 3JIeMeHTbl 3MO-
UHOHaJIbHOCTH, «YKpaWaTeJIbCTBa» H HeKoTopoH BOJlbHOCTH B TepMHHO-
JIOrHH. B PYCCKOM CneUHaJIbHOM TeKCTe (a TaK)l(e HeMeUKOM H lllBe.D.-
CKOM) HCnOJlb3YIOTCSI 4eTKO OnpelIeJIeHHble TepMHHbl. 3Ta OC06eHHOCTb
6blJ1a OTMe4eHa npH pa60Te B I1CO(TK 209 <'YHcTble nOMellleHHSI H
CBSl3aHHble C HHMH KOHTpOJIHPyeMble Cpe.D.bl».

flpUHlI,Unbl pa60mbl no GM P
51
ABTopaMI1 - HOCI1TeJlSlMI1 aHfJll1HCKOro S13bIKa, B 01lI1H 113 CTaH1laPTOB
6blJll1 BKJlI01.JeHbl 1lBa TepMI1Ha: check H test (KOHTpOJIb). D.eJlerall.l1eH fep-
MaHl111 6blJl 3a1laH Bonpoc: B 1.JeM pa3HI1Ua Me>K1lY HI1MI1? 3TOT >Ke Bonpoc
B03HI1K 11 Y Hac npl1 nOllroToBKe nepeB01la CTaHllapTa: S1BJlSlIOTCSI JII1 3TI1
TepMI1Hbl CI1HOHI1MaMI1 11J111 Me>K1lY HI1MI1 eCTb pa3JII11.Jl1e? ECJlI1 3TO CI1HO-
HI1Mbl, TO 01lI1H 113 TepMI1HOB HY>KHO I1CKJlI01.JI1Tb, 1.JT06bl He BHOCI1Tb nYTa-
Hl1l1.Y. ECJII1 eCTb pa3JII11.Jl1e, TO ero HY>KHO 4eTKO onpe1leJlI1Tb.
D.eJIeraUI1I1 CiliA 11 AHrnl111 He CMOrnl1 OTBeTI1Tb Ha 3TOT Bonpoc cpa3Y.
Ha3Ha1.J11J111 CneUl1aJ1bHOe 3aCe1laHl1e B 411 Karo. B pe3YJIbTaTe 6blJlO YCTa-
HORJIeHO, 1.JTO pa3JII11.JI1H Me>K1lY TepMI1HaMI1 check H test HeT. TepMI1H check
6blJl I1CKJlI01.JeH, 11 B TeKCTe CTaH1laPTa 6blJl OCTaRJIeH TOJlbKO TepMI1H test.
npHBeJJ.eHHblH npHMep HJ1JIIOCTpHpyeT KpHTH4ecKoe H BHHMaTeJIb-
Hoe OTHOllleHHe 4JIeHOB Me)I(.D.YHapO.D.Horo TeXHW.lecKoro KOMHTeTa K
pa3pa60TKe CTaHlIapTa, yYHTblBalOlllee nepcneKTHBY ero nepeBO.D.a Ha
.D.PYrHe Sl3bIKH, H nOCJIe.D.YfOIllYIO pa60TY no CTaH.D.apTY. K CO)l(aJIeHHIO,
TaKOH no.D.XO.D. Ha6JIIO.D.aeTCSI .D.aJIeKO He Bcer.aa, TeM 60JIee, 4TO POCCHSI
He MO)l(eT BJlHSlTb Ha nO.D.roToBKY CTaH.D.apTOB H npaBHJI, ,lJ,eHCTBYIOIllHX B
EBponetl:cKoM COI03e.
Ll)l(OH iliapn B CBoeH KHHre 153] MeTKO YKa3aJI Ha TaBTOJIOrHIO, T. e.
HaHMeHOBaHHe O.D.HOro H TOro )l(e pa3HblMH TepMHHaMH, B caMOM Ha3Ba-
HHH EBponeHcKoro COf03a. B pa3HblX .D.OKYMeHTax 3Ta CTpYKTypa Ha3bl-
BaeTCSI no-pa3HOMY: European Community (EC), European Economic
Community (EEC) H European Union (EU). nOnbITKH HaHTH CMblCJI B
3THX pa3J1H4HSlX 6eCnOJIe3Hbl B BH.D.Y OTCyrCTBHSI TaKoBoro.
HaH60JIblllHe cnopbl npH nepeBO.D.e npaBHJI GMP H HX TpaKToBKe
Bbl3bIBalOT TepMHHbl:
- Qualification;
- Validation;
- Validation Master Plan;
- Standard Operation Procedure (SOP).
B Ta6JIHue 2.1 npH Be.D.eH bl aHrJIHHCKHe onpe.D.eJleHHSI 3THX TepMHHOB,
onpe.D.eJ1eHHSI no rOCT P 52249-2009 H KOMMeHTapHH ACI1HKOM.
npSlMoe HCnOJIb30BaHHe aHrJIHHcKOro TepMHHa, T. e. 3aMeHa JIaTHH-
CKHX 6YKB KHpHJlJIHUeH, npH HaJIH4HH H.D.eHTH4Horo TepMHHa, Y)J(e npH-
HSiTOro B OTe4eCTBeHHOH npaKTHKe, HaHOCHT Bpe.D., nOCKOJlbKY C03JJ.aeT
IDIJII03HIO 4ero-To HOBOro, B 4eM CJle.D.yeT pa36HpaTbcSI H BbInOJIHSlTb, B
TO BpeMSI KaK 3TO HOBoe OTcyrcTByeT Hanp04b.
MHOro cnopOB BbI3blBaeT nepeBO.D. caMoro OCHOBHOro TepMHHa -
Good Manufacturing Practice. YTO TOJIbKO He npe.D.J1araeTCSI: «XopOlllaSi
npOH3BO.D.CTBeHHaSi npaKTHKa», «Ha.D.J1e)l(alllaSi npOH3BO.D.CTBeHHaSI npaK-
THKa», <npaKTHKa .D.06pOCOBecTHoro npOH3BOlICTBa» H np.
Jl1060e H3 3THX Ha3BaHHH Bbl3bIBaeT Y npaKTH4ecKoro pa60THHKa
He.D.OYMeHHe: a 4TO, 6blBalOT HopMaTHBHble .D.OKYMeHTbl, YCTaHaBJlHBalO-
ume Tpe60BaHHSI K «HeHa.D.Jle)l(allleH H np04eH npaKTHKe?» KYlIa JIY4we
Ha3BaTb .D.OKYMeHT HMeHHO TeM, 4eM OH SlBJlSleTCSI - «npaBHJIaMH npo-

52
IJw6a 2
H3BOlICTBa JleKapCTBeHHblX cpelIcTB». A HaJIeT peKJIaMbl H HeHy)I(HOH 06-
pa3HocTH - He .D.J1S1 cepbe3Horo TeXHHllecKoro TepMHHa.
B HaUleM BocnpHSlTHH yrBep)l(lIeHHblH HopMamU6Hblii iJoKYMeHm
no OnpelIeJIeHHIO YCTaHaBJlHBaeT Tpe60BaHHSI HMeHHO K «HalIJIe)l(a-
llleH» H np04eH «1I06poCOBeCTHOH» npaKTHKe .D.J1S1 lIaHHoro ypOBHSI
pa3BHTHSI TeXHHKH.
HaH60JIbWYIO nyraHHUY H Bpell npHHec HeYlIa4Hb1H, 6e3 nOHHMa-
HHSI CMbICJIa, nepeBOlI aHrJIHHcKoro CllOBa «validation» KaK «BaJIHlIaUHSI».
PyccKHH CneUHaJIHCT - lleJIOBeK OTKpbITblH H .D.oBep4HBbIH. HHKTO He
3anO.D.03pHJI nO.D.BOxa. Y Bcex cpa3Y )l(e B03HHKJla HJIJII03HSI 4ero-To HOBO-
ro, 3ara.a04Horo H HaM 1I0CeJle HeH3BecTHoro. nOJIO)l(eHHe 6blJlO BKOHeu
3anyraHo TeM, 4TO npH4aCTHaSl K 3TOMY «HaYKa», caMa HH4ero He nOHH-
MaSl, BOBCIO HanYCKaJIa TYMaH.
C TaKHM )l(e ycnexoM MO)l(HO 6blJIO «nepeBeCTH» Ha PYCCKHH Sl3blK
nOHSlTHe «Good Manufacturing Practice» KaK «ry.D. M3HblO<!:>aK4YPHHr
np3KTHc», T04HO TaK >Ke 3aMeHHB aHrJIHHCKHe 6YKBbl PYCCKHMH, H
ynopHo ero HaCa)I(.D.aTb.
npHWJlOCb pa36HpaTbCSI. o Ka3aJIOCb, 4TO «BaJIH.D.aUHSI» - 3TO Ta )l(e
aTTeCTaUHSI, HcnbITaHHSI, 3HaKOMble Ka)l(1l0MY HH)I(eHepy. A «BaJIH.D.aUH-
OHHblH MaCTep-nJIaH» - 3TO Bcero JIHWb nporpaMMa HCnblTaHHH. B
HallleM CJIOBape eCTb H .D.Pyme, 60JIee rJly60KHe TepMHHbI, HanpHMep,
MeTO.D.HKa HcnbITaHHH, nJIaHHpOBaHHe HcnblTaHHH H np.
Bce 3TO .D.aBHbIM-.D.aBHO 6bIJIO o<!:>0pMJIeHO H yrBep)I(.D.eHO B BH.D.e
TOJIKOBOH CHCTeMbl 1I0KYMeHTOB - ECKlI. - ElIHHOH CHCTeMbl KOH-
CTPYKTOpCKOH .D.OKYMeHTaUHH (rJIaBa 9). De3 Hee He TOJIbKO He 6blJIO 6bl
HH O.D.HOro CKOJlbKO-HH6Y.D.b cepbe3Horo H31IeJl, HSI Hac 6bl Ha Ka)I(.D.OM
wary «6HJlO TOKOM», Ha Hac na.D.aJIH 6bl KHpnH4H, a 0 6e30naCHOCTH
TpaHcnopTHblX cpelICTB H roBOpHTb He npHXO.D.HJIOCb 6bl.
Ha.D.YMaHHble nOHCKH HeCYllleCTBYlOlllHX TOHKOCTeH H pa3JlH4HH B
TepMHHax npH nepeBO.D.e C aHrJIHHcKoro Ha .D.PyrHe Sl3blKH CTaJIH
6YKBaJIbHO 6H40M.
nopa YBa)l(aTb ce6S1. B KHHrax H ny6JlHKaUHSlx nOSlBHJIOCb CJ10BO
«i!.Iloccapuu», nO-aHrJIHHCKH - «glossary). B nepeBO.D.e OHO 03Ha4aeT «010-
6apb mepMUH06» HJlH npoCTO «mepMUHbl». B MocKBe eCTb 60JIbWHe Mara-
3HHbl, me Ha cnHHe npOlIaBUOB HanHcaHO «MepLfeHdaU3ep» , nO-PYCCKH -
npOlIaBeu, a eCTb H «cblOnep6au3uH2 MepLfeHdau3ep» - cTapwHH npO.D.aBeu.
nOHeBOJIe BcnOMHHalOTCSI CTpaHbl, me 3a HeYBa)l(eHHe K CBoeMY Sl3blKY
lllTpa<!:>YIOT, .D.a TaK, 4TO npOCBeTJIeHHe HacrynaeT 04eHb 6bICTpO.
3allll1Ta PYCCKoro S13blKa - OTlIeJlbHaSl 60JIbWaSi np06JleMa, OHa Bbl-
XOlIHT 3a paMKH KHHrH. Ho Mbl He MO)l(eM OCTaBaTbCSl paBHOlIYWHblMH K
rJIYMJleHHIO Hall HaWHM S1JLIKOM H HaweH KYJIbTYPoH.

flpuHu,unbl pa60mbl no GM P
53
Ta6J/uu,a 2.1
TepMHHbl npaBHJI GMP, BHeClliHe HaH60JlbmylO nYTaHHUY
OnpeD.eJleHHR Ha nepeBOD. onpe1le- TepMHHbl
TepMHH aHrJlHHCKOM S13b1- JleHHR Ha PYCCKHH KOMMeHTapHH no rOCTy
Ke R3blK
Qualification Action of proving !IeAcTIJl.HI. 1l0KaJbl- CMbICJ1 060HX I-1cnOJ1bJOBaTb
that any equipment BalOllU1C, 'ITO 060py- TCpMHHOIJ 01ll1Ha- npHH!!TbIC B
works correctly and 1l0BaHHC pa60TaeT KOB H OJHa'mCT PYCCKOM IIJblKC
actually leads to ex- npaBlIJ1bHO H cro nOllT!!Cp)I(jJCH HC TCpMHHbl «HC-
pected results. Thc HCnOJ1bJOllaHHe llCH- COOTIJCTCT!!H!!. nbITaHHfI') H
word validation is CTBHTCJ1 bHO llaeT TepMHH «(1TTeCTaUI1S1) C
somctimes widened OJKHllaCMblC peJYJ1b- «Qualification.) YK,naHHeM
to incorporate the TaTbL TCPMHHY «Ba- npHMCH!!CTCII. B npellMeTa npo-
concept of qualifica- J1HllaUHII') HHoma OCHOBHOM K 060- HCpKH, HanpH-
tion npHllaeTclI 60J1ee PYllomlHHIO (lQ, MCP, «HcnbITa-
WHpOKHA CMbICJ1 H OQ. PQ). HH!! 060PYllolla-
OH BKJlIO'laeT B ce611 TepMHH "Valida- HJ1S1). «3rreCTa-
nOHIITHe «aTTeCTa- tion" npI1MCH!!eT- UHII MeTOlla».
UI1S1) CII. B OCHOIIHOM K
Validation Action of proving in !IeAcTBH!!, 1l0KaJbl- npoueccaM, HO
accordance with the BalOWHe B COOTlleT- :no pa3J1H'IIIC HC
principles of Good CTBHH C npaBHJ1aMH 'IeTKoe. llPyrHe
Manufacturing Prac- GMP, 'ITO J1106all HopMaTHBHble 110-
tice. that any procc- MeTOllHKa, npouecc, KYMeHTbl npHBHO-
dure, process, mate- 060PYlloBaHHe, Ma- CIIT llPyroH
rial, activity or sys- TepH<lJ1, lleAcTBHe CMbICJ1, 'ITO ycy-
tern actually leads to HJ1H CHCTeMa lleA- ry6J1l1eT nYTaHiIUY.
expected results (see CTBHTeJ1bHO llalOT 06a TepMHHa 'Ia-
also qualification). OJKHllaeMble peJYJ1b- CTO HCnOJ1bJYIOTC!!
TaTbl (CM. TaKJKe KaK CHHOHHMbl.
«aTTeCTaUHII» )
Validation B PYCCKOM IIJblKe CCTb TepMHH
Master Plan «nporpaMMa HcnbITaHHfi». BKJlIO'leH
B fOCT.
Proced u res. Give directions for !IalOT YKaJaH HII no B PYCCKOM IIJblKe I-1cnOJ1bJOllaTb
performing certain BbIllOJ1HeHHIO onpe- HlleHTH'IHbIMH H TepMHHbl «HH-
Standard operations lleJ1eHHblX lleHcTBHH 06wenpHHIITblMH CTPYKUHII» H
Operation TepMHHaMII HlJJ1!!- «(MCTOllHKa).
Procedure IOTCII «HHCTPYK-
(SOP) UHII') (no IIbIllOJ1-
HeHHIO pa60Tbl) II
«MCTOllHKa.) (npo-
Belle H Hfl HcnblTa-
HHH).
nOlIBOlISi HTOr paCCMOTpeHHIO BOnpOCa 0 TepMHHaX, nO.D.4epKHeM,
'ITO K HHM HY)I(HO nOlIXOlIHTb OC03HaHHO.
B poMaHe B. nl1KYJlSI «1-13 rynI1Ka» eCTb TaKOH 3nI13011. B Ha1.JaJle 1918 r.,
B MYPMaHcKe, BepHYBWI1HCSI B POCCI1IO MOpSlK yrolllaJl 6apblwHIO 4>paHuY3-
CKI1M KOHbSlKOM. Ha 6YTblJlKe 6bllla Ha1lnl1Cb «COGNAC». MOpSlK He Y1la-
pl111 JlI1UOM B rpSl3b 11 nepeBeJl: «BOT, K npl1Mepy, 3TOT CocHac ...».
HaM BceM nopa, HaKOHeu, YBa)l(aTb CaMI1X ce6S1 H Haw BeJlHKHH
PYCCKHH 513bIK, He n03BOJlSI1 nOPICBaTb ce61 «COCHaCOM» OT G MP.

54
1J1Oea 2
2.6 rOpbl 6YMar " 6H3Hec Ha GMP
nOCJle TOro, KaK npaBHJIa GMP CTaJIH Ha 3anane 06S13aTeJlbHbIMH,
04eHb CKOpO nmlBHJIHCb JIlOlIH, KOTopble co06pa3HJIH, 4TO Ha HHX MO)l(-
HO 3apa60TaTb. nepBblMH npHWJIH «BaJIHlIaTOpbl'). 3TO HMH 6blJI HCKYC-
CTBeHHO BBClIeH TepMHH «BaJIHllaUHSI» (validation), HecMoTpSl Ha HaJIH4He
H.D.eHTH4Horo TepMHHa «HcnbITaHHSI» (testing).
B KOHue 60-x - Ha4aJIe 70-x ro.D.OB B MHp npOH3BO.D.HTeJIeH JIeKap-
CTBeHHblX Cpe.D.CTB npHWJlO nOHHMaHHe, 4TO 060PY.D.OBaHHe .D.OJI)I(HO co-
OTBCTCTBOBaTb Tpe60BaHHSlM npouecca, ero Hy)I(HO HCnblTblBaTb .D.O Ha4a-
JIa HCnOJIb30BaHHSI H npOBepSlTb B 3KCnJIyaTaUHH.
nepBblM TOJl4KOM K 3TOMY nOHHMaHHIO 6bIJI HeC4aCTHblH CJIY4aH B
CKaJIHCTblX ropax (Rocky Mountain), CWA, Koma H3-3a HerolIHoro CTe-
pHJlH3aTOpa 6blJIa BbInYllleHa cepHSI HeCTepHJIbHblX HH<!:>Y3HOHHbIX pac-
TBOpOB. l1.D.eoJlorHSI npoBepKH COOTBeTCTBHSI o60PY.D.oBaHHSI, ero Hcnbl-
TaHHH CTaJIa OCTpO BOCTpe60BaHHOH. ct>apMaueBTH4eCKaSi npOMbllllJleH-
HOCTb, TOJIbKO HelIaBHO nepeH.aSl OT anTe4HblX MaClllTa60B K npOMblW-
JIeHHOMY npOH3BO.D.CTBY, He HMeJIa HH onblTa, HH CneUHaJIHCTOB, BJla.D.e-
IOIllHX MeTO.D.HKOH 3a.D.aHHSI Tpe60BaHHH K 060PY.D.OBaHHIO H ero HCnblTa-
HHSlM.
ECTecTBCHHblM H npaBHJIbHblM peweHHeM 6blJI0 6bl B3S1Tb OnblT .D.PY-
mx OTpaCJleH. B .D.eHCTBHTeJlbHOCTH npOH30WJlO He4TO npoTHBOnOJIo)J(Hoe.
06 3TOM paCCKa3bIBaeT ll)l(oH Wapn, H31IaTeJIb npaBHJI GMP BeJIH-
K06pHTamu1 H O.D.HH H3 nepBbIX HHcneKTopOB GMP B CBoeH KHHre [53,
CTp. 357].
B 1974 r. .D.Ba PYKOBO.D.SlIllHX pa60THHKa FDA (E. Beyers u B. Loftus)
BBeJIH TepMHH «validation». BCKope nOCJle 3TOro OHH YBOJIHJIHCb H opra-
HH30BaJIH c06cTBeHHble KOHcYJlbTaUHOHHble <!:>HpMbl. Ha4aJICSI 6YM KOH-
<!:>epeHUHH, ceMHHapoB, KHHr no BaJIHllaUHH, KOHe4HO, B COOTBeTCTBHH C
Tpe60BaHHSlMH Han30pHoro opraHa. 3TOT 6YM Ha6paJI 60JIbWHe 060POTbl
H CTaJI 6H3HecoM .D.J1S1 MHOrHX JIlOlIeH. Koma B cpelIY CneUHaJIHCTOB
npHlllJIO nOHHMaHHe, 4TO 3a TYMaHHblM MHoroCJlOBHeM CTOSIT .D.aBHO H3-
BeCTHble MeTO.D.HKH HCnbITaHHH, TOJIbKO pa3pa60TaHHble C Y4eToM cne-
UH<!:>HKH <!:>apMaueBTH4ecKoro 060PY.D.OBaH, HSI .D.eJIO 3aWJIO CJlHlllKOM .D.a-
JIeKO. 3TOT 6H3Hec CTaJI .D.HKTOBaTb npaBHJla HrpbI.
HaBelIeHHe nOpSl.D.Ka OKa3aJIOCb np06JIeMoH.
B 90-e ro.D.bl pa60Ta no G M P npeBpaTHJIaCb B 6YMaroTBop4ecTBo H
caM TepMHH GMP CTaJIH C ropbKoH HpoHHeH pacwH<!:>poBblBaTb KaK
«Great Mounts of Papel'» - «EOJ1bUlUe Opbl 6YMaU') (pHC. 2.2, H3 )l(ypHaJIa
«TeXHOJlOrHSi 4HCTOTbl» NQ 2/2009, c. 24, LlOKJIalI r. ct>apKBapcoHa Ha
KOH<!:>epeHuHH PHSS B oKTSl6pe 2008 r., HOTTHHreM, AHrnHSI).
l(eJlb - 6e30naCHocmb U Kallecm60 6blJla noOMeHeHa npou.eccoM!
3TY onaCHOCTb nOHHMalOT MHOrHC, H C HelO BelIeTCH 60pb6a, He
Bcema ycneWHa51 (rnaBbl 9, 14 H 15).

flpUHlI,Unbl pa60mbl no GM P
55
Ha.D.YMaHHbIM SlBJlSleTCSI no-
HSiTHe «MeHelI)I(MeHT Ka4eCTBa».
npOnaraH.D.a CHCTeMbl I1CO 9000
.D.J1S1 npOH3BOlICTBa JleKapCTBeH-
HblX Cpe.D.CTB Ha 3analle pe3YJIbTa-
Ta He .D.aJIa BBHlIY TOro, 4TO OHa
HH4ero K GMP He .D.06aBJlSleT. B
CTpaHax, me GMP HeT, MapKeTO-
110rH OT I1CO 9000 npOUBeTaIOT,
HeCMOTpSl Ha TO, 4TO HH4ero He
.D.alOT llJlSl Ka4eCTBa H .D.e30pHeH-
THPYIOT Bcex: npOH3BOlIHTeJleH,
Ha.D.30pHble opraHbl H nOTpe6HTe-
l1eH (maBa 14).
B nOCJle.D.HHe ro.D.bl B EBpone
ynopHo HaCa)I(.D.aIOTCSI MeTO.D.bl
aHaJIH3a pHCKOB. CaMa H.D.eSl aHa-
JIH3a pHCKOB He HOBa H CO.D.ep)l(HT
paUHOHaJIbHble 3JleMeHTbl, HO HCKyCCTBeHHO C031IaHHble MeTO.D.bl a6COJlIOT-
HO He npHrolIHbl H ynO.D.S1T B CTOPOHY OT 3a.D.a4 GMP (maBa 15).
Bce 3TO JIHlllb cnoc06bl 3apa6aTbIBaHHSI .D.eHer Ha GMP. OHH He
TOJIbKO 6eCnOJIe3Hbl, HO H Bpe.D.Hbl, nOCKOJIbKY nOlIMeHSIIOT .D.eJIO nYCTbIM
COCTaBJleHHeM 6YMar H C03.D.aIOT HJIJII03HIO .D.eJIa BMeCTO caMoro .D.eJla.
I-b06peTaTeJlH HaYKo06pa3Hblx MeTO.D.OB .D.eHCTBYIOT Be3.D.e, H 60-
JIe3Hb npH06peJla onaCHblH xapaKTep.
'-
-......-= .,
J-
#
-
-'"
l':-
-
--
-,\_,
- ..4-,
".. ';I
. - ,
....
..
'\
...
... .
..... ......&....-
PHC. 2.2. 11 3TO GMP?

-
113BecTHblM CneUl1aJ1l1CT no Ha1le>KHOCTI1 npo4>. 11. A. YwaKoB, nepe-
eXaBWI1H B CiliA, nl1WeT [8], 4TO OH 3a1laJI Bonpoc CBoeMY 1lPYry P. MaKo-
llY, OllHOMY 113 aBTopoB 4>YHllaMeHTaJlbHOH KHl1rH «CI1CTeMOTeXHI1Ka» (rY1l
11 MaKoJl):
- lJeM Bbl3BaHO nOSlBJleHl1e HOBOro HanpaRJIeHHSI - HaYKI1 ynpaRJIe-
HI1$1, «Management Sciences»? Be1lb 6blJla 01lHO BpeMSI Ku6epHemUKG, nOTOM
OHa nopo1ll1J1a cucmeMOmeXHUKY, nOTOM B03HI1KJ10 UCCJle006GHUe onepat(uit, a
Tenepb - HGYKG ynpG6J1eHUR.
- TaK Tbl Y>Ke OTBeTI1JI Ha CBOH Bonpoc: CMeHa M01lbl! Ka)I(1lbIM pa3
npl11lYMblBaeTCSI HOBoe Ha3BaHl1e, 1.JT06bl 3aCTaBI1Tb TOro, KTO nJlaTHT, pac-
KOWeJII1TbCSI - 3TO >Ke HOBOe! 31'0 >Ke JlY'Iwe, 1.JeM 6blJl0 paHbwe! - CKa3aJl
c aMepl1KaHCKOH npSlMOTOH MaKoJI.
na, Bce 3TH MeHelI)I(MeHTbl, I1CO 9000, aHaJIM3bl pHCKOB H BaJIH.D.a-
UHH - JIHWb 6pocKHe Ha3BaHHSI, 0603Ha4alOIllHe 3Tanbl HCKYCCTBeHHoro
H3MeHeHHSI MO.D.bl Ha MeTOlIbl B3HMaHHSI lIeHer C npOH3BOlICTBa.
T04Ho TaK )l(e npelIHaMepeHHO pe)l(HCCHpYIOTCSI H3MeHeHHSI B MHpe
)KeHcKOH MOlIbl. Ho )l(eHCKaSi MOlIa He CBSl3aHa C 6e30naCHOCTbIO H He
npHKpblBaeTCSI «HaYKOH». TaM Hapoll 4eCTHee H np5lMee.

.
-
....-
'" . 
.........".-«....-_.
"0'
...r
, .,
- ,
. ..
I
\
.....
PHC. 2.2. 11 3TO G MP?

56
IJw6a 2
MHp JIeKapCTBeHHblx cpelIcTB, KaK H Jl1060e cepbe3Hoe .D.eJIO, OTJlH-
4aeTCSI OT lIeKopauHH: HHKaKaSi MOlla B HeM HelIonYCTHMa, Bce .D.OJI)I(HO
6bITb nO.D.4HHeHO 06ecne4eHHIO 6e30naCHOCTH H Ka4eCTBa, S1CHO H npo-
3pa4HO, 6e3 3aTYMaHHBaHHSI H pHTOpHKH B yrolIY 4bHM-TO KapMaHaM!
I1cKyccTBeHHoe 3aryMaHHBaHHe H MeHelI)I(MeHTbl BpelIHbl H npeBpa-
THJlHCb B pHryaJIbHblH TaHeu, KOTOpblH Koe-me Tpe6YIOT OT npOH3BO.D.-
CTBCHHHKOB. 3TO lIHCKpelIHTHpYIOT npaBHJIa GMP B 31I0pOBOM BocnpHSI-
THH npaKTH4eCKHX pa60THHKOB, KOTopble HHTYHTHBHO 4YBcmYIOT
<!:>aJlbWb.
ABTop pe3KO BblCrynaeT npOTHB HeHY)I(HbIX, HCKYCCTBeHHO npHlIY-
MaHHblX MeTOlIOB, nOCKOJIbKY Ha JlH4HOM on bITe 3HaeT HX Bpe,lJ,. Y npOH3-
BO.D.CTBeHHHKa O.D.Ha H TOJIbKO OlIHa Jana4a: BbInYCKaTb npOlIYKUHIO B CO-
OTBeTCTBHH C 3a.D.aHHbIMH Tpe60BaHHSlMH, B nOCTOSlHHO MeHSIlOweHcSI 06-
CTaHOBKe, B peaJIbHOM BpeMeHH. Bce OCTaJIbHble .D.OJDKHbl eMY nOMoraTb.
KOMY ew.e 6bllOiJHbi «6aJluiJau.UH» U npollee?
nyraHHua B TepMHHOJlOrHH (BaJIHlIaUHSI, MeHe.il)l(MeHT Ka4eCTBa H
np.) Hy)I(Ha He TOJIbKO TeM, KTO Ha 3TOM 3apa6aTblBaeT. OHa HY)I(Ha He-
.D.06pOCOBCCTHbIM JlHuaM H3 4HCJla PYKOBOlIHTeJleH CJIY)I(6 Ka4eCTBa OT-
.D.eJIbHblX npe.D.npHSITHH, KOTopble .D.aBHO nOHSlJIH, 4TO BMeCTO npe.D.MeT-
HOH pa60Tbl H peaJIbHoro 06ecne4eHHSI Ka4eCTBa MO)l(HO )l(OHmHpOBaTb
HaYKo06pa3HblMH TepMHHaMH H C031IaBaTb ropbl 6YMam, BocnpHHHMae-
MblMH HHcneKTopOM.
B CTpaHe eCTb npe.D.npHSITHSI, KOTOpble Y)I(e C03.D.aJIH ropbl 6YMarH
no,lJ, BH.D.OM GMP, B TOM 4HCJle no BaJIH.D.aUHH. D.nSl HHX HaBe.D.eHHe no-
pSl.D.Ka B TepMHHOJIOrHH rp03HT onaCHOCTbfO nepeCMOTpa CBoeH .D.eSlTeJIb-
HOCTH H He06xo.D.HMOCTblO 3aHSlTbCSI 06ecne4eHHeM Ka4eCTBa no cYllle-
CTBY, a He Ha 6YMare. OHH, nOXO)l(e, H SlBJlSlIOTCSI OCHOBHblMH anOJIore-
TaMH TepMHHa «BaJIH.D.aUHSI».
nyraHHua HY)I(Ha H Koe-KOMY H3 Ha1I30pHblX opraHOB, KTO He B CO-
CTOSlHHH .D.aTb peaJIbHYIO oueHKY pa60Te npelInpHSlTHH BBHlIY c06CTBeH-
HOH HeKOMneTeHTHOCTH. rOpa3.ll0 Jler4e onepHpOBaTb 06WHMH TYMaH-
HblMH <!:>pa3aMH, 4eM 3HaTb .D.eJIo.
Ha 3ana.D.e nOSlBHJIOCb HOBoe - "know/edge management". no PYC-
CKHH 3TO 03Ha4aeT «opraHH3aUHSI 06Y4eHHSI». HH4ero HOBOro B HeH HeT,
HO OHa aKTYaJIbHa. Y Hac Hai1nyrcSi JlHua, KOTopble ee nepeBe.D.yr KaK
«MeHedJICMeHm 3HaHUU», a TO H «HoYJleoJIC MeHeo.JlCMeHm», .D.OKa3blBaSl, 4TO
B PYCCKOM S13blKe HeT aHaJIoroB 3THM Y4eHbiM CJlOBaM, H 04epelIHaSl
KopMYWKa THna BaJIHlIaUHH roToBa. Ha npelInpHSlTHSlX Hai1nYTCSI JllOlIH,
KOTopble BMeCTO c06CTBeHHOH pa60Tbl no opraHH3aUHH 06Y4eHHSI (a 3TO
HeJlerKO!) 3aXOHn nOHTH no nyrH C031IaHHSI 04epelIHblX rop 6YMam.
KOMY 6ce :Jmo He 6blloOHO?
BcSI 3Ta MHwypa npOTHBope'IHT l1HTepeCaM maBHblX lIeHCTI3YIOWHX
JlHU - nOTpe6HTeJleH npOlIYKUHH. OHa HC BblrolIHa lIo6poCOBCCTHblM

flpuHu,unbl pa60mbl no GM P
57
npOH3BOlIHTeJISlM H npo<!:>eCCHOHaJIbHblM opraHH3aUHSlM, BXOlISlIllHM B
HH<!:>paCTPYKTYPY npOH3BOlICTBa.
nOlIMeHa lIeJla ropaMH 6YMar ry6HT npOH3BO.D.CTBO.
HeHY)I(HOe 6YMaroTBop4eCTBO paBHOCHJIbHO 06paCTaHHIO Kopnyca
Kopa6JISI paKYWKaMH. HOBblH Kopa6JIb lIBH)I(eTCSI YBepeHHO, 3aTeM, no
Mepe 06paCTaHHSI paKYWKaMH, 3aMe.D.J1S1eT XO.D., a Koma HX Macca npe-
BblwaeT KpHTH'leCKHH npe.D.eJI - MO)l(eT nOHTH Ha .D.HO.
-
---
-
toO
--
a) LlBI1>KeHl1e 6e3 nOMex
b) 06paCTaeM paKYWKaMI1 c) MlleM KO 1lHY
PHC. 2.3. HapoCT nory6HT, eCJIH ero He y6paTb
B TeopHH nepelIa4H .D.aHHbIX eCTb TaKoe nOHSITHe KaK COOTHoweHHe
CHrHaJI/WYM. ECJlH BeJIH4HHa WYMa npH6JlH)I(aeTCSI K BeJlH4HHe CHrHaJIa,
TO CHrHaJI CTaHOBHTCSI Hepa3JlH4HMbIM, T. e. WYM nOlIaBlISleT ero.
HeJIb3S1 .D.OnYCTHTb, 4T06bl CMblCJI GMP yrOHYJI B CJlOBeCHOH weJIyxe.
2.7 TpY,lJ,HOCTH OCBoeHHH GMP
Mbl - CTpaHa napalIOKCOB. Y Hac CHa4aJIa BBSl3bIBalOTCSI B 601'1, a
nOTOM Ha4HHalOT .D.YMaTb. PeKoHcTPYKUHIO Ha4HHalOT 6e3 npoeKTa HJlH
3aKa3bIBalOT npoeKT Y JlHU, KOTopble KpaCHBO roBOpSiT H npe1lJlaralOT
HH3KHe ueHbl. nOTOM OKa3bIBaeTCSI, 4TO C.D.eJIaHO He Bce HJIH Bo061lle He
TO. Ha nepe.D.eJIKH TpaTSIT 60JIbllle, 4eM Ha C03.D.aHHe npOH3BO.D.CTBa KaK
CJlelIyeT C nepBoro pa3a.
npHHSlTO C4HTaTb, 4TO BHelIpeHHe GMP Tpe6yeT HenOMepHblX Ja-
TpaT. OnblT roBOpHT 0 npSlMO npOTHBOnOJlO)l(HOM: lIeHbrl1 TpanITCSI, no-
POH 6oJlbwe, 4eM HMO, a npOH3BOlICTBO He COOTBeTcTByeT G M P.
B 4eM npH4HHa?
ECTb HeCKOJIbKO onacHocTeH, KOTopble nOlICTeperalOT npelInpHSlTHSI,
OCBaHBalOlllHe pa60TY no G M P.
1. CllMblii cmpaUlHblii 6pal - HeKOMnemeHmHocmb
3a pa3pa60TKY HopMaTHBHblX 1I0KYMeHTOB, npoeKTOB, 3a KOHCYJlb-
THpOnaHl1e, npenOlIaBaHHe, aTTeCTaUHIO 6epYTcSI Bce. Ho .D.aJleKO HC Bce
11 Me lOT JlH4HblH OnbIT pa60Tbl H pe3YllbTaTbl CBoeHlIeHTeJlbHOCTH, nOlI-
TBCp)l(lICHHblC npaKTI1Koi1. B HTore Y Hac Moryr BblKJIa.lJ.blBaTb TpoTyap

58
[;106a 2
H3 30JIOTblX nJIHTOK, a Ha Konee4HblX <!:>HJIbTpaX 3KOHOMHTb. 113-3a 6e3-
rpaMoTHoro npoeKTa, HeHY)I(Horo YCJIO)l(HeHHSI peweHHH, npH06peTe-
HHSI 1I0pororo, HO nJlOxoro 060PYlIOBaH, HSI 6e30TBeTCTBeHHoro OTHO-
llleHHSI nepCOHaJIa lIa)l(e 60JIbWHe 3aTpaTbl He .D.alOT pe3YJlbTaTa.
2. llpuiJaHue GMP CMbICJla, KomopOlO 6 IlUX Hem
O.n.HH H3 KOMMeHTaTopOB GMP, CTapaSiCb HMeTb Y4eHblH BH.D., BMe-
CTO CJIOBO «HHTepnpeTaUHSI GMP» CKa3aJI «UHmepmpenau,UfI».
06paCTaHHe KOMMeHTapHSlMH, HeHY)I(HblMH YCJIO)l(HeHHSlMH H 3any-
TbIBaHHe, no He3HaHHIO HJIH HaMepeHHO, ry6S1T .n.eJlo. He TaK CTpaWHbl
G MP, KaK HX UHmepmpenau,UfI, T. e. 6e3rpaMoTHaSl. MHoroCJlOBHaSi H
6eCCMblCJIeHHaSi TpaKTOBKa, HaCa)l(.D.aeMaSi npelInpHSlTHSlM.
3. (/)0PMtLIlU3.M - lie MeHbUlee 3.tl0
rOpbl He HMelOlllHX OTHoweHHSI K npe.D.MeTY .n.OKYMeHTOB, 60JIblllHX
no o6DeMY H Becy, nJIOXO H npOTHBope4HBO HanHcaHHblX, C03.D.aIOT UJl-
Jl103UlO iJeJla 6Mecmo CllMOlO iJeJla. 3TH .D.OKYMeHTbl HHKTO He 4HTaeT. I1x
Ha3Ha4eHHe - JIe)l(aTb Ha nOJlKe .D.J1S1 BH.D.a, .D.J1S1 KOMHCCHH. TaKoH no.D.XO.D.
HCKa)l(aeT caMY Cyrb GMP.
4. HeHY:JICHOe YCJlO:JICHeHUe U 3anymbl6allue iJeJla
MHOrHe BbInOJlHSlIOT JIHlllHIOIO, HeHY)I(HYIO H YBO.D.SlIllYIO B CTOpO-
HY pa60TY.
BepHble peUleHUH, KaK npa6UJlO, npocmbl. Ho OHH He JIe)l(aT Ha no-
BepXHOCTH H He Bcer.aa 04eBH.D.Hbl. Kor.aa OHH Hai1.D.eHbl, HX JIOrHKa MO-
)l(eT 6blTb 06"bSlCHeHa B npoCToH H .D.OcTynHoH <!:>opMe.
YT06bl npHHTH K npaBHJIbHOMY peweHHIO, Hy)I(HO HMeTb onblT, HY)I(-
HO caMoMY npOaHaJIH3HpOBaTb cHryaUHIO H HH4ero He npHHHMaTb Ha Be-
Py. HY)I(HO OCTOpO)l(HO nO.D.XO.D.HTb K COBeTaM KOHcYJlbTaHTOB, oc06eHHo
TeopeTH3I1pYIOIllHX. C4HTaTb, 4TO 3a ryMaHHblMH <!:>pa3aMH H Y4eHblM BH-
.D.OM KpoeTcSI 4TO-TO cToSllllee, 03Ha4aeT 3aHHMaTbCSI caMo06MaHoM.
5. HenpoiJYMaHHocmb peUleHuii
Y MHOrHX OTcyrcTByeT nOHHMaHHe TOro, 4TO Jl1060e iJeJlo HY:JICHO xo-
pOUlO npoiJYMamb, H3JlO)l(HTb Ha 6YMare H oueHHTb pa3Hble BapHaHTbl pe-
aJIH3aUHH. npH 3TOM HY)I(HO SlCHO nOHHMaTb ueJIeBYIO 3a.D.a4Y H Tpe60-
BaHHSI, KOTopble HY)I(HO BbInOJlHHTb. ECJIH pe'lb H.D.eT 0 CTpOHTeJlbCTBe H
peKOHCTpYKUHH, TO HY)I(HO Ha4HHaTb C npoeKma. De3 npOCKTa HeJlb3S1
.D.eJlaTb HH wary.
HY:JICHO ceMb pa3 OmMepUmb U OiJUH pa3 ompe3amb. XopowaSi npo-
eKTHaSl opraHH3aUHSI lIeJIaeT HeCKOJlbKO BapHaHTOB npoeKTHblx pewe-
HHH. PaCCMaTpHsaSl I1X, JaKa34HK JIY4we nOHHMaeT 3alIa4Y (a HHor.aa
TOJIbKO Ha4HHaeT ee nOHHMaTb) H nOJlY4aeT OCHOBY .D.J1S1 OC03HaHHoro
npHHSlTH1 peweHHSI.

flpUHlI,Unbl pa60mbl no GM P
59
LlYMaTb caMOMY TpYlIHee, 4eM CJIYlllaTb KOro-TO. Ho 3TOT TPY.D.HbIH
nyrb - e.D.HHCTBeHHbIH .D.J1S1 Tex, KTO lIeHCTBHTeJlbHO 03a604eH .D.eJIOM H
X04eT HaHTH BepHoe peweHHe.
6. heCCUCmeMHOCmb 6 pa60me
Jl1060e lIeJIO Ha4HHaeTCSI C nJIaHa opraHH3aUHOHHO-TeXHH4eCKHX
MeponpHSITHH.
B HeM 4eTKO H SlCHO .D.OJl)l(Hbl 6bITb H3JlO)l(eHbl OCHOBHble Mepbl no
OCBoeHHIO Tpe60BaHHH GMP, 6e3 JIHWHeH lIeTaJIH3aUHH BTOpOCTeneH-
HblX nYHKTOB. nJlaH .D.OJl)l(eH 6bITb peaJIbHblM, 06ecne4eH pecypcaMH H
pa3BepHyr BO BpeMeHH. OH MO)l(eT COlIep)l(aTb BCero HeCKOJIbKO nYHKTOB,
HO OHH .D.OJI)I(Hbl 6blTb BbInOJIHHMbl.
Ype3MepHO 60JIblllHe nJIaHbl, KaK npaBHJIO, HepeaJIH3yeMbl. OHH
CKopee lIe30pHeHTHpYfOT, 4eM CJIY)I(aT SlCHblM PYKOBO.D.CTBOM K .D.eHCTBHIO.
BbInOJIHeHHe nJIaHa Hy)I(HO KOHTpOJlHpOBaTb H BHOCHTb, npH He06xo.D.H-
MOCTH, Koppe KTH Bbl B Hero.
7. Pa60ma no OmCmaJlblM iJoKYMeHmllM
Pa60TaTb HY)I(HO no COBpeMeHHblM CTaHlIapTaM, 4T06bl MO)l(HO 6blJIO
npO.D.aBaTb np0.D.YKUHIO Ha JII060M pblHKe H B .D.J1HTeJIbHOH nepCneKTHBe.
YTO KacaeTCSI GMP, TO 3TO - GMP EC. MO)l(HO HCnOJIb30BaTb cGMP
FDA CiliA, eCJIH CTaBHTCSI xopOlllaSi 3a.D.a4a BXO)I(.D.eHHSI Ha pblHOK 3TOH
cTpaHbl no npHMepy I1H.D.HH H KHTaSi.
8. Henpa6UJlbllaH 3KCTl.Ilyamau.UH npou360iJcm6a
nOCTpOHTb npOH3BOlICTBO, OCHaCTHTb ero XOpOlllHM 060PY.D.OBaHH-
eM, HaJIa.D.HTb ero pa60TY H aTTeCTOBaTb Ha COOTBeTCTBHe G M P MaJIO.
HY)I(HO TaK opraHH30BaTb 3KCnJlyaTaUHIO npOH3BO.D.CTBa (BbInOJIHeHHe
Bcex npoueccoB, y60PKY, TeXHH4eCKoe 06CJIY)I(HBaHHe, nOBelIeHHe H rH-
fHeHY nepCOHaJIa), 4T06bl ypoBeHb pa60Tbl He CHH)I(aJICSI B Te4eHHe Bce-
ro nepHO.D.a pa60Tbl npOH3BO.D.CTBa.
3TO TpYlIHaSi 3a.D.a4a. OnblT aY.D.HTa H HHcneKTHpOBaHHSI .D.a)l(e H3-
BeCTHblX 3analIHblX <!:>HPM roBOpHT, 4TO .D.opOrHe, OTJIH4HO OCHallleHHble
HOBbIe npOH3BO.D.CTBa MOryT 4epe3 HeCKOJlbKO JIeT nOCJIe nYCKa CTaTb He-
Y3HaBaeMbIMH. npH4HHa - OTcyrcTBHe .D.OJI)I(HOH opraHH3aUHH .D.eJla H
KOHTpOJISI HCnOJIHeHHSI.
B cepelIHHe 90-x rolIOB B MOCKBe nOSlBHJIHCb BeJIHKOJIenHble CY-
nepMapKeTbl, npeBOCXO.D.S1IllHe no 4HCTOTe H KYJlbType JIY4WHe 3apy6e)l(-
Hble aHaJIOm. Bce JlH CMOrJIH YlIep)l(aTb .D.OCTHrHyrbIH YPOBeHb? YBbl,
HeT. MHome H3 HHX npeBpaTHJIHCb B y60rHe ToproBble ueHTpbl, TaKHe
)l(e, 4TO 6blJIH 30 JIeT Ha3M, TOJlbKO 60JlbWHe no pa3MepaM.
npOH3BOlICTBO JleKapCTBeHHblX cpelICTB OTJlH4aeTCSI OT Mara3HHOB
TeM, 4TO OHO CBSl3aHO C 6e30naCHOCTbIO naUHeHTOB. CHH)I(eHHe YPOBHSI
pa60Tbl npelInpHITHH a6COJllOTHO HelIonYCTHMO.

60
[,106a 2
2.8 eHa - 6e30naCHOCTb H KalfeCTBO
KaKOBa ueHa G M P'? 3TOT Bonpoc JalIalOT 4aCTO. Ho OH He KOp-
peKTeH no cBoeH CYTH. OH npClInOJIaraeT, 4TO MO)l(CT 6bITb npoH3BolI-
CTBO no GMP, a MO)l(eT 6bITb He no GMP. Pa3HHua .D.aeT ueHY GMP. 11
HalIO e Ille nOlIYMaTb, CTOHT Jl H BBOlIHTb G M P.
CTaBHTb T<lK Bonpoc Bce paBHO, 4TO paCCY)I(1laTb, CKOJlbKO 6Y.D.eT
CTOHTb aBTOM06HJIb C TopM03aMH, a CKOJlbKO 6e3? ECJlI1 pa3HHua BeJlHKa,
TO nonp06yeM Ha TopM03ax C3KOHOMHTb. TaKaSi nOCTaHOBKa Bonpoca
HeB03MO)l(Ha. ABTOM06HJlb 6e3 TOpM030B HHKTO He BblnYCTHT B npO.D.a)l(Y.
D.nSl Ka)l(1loro npOH3BOlICTBa eCTb CBOH MHHHMaJIbHO .D.onycTHMblH
ypOBCHb 3aTpaT. YXOlI OT Hero B MeHbWYIO CTOPOHY npHBOllHT K ynpo-
llleHHIO H oWH6KaM. I1x nOCJlelICTBHSI He BH.D.Hbl cpa3Y.
Mbl Ha Ka)l(1l0M wary CTaJIKHBaeMCSI C cHTyauHeH, Koma 3aKa3LJHK,
)l(eJlafOIllHH opraHH30BaTb npoH3BolICTBO, 3KOHOMHT Ha Ka4eCTBe pewe-
HHH. EMY He HpaBHTCSI npaB.D.a, Koma CneUHaJIHCTbl roBOpSlT, 4TO H KaK
HY)I(HO ClIeJlaTb H CKOJIbKO HY)I(HO BpeMeHH, 4T06bl nOJIY4HTb npOH3BOlI-
CTBO no GMP. OH OXOTHO BepHT aBaHTlOpHCTaM, HX JaBepeHHSlM 0 COOT-
BeTCTBHH GMP no CXO.D.HOH ueHe. nOTOM, cnYCTSI ro.D.bl, C HHX HH4ero
cnpOCHTb 6YlIeT HeJIb3S1.
I1HorlIa Ha G M P OTHOCSIT paCXOlIbl. He06xOlIHMble .D.J1S1 Jl1060ro
npOH3BOlICTBa: CTpOHTeJlbCTBO TpaHc<!:>opMaTopHOH nO.D.CTaHUHH H
04HCTHblX cOOPY)I(eHHH, npOKJIa.D.KY HapY)I(HblX ceTeH, OT.D.eJlKY <!:>aCa.D.a
3.D.aH, HSI MeponpHSITHSI no nO)l(apHOH 6e30naCHOCTH H np. K GMP OHH
HHKaKoro OTHoweHHSI He HMelOT. ECJlH paCCY)I(1laTb, BO CKOJIbKO 06xo-
.D.SlTCSI GMP, HY)I(HO cpaBHHBaTb cpaBHHMoe, 6e3.D.06aBoK.
CKynoH nllaTHT .D.Ba)l(1lbl. 3TO CTapaSl HCTHHa. Ho .D.JlSl opraHH3a-
UHH npOH3BO.D.CTBa OHa He T04Ha. CKynoH H He.D.aJIbHOBHlIHbIH MO)l(eT
nOTepSlTb Bce.
Mbl He Yllacm6Ye.M 6 lOHKe 3a iJeUle6U31l0ii 6 ylU,ep6 Kallecm6y» - 3TO
n03HUHSI HeMeUKOH )J1pMbl MHJle - JlHlIepa B 06Jl<lCTH npOH3BOlICTBa
CTl1paJlbHblX H Moe4HblX MaWHH. 3Ta )pa3a OTpa)l(aCT CYTb lIeJla.
MHOrHe cPHpMbl TpaTSIT Ha pa3BHTHe npOH3BOlICTBa 60JlbWe, 'leM
Tpe6yeTcSI no MHHHM,lJlbHOMY paC4eTY. Y)I(e Ha nO.D.XOlIe K npelInpHSlTH-
SlM BH.D.HO, 4TO TaM lIeJIO HaJIa)l(eHO KaK CJIe.D.yeT, lITO HX COTPYlIHHKH
YBa)l(alOT ce6S1 H nOTpC6HTeJIeH CBodi npOlIYKUHH, 4TO TaM Bce HanpaB-
JleHO Ha rJlaBHOe - Ka'leCTBO.

nplIHl(1II1bl pannl11bl /10 GM P
61
Bo BpeMSI OlIHOii H3 nOe31I0K

B repMaHI110 Mbl nOCeTI111H 3aBOlI
j (Hp1\lbl E>aHep B JleBepKY3eHe.
/" : TaM pa60THHKH uexa no npoH3-
. _ BOlICTBY meplIblx <!:>OpM npoxolISiT
:..;' Ha pa60TY 4epe3 <'SlnoHcKHH Ca.D.') ,
. pa36HTblii Ha OTKpblTOM B031Iyxe
.. (pHC. 2.4). TaKoH call - .D.oporoe
YlIOBOJl, bCTIn1e HO OH C031IaeT
maBHoe - xopowee HaCTpoeHHe
nepCOHaJIa 11 nOlIcnYlIHO, Ha
ypOBHe nOlIC03HaHHSI <!:>opMHpyeT
CTepeOTHn nOBelIeHHSI, B KOTOpOM
HeT MeCTa pa360JlTaHHOCTH H
HepSlWJIHBOCTH, a Ha060poT, Ka)l(-
.D.blH C03HaeT, 4TO OH H.D.eT 3aHH-
MaTbCSI B BblcweH CTeneHH OTBeT-
CTBeHHblM .D.eJlOM npOH3BO.D.-
CTBOM JleKapCTBeHHblX cpelICTB.
HelIapOM 3TH <!:>HpMbl - JIH.D.e-
pbl. OHH npHWJlH BcepbC3 H Ha.D.OJl-
roo 11 OHH 3aCJly)l(HBalOT 1I0BCpHSI.
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3aBOlI <!:>HpMbl E>aHep,
JleBepKY3eH, repMaHHSI
2.9 EUJ,e p33 0 npHHHn3X
KpaeyroJlbHblM KaMHeM <!:>HJIOCOctJHH G M P S1BJlSleTCSI npHHUHn:
«flPOu36oiJumb npoiJYKu.UIO maK, IIm06bl iJefjJeKm 6blJl He603MO:JICeH». 3TOT
npHHUHn CTap, KaK MHp.
HamSllIHblM npHMepOM MO)l(eT CJlY)l(HTb HCTOpHSI C MOCKOBCKHM ne-
KapeM cDHJlHnnOBbIM, KOTOpblH B XIX BeKe OCHOBaJI H3BeCTHYlO 6YJI04HYlO
Ha TBepcKoH. HelIaJleKO OT EJlHceeBCKoro Mara3HHa. CJlY4aH C HHM onHcaH
B KHHre B. A. rl1JlSlpOBCKOro «MOCKBa H MOCKBJ1LIH».
01lH<1>K1lbl MOCKOBCKHH reHepaJI-ry6cpHaTOp, paJJlOMI1B 3a 3a1npaKOM
6YJlO'IKY, YBl111eJl B Heii TapaKaHa.
- bSI cai1Ka?
- $I1JIl1nnOBa.
- nOllaTb ero CI01la!
$11J1l1nnOB TYT >Ke S1BI1JICSI.
Pa3bSlpcHHblH ry6epHaTOp CYHYJI eMY nOlI HOC caHKY:
- 3TO 1.JTO?
- H3IOM. Bawe npeBOCXOmITeJlbCTBO.
H npomOTI1JI caHKY C TapaKaHOM.
- Bpewb! Pa3Bc CaHKI1 C I1JIOMOM 6blBalOT?
cDl111l1nnOB nOM1.JaJlCSI B neKapHIO, CXllaTI1J1 peweTO C I1JIOMOM 11 BbIBa-
111111 ero B TeCTO. epe3 'laC ry6epHaTopa yrOlU<UHI CaHKal\HI C 113IOMOM.

62
1:106a 2
113 :nOH HCTOpHI1 CJlelIyeT Ba)l(HblH BbIBOlI: TapaKaHa HeJlb3S1 1I0ny-
CTHTb B 6YJIKY. neKapHoe .D.eJIO HY)I(HO opraHH30BaTb TaK, 4T06bl TapaKaH
He Mor nonaCTb B TecTO. 3T0 - Tpe60BaHHe G M P .D.J1S1 XJle606YJl04Horo
npoH3BOlIcTBa.
O.D.HOH H3 ueJIeH npaBHJI npOH3BOlICTBa JleKapCTBeHHblX cpelICTB SlB-
JISleTCSI He iJonycmumb 3alpH3HeHUH npoiJYKu.uu nOCTopOHHHMH BellleCTBa-
MH. HanpHMep, HeJIb3S1 1I0nYCTHTb, 4T06bl H3-3a nJlOXOH KOHCTPYKUHH
Ta6JIeT04Horo npecca MeTaJIJIH4eCKHe '/aCTHUbl nOnaJIH B Ta6JleTKY. D.nSl
3TOro cyweCTBYIOT CneUHaJIbHble Tpe60BaHHSI K Ta6JIeTnpeccy, ero MaTe-
pHaJIaM, KOHCTPYKIlHH, HaJIH4HIO lIeTeKTopa MeTaJIJlH4eCKHX 4aCTHU H np.
)10JI)I(HO 6blTb HCKJlI04eHO H nepeKpecmHoe 3alpH3HeHue. llJlSl 3TOH
ueJIH C03.D.aHbl MeTO.D.bl 04HCTKH 060PY.D.OBaHHSI npH CMeHe HOMeHKJlaTY-
pbl npO.D.YKUHH. 3alllHTa OT nepeKpecTHoro 3arpfl3HeHHSI .D.OJDKHa 6bITb
npe,lJ,YCMOTpeHa npOeKTOM npOH3BOlICTBa.
Ellle O.D.HH Bpar - nepenymbl6allue npO.D.YKUHH, MaTepHaJIOB H 3TH-
KeTOK. OHO .D.OJI)I(HO 6bITb HCKJlI04eHO opraHH3aUHOHHblMH H TeXHH4e-
CKHMH MepaMH.
Oc06ble Tpe60BaHHSI npe.D."bSlBJlSlIOTCSI K npOH3BOlICTBY CmepUJlbHblX
npenapam06. OHH 1I0JI)I(Hbl 6bITb CTepHJIbHbIMH, anHporeHHblMH H He
CO.D.ep)l(aTb nOCTopOHHHX He)l(HBblX 4aCTHU. BCTpe4afOTCSI paCCY)I(1leHHSI 0
TOM, 4TO .D.J1S1 HH"beKUHoHHOro npenapaTa rJIaBHOe - CTepHJlbHOCTb, a
3alllHTa OT 3arpSl3HeHHSI 4aCTHuaMH - .D.eJIO BTopOCTeneHHoe.
TaK JIH 3TO? J.1H"beKUHOHHbIH paCTBOp - HHOpO.D.HOe, 4y)1(1l0e eCTe-
CTBCHHOH npHpO.D.e 4eJIOBeKa BellleCTBO. Ho BBO.D.HTb ero 60JlbHOMY HY)I(-
HO. A BOT «nonyr4HKH», HeBH.D.HMble rna30M 4aCTHUbl, COlIep)l(alllHeCSI B
npenapaTe, - nOCTopOHHHe H onaCHble BKJlI04eHHSI. BOJIOKHa (lIJlHHHble
TOHKHe 4aCTHUbl) 6YKBaJIbHO pe)l(yr TKaHH. YaCTHUbl OCe.D.aIOT Ha CTeH-
Kax COCY.D.OB, cnoc06CTByeT 06pa30BaHHIO 6JISlWeK H TpOM60B CO BceMH
BblTeKalOlllHMH nOCJIe.D.CTBHSlMH. Mbl He 3HaeM ewe Bcex nOCJlelICTBHH,
KOTopble Bbl3bIBaeT MYCOP, BBO.D.HMbIH 4eJIOBeKY C HH"beKUHeH. 3TO
HMeHHO MYCOP, HeCMOTpSl Ha TO, 4TO OH He BHlIeH rna3Y.
llOKa3aTb, 4TO .D.aHHbIH 60JIbHOH CTpa.D.aeT HMeHHO H3-3a BHeceHHblX
B Hero 4aCTHU TPY.D.HO H Bo061lle np06JleMaTH4HO. 11 UpSl.D. JIH B 3TOM eCTb
CMbICJI. HY)I(HO npoCTO He .D.OnYCTHTb HX nOna.D.aHHSI BO BHyrpeHHlO1O cpe-
,lJ,Y 4eJIOBeKa. HeCJlY4aHHO EBponeHcKoH cI>apMaKoneeH H cI>apMaKoneeH
COe.D.HHeHHbIX iliTaTOB YCTaHOBJleHbl npe.D.eJIbHO .D.OnYCTHMble KOHueH-
TpaUHH 4aCTHU B paCTBOpaX.D.J1S1 napeHTepaJIbHoro BBelIeHHSI.
npOCTble HlIeH TaKoro pOlIa H JIe)l(aT B OCHOBe GMP. OHH 6blJlH 3a-
JIO)l(eHbl B HHX OTuaMH-OCHOBaTeJISlMH 3THX npaBHJI.
CHTyauHSI C GMP HanOMHHaeT WYMHYIO KaMnaHHIO 60-70-x rolIOB
no BBelIeHHIO HOT - «HaY4HoH opraHH3aUHH TPYlIa». O.D.HH YMHbIH'leJlo-
BeK HanHCaJI B Te rolIbl: «HHKaKoH HaYKH B opraHH3aUHH TpYlIa HeT, HO
BceM HY)I(eH HOT, nOHHMaeMblH KaK «HopMaJlbHaR opc>aHU3al{UR mpyoa».

63
f JIaBa 3
MA TEPHAJIbJ
3.1 8Mbl MaTepH3JlOB
113BecTHblH CneUHaJIHCT B 06JIaCTH BHHOlIeJIHSI K. KaJIJleK nHweT:
«113 2HUJlbiX H200 xopOUle20 eUHa He cdeJWlnb. U HUilailaH meXHOJ102UH mym
He nOMO.>lCem».
3TO B nOJlHoH Mepe OTHOCHTCSI H K npoH3BolICTBY JIeKapCTBeHHblx
cpelIcTB. MaTepHaJIbl OnpelIeJISlIOT Bce. ll06pOKa4eCTBeHHble MaTepHaJIbl -
nepBoe H He06xolIHMoe YCJIOBHe BbmycKa xopoweH npO.D.YKUHH B JII060H
OTpaCJIH.
B npOH3BO.D.CTBe J1eKapCTBeHHbIx Cpe.D.CTB HCnOJIb3YIOTCSI HCXO.D.Hble
H ynaKoB04Hble MaTepHaJIbl. OHH MOryT 6bITb CTepHJlbHblMH H HeCTe-
pHJlbHbIMH, HMeTb eCTeCTBeHHoe npOHCXO)l(1leHHe (pacTHTeJIbHOe, MHHe-
paJIbHOe, )l(HBOTHoe), 6bITb npO.D.YKTOM XHMH4ecKoro HJIH 6HOJlOrH4e-
CKOro CHHTe3a.
nO.D. HCXOlIHblMH MaTepHaJIaMH nOHHMaeTCSI JII060e BewecTBo, HC-
nOJIb3yeMoe .D.J1S1 npoH3BolIcTBa JIeKapCTBeHHblx Cpe.ll.CTB (rOCT P
52249- 2009 [I]).
HCXOOHbLMU MamepUaJlllMU H6JlHlOmCH:
- aKTHBHble <!:>apMaueBTH4ecKHe cy6cTaHuHH - Act>C;
- BcnOMOraTeJIbHble BellleCTBa.
AKTHBHble <!:>apMaueBTH4ecKHe cy6CTaHuHH - OCHOBa JIeKapCTBeH-
HblX cpelICTB, KOTopaSi OnpelIeJlSleT HX Ha3Ha4eHHe.
nOMHMO Act>C npH npOH3BO.ll.CTBe JleKapCTBeHHblX Cpe.D.CTB HCnOJlb-
3YlOTCSI BcnOMOraTeJIbHble BellleCTBa: caxap, KpaXMaJI, pa3Horo pO.D.a .D.O-
6aBKH, BO.D.a .D.J1I HH"beKUHH H np.
KaK 6bITb C HHMH? - K HHM HY)l(HO nOlIXO.ll.HTb TaK )l(e, KaK H K
Act>C. oeCCMblCJIeHHO .lI.06HBaTbCSI 4HCTOTbl Act>C, eCJIH OCTaJIbHble co-
CTaBJlSllOlllHe 6y.D.yr rpSl3HblMH HJlH HX COCTaB 6Y.D.eT OTJIH4aTbCSI OT Tpe-
6yeMoro.
Pa3BHTHe Tpe60BaHHH GMP K HCXOlIHblM MaTepHaJIaM HMeeT CBOIO
.D.HHaMHKY. B 90-e rolIbl 6blJIO npH3HaHO, 4TO YCJIOBHeM nOJIY4eHHSI xo-
POWHX cy6cmaHu.uii - A(/)C S1BJlSleTCSI COOTBeTCTBHe HX npOH3BOlICTBa
4eTKHM Tpe60B<lHHSlM, KOTopble 6blJIH o<!:>opMJIeHbl B BH.D.e PYKOBO.D.CTBa
ICH Q7 lIJISI Act>C [36]. EBponeHcKHH COlO3 BKJlIOLJHJI :no PYKOBOlICTBO
B COCTaB npaBHJl GMP EC, a Mbl - B Haw CTaHlIapT (YaCTb II rOCT P
52249- 2009).

64
l{J6a 3
LlaJIee B CiliA 6blJlH p<upa6OT<lHbl npaBI1JI<l G M P Ha npou360ocm60
6cnOMOlameJlbHbiX 6ew,ecm6, o<!:>opl\lJIeHHble B BMe CTaTbH cDapMaKoneH
CoelIHHeHHblx iliTaTOB - USP [54] (CI\I. Hl1)1(e n. 3.3). EBpona 110 HacTO-
S1wero BpeMeHH He npUHH11a peweHHSI 0 BBelIeHHH Tpe60BaHHH GMP K
npoH3BolICTBY BcnOMOraTeJlbHblX BeWCCTB. MO)l(HO nOmmlTb, 4TO TaK<U1
CHTyauHSI HOCHT Bpel\leHHbl1 xapaKTep H 3TH Tpe601mHH1 6YlIyr BBClIC-
Hbl. 3TO JlOrWIHO. Bce. 4TO BXOlIHT B COCTaB JIeKapCTBeHHoro cpelICTBa,
H Bce, 4TO Y4aCTByeT B npOH3BOlIcme, .D.OJl)l(HO COOTBeTCTBOBaTb GMP.
npaBHJIa GMP TaK)l(e COlIep)l(aT Tpe60BaHHSI K ynaKon04Hbll\l l\IaTe-
pHaJlaM.
3.2 AKTHBHble apMal\eBTHlfecKHe cy6cTaHI\HH
3.2.1 HopMaTHBHble Tpe60BaHHH
Tpe60BaHHSI K npOH3BOlICTBY AcDC YCTaHOBJleHbl LJacTblO II rOCT
P 52249-2009 II].
C01lep)KaHHe
qacTH II «OCHOBHble Tpe60BaHHH K aKTHBHbIM apMaueB1WIecKHM
cy6CT3HI(HJIM (A<I>C), HCnOJlb3yeMbIM B Ka'leCTBe HCX01lHb1X M3TePH3JlOB"
rOCT P 52249-2009
I BBelleHl1e
2 06eCne1.JeHI1e Ka1.JeCTBa
3 nepCOHaJl
4 l1laHI1S1, nOMellleHI1S1 11 I1H>KeHepHble CI1CTeMbl
5 TeXHOJlOrH1.JeCKOe 060PY1l0BaHl1e
6 LloKYMeHTaul1S1 11 npoTOKOJlbl
7 Pa60Ta C MaTepl1aJlaMI1
8 TCXHOJlOrH1.JeCKI1H npouecc 11 BHYTpl1npOHJB01lCl BeHHblH KOHTpOJlb
9 YnaKoBKa 11 MapKl1poBKa A<DC 11 npoMe>KYT01.JHbIX np01lYKTOB
10 XpaHeHl1e 11 peaJIl13aUl1S1
II 11a60paTOpHbli KOHTpoJlb
12 ATTeCT<1UI1S1 (l1cnblTaHI1S1)
13 KOHTpoJlb 113MeHeHI1i1
14 OTKJlOHeHl1e 11 nepepa60TKa MaTepl1aJ10B
15 PeKJIaMatil111 11 OT3blHbl
16 Pa60Ta no KOHTpaKTY (B T. lJ. npoBe1leHl1e aHaJll1JOB)
17 PeaJI113aUI1S1, xpaHeHHe, ncpcynaKoBKa 11 nepCMapKl1pOBKa
18 A<DC. npol13B01lI1Mble nYTCM KYJIbTI1Bl1ponaHI1S1 KJleTOK
(4)epMeHTaUI1I1)
19 A<DC, npellHa3Ha1.JeHHble LUII npoBelleHH1
KJlIIHH'leCKIIX IICC11ellOBaHI1H
20 TCpMIIHbl II onpellC11CHIISI
UeJlb .nux Tpe60BaHIIii - rapaHTlHI Ka'ICCTBa 11 llllCTOTbl AcDC

.fo.,fomepuaAbl
65
fOCT P 52249-2009 llaeT CJle1lYIOWl1e on pclle11eHI1S1:
- aKTHBHaH apMaueBTH'JecKaH cy6cTaHLlHH; A<I>C: 111060e Bewecmo
Hl1l1 CMeCb BeweCTB, npellHa3Ha1.JeHHbie LUISI np0l13BOllCTBa 11eKapCTBeHHbIX
Cpe1lCTB, KOTopble B npOtieCce npOI1JB01lCma 11eKapcmeHHoro cpellCTBa
CTaHOBSlTCSI aKTI1BHblM I1Hrpelll1eHTOM 3TOro 11CKapCTBeHHoro cpellCTBa. Ta-
KHe BeweCTBa npellHa3Ha ' leHbl LUISI npoSlBJleHml cpapMaKOJlOrl1'leCKOM aK-
THBHOCTI1 HJlH llPYroro npSlMoro 34>4>eKTa npl1 1lIIarHOCTIIKe, _le1.JeHHI1, 06-
JICfLleHIHI CI1MnTOMOB HJIJI npo4>I1JIaKnlKe 60Jle3HI1 I1J1H 1lJISI B031leHCTBI1S1
Ha CTpYKTYPY 11J111 4>YHKUI1H OpraH113Ma;
- HCX01lHbIH 'VIaTepHaJJ A<I>C: CblPbe, npOMC)KYTO'IHbIM npOllYKT 111111
A<DC, KOTopble I1CnOJlb3YIOTCSI npl1 np0l13BOllCTBe A<DC 11 BHellpIIOTC1 B
CTPYKTYPY A<DC B Ka'leCTBe CYllleCTBeHHoro 3J1eMeHTa. !;JCX01lHbIM MaTepl1-
aJl A<DC MO>KeT 6blTb npOllYKTOM (MaTepl1aJlOM), nOJlY'laeMbIM OT 01lHOro
I111H 60Jlee nOCTaBllll1KOB no KOHTpaKTY (KoMMCp1.JeCKoMY cOmaWeHI1IO),
11J111 MaTepl1<UlOM, np0l13BOlll1MbiM Ha caMOM npe1lnpl1lTl1l1. KaK npaBI1110,
LUISI npoI13B01lCTBa A<DC I1CnOJlb3YIOTCSI I1CXOllHble MaTe pl1aJ1 bl C KOHKpeT-
HblMI1 XI1Ml11.JeCKI1MH CBOHCTBaMI1 11 CTPYKTypoM.
Tpe60BaHHSI K npOH3BO.D.CTBY AcI>C nOlIp06Hbl H 3aHHMalOT 60Jlb-
WOH 06"beM TeKCTa. MHome H3 HHX 6JlH3KH I1JIH aHaJIOrH4Hbl Tpe60Ba-
HHSlM K npOH3BO.D.CTBY roTOBblX <!:>OPM, KOTopble paCCMOTpeHbl B lIPYrHX
rJlaBax. Ho B npOH3BO.D.CTBe AcI>C eCTb CBOH oc06eHHOCTH. 3TH oc06eH-
HOCTH MOrYT HOCHTb 061llHH xapaKTep, a MorYT 6bITb cneUH<!:>WleCKHMH
.D.JlSl pa3Hblx BHlIOB AcI>C.
3.2.2 CT3)IJfH npoH3BolIcTBa A<I>C
Oc06eHHocTbIO npOH3BOlICTBa AcI>C S1BmleTC1 TO, 4TO OHO HaXOlIHT-
CSI Me)l(1lY CblpbeM. He n01I4HHIIOIllI1MOI Tpe60I3aHHIM GMP, H npOHJ-
BO.D.CTBOM lom06blX JleKapCm6ellHbiX cpeocm6, me npaBHJla G M P 06S13a-
TeJlbHbl H )l(H3HeHHO Heo6xo.D.HMbl.
D.nSl CTepHJlbHblX AcI>C 4aCTb II rOCT P 52249-2009 .D.eHcTByeT
TOJIbKO .D.O CHUlHH CTepI1JlH3aUHH. Ha'IIlHaSl C ,noH CTalIHH, BCTynacT 13
CIIJlY npHJIO)l(eHHe I K rOCT, KOTopoe nOlIp06HO paCCMaTpHHaeTOI 13
KHl1re <,npOH3BOlICTBO CTepHJlbHblX JleKapCTBCHHblX cpelICTB» 1101.
npOH3BOlIHTeJlb AcI>C 1I0Jl)l(eH OnpelIeJII1Tb H .D.OKYMeHHUlbHO
OCpOpl\H1Tb CHUlHIO, C KOTOpoii HallHHaeTOI npOHJBOlICTBO AcI>C. Llml
npOUCCCOB XHMH4ecKoro CHHTe3a 3Ta CHUlH1 onpelIcmleTCSI KaK CTalIH1
ImOlla HCXOlIHblX l\f<nepHaJlOB B TeXHOJIorWleCKHH npouecc. D.n1 lIpyrHx
npoueCCOB (cPepMeHTauHI, 3KCTpaKUHSI, O'IHCTKa H np.) lIaHHYIO CTa.D.HIO
OnpClICJIIIOT C Y'leTOM KOHKpCTHblX oc06eHHocTcH npOI1JBO.D.CTBa.
B Ta6mmc 3.1 nplmelIeHa nOCJlelIOBaTeJIbHOCTb npOH3BOlICTBa paJ-
JlII'IHbIX AcI>C C YKa3aHHeM CT<UlIIH BBelIeHIUI I1CXOlIHblX MaTepl1<lJlOB.
npaBH11a GMP .D.eHcTBYIOT, H,PII1Hml C :}THX CTalIHH (BbllIeJleHbl CCpblM
(IJOHoM). Ta6Jl1ma lIaCT 06WYK) cxeMY. KOHKpCTHblC pcweHHH onpClIC-
JISIIOTOI KOHKpCTHbll\1 IIpOUCCCOl\1.

66
{,106a 3
Ta6J1Ut(a 3.1
npHMeHeHHe Tpe60BaHHH GMP K npOH3BOlICTBY AcDC
BHll npOH3- CnuuIH npOH3BOIICTBa A<DC, Ha KOTOpble pacnpOCTpaHI-
BOllCTBa eTCSlllaHHblH CTaHllapT (BblllelleHbl cepblM cjJOHOM)
XHMHLJeCKHH npOH3BOll- BBOll I1CXOll- npOH3BOll- BblllelleHHe <DH3I11.JeCKa51
CIHTe3 CTBO 11 CXOll- Horo MaTe- CTBO npOMe- 11 OLJI1CTKa o6pa6oTKa 11
HOro MaTe- pl1aJ1a A<DC }((yrOLJHOro ynaKoBKa
pl1aJ1a 1lJl1 B npouecc npOllYKTa
A<DC
A<DC, Bbille- nOJlY1.JeHl1e 1-13MeJlbLJe- BBOll I1CX01l- BblllelleHl1e <D113I1LJeCKa51
JleHHbie H3 (c60p) opra- HHe, CMeWI1- HOro MaTe- 11 01.JI1CTKa o6pa60TKa 11
I1CTOLJHI1KOB Ha, }((1111KO- BaHHe 11/l1lll1 pl1aJ1a A<DC ynaKoBKa
}((I1BOTHOro CTH I1lll1 nepBOHa- B npouecc
npOI1CXO}((- TKaHeH LJaJlbHa51 06- np0113BOll-
lleHI1S1 pa60TKa CTBa
A<DC, Bbille- C60p paCTe- 1-13MellbLJe- B BOll 11 CX01l- BbUlelleHl1e <D113I1LJeCKaSl
JleH Hble 113 HI1H Hl1e 11 nep- HOro MaTe- II OLJHCTKa 06pa60TKa 11
I1CTOLJHI1KOB BOHaLJaJlbHa51 pl1aJ1a A<DC ynaKoBKa
paCTI1Tellb- 3KCTpaKUH5I B npouecc
HOro npOHC- npOl13BOll-
XO}l(LleHHSI CTBa
PaCTI1Tellb- C60p paCTe- 1-13MellbLJe- - L!.aJlbHeHWaSl <D113I11.JeCKaSl
HbIe 3KC- HI1H HHe 11 nep- 3KCTpaKUI1S1 o6pa6oTKa 11
TpaKTbl, I1C- BOHaLJaJlbHaSl ynaKoBKa
nOJlb3yeMble 3KCTpaKUI1S1
B KaLJeCTBe
A<DC
A<DC, CO- C60p paCTe- 1-13MeJlbLJe- - - <DH3I11.JeCKaJI
CT05lWI1e 113 HI1H 11/l1lll1 Hl1e (paCTI1- o6pa60TKa 11
pa3MellbLJeH- KYllbTI1Bl1pO- paHl1e) ynaKoBKa
HblX 11J111 BaHl1e 11
paCTepTblX B c60p
nopOWOK
paCTeHI1H
6HOTeXHOllO- C0311aHHe n OlUlep}((l1- KYllbTYpa BbI1lelleHHe <D113HLJeCKaSl
nUl: rllaBHoro 11 BaHl1e pa6o- KJleTOK 11 OLJI1CTKa 06pa60TKa 11
cjJepMeHTa- pa601.Jero 'Iero 6aHKa 11/l1lll1 cjJep- ynaKoBKa
UI151/KYllbTYP 6aHKOB KJleTOK MeHTaUI151
a KJleTOK KlleTOK
«Kll aCCH LJe- C0311aHl1e nOlUlep}((H- BBOll KJleTOK BblllelleHl1e <D113I1LJeCKaJI
CKaH cjJep- 6aHKa BaHHe 6aHKa B npouecc 11 OLJI1CTKa o6pa6oTKa 11
MeHTaUI1I» KlleTOK KJleTOK cjJepMeHTa- ynaKoBKa
1lJl I n pml3- UI1I1
BOllCTBa
A<DC
YCI-111EHI-1E TPE60BAHI-11-1 GMP-+

MamepuaJlbl
67
CTpOroCTb CJlelIOBaHHSI Tpe60BaHHSlM GMP .D.OJI)I(Ha B03paCTaTb OT
paHHHX CTallHH npOH3BOlICTBa AcDC K 3aBepwalOIllHM CTa.D.HSlM TeXHOJIO-
rH4ecKoro npouecca, 04HCTKH H ynaKOBKH. Te3HC 0 B03paCTaHHH I1JlH
y6bIBaHHH Tpe60BaHHH GMP HOCHT B H3BCCTHOH CTeneHH YC110BHbIH
xapaKTep. Tpe60BaHHSI K Ka4eCTBY, KOHTpOJIb H .D.OKYMeHTaJIbHOe
o<!:>opMJleHHe 1I0Jl)l(Hbl 6bITb Be31Ie, C caMoro paHHero :nana.
rJlaBHOe YCJIOBHe - COOTBeTCTBHe HCXO.D.HbIX MaTepHaJIOB 3a.D.aHHbIM
Tpe60BaHHSlM, npH4eM 3TO COOTBeTCTBHe .D.OJI)I(HO 6bITb HeH3MeHHbIM.
D.nSl 3TOro CJle.D.yeT BbInOJIHSlTb HeCKOJlbKO YCJIOBHH:
- Hy)I(HO HCnOJIb30BaTb TOJlbKO xopowee Cblpbe (HCXO.D.Hble MaTepH-
aJIbl AcDC);
- TeXHOJIOrH4eCKHH npouecc, nOMellleHHSI H 060PYJJ.OBaHHe .D.OJI)I(Hbl
06ecne4HBaTb nOCTOSlHCTBO Ka4eCTBa npO.D.YKUHH;
- nepCOHaJI .D.OJI)I(eH 6blTb 06Y4eH H .D.OJI)I(eH C06JIIO.D.aTb npaBHJIa
pa60Tbl H nOBe.D.eHHSI;
Ha npe.D.npHSlTHH-npOH3BOlIHTeJle MaTepHaJIOB .D.OJl)l(eH 6bITb
HaJIa)l(eH CKB03HOH KOHTpOJIb, HallHHaSi C nepBH4HblX MaTepHaJIOB H 3a-
KaH4HBaSi roTOBOH npOlIYKUHeH, T. e. .D.OJl)l(Hbl BbInOJlHSlTbCSI Bce Tpe60-
BaHHSI K HOpMaJIbHOMY npOH3BO.D.CTBY.
3.2.3 Pa3pa6oTKa H nOCTaHOBKa Ha npOH3BO,lJ,CTBO
npouecc C03.D.aHHSI HCXOJJ.HbIX MaTepHaJIOB npOXO.lUff PM CTa.D.I1H:
Pa3pa60mKa - flocmaH06Ka Ha npOU3600cm60 - CepuilHoe npOU360dcmeo -
HcnoJ/b306aHUe dJ1H npOU360dcm6a 20m06bIX J/eKapcm6eHHblx cpeocm6
COOTBeTCTBHe AcDC, ee COCTaBa, xapaKTepHCTHK H cTa6HJlbHOCTH
3aJJ.aHHb1M Tpe60BaHHSlM 3aKJIa.D.blBaeTCSI B npouecce pa3pa60TKH.
D.nSl 3TOro HY)I(HO:
I) 03HaKOMHTbCSI C npoueccoM pa3pa60mKu;
2) y6e.D.HTbCSI, 4TO eCTb npOMbIWJIeHHaSl, a He KYCTapHaSi meXHO/lO-
lUH npOH3BOlICTBa AcDC, KOTopaSl oTpa60TaHa Ha onblTHblX H YCTaHO-
B04HblX cepHSlX, H 3TO nO.D.TBep)I(.D.eHO npOTOKOJIaMH I1CnbITaHHH, T. e.
np0u.ecc npOMblUlJleHHOlO npOU3600cm6a TO)l(e oTpa60T<\H (cepHHHoe npo-
MblWJIeHHOe npOH3BO.D.CTBO oTpa6aTbIBaeTCSI Ha YCTaHOB04HblX cepHSlX);
6e3 3TOro CMOTpeTb npOH3BO.D.CTBO 6eCCMbICJleHHO;
3) npOBepHTb CllMO npou360ocm60 Ha COOTBeTCTBHe G M P.
KOHe4Ho, eCTb H3BeCTHble H XOpOlllO 3apeKOMeH.D.OBaBlllHe ce6S1
np e .D.npHSITHSI-npOH3BO.D.HTeJIH AcDC, HO 3TO He MeHSIeT 061llero nO.D.XO.D.a.
TexHoJlorH4ecKHH npouecc .D.OJI)I(eH 6bITb pa3pa60TaH TaK, 4T06bl
AcDC npOH3BOlIHJlaCb H3 MaTepHaJIOB H B YCJ10BHSlX, 06ecne4HBalOIllHx
nOCTOSlHCTBO xapaKTepHCTHK AcDC B COOTBeTCTBHH C 3a.D.aHHbIMH Tpe60-
BaHHSlMH. OH .D.OJI)I(eH 6bITb o<!:>0pMJIeH B BHlIe, He06xolIHMOM .D.J1}) npelI-
CTaBJIeHHSI B Ha.D.30pHble OpraHbI.

68
1Q6a 3
npouecc 1I0Jl)l(eH 6bITb npOBepeH H OTKoppeKTHpOBaH Ha 3Tane
OnblTHoro npOH3BOlICTBa. OT4eT 0 pa3pa60TKe npouecca 1I0JI)I(eH COlIep-
)l(aTb YKa3aHHe Ha KpHTH4eCKHe napaMeTpbl, no KOTOpblM 6Y.D.eT BbInOJl-
HSlTbCSI aTTeCTaUHSI npouecca B cepHHHoM npOH3BOlICTBe.
KaK np06epumb Kallecm60 pa3pa60mKu A(/)C?
B HaCTOSllllee BpeMSI roTOBHTCSI PYKOBOlICTBO ICH QII «Pa3pa60TKa
H npoH3BolICTBO cy6cTaHUHH JleKapCTBeHHblX Cpe.D.CTB (xHMH4ecKHx H
6HOTeXHOJlOrH4eCKHx/6HOJlOrH4eCKHX MaTepHaJIOB») - «Development and
Manufacture of Drug Substances (Chemical Entities and Biotechnologi-
cal/Biological Entities»> [40], pacnpOCTpaHSllOllleecSi Ha AcDC, B TOM 4HC-
JIe n0J1Y4aeMble XHMH4eCKHM CHHTe30M HJIH C nOMOlllblO 6HOTeXHOJIO-
rHH.
lleHCTByeT PYKOBO.D.CTBO ICH Q8 (R2) «Pa3pa60TKa JIeKapCTBeHHblX
cpenCTB» - «Pharmaceutical Development» [37] no pa3pa60TKe roTOBblX
<!:>OPM, KOTopoe .D.aeT OnpelIeJleHHSI KpHTH4eCKHM napaMeTpaM H .D.ony-
CTHMblM npe.D.eJIaM, Y4HTbIBaSi CBOHCTBa MaTepHaJIOB H napaMeTpbl npo-
uecca.
3TH PYKOBO.D.CTBa .D.alOT 061llHe Tpe60BaHHSI.
npOBepHTb Ka4eCTBO pa3pa60TKH KOHKpeTHoro MaTepHaJIa MO)[(HO
no Omllemy 0 pa3pa60mKe AcDC.
3J1eMeHfbI OT'leTa 0 pa3pa60TKe A<I>C
I. BBe1leHl1e:
A) C01lep>KaHl1e;
B) 06111l1e 1laHHble 0 nporpaMMe pa3pa60TKI1 11 nOJlY1.JeHHblX pe-
3YJIbTaTaX;
C) XapaKTepI1CTI1KH A<J>C:
- XI1Ml11.JeCKl1e xapaKTepl1CTI1KI1;
- TOKCI11.JHOCTb;
- 1laHHble 0 3arpSl3HeHI1S1X;
- TepaneBTI14eCKI1H 34>4>eKT;
- Tpe60BaHI1S1 6e30naCHOCTI1.
D) 3aKJIlO1.JI1TeJlbHaSl 1.JaCTb:
- 1laHHble 0 pa3pa60T'lI1KaX;
- llaHHble 0 PYKOB01lI1TeJle pa3pa60TKI1 (oT1leJla);
- 1laHHble 0 PYKOB01lI1TeJlSlX OpraHl13aUI1I1.
2. \IICTOpl1S1 pa3pa60TKI1
3. 11a60paTOpHble cepl1l1:
- 1laHHble 0 Cblpbe, peareHTax, KaTaJll13aTOpax 11 np.;
- 6JIOK-CXeMa npouecca CI1HTe3a;
- OnHCaHl1e np0l13BClleHHbiX Cepl1M C YKa3aHI1CM I1X 06"bCMa, CYllle-
CTBeHHblX xapaKTCpl1CTI1K 11 B03MO>KHbIX TPYllHocTeH;
- llaHHblC 0 Kpl1Tl11.JeCKI1X napaMeTpax, I1X B3aHMHOH 3aBI1CI1MOCTI1 11
npClle11ax 113MeHCHI1H;

MamepuaJlbl
69
- peaJIbHble napaMeTpbl npouecca 11 npelleJlbI I1X 113MeHeHI1S1 B 11£1-
60paTopHblX cepl1S1X LUISI KJlI1Hl11.JeCKoro I1CnOJlb30BaHI1S1;
- 1laHHble 0 3arpSl3HeHHSlX;
- nepe1.JeHb xapaKTepl1CTI1K 060PYllOBaHI1S1 LUISI npoI13B01lCTBa JIa60-
paTopHblX Cepl1H;
- 06HapY>KeHHble pa3J1I11.JI1S1 Me>K1lY Cepl1S1MI1;
- 1laHHble 0 Kpl1Tl11.JeCKI1X npoBepKaX LUISI 3TI1X 11a60paTopHblX Cepl1H.
4. OnblTHble cepl1l1:
- 6JIOK-CXeMa npouecca CI1HTe3a:
- Onl1CaHl1e npouecca CI1HTe3a:
. CneUI14>I1KaUI1I1 Ha Cblpbe;
. D.aHHble 06 I1CnOJlb30BaHI1I1 pereHepl1poBaHHblx paCTBOpl1TeJleH
11 MaT01.JHblX paCTBopOB;
. CI1HTe311poBaHHbIe npOMe>KYT01.JHble BellleCTBa;
. D.aHHble 06 OCHOBHblX npOMe>KYT01.JHbIX BellleCTBax;
. BI11lbI BHYTpl1np0I13B01lCTBeHHoro KOHTpOJISI: BpeMeHI1 peaKUI1I1,
TeMneparypbl, 1laRJIeHI1S1 pH 11 T. 1l.;
. CTa1lHH npouecca, Hanpl1Mep, KpI1CTaJIJII13aUI1S1, Y1laJleHl1e BO-
1lbl, 113MeJIb1.JeHl1e, CYWKa, CMeWI1BaHl1e, peaKU1111 CI1HTe3a (4)ep-
MeHTaUI1I1);
. Konl1l1 npoTOKOJlOB Cepl1H;
. npoeKTbl CneUI14>HKaUI1M, KOTopbIe MOryT 6blTb nepeCMOTpeHbl
nocJle 1laJlbHeHwero 113Y1.JeHI1S1;
. Pe3YJlbTaTbi KOHTpoJISI KaK XI1M114ecKoro, TaK 11 4>113I11.JeCKoro;
. D.aHHble 0 3arpSl3HeHHSlX.
5. PeKOMeH1laUI1I1 LUISI Cepl1HHoro npoI13B01lCTBa:
- 1leTaJll1 npouecca CI1HTe3a C 060CHOBaHI1eM 3aBepWalOllll1X onepaUI1H;
- o60cHoBaHl1e npoBe1leHI1S1 BHYTpl1npoH3BOllCTBeHHoro KOHTpOJlSl B
onpe1leJleHHblX T01.JKaX LUISI KOHTpoJlSl CHHTe3a 11 01.JI1CTKI1 A<t>C;
- YKa3aHI1e Ha npoueCCbl, HanpHMep, 113MeJIb1.JeHl1e, CYWKY 11
CMeWI1BaHl1e, KOTopble 1l0Jl>KHbl 6blTb aTTeCTOBaHbI npl1 nepeXOlle Ha
Cepl1HHblH BbmYCK B npOMbllliJleHHblX MacwTa6ax, I1CX01lSl 113 BJlI1S1HHSI
3TI1X npoueCCOB Ha XI1Ml11.JeCKl1e 11 4>113111.JeCKl1e xapaKTepl1CTI1KH A<t>C;
- oueHKa JlI06blX B03MO>KHbIX OTKJlOHeHI1H B Cblpbe, 060PY1l0BaHI1I1
I1JIH npoueccax Me>K1lY Cepl15lMI1 LUISI aHaJll13a B npOMbllliJleHHOM npoH3-
B01lCTBe.
6. EI103KBI1BaJleHTHocTb:
- 3KBI1BaJleHTHOCTb np01lYKUI1I1 LUISI aTTeCTaUl111 npouecca npo-
MbIlliJIeHHoro np0l13BOllCTBa H cepHH, I1CnOJIb3yeMblx LUISI aHaJll13a roTO-
Bora JleKapcTBeHHoro Cpe1lCTBa:
.1laHHble 0 3arpSl3HeHI1S1X;
· Mop4>oJlOrl1S1 1.JaCTI1U;
· pacnpe1leJleHl1e pa3MepOB 1.JaCTI1U, I1X 4>opMa (I1roJlb1.JaTOCTb) 11
nJlOllla1lb nOBepXHOCTI1;
. nJIOTHOCTb;
- llaHHbIe 0 cepl1S1x LUISI aHaJlI13a 6110110rl11.JeCKOH l11leHTI11.JHOCTI1 11
ncpe1.Jl1CJ1eHHble Bblwe CBOHCTBa.

70
1J106a 3
7. CTa6HJIbHOCTb:
- 1laHHble 0 BI111aX ynaKoBoK, I1CnOJIb30BaBWI1XCSI npl1 aHaJll13e;
- TeMneparypa 11 RJla>KHOCTb;
- pe3YJIbTaTbl I1CnblTaHI1H;
- 1laHHbIe 0 3arpSl3HeHHSlX;
- aTTeCTOBaHHaSI MeTOllI1Ka;
- 1laHHble 06 I-ICnbITaHI1S1X Ha CpOK r01lHOCTI1 I1JII1 nOBTopHblX
I1cn blTaHI1S1X.
8. BbIB01lbl H 3aKJIlO1.JeHI1e
- CTpaTemSl pa3pa60TKH cy6cTaHul1l1;
- onblT pa3pa60TKI1;
- peKOMeH1l0BaHHbIH nYTb CI1HTe3a;
- cnoc06HoCTb npouecca Ha1le)l(HO npol13BO)J.I1Tb A<1>C C nOCTOSlHHbIMH
xapaKTepl1CTI1KaMI1 11 1.JI1CmTOH.
3ToT OT'-IeT HY)I(HO npoBepHTb H oueHHTb npH aYDHTe nOCTaBIllHKa
A<1>C. B OT4eTe .D.OJI)I(HO 6bITb YKa3aHo, C KaKoH CTa.D.HH npe.D."bSlBJlSlIOTCSI
Tpe60BaHHSI GMP (Ta6JIHua 3.1).
I1HcneKTop, npOBepSiSI npOH3BO.D.CTBO roTOBbIX JIeKapCTBeHHblX
Cpe.D.CTB (rJ1C), .D.OJI)!(eH npOBepHTb, Ha OCHOBaHHH 4ero Bbl6paH .D.aHHbIH
nOCTaBIllHK A<1>C H KaK 6blJl paCCMOTpeH OT4eT 0 pa3pa60TKe.
Pa60ma c nocma6lU,UKllMU (nocpeOHUKllMu)
npH nOCTaBKe MaTepHaJIOB nOCpe.D.HHKOM, HY)I(HO paCCMOTpeTb:
- KaK OH npOBepHJI npOH3BOlIHTeJISI A<1>C;
- ero CKJla.D.bl (eCJlH eCTb);
- .D.0KYMeHTaUHIO;
- nepCOHaJI H np.
3.2.4 npOH3BO,lJ,CTBO A<I>C
061llHe Tpe60BaHHSI K npOH3BOlICTBY A<1>C .D.aHbl B YacTH II rOCT
P 52249-2009. PeKOMeH.D.aUHH no 3alllHTe OT 3arpSl3HeHHH npHBe.D.eHbl B
PYKOBOlICTBe ISPE no npOH3BOlICTBY A<1>C 141].
3TOT .D.OKYMeHT npelIYCMaTpHBaeT TPH ypOBHSI 3alllHTbl MaTepH<lJlOB
H A<1>C B npouecce npOH3BOlICTBa. B Ta6JlHuaX 3.2 H 3.3 lIaHbl peKOMeH-
.D.aUHH no MeTOlIaM 3aIII HTbl B COOTBeTCTBHH C 3THM PYKOBOlICT130M H
CJIO)l(HBWeHCSI npaKTHKoH.
3<!:><!:>eKTHBHbIM cpelICTBOM 3alllHTbl OT nepeKpeCTHblX 3arpSl3HeHHH
H 3alllHTbl OT BpelIHblX BellleCTB S1BJlSlIOTCSI nepena.D.bl ,lJ,aBJleHHSI B03.D.yxa.
B npOH3BOlICTBe CTepHJIbHblX A<1>C nepena.D.bl .D.al3JleHHSI CJIY)I(aT .D.ml pa3-
.D.eJIeHHSI 30H C pa3JlH ' IHbIMH KJlaCCaMH 4HCTOTbl.

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YpOBHH 3alllHTbl npH npOH3BOlICTBe A<DC
NQ
YpOBeHb I
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30Hbl
(noMellleHI1S1)
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KOHTpOJlI1PY-
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K 3allll1Te
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(xopowee)
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OT nepeKpeCTHblX
3arpSl3HeHI1H
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3allll1Ta OT nepe-
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p06110JlOm1.JeCKI1X
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n11yaTaUI1I1 11 n01l1lep>Ka-
HI1S1 lll1CTOTbI
Pa60Ta C OTKpblTblMI1
npoueCCaMI1 111111 KpaTKO-
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060pY1l0I3aHl1eM
3aBepWalO1lll1e onepaUl111
no CYWKe, ynaKoBKe 11
np. MoryT BbInOJlHSlIOTCSI
B LJI1CTblX nOMellleHI1S1X
(1.JI1CTbIX 30Hax).
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<DHJlbTpbl H nepena.D.bl .D.aBJleHH5I npH npOH3BO.D.CTBe A<DC
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11
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D.nSl 3allll1Tbl np01lYKTa He Tpe-
6YIOTCSI. D.nSl JaWI1Tbl KOH1lI1-
UI10Hepa npellYCMaTpl1BalOTCSI
4>11J1bTpbl G4.
D.nSl 3allll1Tbl np01lYKTa npe1lY-
CMaTpI1BaIOTCSI, KaK MI1HI1MYM,
qmJIbTpbl F7.
HEPA* 4>I1JlbTpbI (HanpI1Mep,
H 13) npe1lYCMaTpI1BaIOTCSI B
MHoroHoMeHKJlaTypHOM npo-
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B031lyxa. npl1 He06xOlll1MOCTI1
MOryT YCTaHaRJII1BaTbCSI 1lBa
4>HJlbTpa nOCJle1l0BaTeJlbHO.
nOJlO>KI1TeJlbHbIH nepena1l 1laB-
JleHI1S1 (HanpI1Mep, B MHOroHO-
MeHKJlaTypHOM np0I13I30nCTBe,
pl1C. 3.2) I1JII1 npl1MeHeHl1e 3£1-
KpblTOro 060pYllOBaHHSI.
npH np0l13BOllCTBe CHJlbHOlleH-
CTI3YlOllll1X cy6cTaHuHM npellY-
CMaTpl1BaeTCSI OTpl1UaTeJlbHblM
nepenall1laRJIeHI1S1.
*H EPA 4>1111bTpbl Yllep>KI1BalOT T011bKO 'JaCTI1Ubl 11 HC 3allll1111alOT OT TOK-
CH1.JHblX BellleCTB, C01lep)f(aWI1XCSI B BOJllyxe 11 napax.
** D.nSl 3£1 11111Tbl np01lYKTa MO>KCT npe1lYCMaTpI1I3aTbCSI pa31le11CHl1e 30H no-
TOKaMI1 B0311yxa (pl1c. 3.1).
3Ha1.JeHI1e nepenana naRJIeHI1S1 paBHO 10-15 na.
B KpHTJ1LIeCKHX 30Hax MorYT npHMeHSlTbcSI YKpblTml C olIHoHanpaB-
JIeHHblM nOTOKOM B031Iyxa (JlaMHHapHbIe 30HbI).

72
IJw6a 3
3alU,uma om nepeKpecmHblX 3alpH3HeHuii
Tpe60BaHHSI K 3alllHTe pa3JlH ' IaIOTCSI .D.J1S1 CneUHaJIH3HpOBaHHblX
npOH3BO.D.CTB, Koma BbInYCKaeTCSI OlIHH npOlIYKT, H MHoroHoMeHKJlaTYP-
HblX npoH3BolICTB.
B nepBOM CJIY4ae peUHpKYJISlUHSI B03lIyxa He MO)l(eT npHBeCTH K 3a-
rpSl3HeHHIO npOlIYKTa, BO BTOpOM - MO)l(eT. YaCTHUbl npO.D.YKTa MOryr
ocelIaTb Ha CTeHKax B031IYXOBOlIOB H nOna.D.aTb B CJIelIYlOlllHH npOlIYKT
.D.a)l(e 4epe3 HEPA cpHJl, bTp KOTOpblH He H.D.eaJIeH H 06JlalIaeT orpaHH-
4eHHOH 3<!:><!:>eKTHBHOCTblO. 3TO He 03Ha4aeT, 4TO npH BbInYCKe pa3HOH
npOJIYKUHH B O.D.HHX H Tex )l(e nOMellleHHSlX peUHpKYJlSlUHSI HelIonYCTH-
Ma. OHa B03MO)l(Ha npH HaJIH4HH 060CHOBaHHSI H OTCyrCTBHH onaCHOCTH
nepeKpeCTHblX 3arpSl3HeHHH.
nOTOKH B03.D.yxa .D.OJI)I(Hbl 6bITb opraHH30BaHbl TaK, 4T06bl HMH He
nepeHOCHJlHCb 4aCTHUbl H3 O.D.HOro peaKTOpa B .D.PyroH (pHC. 3.1).
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pH.D.Opa» (pHC. 3.2). B KOpH.D.Ope nO.D..D.ep)l(HBaeTCSI H36bIT04HOe .D.aBJleHHe
no OTHOllleHHIO K pa604HM nOMellleHHSlM 10-15 na.
B KPynHocepHHHblX npOH3BO.D.CTBaX opraHH3YIOTCSI CneUHaJIH3HpOBaH-
Hble uexa C <!:>H3H4ecKHM pa3.D.eJIeHHeM 30H npOH3BOlICTBa pa3HblX npOMe-
04Hb1X npOlIYKT0B. B 3THX CJlY4aSlx OCHOBHblMH npH4HHaMH nepeKpeCT-
HblX 3arpSl3HeHHH MOryr 6blTb nepCOHaJI, MaTepHaJIbl H B03.D.YX, nocrynalO-
IllHe H3 OKpy)l(alOllleH CpeJIbl. 3alllHTa OT 3THX JarpSl3HeHHH 06ecne4HBaeTCSI
MepaMH rHrHeHbl nepCOHaJIa, npaBHJlbHOH opraHH3auHeH TeXHOJIOrH4eCKHX
nOTOKOB MarepHaJIOB, nepCOHaJIa H np., peweHHSlMH no BCHTHJlSlUHH H
KOH.D.HUHOHHpoBaHHIO, 06pa60TKoH Tapbl H ynaKoBKH H np.

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B b1TSI)I(Ka
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KaJaHO HanpaBJleHHe nOTOKOB B03.D.Yxa

MamepuaJlbl
73
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KOHTYPY 31IaHHSI 1I0JI)I(Hbl 6bITb pacnOJIO)l(eHbl KaK MO)l(HO .D.aJIbWe lIPyr
OT lIpyra. ECJlH 3TO HeB03MO)l(HO, TO CJlelIyeT npelIYCMaTpHBaTb <!:>HJIb-
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BaTb HEPA <!:>HJlbTpbl. FDA CiliA peKoMeHlIyeT opraHH30BbIBaTb KOH-
TpOJlb HaJIH4HSI 6eTa-JIaKTaMHblx coelIHHeHHH H 3a npelIeJlaMH 31IaHHSI.
MamepuQJl 603iJYX060iJ06
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BO.D.bl HeJlb3S1 OKpaWHBaTb.
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D.nSl YBJla)l(HeHHSI B03.D.yxa B KOHlIHUHOHepe CJIe.D.yeT HCnOJIb30BaTb
4HCTblH nap. nap He .D.OJl)l(eH COlIep)l(aTb MaCeJI H XHMH4eCKHX COe.D.HHe-
HHH, OT KOTOpblX HEPA <!:>HJIbTpbl He 3alllHlllalOT.
Ammecmau.UH npou36oiJcm6 AfPC
npH aTTeCTaUHH CJle.D.yeT 06paTHTb BHHMaHHe Ha KpHTH4eCKHe CTa-
.D.HH npOH3BO.D.CTBa AcDC (FDA Draft Guidance for Industry, Manufacturing,
Processing or Holding of Active Pharmaceutical Ingredients), B 4aCTHOCTH,
CJ1e.D.yeT:
I) Y4ecTb OCHOBHble CBOHCTBa AcDC, I3KJ1104aSl XHMH'leCKYIO lIHCTO-
TY; KOJIH4eCTBeHHble H Ka4eCTBCHHble lIaHHble 0 3arpSl3HeHHSlX, <!:>H3H4e-
CKHe xapaKTepHCTHKH (pa3Mep H <!:>OPMY 4aCTHU, OTKJlOHeHHH <!:>OpMbl
4aCTHU OT Ja.D.aHHOH, nJIOTHocTb), CO.D.ep)l(aHHe BJlarH H COCTaB paCTBO-
pHTeJleH, OlIHOpOlIHOCTb, MHKp06HOJIOrH4eCKOe Ka'leCTBO;
2) YCTaHOBHTb napaMeTpbl npouecca, KOTopble MOryT nOBJlHSlTb Ha
KpHTH4eCKHe CBoHcTBa AcDC. KpHTH4ecKHe CBoHcTBa .D.OJI)I(Hbl 6blTb
OnpelIeJIeHbl H 060CHOBaHbl Ha CTMHH paJpa60TKH H nO.D.TBep)I(.D.eHbl B
onblTHOM H cepHHHoM npOH3BOlICTl3aX;

74
/'.;106a 3
3) 3alIaTb npelIeJIbl H3MeHeHHSI Ka)l(1loro KpHTH4ecKoro napaMeTpa,
KOTOpbli1 npelIn011araeTCSI KOHTpOJlHpOBaTb B npouecce npoH3BolICTBa.
3TH .D.aHHble OnpelIeJISlIOT Ha CTa1lHSlX pa3pa60TKH H JIa60paTopHoro
(onbITHoro) npoH3BOlICTBa.
3Ta )l(e MblCJlb nOlI'lepKHBaeTcSI B PYKOBolICTBe ICH Q7A no Act>C:
«3Ha4eHHSI KpHTH4eCKHx napaMeTpoB .D.OJI)I(Hbl 6blTb, KaK npaBHJIO,
OnpelIeJleHbl Ha CTa.D.HSlX pa3pa60TKH I1JlI1 no lIaHHblM OnblTa npoH3BOlI-
CTBa TaK, 4T06bl 06eCne4HBaJIaCb HeH3MeHHOCTb CBOHCTB Act>C».
OCHOBOi1 .D.J1S1 aTTeCTaUHH npoH3BOlICTBa Act>C SlBJlSleTCSI:
- onHcaHHe Bcex peaKuHH XHMH4eCKoro cHHTe3a;
- .D.aHHble 0 KpHTH4eCKHx TeXHOJlOrWleCKHX onepaUHSlx;
- YKa3aHHe CTa.D.HH 04HCTKH;
- .D.aHHble 0 3arpSl3HeHHSlx;
- pe3YJIbTaTbl KOHTpOJISI B JIa60paTOpHH.
B CiliA HHcneKTHpOBaHHe npOH3BO.D.CTB Act>C npOBO.D.HTCSI no PY-
KOBO.D.CTBY FDA «Active Pharmaceutical Ingredient Manufacturers» [53].
3.3 BcnOMOraTeJlbHbie Bell\eCTBa
BcnOMOraTeJIbHble BCllleCTBa (excipients, auxiliary substances) - 3TO
BellleCTBa, He OTHOCSlIllHecSi K Act>C, HO BXOlISlIllHe B COCTaB JIeKapCTBeH-
HOro Cpe.D.CTBa H oueHeHHble COOTBeTCTBYlOlllHM 06pa30M Ha 6C3onac-
HOCTb. Ha3Ha4eHHeM BcnOMOraTeJlbHblX BellleCTB MO)l(eT 6bITb:
- 3alllHTa npO.D.YKTa, C03lIaHHe 06"beMa JleKapCTBeHHoro Cpe.D.CTBa,
06ecne4eHHe cTa6HJIbHOCTH H 6HolIocTynHocTH;
- 06Jler4eHHe pacn03HaBaHHSI npOlIYKTa;
- YCHJleHHe JII06blX .D.Pyrl1x CBOHCTB B nJlaHe 061llcH 6e30nacHocTH,
3<!:><!:>eKTHBHoCTH, coxpaHHOCTH HJlH npHMeHeHHSI.
3TH BellleCTBa MOryr CJlY)I(HTb BcnOMOraTeJlbHblM Cpe.D.CTBOM B npo-
H3BOlICTBe JleKapCTBeHHblx Cpe.D.CBTB, 6blTb CTa6HJlH3aTOpaMH, KOHcepBaH-
TaMH, paCTBOpHTeJlSlMH, H T. .D..
B EBponeHcKoH ct>apMaKonee nOlI BcnOMOraTeJIbHblM BellleCTBOM
nOHHMaeTCSI JII06aSl COCTaBJlSllOlllaSl JleKapCTBeHHoro cpelICTBa, KOTopaSl
He OTHOCHTCSI K Act>C.
BcnOMOraTeJIbHble BellleCTBa BXOlISlT B COCTaB npaKTWleCKH Bcex JIe-
KapCTBeHHblX <!:>OPM: Ta6JleTOK H KanCYJI, )l(HlIKHX <!:>OPM lIJlSl BHYTpeHHero
npHMeHeHHSI, MSlrKHX >OpM, npenapaTOB .D.JlSl HapY)I(Horo npHMeHeHHI,
cynn03HTopHeB, napeHTepaJIbHblX npenapaTOB H a3p03011eH. Ka4eCTBO
JIeKapCTBcHHOro cpelICTBa BO MHOroM 3aBHCHT OT Ka4eCTBa BcnOMora-
TeJlbHblX BellleCTB: pa3McpOB 'IaCTHU, (l>paKuHoHHoro COCTaBa H n110W<\1lH
nOBepXHOCH1 'JaCTHU. COCTaB H cBoi1cTBa BcnOMOn1TeJIbHbIX BellleCTB
1I0Jl)l(Hbl COOTBCTCTBOBaTb "3alIaHHblM Tpc60BaHHIM. 06ccne'II1Tb :no co-
OTBeTCTlU1C - 3alIa ' la IIp0l13BOJl.I1TCJUI BCIIOMOraTCJIhHblX BeWCCTB, a npo-

MamepuaJlbl
75
BepHTb cTa6HJIbHOCTb npOH3BOlICTBa - 3ana4a npOH3BOlIHTeJISI rOTouoro
JleKapCTBeHHoro Cpe.D.CTBa, HCnOJlb3YlOwero 3TH BeweCTBa.
(})apMaKoneSi CoelIHHeHHblX iliTaTOB - USP (1078) 154] - Tpe6yeT
KOHTpOJISI npOH3BO.D.CTBa BcnOMOraTeJIbHblX BellleCTB, KOHTpOJISI H3MeHe-
HHH OT cepHH K cepHH H OT npOH3BO.D.HTeJlSl K npOH3UO.D.HTeJIIO. 3TO
HecoMHeHHblH war Bnepell no cpaBHeHHIO C EBponoH. BcnoMOraTeJIb-
Hble Be llleCTBa , TaK )l(e KaK H A(})C, BXOlISiT B COCTaB JleKapCTBeHHoro
Cpe.D.CTBa, Moryr BCTynaTb B peaKUHIO, .D.OJl)l(Hbl 6bITb 'IHCTbIMH, a HX
npOHJBOlICTBa TaK>Ke .D.OJI)I(Hbl COOTBeTCTBOBaTb Tpe60BaHHSlM GMP.
GMP OAR npou360ocm6a 6cnOMOlameJlbHbiX 6elU,ecm6
Pa3.D.eJI USP ( 1078) TaK H Ha3blBaeTCSI: «Good Manufacturing Practice
for Bulk Pharmaceutical Excipients» - «npaBHJla npOH3BO.D.CTBa BcnOMora-
TeJIbHblX BellleCTB B 6aJIK-<!:>0pMe». OH YCTaHaBJIHBaeT Tpe60BaHHSI K
npoueccaM, 1I0KYMeHTaUHI1, npOCJIe)l(HBaeMOCTH npOH3BO.D.CTBa, 060PY-
.D.OBaHHIO, KOHTpOJIIO H np. C ueJIblO rapaHTHpOBaHHSI HX COOTBeTCTBHSI
Tpe60BaHHSlM K Ka4eCTBY, 4 HCTOTe, 6e30naCHOCTH H CBoeMY Ha3Ha4e-
HHIO.
Pa3.D.eJI COCTaBJleH C Y4eTOM:
- PYKOBOlICTBa B03 no G M P .D.J1S1 BcnOMOraTeJlbHblX BellleCTB -
WHO GMP Guidelinesfor Excipients,
- G M P .D.J1S1 <!:>apMaueBTH4ecKHx BcnOMOraTeJIbHblX BCllleCTB B 6aJIK-
<!:>opMe Me)l(1lYHapolIHoro COBeTa no <!:>apMaueBTH4ecKHM BcnOMOraTeJIb-
HblM BellleCTBaM - <<International Pharmaceutical Excipients Council
(1 PEC). Good Manufacturing Practices Guide for Bulk Pharmaceutical Ex-
cipients» H lIPYrHX 1I0KYMeHTOB.
OCH06Hbie npuHu.unbl GMP OAR 6cnOMOlameJlbHbiX 6ew,ecm6:
I. KOHTPOJlb nOCTopOHHHX BKJllOllCHHH H 3arpSl3HeHHH.
npOH3BO.D.HTeJIb roTOBblX JIeKapCTBeHHblX Cpe.D.CTB, KaK npaBHJIO, He
BbInOJIHSleT 04HCTKY BcnOMOraTeJIbHblX BellleCTB, H COlIep)l(alllHeCSI B HHX
3arpSl3HeHHSI nOna.D.alOT B roTOBblH npOlIYKT. HeCMOTpSl Ha TO, 4TO Bcno-
MOraTeJlbHble uellleCTBa uo MHOrHX CJlY4aSlX npOH3BO.D.S1TC1 Ha XHMH4e-
CKHX npOH3BOlICTBax B 3aKpblTOM 060PY.D.OBaHHH, He06xOlIHMO npe.D.Y-
CMaTpHBaTb 3alllHTY OT 3arpSl3HeHHH H3 OKPY)I(alOllleH Cpe.D.bI.
2. XapaKTepHcTHKH H CBOHCTBa ucnOMOraTeJIbHblX BellleCTB.
n POH3BOlICTUO BcnOMOraTeJlbH blX BellleCTB .D.OJl)l(HO 6bITb TaK>KC CTa-
6HJIbHbiM H 06ecne4HBaTb HeH3MeHHblH COCTaB JIeKapCTBeHHoro cpelI-
CTBa comaCHO cneUH<!:>HKaUHH. 3TO oc06eHHo Ba)l(HO lIJlSl npoH3BolIcTBa
CTepHJIbHblX H anHporeHHblx BcnOMOraTeJlbHblX nellleCTB.
3. HeH3MeHHOCTb COCTaBa BcnOMOraTeJlbHblX BellleCTB OT cepHH K
cepHH H KOHTp011b H3McHeHHH.
npH nOCTaHOBKe BcnOMoraTe11bHblX BellleCTB Ha npOH3BOlICTBO Tex-
HOJlOrWleCKHH npouecc MO)l(eT MeHITbCSI. 3TO 1I0JI)I(HO ytlHTblBaTbCSI CH-
cTeMoH KOHTpOJI1 H3MeHcHHH.

76
{,W6a 3
4. Ha Ka)l(1lYIO cepHIO 1I0JI)I(eH O<!:>OPMJISlTbCSI npOTOKOJl cepHH. BeCb
npouecc npoH3BolIcTBa H KOHTpOJlSl Ka4eCTBa 1l0Jl)l(eH npOCJle)l(HBaTbCSI
no npOTOKOJIY cepHH.
Tpe60BaHHSI GMP .D.J1S1 BcnOMOraTeJIbHblX BeweCTB aHaJIOrH4Hbl Tpe-
60BaHHSlM GMP K npOH3BO.D.CTBY A<DC H rJlC H pacnpOCTpaHSlIOTCSI Ha:
- .D.OKYMeHTaUHIO H KOHTpOJIb H3MeHeHHH;
- OTBeTCTBeHHOCTb H nJIaHHpOBaHHe;
- nepCOHaJI, ero nOlIroToBKY H rHrHeHY;
- 3.D.aHHSI, nOMellleHHe H 060PYlIOBaHHe;
- TeXHOJIOrH4eCKHe MaTepHaJIbl (BO.D.Y, nap, ra3bl), KOMnblOTepHble
CHCTeMbl H HH<!:>paCTPYKTYPY;
- 3alllHTY OT HaceKOMbIX, rpbI3YHOB, nTHU H np.;
- y60PKY, KOHTpOJlb napaMeTpoB OKPY)I(alOllleH Cpe.D.bl, BeHTHJlSlUHIO
H KOH,LI.HUHOHHpoBaHHe, oCBellleHHe, .D.peHa)l( H np.;
- npOH3BO.D.CTBO H CKJla.D.bl;
- peaJIH3aUHIO npO.D.YKUHH;
- aHaJIH3 He.D.OCTaTKOB H pa60TY no HX YCTpaHeHHIO;
- npOBe.D.eHHe aY,lJ,HTa C YKa3aHHeM KOHTpOJIbHblX T04eK.
AyiJum npou36oiJumeJlH 6cnOMOlameJlbHblX 6ew.ecm6
npOH3BO.D.HTeJIb roTOBblX JIeKapCTBeHHblx Cpe.D.CTB .D.OJI)I(eH npoBo-
.D.HTb aYlIHT nOCTaBIllHKOB (npOH3BO.D.HTeJleH) BcnOMOraTeJIbHblX BellleCTB
aHaJIOrH4HO aYllHTY .D.JlSl A<DC. PeKOMeHlIaUHH no npoBelIeHHIO TaKoro
aY.D.HTa .D.aHbl B npHJIO)l(eHHH I K CTaTbe USP (l078) 154].
B CiliA npOH3BO.D.HTeJlb BcnOMOraTeJlbHblX BellleCTB .D.OJI)I(eH HMeTb
.D.OKYMeHT, B KOTOpOM YKa3aHO, C KaKOH CTMHH npouecca .D.eHcTBYfOT
npaBHJIa GMP. KOHTpOJlb Tpe6yeTcSI He Be3.D.e H He Be3.D.e OH B03MO)l(eH,
HO npOH3BO.D.HTeJIb 1I0Jl)l(eH YKa3aTb KpHTH4eCKHe T04KH npouecca, B KO-
TOpblX oT6HpalOTCSI np06bl H npOBO.D.HTCSI aHaJIH3.
npH aY.D.HTe (HHcneKUHSlX) npOBepSiIOTCSI:
- npHCBoeHHe HH,LI.HBH,lJ,YaJIbHOro HOMepa cepHH;
- BC.D.eHHe npOTOKOJlOB cepHH, )l(YPHaJIOB H .D.PyroH .D.OKYMeHTaUHH;
- nO,lJ,TBep)I(.D.eHHe COOTBeTCTBHSI npouecca Tpe60BaHHSlM G M P,
Ha4HHaSi co CTa.D.HH, C KOTopOH 3TH npaBHJIa .D.eHCTBYIOT;
- nO.D.TBep)I(.D.eHHe TOro, 4TO B cepHH OTCyrCTBYIOT MaTepHaJIbl H3
.D.Pymx cepHH;
- .D.OKYMeHTaUHIO 06 oT60pe np06, nOKa3blBalOlllYIO, 4TO np06bl
oT06paHbl B COOTBeTCTBHH C nJlaHOM oT60pa np06, rapaHTHpYlOlllHM
npelICTaBHTeJIbHOCTb np06;
- .D.OKYMeHTaUHIO 06 aHaJIH3e np06 060CHOBaHHblMH MeTOlIaMH;
- .D.aHHble 0 cTa6HJlbHOCTH BcnOMOHneJlbHoro BC, llleCTBa nO.D.TBep-
)I(1lalOlllHe ero CpOK rolIHOCTH.

MamepuaJlbl
77
CepmufjJuKam aHaJlU3a 6cnOMOlameJlbHblX 6elU,eCm6
CTaTbSl USP (1080) YCTaHaBJlHBaeT Tpe60BaHHSI K cepTH<!:>HKaTY aHa-
JIH3a BCnOMOraTeJlbHblX BellleCTB. CTPYKTypa cepTH<!:>HKaTa:
- 3aroJIOBOK, B KOTOpOM YKa3blBaeTCSI HaHMeHOBaHHe npOH3BO.D.HTe-
JISI, HaHMeHOBaHHe BcnOMOraTeJIbHoro BellleCTBa C YCTaHOBJleHHblM 060-
3Ha4eHHeM,
- OCHoBHoe COlIep)l(aHHe (HoMep cepHH, .D.aTa npOH3BO.D.CTBa, KO.D.
HJlH HOMep npO.D.YKTa, CpOK ro.D.HOCTH H np.);
- Pe3YJIbTaTbl aHaJIH3a H 3aKJIlO4eHHe C BbIBO.D.OM 0 COOTBeTCTBHH
npOH3BO.D.CTBa Tpe60BaHHSlM GMP.
BcnoMOraTeJIbHble BellleCTBa .D.OJI)I(Hbl 6bITb 6e30nacHblMH, B TOM
4HCJIe 6UOJlOlUlleCKU 6e30naCHblMU. CTaTbSl <!:>apMaKoneH COe.D.HHeHHbIX
iliTaTOB USP (1074) CO.D.ep)l(HT peKOMeH.D.aUHH no oueHKe 6HOJIOrH4e-
CKOH 6e30nacHocTH HOBblX BcnOMOraTeJlbHblX BellleCTB. npelInOJIara-
eTCSI, 4TO 6e30nacHocTb Y)I(e HCnOJlb3YIOIllHXCSI BcnOMOraTeJIbHblX Be-
llleCTB Y)I(e .D.OKa3aHa. 3TH peKOMeH.D.aUHH pacnpOCTpaHSIIOTCSI Ha npo-
H3BO.D.CTBO BcnOMOraTeJIbHblX BellleCTB .uJISI JleKapCTBeHHblx Cpe.D.CTB,
npe.D.Ha3HaLJeHHblX KaK .D.JlSl 4eJIOBeKa, TaK H .D.J1S1 )l(HBOTHbIX.
3.4 Bbl60p nOCTaBllI,HKOB
K Bbl60PY npOH3BOlIHTeJISI H/HJlH nOCTaBIllHKa HCXOlIHblX MaTepHa-
JIOB CJIe.uyeT nO.D.XO.D.HTb B BblcweH CTeneHH TlllaTeJIbHO. OT 3TOro 3aBH-
CHT BCSI .D.aJIbHeHlllaSI pa60Ta.
HCxooHble MamepUaJlbl
rOCT P 52249-2009, YacTb I, YKa3blBaeT:
5.25. 06eCne1.JeHI1e I1CXOllHblMI1 MaTepl1aJ1aMH S1RJ1S1eTCSI OTBeTCTBeH-
HOi-i onepaUl1eH, Tpe6YlOllleH nOJIHblX CBelleHI1H 0 nOCTaBllll-1Kax.
5.26. HCxollHble MaTe pl1aJl bl CJle1lyeT 3aKynaTb TOJlbKO y YTBep>K1leH-
HblX nOCTaBllll1KOB (YKa3aHHbIX B CneUI14>I1KaUI1I1) 1-1, no B03MO>KHOCTI-1,
HenocpellCTBeHHO y npol13BOlll1TeJIeH 3TI1X MaTepl1aJ10B. Tpe60BaHI1S1 K HI1M
1l0Jl>KHbl 6blTb YKa3aHbl B CneUI14>I1KaUI1S1X Ha I1CX01lHble MaTepl1aJlbl,
YTBep>K1leHHbIX np0I13B01lI1TeJleM JleKapCTBeHHblX Cpe1lCTB, 11 cornaCOBaHbl C
nOCTaBlllI1KOM. Bce BonpoCbl, CBSl3aHHble C npoI13B01lCTBOM 11 KOHTpoJleM
I1CX01lHbIX MaTepl1aJlOB, B T. 'I. pa60Ta C HI1MI1, MapKl1pOBKa, ynaKoBKa, no-
pSl1l0K npe1l"bSlRJIeHI1S1 peKJIaMaUI1H 11 OTKJlOHeHI1H, 1l0Jl>KHbl 6blTb cornaco-
BaHbl Me>K1lY npol13BOlll1TeJIeM 11 nOCTaBlllI1KOM.
CJIelIyeT npOBOlIHTb oueHKY H aYlIHT nOCTaBIllHKa, 3aTeM ero KOH-
TpOJIb B xOlIe lIaJIbHeHWeH pa60Tbl. 3aKa34HK \1aTepHaJIOB .D.OJl)l(eH npo-
BOlIHTb KOHTpOJIb 1I0KYMeHTaUHH H KOHTpOJlb Ka:JICiJoii cepuu nocTynHB-
WHX MaTepHaJIOI3.

78
[;106a 3
llocma6KU U3-3a py6e:JICa
D.o 1991 r. Mbl HMeJlH MOIllHble npOH3BOlICTBa A<])C, KOTOpble 06ec-
ne4HBaJIH HaWH nOTpe6HocTH H nOCTaBJlSlJIH A<])C Ha 3KcnopT 60JIee
LJeM B 100 CTpaH MHpa. 3aTeM POCCHSI n04TH nOJlHOCTblO nOTepHJIa c06-
CTBeHHoe npOH3BO.D.CTBO A<])C H K HaCTOSlllleMY BpeMeHH Ha 85% no-
KpblBaeT CBOH nOTpe6HocTH 3a C4eT HMnopTa.
3TO He npOCTO nJIOXO, 3TO onaCHO.
rOBOpSlT, 4TO pOCCHHCKaSi npOMblWJleHHOCTb A<])C He BbllIep)l(aJIa
KOHKypeHUHH CTpaH, npOH3BO.D.S1IllHX .D.ellleBble A<])C no ueHe B TPH-
4eTblpe pa3a HH)I(e pOCCHHCKOH.
OCTaHoBHMcSI Ha 3TOM Be3.D.e 3BY4allleM .D.OBO.D.e nO.D.p06Hee.
YTO MO)l(HO cpaBHHBaTb no ueHe? - MO)l(HO cpaBHHBaTb TOJlbKO
np0.D.YKuHIO O.D.HHaKoBoro Ka4eCTBa. 3TO SlCHO Ka)I(.D.OMY. HeJlb3S1 cpaB-
HHBaTb no ueHe Ha.D.e)l(HbIH, 6e30nacHblH H 3KOJlOrH4eCKH 3<!:><!:>eKTHBHbIH
aBTOM06HJIb C TpaHcnopTHblM Cpe.D.CTBOM Ha KOJIeCaX, OTpaBJlSllOlllHM
oKpY)I(alOlllYIO cpelIY H onaCHblM .D.JlSl Bcex.
COBeTcKaSi npOMblWJIeHHOCTb npoH3BOlIHJIa cy6CTaHuHH BblCOKOro
Ka4eCTBa. 3T0 nO.D.TBep)I(.D.aeTCSI BblCOKHM 06"beMOM 3KcnoPTa.
KTO H KaK npoBepSieT Ka4eCTBO HMnopTHpyeMblx cy6CTaHUHH ceH4ac?
KaK Bo061lle MO)l(HO roBOpHTb 0 Ka4eCTBe HMnopTHpyeMblx cy6cTaHuHH,
eCJIH HX npOH3BO.D.HTeJIeH He npOBepSieT HHKTO?
OTBeT SlceH: HH 0 KaKOM Ka4eCTBe roBOpHTb HeJIb3S1.
Cpa6HU6amb MO:JICIIO mOJlbKO cpa6HUMoe. BblCOKoe Ka4eCTBO HaWHX
npe)l(HHX cy6CTaHuHH H KOHTpOJlb 3a HX npOH3BO.D.CTBOM HHKaK HeJIb3S1
cpaBHHBaTb C «3apy6e)l(HbIM» ypOBHeM. Y Hac Ka4eCTBO 6blJlO Bblwe.
npOH3BO.D.CTBO A<])C nOTepSlJla He TOJIbKO POCCHSI. 20 JleT Ha3a.D.
CiliA H .D.pyme CTpaHbl npOH3BOlIHJlH A<])C, B OCHOBHOM, caMH. CeH4ac
BB03S1T H3 IOro-BocT04HoH A3HH.
Ho npOBOlIHTb napaJIJIeJlb POCCHH C 3ana.D.HblMH CTpaHaMH HeJlb3S1.
B pOCCHHCKOH my6HHKe JlIO.D.H roTOBbl pa60TaTb 3a 300-400 EBpo B MecSiU.
3TO B 10 pa3 HH)I(e, 4eM B EBpone H CiliA. HanpHMep, B <])HHJISlH.D.HH
Cpe.D.HSlSI 3apa60THaSi nJIaTa y MY)l(4HH COCTaBJlSleT 60Jlee 3 TbIC. EBpo.
Mbl BnOJlHe MomH 6bl KOHKypHpOBaTb C A3HeH, BbInYCKaSl A<])C 60JIee
BblCOKOro Ka4eCTBa B COOTBeTCTBHH C GMP.
Mbl nOTepSlJIH He TOJlbKO JleKapCTBCHHYIO He3aBHCHMOCTb. Mbl no-
TepSlJIH He3aBHCHMOCTb B nOJlY'leHHH HCXOlIHblX MaTepHaJIOB .D.a)l(e .D.J1S1
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rocY.D.apCTBO YCTaHaBJlHBaeT 6apbep - Tpe60BaHHSI K HCXO.D.HbIM MaTepH-
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PaCCMOTpeHHblH npHMep BblSlBHJl ellle OlIHH He.D.OCTaTOK B pa60Te
3Toro npe.D.npHSITHSI - HeCOl.llaC06aHHocmb pa60mbl noopa3iJeJleHUii Ka4e-
CTBa, npOH3BO.D.CTBa H HH)I(eHepHOH CJlY)I(6bI. Ka)I(.D.oe H3 HHX caMO no
ce6e 3aHHMaJIOCb «caMOHHcneKUHIMH», 6e3 06MeHa HH<!:>opMaUHeH.
Ha cmblKax mepHJlOCb 6ce. 3TO 04eHb pacnpOCTpaHeHHoe SI BJleH He.
Pa60Ta Bcex CJIY:>K6 .D.OJI)I(Ha 6blTb comaCOBaHHOH, pa360p TPY.D.HbIX CJlY-
4aeB .D.OJI)I(eH npOBO.D.HTbCSI TOJIbKO COBMeCTHO. npeHe6pe)l(eHHe 3THM
npocTblM npaBHJIOM CTOHT .D.Oporo.
nOBepXHOCTH nepBH4HOH ynaKoBKH, conpUKaCalOlU,UeCH C npOOYK-
mOM - KpHTH4eCKHe. D.nSl HeCTepHJlbHblX <!:>OPM OHH 1I0JI)I(Hbl 6blTb 4H-
CTbIMH, a .D.JlSl CTepHJIbHblX - CTepHJlbHbIMH. YHCTOTa nOBepXHOCTeH
Ba)l(Hee 'IHCTOTbl OKpY)I(alOlllero B03.Llyxa.
Oc06yIO TPYlIHOCTb npe.D.CTaBJlSleT HCnOJIb30BaHHe CTepHJlbHblX yna-
KOB04HblX MaTepHaJIOB, npOlllelIWHX CTepHJIH3aUHIO Ha MeCTe H3roTOB-
JIeHHSI H11H B CTopoHHeH opraHH3aUHH, no 1I0roBOpy. npouecc CTepHJIH-
3aUHH 1I0JI)I(eH 6blTb J.1CnblTaH, ynaKoBKa H TpaHcnopTHaSl Tapa 1I0Jl)l(Hbl
rapaHTHpOBaTb coxpaHCHHe CTepl1J1bHOCTH npH TpaHcnopTHpOBaHHI1 H
xpaHeHHH B TelleHHe YCTaHOBJleHHoro cpOKa rolIHOCTH. Oc06ylO np06JIe-

84
FW6a 3
MY MO)l(eT npelICTaBHTb nO.D.TBep)I(.D.eHHe coxpaHeHHSI CTepHJlbHOCTH npH
HMnopTe C Y4eTOM TaMO)l(eHHblX npoue.D.Yp.
O.D.HHM H3 nOKa3aTeJIeH 4 HCTOTbl SlBJlSleTCSI ypOBeHb 061llero opra-
HH4ecKoro yrnepolIa, Bbl.D.eJISIeMOrO CTeKJIOM B paCTBOp.
npHMep H3 npaKTHKH
Mbl CTOJlKHYJII1Cb C I1HTepeCHblM CJlY1.JaeM, nOCTaBI1B OllHY 113 nepBblX
YCTaHOBOK KOHTpoJlSl 06111ero OpraHl11.JeCKOrO yrnepo1la B BOlle Sievers 800
Ha Haw pbIHOK. npe1leJIbHO 1l0nYCTI1MaSI KOHueHTpaUI1S1 TOC B B01le 0'111-
llleHHOH 11 BOlle LUISI I1H"bCKUI1H - 500 ppb. OKa3aJ10Cb, 1.JTO OTe1.JeCTBeHHble
4>JlaKOHbI llalOT 4>OH 800 ppb, T. e. 3Ha1.JHTeJIbHO 60JlbWe npe1leJIbHO 1l0ny-
CTI1MOH KOHueHTpaUI1I1. 3aMeHa OTe1.JeCTBeHHoro 4>JlaKOHa Ha I1MnopTHblH
1laJIa pe3YJlbTaT 30 ppb.
<DOH HMnopTHblX <!:>JIaKOHOB COCTaBJlSleT 10-20 ppb. I1cnoJlb30BaHHe
<!:>JIaKOHOB C 60JIee BblCOKHM Bbl.D.eJIeHHeM opraHH4eCKHX BellleCTB H3
CTeKJIa .D.OJI)I(HO 6bITb 3anpellleHO, npH4eM HeMe.D.J1eHHO.
3.6 EHOTeXHOJlOrHH
npOH3BO.D.CTBO 6HOJIOm4eCKH aKTHBHblX cy6cTaHuHH HMeeT CBOH
LJeTKO Bblpa)l(eHHbIe oc06eHHOCTH:
- B npoueccax Y4aCTBYlOT MaTepHaJIbl )J(HBOH npHpOlIbl - MHKpOOp-
raHH3Mbl, OHH H3MeH4HBbI B OTJIH4He OT XHMH4eCKHX COe.D.HHeHHH, npo-
ueCCbl m6eJlH H pa3MHO)l(eHHSI MHKpoopraHH3MOB CHJIbHO 3aBHCSlT OT
BHeWHHX YCJlOBHH, 3TO MO)l(eT BJlHSlTb Ha COCTaB Cpe.D.bl H npouecc
04HCTKH, YCJIOBHSI MOryT MeHSlTbCSI OT cepHH K cepHH;
- MO)l(eT nOTpe60BaTbcSI 60JIee )l(eCTKHH KOHTpOJIb 060PYlIOBaH, HSI
MaTepHaJIOB H oKPY)I(alOllleH Cpe.D.bl .lLJISi CBe.D.eHHSI K MHHHMYMY pHCKa
3arpSl3HeHHH;
- Ha npoueCCbl BJlHSleT pSl.D. napaMeTpOB, K H3MeHeHHIO KOTOpblX
MHKpoopraHH3Mbl HMelOT BblCOKYIO 4YBCTBHTeJIbHOCTb, npO.D.YKT H npo-
uecc He Moryr 6bITb oxapaKTepH30BaHbl T04HO;
- He3Ha4HTeJIbHOe H3MeHeHHe YCJlOBHH MO)l(eT npHBCCTH K He)l(eJIa-
TeJIbHblM H HeO)l(H.D.aHHbIM H3MeHeHHSlM cy6cTaHuHH H roTOBOro npOlIYKTa.
TaKHM 06pa30M, rnaBHblM OTJlH4HeM 6HOTeXHOJlOrHH OT XHMH4e-
CKOro CHHTe3a SlBJlSleTCSI 6apua6eJlbHOCmb npouecca. OH CHJIbHO 3aBHCHT
OT KOJIH4eCTBa MHKpoopraHH3MOB. npoueCCOB 04HCTKH H IIp.
Bce 3mo omllocumCH KaK K cy6cmaHu.UHM, maK u K lom060MY npo-
OYKmy, nOJlY'laeMOMY MemOOaMU 6UOmeXHOJlOlUU!
ATTeCTauHSI npoueCCOB BbInOJIHSleTCSI .D.J1S1:
- .D.eMOHCTpaUHH cTa611JIbHOCTH H Ha.D.e)l(HOCTH npouecca;
- OueHKI1 BJlHSlHH1 H3MeHeHI1H napaMeTpOB npouecca Ha KalleCTBO
npOlIYKUHH.

MamepuaJ1bl
85
3TY OueHKY H3MeH4HBOCTH Ha.D.O Ha4HHaTb C pa3pa60TKH npouecca
npHroTOBJleHHSI cy6CTaHuHH, C KJlHHH4ecKoH CTMHH. MO)l(eT OKa3aTbCSI,
4TO npouecc He MO)l(eT 6blTb aTTeCTOBaH, H Bce Hy)I(HO Ha4HHaTb CHa4aJIa.
KaK H Be31Ie, BHa4aJIe CJlelIyeT nOCTpOHTb .D.HarpaMMY npouecca
(6JIOK-cxeMY). D.nSl 6HOTeXHOJlOrHH THnOBblMH 3TanaMH S1BJlSlIOTCSI:
- HHOKYJIHpOBaHHe (B npOH3BO.D.CTBe BaKUHH);
- <!:>epMeHTaUHSI (KYJIbTHBHpOBaHHe KJleTOK);
- c60p KJleTOK;
- <!:>HJIbTpaUHSI;
- ueHTpH<!:>yrHpoBaHHe;
- xpOMaTorpa<!:>HSI;
- BbI.D.eJleHHe H 04HCTKa;
- CTepHJlH3aUHSI;
- HanOJlHeHHe;
- JIHO<!:>HJlbHOe BbICYWHBaHHe.
D.nSl Ka)I(.D.oro 3Tana 1I0JI)I(Hbl 6bITb YKa3aHbl 060PYlIOBaHHe, HCXO.D.-
Hble H TeXH0J10rH4eCKHe MaTepHaJIbl, He06xo.D.HMOCTb npOBe.D.eHHSI BHyr-
pHnpOH3BO.D.CTBeHHoro KOHTpOJlSl H ero CO.D.ep)l(aHHe, npHMeHSIeMble aHa-
JIHTH4eCKHe MeTO.D.bl H KOHTpOJlbHO-H3MepHTeJIbHble npH60pbl.
HY)I(HO CneUHaJIH3HpOBaTb 6HopeaKTopbl no BHllaM 6aKTepHH,
,lJ,p0)l()l(eH HJlH KJleTOK MJIeKOnHTaIOIllHX.D.J1S1 HCKJlf04eHHSI nepeKpecTHoro
3arpSl3HeHHSI (nolIp06HO 06 HCKJlI04eHHH nepeKpeCTHblX 3arpSl3HeHHH
CM. rJlaBY 4).
3.7 Oc06eHuocTH MaTepH3JlOB ,lI,.JUI BaKl\llU
BaKUHHbl - B BblcweH CTeneHH OTBeTCTBeHHaSi npO.D.YKUHSI.
Bo-nepBblx, BaKUHHbl .D.OJl)l(Hbl 6blTb CTepHJlbHblMH H anHporeHHblMH.
BO-BTOPbIX, OHH BKJlI04alOT B ce6S1 npO.D.YKTbl )l(HBOH npHpOlIbl HJlH
npOH3BO.D.S1TCSI Ha HX OCHOBe;
B-TpeTbHx, OCHOBHblM nOTpe6HTeJleM BaKUHH SlBJlSIIOTCSI lIeTH. D.nSl
TaKOH npOlIYKUHH HHKaKHe nOCJIa6JleHHSI He.D.OnYCTHMbl.
npOH3BOlICTBO SlBJlSleTCSI CJlO)l(HblM MHOroCTa.D.HHHbIM npoueCCOM C
HCnOJIb30BaHHeM MHOrHX HCXO.D.HbIX MaTepHaJIOB. nO.D.p06HO Tpe60BaHHSI
K npOH3BO.D.CTBY BaKUHH .D.aHbl B EBponeHcKoH <!:>apMaKonee. 3THM .D.O-
KYMeHTOM CJIe.D.yeT PYKOBO,lJ,CTBOBaTbCSI npH C03.D.aHHH HOBblX npOH3-
BOlICTB BaKUHH H oueHKe lIeHCTBYIOIllHX. OTe4ecTBeHHbie 1I0KYMeHTbl
YCTapeJIH H .D.e30pHeHTHpYIOT nOJIb30BaTeJleH.
PaccMoTpHM B Ka4eCTBe npHMepa O.D.HH BH.D. HCXO.D.HbIX MaTepHaJlOB -
KypHHble IHua, KOTopble HCnOJlb3YIOTCSI B npOH3BOlICTBe rpHnn03HoH
BaKUHHbl.

86
DlO6a 3
no EBponeHcKoH <!:>apMaKonee .aonYCKaeTCSI HCnOJlb30BaHHe TOJIbKO
SlHU OT SPF-CTa.D. KYP (chicken flocks free form specified pathogens) - CTa.D.
KYP, cBo60.aHblx OT cneUH<!:>H4ecKHx naToreHHblX MHKpoopraHH3MoB
ECTb CneUHaJIbHble npaBHJIa <!:>OpMHpoBaHHSI H COlIep)l(aHHSI TaKHX CTa.D..
ComaCHO n. 5.2.2 EBponeHcKoH <!:>apMaKoneH CTa.D.O - 3TO rpynna
nTHU, co.aep)l(alllHXCSI B O.aHHX YCJIOBHSlX, YXOlI 3a KOTOpblMH OCYllleCTB-
JISleT CneUHaJIbHO BbIlleJleHHblH .D.J1S1 3TOro nepCOHaJI, He HMelOlllHH KOH-
TaKTa C He SPF-CTa.D.aMH H BellleCTBaMH, KOTopble MOryr npHBeCTH K
HH<!:>HUHpOBaHHIO CTalIa. nOCJle TOro, KaK SPF-CTa.D.O onpe.aeJleHO, B He-
ro He .a06aBJlSlIOTCSI He SPF-nTHUbl.
Bce MaTepHaJIbl, HCnOJIb3yeMble .aJlSl co.aep)l(aHHSI SPF-CTalIa, 1I0JI)I(-
Hbl 6bITb CTepHJIbHbIMH. OpraHH3yeTcSI CneUHaJIbHOe nHTaHHe, HCKJlIO-
LJalOlllee nOna.D.aHHe KypaM He)l(eJIaTeJlbHblX MHKpoopraHH3MOB H T. .a.
nOMellleHHSI opraHH3YIOTCSI B BHlIe H30JISITOpOB HJlH Haxo.aSlTCSI no.a
H36bIT04HbiM .aaBJleHHeM C no.aa4eH B03.ayxa 4epe3 <!:>HJIbTpbl. BbInOJlHSI-
IOTCSI CneUHaJIbHble Tpe60BaHHSI K nepHo.aH4eCKOMY KOHTpOJlIO 3,lJ,OpOBbSi
nTHU H MHoroe .apyroe.
3TO no,lJ,Xo.a GMP. llpyroH no.axo.a - 3TO HCnOJlb30BaHHe KaKHX
yrolIHO SlHU H Bbl60p04HblH KOHTpOJlb Ha npHcyrcTBHe naToreHHblX
MHKpoopraHH3MOB. 3TOT KOHTpOJlb KpaHHe He3<!:><!:>eKTHBeH H nponYCKa-
eT MHOro HH<!:>HUHpOBaHHbIX SlHU (KpaHHSlSI He3<!:><!:>eKTHBHOCTb Bb160p04-
HOro KOHTpOJISI CTepHJlbHOCTH nOKa3aHa BO BBe.aeHHH K KHHre). ECJIH
TaK pa60TaTb, TO BaKUHHa BnOJIHe MO)l(eT co.aep)l(aTb BHPYC capKOMbl, He
BblSlBJleHHblH npH KOHTpOJIe cepHH S1HU.
BblCOKaSi .aeTCKaSi CMepTHOCTb B POCCHH - npSlMoe CJIe.aCTBHe He-
BbInOJIHeHHSI B POCCHH UHBHJIH30BaHHblX Tpe60BaHHH K npOH3Bo.aCTBY
BaKUHH.
I1HTepecHo, 4TO poccHHcKaSi BeTepHHapHaSl HaYKa HCnOJIb3yeT S1Hua
HMeHHO OT SPF-CTaD., 3aKynaSi HX B EBpone. BaKUHHbl .D.J1S1 )l(HBOTHbIX
(no .aaHHbIM BHI1113)1( - BcepoccHHcKoro HaY4HO-HCCJIelIOBaTeJIbCKoro
HHcTHTyra 3alllHTbl >KHBOTHbIX) npOH3Bo.aSlTCSI H3 TaKHX SlHU.
3TO XopOWO. Ho 3TO H ropbKaSi HpOHHSI - B POCCHH BeTepHHapbl 0
)l(HBOTHbIX 3a60TSlTCSI 60JIbWe, 4eM Te, KOMY 3TO nopY4eHO - 0 JIIO.aSlX.
1..1TaK, nepBblM YCJlOBHeM BbInYCKa 6e30naCHblX H 3<!:><!:>eKTHBHbIX JIe-
KapCTBeHHblX cpe.aCTB SlBJlSleTCSI HCnOJIb30BaHHe XOpOUlUX UCXoOIlblX U
ynaK060llHblX MamepUQJl06. De3 3TOro HeT CMblCJIa C031IaBaTb CHCTeMY
.aOKYMeHTaUHH, npH06peTaTb xopowee 060py.aOBaHHe, HCnblTblBaTb ero
H np. ECJlH 3TO .aeJlaTb npH nJlOXHX MaTepHaJIaX, TO npOH3BOlICTBO 6y.aeT
YCToi14HBO H rapaHTHpOBaHHO npOH3BOlIHTb Hero.aHYIO npOlIYKUHIO.
XopOWHe M,nepHaJIbl - 06S13aTeJIbHOe Tpe60BaHHe GMP.

87
f JIaBa 4
np01l3BO)J:CTB0
4.1 CxeMa npOH3BO,lJ,CTBa
nOlI np0U3600cm60M nOHHMalOTCSI Bce onepaUHH H BH.D.bl KOHTpOJlSl,
CBSl3aHHble C nOJIY4eHHeM, npHeMOM H 06pa60TKoH HCXOlIHblX MaTepHaJIOB
(TeXHOJIOrH4eCKHe npoueCCbl), ynaKoBKoH, BbInYCKOM B peaJIH3aUHIO,
xpaHeHHeM H OTrpY3KOH JIeKapCTBeHHblX Cpe.D.CTB [I]. TaKHM 06paJOM, B
nOHSlTHe «npOH3BOlICTBO» BXO.D.SlT Bce onepaUHH OT nOJIyYeHHSI MaTepHa-
JIOB .D.O OTrpY3KH roTOBOH npO.D.YKUHH. AHaJIorH4Hoe nOHHMaHHe B 3TOT
TepMHH BKJla.D.blBaeTCSI H npaBHJlaMH cGMP CiliA. CxeMa npOH3BO.D.CTBa
JIeKapCTBeHHblX Cpe.D.CTB nOKa3aHa Ha pHC. 4.1.
B OTe4eCTBeHHOH npaKTHKe nOHSITHe «npOH3BO.D.CTBO» MO)l(eT HMeTb
60JIee Y3KHH CMbICJI, orpaHH4HBaSi ero HHTepBaJIOM OT nOJIY4eHHSI MaTe-
pHaJIOB ueXOM .D.O C.D.a4H npO.D.YKUHH Ha CKJla.D. rOTOBOH npO.D.YKUHH.
TeXHOJlOrH4eCKHe onepaUHH CJIe.D.yeT BbInOJIHSlTb COrJlaCHO npo-
MbllllJIeHHOMY perJIaMeHTY H HHCTPYKUHSlM, Tpe60BaHHSlM GMP, .D.PyrHx
HopMaTHBHblX .D.OKYMeHTOB 11 Tpe60BaHHSlM, YCTaHOBJ1eHHbIM npH perH-
CTpaUHH JIeKapCTBeHHoro Cpe.D.CTBa.
r--------------r----------------------r------------
I
I
I
I
I
CIUIU ManpHanoB
npoH]BOD.CTBO
nn1Y'leHIfC
M.neplla.lOB
H3 CeplllO
nponYKUl1il
TeXHOJlont..eCKHH
npouecc
BbL101''1a
pollpCUlClllnl H3J
I"C,L1HJ31111KJ
cepllH I
I
I
I
I
I-1cxollHble
II
- _1- _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ __
PHC. 4.1. CxeMa npOH3BO.D.CTBa JleKapCTBeHHblX cpelICTB
OCHOBHblMH 3TanaMH npOH3BOlICTBa S1BJlSlIOTCSI:
- npHeM MaTepHaJIOB OT nOCTaBIllHKOB;
- nOMellleHHe HX B KapaHTHH, oT60p np06 H KOHTpOJlb Ka4eCTBa Ma-
TepHaJIOB;
- BbllIa'la MaTepHaJIOB Ha cepHIO npOlIYKUI1H H npHeM HX npOH3BOlI-
CTBeHHblM nOlIpa31ICJleHHeM;

88
1J106a 4
- BbInOJlHeHHe TeXHOJlOrH4eCKHX onepauHH H npOBelIeHHe BHyrPH-
npoH3Bo.acTBeHHoro KOHTpOJlSl;
- KOHTpOJIb cepHH roTOBOH npOlIYKUHH, KapaHTHHHoe xpaHeHHe H
nOJlY4eHHe pa3peweHHSI Ha ee peaJIH3aUHIO;
- nepelIa4a npolIYKUHH Ha CKJla.D. roTOBOH npOlIYKUHH.
Oc060e BHHMaHHe y.aeJISleTCSI HCKJlI04eHHIO nepenYTblBaHHSI MaTe-
pHaJIOB, 3THKeTOK H npolIYKUHH H np., He.aonyweHHIO nepeKpecTHblx H
.aPyrHX 3arpSl3HeHHH. KJ1104eBb1M nOHSITHeM B npoH3Bo.acTBe S1BJlSleTCSI
«cepUH npooYKu.uu» (n. 4.6).
Ha npOH3Bo.aCTBO pa60TalOT Bce:
- KOMMep4eCKaSl cJIY)I(6a 06ecne4HBaeT npOH3Bo.aCTBO MaTepHaJIaMH
H 3aKa3aMH Ha npo.aYKUHIO (3.aecb H .aaJIee HaHMeHOBaHHSI no.apa3.aeJle-
HHH .aaHbl YCJlOBHO);
- HH)I(eHepHble no.apa3.aeJIeHHSI 06ecne4HBalOT pa60TY nOMellleHHH,
060Py.aoBaHHSI, ceTeH H CHCTeM B COOTBeTCTBHH C YCTaHOBJleHHblMH Tpe-
60BaHHSlMH;
- OT.aeJI KOHTpOJISI Ka4eCTBa KOHTpOJIHpyeT HCxo.aHble H ynaKoB04-
HbIe MaTepHaJIbl, npoMe)l(yr04HYlO H roTOBYfO npo.aYKUHIO (3a HCKJlI04e-
HHeM BHyrpHnpOH3Bo.aCTBeHHoro KOHTpOJISI, BbInOJIHSleMoro npOH3BO.a-
CTBCHHblMH no.apa3.aeJIeHHSlMH);
- OT.aeJI 06Y4eHHSI roTOBHT Ka.D.Pbl H T. .a.
BcSI 3Ta .aeSlTeJIbHOCTb .aOCTHrHeT ueJlH npH YCJIOBHH 4eTKOH pa60Tbl
npOH3Bo.aCTBa, KOTOpaSI .aOJI)I(Ha 6blTb nOCTpoeHa B CTpOroM COOTBeT-
CTBHH C npaBHJlaMH GMP (pa31IeJI 5 YacTH I).
4.2 06paIUeHHe C MaTepHanaMH ,lJ,0 nepe,lJ,alfH B npOH3BO,lJ,CTBO
HCXOOHble MamepUaAbl nO.D.J1e)l(aT BXO.aHOMY KOHTpOJIIO H nOMellla-
IOTCSI B KapaHTHH (KapaHTHHHoe xpaHeHHe) Ha CKJla.D.e MaTepHaJIOB. UeJlb
KapaHTHHa - H30JIHpOBaTb MaTepHaJIbl .ao nOJlY4eHHSI pa3peweHHSI Ha
nepelIa4Y B npOH3Bo.aCTBO. D.J1S1 BXO.aHOro KOHTpOJlSl oT6HpalOTcSI np06bl
(06pa3Ubl) HCXOlIHblX MaTepHaJIOB C ueJlblO npOBepKH HX COOTBeTCTBHSI
cneUH<!:>HKauHH.
YnaK0601lllbie MamepUaAbl TaK)I(e nOlIJle)l(aT BXO.aHOMY KOHTpOJIIO.
OHH 1I0JI)I(Hbl COOTBeTCTBOBaTb Tpe60BaHHSlM cneuH<!:>HKaUHH, B TOM
4HCJle Tpe60BaHHSlM K 4 HCTOTe. YHCTOTa nepBH4HblX ynaKoB04HblX Ma-
TepHaJIOB (<!:>JIaKOHOB, aMnYJI, 6JlHCTepHOH JleHTbl H np.) .aOJI)I(Ha COOT-
BeTCTBOBaTb YPOBHIO MHpOBblX Tpe60BaHHH. ECJIH HCnOJlb30BaTb rpSl3Hble
nepBH4Hble ynaKoB04Hble MaTepHaJIbl HJIH MaTepHaJIbl, BbllIeJlSlIOIllHe 3a-
rpSl3HeHHSI, TO HH 0 KaKOM COOTBeTCTBHH npaBHJlaM GMP He MO)l(eT
6bITb H pe4H.

flp0U3600cm60
89
Llo nOJIY4eHHSI nOJIO)l(HTeJlbHblX 3aKJIlO4eHHH no pe3YJIbTaTaM BXOlI-
HOro KOHTpOJISI nepelIa4a MaTepHaJIOB B npOH3Bo.aCTBeHHble nOlIpa31IeJle-
HHSI H HX Hcn011b30BaHHe He 1I0nYCKaIOTCSI.
PSllI HCXOlIHblX MaTepHaJIOB npe.anpHSlTHe roTOBHT caMOCTOSlTeJlbHO,
HanpHMep, BOlIY.D.J1S1 HH"beKUHH, BXOlISlIllYIO B COCTaB npOlIYKTa. npouec-
Cbl npHroTOBJleHHSI TaKHX I1CXO.aHbIX MaTepHaJIOB, npHMeHSleMoe 060PY-
.aOBaHHe, TPy60npoBolIbl H ceTH 1I0JI)I(Hbl COOTBeTCTBOBaTb Tpe60BaHHSlM
GMP.
YCJlOBHSI xpaHeHHSI MaTepHaJIOB 3a.D.aIOTCSI I1X npoH3Bo.aHTeJIeM. Ma-
TepHaJIbl B ynaKoBKax .aOJI)I(Hbl xpaHHTbCSI Ha CTeJIJIa)l(ax, He KacaSlCb no-
JIa, TaK, 4T06bl MO)l(HO 6blJIO BbInOJlHSlTb HX OCMOTp H y60PKY OKpY)l(a-
IOllleH 30Hbl.
llpueM MamepUQJl06 om nocma6U1,UK06
Tpe60BaHHSI K HCXO.aHbIM H ynaKoB04HblM MaTepHaJIaM H pa60Te C
nOCTaBIllHKaMH npHBe.aeHbl B maBe 3. 3.aecb paCCMaTpHBaeTCSI TOJIbKO
.aBH)I(eHHe MaTepHaJIOB Ha npelInpHSlTHH-npOH3BOlIHTeJIe JIeKapCTBeHHblX
cpelICTB:
I. KOMMep4ecKaSi cJIy)I(6a (oT.aeJI cHa6)1(eHHSI) 3aKa3bIBaeT MaTepHa-
JIbl y nOCTaBIllHKa, KOTOpblH 6blJI 3apaHee onpe.aeJleH PYKOBo.aHTeJlSlMH
CJIy)I(6 Ka4eCTBa H npOH3Bo.aCTBa. 3aKa3 MaTepHaJIOB BbInOJIHSleTCSI no
cneuH<!:>HKauHSlM, COrJlaCOBaHHblM OT.aeJlOM KOHTpOJISI Ka4eCTBa.
2. KonHSI 3aKa3HOH cneUH<!:>HKauHH nepe.aaeTCSI B no.apa3.aeJIeHHe,
nOJIY4alOIllee MaTepHaJIbl (eCJlH nOJlY4eHHe MaTepHaJIOB O<!:>opMJlSleTCSI He
OT.aeJlOM cHa6)1(eHHSI, a .aPYrHM nOlIpa31IeJleHHeM, HanpHMep, Henocpe.a-
CTBeHHO CKJla.D.OM).
3. MaTepHaJIbl OT nOCTaBIllHKOB npHHHMalOTCSI Ha cKJla.a MaTepHa-
JIOB.
4. nepBblMH .aeHcTBHSlMH nOCJIe nOJIY4eHHSI MaTepHaJIOB SlBJlSlIOTCSI:
- npOBepKa Ha COOTBeTCTBHe 3aKa3Y no MapKHpOBKe Ha Tape, TOBap-
HOH HaKJIa.aHOH H 3aKa3HOH cneUH<!:>HKaUHH;
- npOBepKa COOTBeTCTBHSI HOMepOB cepHH nOCTaBIllHKa, YKa3aHHblX
B HaKJIa.aHOH H Ha Ka)l(1l0H ynaKoBKe;
- B CJlY4ae paCXO)l(1leHHH CJIe.ayeT HeMe.D.J1eHHO nOCTaBHTb B H3BeCT-
HOCTb OT.aeJl Ka4eCTBa H OTlIeJl cHa6)1(eHHSI;
- npOBepKa ueJlOCTHOCTH TpaHcnopTHOH Tapbl, ynaKoBKH H nJlOM6,
COOTBeTCTBHe HaKJIa.D.HOH MapKHpOBKe Ha Tape (ynaKOBKe);
- 04HCTKa Tapbl H ynaKoBKH;
- eCJIH Tapa H ynaKoBKa nOBpe)I(.D.eHbl H 3TH nOBpe)I(.D.eHHSI MoryT
OTpHuaTeJIbHO BJlHSlTb Ha Ka4eCTBO MaTepHaJlOB, TO O<!:>opMJlSleTCSI aKT 0
nOBpe)I(.D.eHHH c YKa3aHHeM ero xapaKTepa; aKT HeMelIJleHHO nepe.aaeTCSI
B OT.aeJlbl KOHTpOJlSl Ka'leCTBa H cHa6)1(eHH.

90
J:W6a 4
MapKup06Ka MamepUQJl06
Bce MaTepHaJIbllIOJI)I(Hbl HMeTb MapKHpoBKY (n. 4.4 KHHm).
Ka)I(.D.OMY nOCTynHBllleMY MaTepHaJIY .D.OJI)I(eH 6bITb npHCBoeH BHYT-
pH3aBO.D.CKOH (cBoero npelInpHSlTHSI) HOMep cepHH. npH OlIHOBpeMeHHOM
nOJlyYeHHH OT OlIHoro nOCTaBIllHKa HeCKOJIbKHX cepHH MaTepHaJIa HX CJle-
.D.yeT pa3.D.eJIHTb H npHCBOHTb HM OT.D.eJlbHble BHyrpH3aBO.D.CKHe HOMepa.
Ha MapKHpOBKe (3THKeTKe) .D.OJI)I(HO 6blTb YKa3aHo:
- HaHMeHOBaHHe npe.D.npHSITHSI (nOJlY4HBwero MaTepHaJI);
- HaHMeHOBaHHe MaTepHaJIa;
- BHYTPH3aBO.D.CKOH KOlI MaTepHaJIa (BHyrpeHHHH KOlI npe.D.npHSlTHSI,
nOJIY4HBwero MaTepHaJI);
- BHyrpH3aBO.D.CKOH HOMep cepHH MaTepHaJIa, npHcBoeHHblH npH
npHeMKe;
- CTaT)'C MaTepHaJIa: «KapaHTHH», «l1cnblTaHHSI», «Pa3peWeHO»,
«OTKJlOHeHo» H T. n., KOTOpblH MO)l(eT 6bITb nOKa3aH UBeTOM 3THKeTKH;
- .D.aTa nOJIyYeHHSI MaTepHaJIa;
- CpOK ro.D.HOCTH HJIH .D.aTa, nOCJIe KOTOpOH He06xo.D.HMO npOBe.D.eHHe
nOBTopHOro KOHTpOJISI;
- nO.D.nHCb JIHua, HaHecwero 3THKeTY Ha ynaKOBKY.
Ha 3THKeTKY MO)l(eT HaHOCHTbCSI .D.OnOJlHHTeJIbHaSi HH<!:>opMaUHSI,
HanpHMep, Ha CTaTYCHOH 3THKeTKe «KapaHTHH» CJIe.D.yeT YKa3bIBaTb .D.aTY
oT60pa np06bl (CM. HH)I(e).
ECJIH CKJla.D.CKOe X03S1HCTBO nOJIHOCTblO OCHallleHO KOMnbIOTepaMH,
YKa3bIBaTb BCIO 3TY HH<!:>opMaUHIO B MapKHpOBKe He06S13aTeJIbHO.
KOHmpOJlb nOOJlUHIlOCmU MamepUQJl06
ECJIH MaTepHaJIbl 6JIarOnOJlY4HO npOWJlH nepBH4HYIO npOBepKY, TO
OT.D.eJIOM KOHTpOJISI Ka4eCTBa npOBepSleTCSI HX nO.D.J1HHHOCTb. nOpSilIOK
npOBepKH pemaMeHTHpyeTcSI CneUHaJIbHblMH HHCTPYKUHSlMH H MeTO-
.D.HKaMH. Oc06ylO pOJlb HrpaeT npaBHJlbHOCTb oT60pa np06 MaTepHaJIOB
(n. 4.3 KHHrH).
He .D.OnYCKaeTCSI nepelIa4a MaTepHaJIOB B npOH3BOlICTBO .D.O nOJlY4e-
HHSI pa3peweHHSI OT OTlIeJIa KOHTpOJlSl Ka4eCTBa. C 3TOH ueJIblO MaTepH-
aJIbl nOMelllalOTCSI B KapaHmUH (KapaHTHHHoe xpaHeHHe) .D.O nOJIY4eHmi
pa3peweHHSI Ha HCnOJIb30BaHHe (nepe.D.a4Y B npOH3BO.D.CTBO) HJlH OTKJlO-
HeHHSI MaTepHaJIa.
YnaKoBKH C Hepac<!:>acoBaHHoH npolIYKUHeH, H3 KOTOpblX 6blJIH
oT06paHbl np06bl, .D.OJl)l(Hbl HMeTb COOTBeTCTBYlOlllYIO MapKHpOBKY.
npH nOCTaBKe HCXOlIHblX MaTepHaJIOB H3 HeCKOJlbKHX cepHH Ka)l(-
.D.YIO cepHIO CJIe,lJ,yeT paCCM,npHBaTb KaK He3aBHCHMYIO B OTHoweHHH OT-
60pa np06, npOBClIeHHSI HcnbITaHHH 11 nOJIY4CHHSI pa3peweHHSI Ha HC-
n0J1b30BaHHe.

flpOU3600cm60
91
KapaHmUH
nOlI KapaHTHHOM nOHHMaeTCSI CTaTYC HCXOlIHblX HJlH ynaKoB04HblX
MaTepHaJIOB, npOMe)l(yr04HoH, Hepac<!:>aCOBaHHOH HJlH roTOBOH npo.aYK-
UHH, H30JlHpOBaHHbiX <!:>H3H ' leCKH HJlH HHblM 06pa30M .ao BblHeceHHSI
peweHHSI 06 HX BbInYCKe HJlH OTKJlOHeHHH.
D.OJI)I(HO 6bITb HCKJlI04eHO nepenyrblBaHHe MaTepHaJIOB H npo.aYK-
UHH KaK Me)l(1lY c060H, TaK H C .apyrHMH MaTepHaJIaMH H npOlIYKUHeti.
ll.rISI 3TOro KapaHTHH CJle.ayeT opraHH30BaTb no npHHUHny pa31IeJlbHoro
xpaHeHHSI HJIH npelIYCMaTpHBaTb opraHH3aUHOHHbie Mepbl no 3aWHTe OT
nepenyrblBaHHSI.
MaTepHaJIbl H npo.aYKUHSI .aOJl)l(Hbl COlIep)l(aTbCSI B KapaHTHHe .ao
nOJIY4eHHSI pa3peweHHSI Ha HCnOJIb30BaHHe HJlH peaJIH3aUHIO.
KapaHTHHHoe H nOCJIe.aYlOlllee xpaHeHHe MO)l(eT 6bITb opraHH30BaHO
Ha CKJla.D.e MaTepHaJIOB 6e3 <!:>H3H4ecKoro HX nepeMellleHHSI nYTeM H3Me-
HeHHSI cTaTyca (3aMeHbl CTaTYCHOH 3THKeTKH).
OljJopMJlellue iJaHHblX
Pa60THHK CKJla.D.a MaTepHaJIOB (omeJla cHa6)1(eHHSI) 3anOJlHSleT <!:>op-
MY «OT4eT 0 nOJlY4eHHH MaTepHaJIOB» B 4eTblpex 3K3eMnJlSlpax. O.aHH
3K3eMnJISIp OH OCTaBJ1S1eT y ce6S1, a TPH nepe.aaeT B OT.aeJI KOHTpOJISI Ka-
4eCTBa. 3Ta <!:>opMa co.aep.>KHT [53]:
- HaHMeHOBaHHe npe.anpHSITHSI;
- HaHMeHOBaHHe H KO.a MaTepHaJIa;
- .aaTY nOJIY4eHHSI MaTepHaJIa;
- HaHMeHOBaHHe nOCTaBIllHKa;
- HOMep cepHH nOCTaBIllHKa;
- nOJIY4eHHoe KOJIH4eCTBO MaTepHaJIa (Bec, WTYKH);
- KOJIH4eCTBO ynaKoBoK nOJIY4eHHoro MaTepHaJIa;
- HOMep .aoroBopa (KoHTpaKTa, 3aKa3a) C nOCTaBIllHKOM;
- BHyrpH3aBo.acKoH (c06cTBeHHbIH) HOMep cepHH;
- oc06ble YCJlOBHSI (nOpSI.D.OK 06pallleHHSI, Tpe60BaHHSI K 4HCTOTe H np.);
- 3aMe4aHHSI no pe3YJIbTaTaM nepBH4HoH nponepKH, eCJIH OHH eCTb,
HJIH y.aOCTOBepeHHe COOTBeTCTBHSI MaTepHaJIa 3aKa3Y, ueJIOCTHOCTH Tapbl
H ynaKoBKH H COOTBeTCTBHSI .apyrHM npOBepeHHblM YCJIOBHSIM;
- .aaTY nepBH4HoH npOBepKH;
- <!:>aMH11HIO H HHHUHaJIbl JIHua, BbInOJlHHBwero ,HY npOBepKY.
B HH)I(HeH 4aCTH cPOpMbl .aOJI)I(HO 6blTb nOJle, 3anOJlHSleMOe OT.aeJlOM
KOHTpOJISI Ka4eCTBa, Ha KOTOpOM YKa3bIBaeTCSI ero pellleHHe: pa3peweHO,
OTKJlOHeHO. 113 Tpex nOJlY4eHHbiX KonHH <!:>0PMbl:
- OlIHa KonHSI <!:>OpMbl nepeLlaeTcSI B OT.aeJI cHa6)1(eHHSI;
- BTopaSl - Ha cKJla.a MaTepHaJIOB B Ka4eCTBe YKa3aHHSI Ha nepeMe-
llleHHe MaTCpHaJIa H3 30Hbl KapaHTHHa B 30HY xpaHeHHSI pa3peweHHbix
.D.J1S1 HCnOJIb30BaHHSI MaTepHaJIOB;
- TpeTbH OCTaeTCSI B OTlIeJle KOHTpOJISI KalleCTBa C npHJlO)l(eHHCM K
HCH npOTOKOJIOB aHaJIH3a M,UCpH.lJIOB.

92
D/06a 4
Bee lIaHHble OT nOJlY4eHHSI MaTepHaJIOB npelInpHSlTHeM 110 BbllIa4H
3aKJIlO4eHHSI OTlIeJIOM KOHTpOJISI Ka4eCTBa ueJIeC006pa3Ho O<!:>0PMHTb B
BHlIe Ta6JlHUbl, CTOJl6ubl KOTOpOH COlIep)l(aT .D.aHHble 0 MaTepHaJIe B xpo-
HOJlOrH4eCKOH nOCJIelIOBaTeJIbHOCTH: lIaTY nOJIY4eHHSI, HaHMeHOBaHHe
MaTepHaJIa, ero KOlI, HOMep cepHH nOCTaBIllHKa, c06CTBeHHblH npHCBO-
eHHblH HOMep cepHH H T. 11. 110 YKa3aHHSI peweHHSI OTeJla KOHTpOJISI Ka-
4eCTBa H ero .D.aTbI. TaKHM 06pa30M, Ka)l(1laSi CTpOKa Ta6JIHUbl COlIep)l(HT
BCIO HH<!:>opMaUHIO 0 cepHH MaTepHaJIa .D.O ero Bbl.D.a4H B npOH3BOlICTBO.
BcSI Ta6JIHua .D.aeT B KOMnaKTHOM BHlle HH<!:>opMaUHIO 0 MaTepHaJIaX 3a
.D.JlHTeJIbHbIH nepHO.D. BpeMeHH.
KpOMe 3THX <!:>OPM MOryr 3anOJlHSlTbCSI H lIPYrHe Y4eTHble <!:>OpMbl
()I(YPHaJIbI). npHBe.D.eHHaSi cxeMa .D.aeT 061llee npe.D.CTaBJleHHe 0 pa60Te,
KOTopaSl KOHKpeTH3HpyeTcSI Ha Ka)I(.D.OM npe.D.npHSlTHH.
npH nOJIO)l(HTeJIbHOM 3aKJIlO4eHHH OT OT.D.eJla KOHTpOJISI Ka4eCTBa Ha
Ka)I(.D.YIO ynaKOBKY HaHOCHTCSI CTaTYCHaSi 3TH KeTKa. 3Ta onepaUHSI Bbl-
nOJIHSleTCSI pa60THHKOM OT.D.eJIa KOHTpOJlSl Ka4eCTBa C YKa3aHHeM ero
<!:>aMHJIHH H HHHUHaJIOB.
nOpSl.D.OK HaHeceHHSI 3THKeTOK SlBJlSleTCSI KpHTH4eCKHM: npaBO .D.O-
nYCKa B npOH3BO.D.CTBO H MapKHpOBKH ynaKoBoK HMeeT TOJIbKO OT.D.eJI
KOHTpOJISI Ka4eCTBa.
YnaK060llHbie MamepUll.Ilbl
nOpSl.D.OK pa60Tbl C ynaKoB04HblMH MaTepHaJIaMH aHaJIOrH4eH no-
pSl.D.KY pa60Tbl C HCXOlIHblMH MaTepHaJIaMH (npaBHJla GMP, n.n. 5.40-
5.43 YaCTH I).
Ka)I(.D.OH cepHH nOCTaBJleHHblX ynaKoB04HblX MaTepHaJIOB .D.OJl)l(eH
6blTb npHCBoeH BHyrpH3aBO.D.CKOH HOMep. npaBHJIa GMP (n. 5.42 4acTH
I) .D.OnYCKaIOT npHCBoeHHe .D.Pyroro OTJlH4HTeJlbHoro 3HaKa. BepoSiTHo,
60JIee npaKTH4HblM S1BJlSleTCSI npHCBoeHHe HMeHHO HOMepa cepHH, oco-
6eHHo .D.J1S1 npOH3BO.D.CTB 3Ha4HMblX pa3MepOB.
npOCp04eHHble HJIH HerolIHble MaTepHaJIbl .D.OJl)l(Hbl 6blTb YHH4TO-
)l(eHbl C o<!:>0pMJleHHeM npOTOKOJIa.
4.3 OT6op H 3H3JlH3 npo6 Ma-repH3JlOB
061llHe Tpe60BaHI1H K oT60py np06 YCTaHOBJleHbl B YacTH I H npH-
J10)l(eHHH 8 «OT60p np06 HCXO.D.HbIX H ynaKoB04HbiX MaTepHaJIOB»,
rOCT P 52249-2009.
ComaCHO n. 3.22 lJaCTI1 I «OT60p npo6 I1CX01lHbIX MaTepl1aJlOB, KaK
npaBI1110, cJlellyeT BbIn011HSlTb B oTlle11bHoH 30He. npl1 oT60pe npo6 B
CKJla1lCKOH 30He 1l0Jl>KHbl 6blTb npHHSlTbl Mepbl, npelloTBpalllalOwl1e npSlMoc
111111 nepcKpecTHoe 3arpSl3HeHl1e».
B n.n. 6.11 11 6.13 4acTI1 I 1laH nopSllloK OT60pa np06.

flp01l360dcm60
93
OT60p np06 1l0Jl>KeH npoBOlll1TbCSI B COOTBeTCTBl111 C YTBep>K1leHHbl-
MI1 I1HCTPYKtil1S1MI1, BKJl101.JalOllll1MI1 B ce6S1:
- MeT01lI1KY oT60pa npo6;
- nepe1.JeHb I1cnoJlb3yeMoro 060PYllOBaHI1S1;
- KOJll11.JeCTBO np06bl, KOTopoe 1l0Jl>KHO 6blTb oT06paHO;
- I1HCTPYKtil111 no pa31leJleHI1IO oT06paHHOH npo6bl Ha 1.JaCTI1 (npl1
He06xo1lI1MOcm);
- Tl1n 11 xapaKTepl1CTI1Ka Tapbl LUISI oT60pa npo6;
- HaHeCeHl1e MapKl1poBKI1 Ha Tapy C oT06paHHblMI1 np06aMI1:
- CneUl1aJlbHbIe MepbI npellOCTopo>KHOCTI1, oc06eHHO B OTHOWeHl111
CTepl1JIbHblX 11 onaCHbIX BellleCTB;
- YCJIOBI1S1 XpaHeHI1S1;
- I1HCTPYKUI111 no 01.JI1CTKe 11 XpaHeH1110 060PYllOBaHI1S1 LUISI oT60pa
npo6.
Tapa C oT06paHHoH np060H .D.OJl)l(Ha HMeTb MapKHpOBKY C YKa3aHH-
eM COJIep)l(HMoro np06bl, lIaTbl oT60pa np06bl H 0603Ha4eHHSI ynaKoBKH,
H3 KOTOpOH oT06paHa np06a.
npH oT60pe np06bl cYllleCTByeT pHCK 3arpSl3HeHHSI H nepeKpecTHoro
3arpSl3HeHHSI MaTepHaJIa H np06bl. D.nSl YMeHbweHHSI 3TOro pHcKa MO)l(eT
6bITb opraHH30BaHo <!:>H3H4eCKoe pa31IeJIeHHe nOMellleHHH xpaHeHHSI
pa3Hblx MaTepHaJIOB. npH 60JlbWHX 06"bCMaX npoH3BolIcTBa H pa3Ho06-
pa3HH MaTepHaJIOB <!:>H3H4eCKoe pa3.D.eJIeHHe HenpaKTH4Ho H OT60p np06
BbInOJIHSleTCSI B YCJIOBHSlX olIHoHanpaBJleHHoro nOTOKa 4HCTOro B03.D.yxa
(JIaMHHapHOH 30Hbl).
B naMHHapHOH 30He olIHoBpeMeHHo MOryT HaXO.D.HTbCSI 06pa3Ubl
(np06bl) TOJIbKO OllHOH cepHH. nepCOHaJI, oT6HpalOIllHH np06bl, .D.OJI)J(eH
6bITb OlIeT B COOTBeTCTBHH C Tpe60BaHHSlMH K 4HCTblM nOMellleHHSlM.
Oc06ylO CJIO)l(HOCTb npeJICTaBJl5leT OT60p np06 CTepHJIbHblX MaTepH-
anOB. OH .D.OJI)I(eH BbInOJIHSlTbCSI B YCJIOBHSlX, HCKJlI04alOIllHX 3arpSl3HeHHe
KaK caMHX MaTepHaJIOB, TaK H np06bl.
OT60p np06 BbInOJIHSleTCSI pa60THHKOM OT.D.eJIa KOHTpOJlSl Ka4eCTBa.
B 3ana.D.HOH npaKTHKe ynoMHHaeTcSI OT60p np06 pa60THHKOM lIPYroro
nOlIpa31IeJleHHSI (HanpHMep, npOH3BO.D.CTBa), KOTOpblH yrBep)l(1leH OTlIe-
JIOM KOHTpOJISI Ka4eCTBa H npoweJI 06Y4eHHe [53].
flpeocma6umeJlbHocmb np06bl UcXoOHbLX MamepUQJl06
Ba)l(HblM YCJlOBHeM S1BJlSleTCSI npelICTaBI1TeJIbHOCTb np06bl. Henpe.D.-
CTaBHTeJlbHaSi np06a He n03BOJIleT .D.aTb rapaHTHpOBaHHoe 3aKJIlOLJeHHe 0
Ka4eCTBe BceH cepHH.
nO.D.J1HHHOCTb BceH cepHH MaTepHaJIa MO)l(eT 6bITb rapaHTHpOBaHa
TOJlbKO npH B3S1THH np06 H3 Ka)I(.D.OH ynaKoBKH. Y4HTblBaSi BblCOKYIO
TpYlIoeMKocTb CnJlOWHOrO KOHTpOJISI, npHJlO)l(eHHe 8 K rOCT P 52249-
2009 1I0nYCKaeT oT60p np06 H3 l!aCTH ynaKoBoK npH BbIn011HeHHH CJle-
lIYlOlllHX YCJIOBHH:
- MlTepHaJIbl nocTynalOT OT OlIHOro npOHJBOlIHTe11Sl;

94
£106a 4
- MaTepHaJIbl nOCTynalOT HenocpelICTBeHHO OT npOH3BO.D.HTeJISI HJlH B
one4aTaHHoH npoH3BOlIHTeJleM ynaKoBKe OT nOCTaBIllHKa, KOTOpblM HMe-
eT 6e3ynpe4HYlO penyrauHIO;
- aY.D.HT npOH3BO.D.HTeJISI H nOCTaBWHKa nOlITBeplIHJI HX COOTBeTCTBHe
YCTaHOBJleHHblM Tpe60BaHHSlM;
- eCTb aTTeCTOBaHHaSi MeTO,lJ,HKa, HCKJlI04alOIllaSi B03MO)l(HOCTb He-
npaBHJlbHOH MapKHpoBKH ynaKoBKH.
MeTO.D.HKa Bbl60p04HOro KOHTpOJlSl He MO)l(CT 6bITb aTTeCTOBaHa, eCJlH:
- HCXOlIHble MaTepHaJIbl nOCTynalOT OT nOCpe.D.HHKOB H npOH3BO.D.H-
TeJlb HeH3BeCTeH H11H He npoweJI aY,lJ,HT;
- HCXOlIHble MaTepHaJIbl npelIHa3Ha4eHbl .D.J1S1 npOH3BOlICTBa napeH-
TepaJIbHblX npenapaTOB.
KOJlH4eCTBO ynaKoBOK, H3 KOTOpblX oT6HpalOTCSI np06bl H nOpSl.D.OK
oT60pa np06 OnpelIeJISIIOTCSI nJIaHOM OT60pa np06.
06lJeM np06bl
06"beM np06bl .D.OJl)l(eH 6bITb .D.OCTaT04HbIM .D.J1S1 npOBe.D.eHHSI Hcnbl-
TaHHH Ha nO.D.J1HHHOCTb. Ho 3TOro MaJIO. npH HCnbITaHHSlX MO)l(eT 6bITb
06HapY)l(eH BbIXO.D. 3a npe.D.eJlbl cneUH<!:>HKaUHH (CM. rJlaBbI 19 H 20 06
HHcneKTHpoBaHHH) H3-3a .D.e<!:>eKTa caMoro MaTepHaJIa HJIH JIa60paTOpHOH
oWH6KH. B 3THX CJIY4aSlX HY.>KeH nOBTopHblH KOHTpOJIb, T. e. CJle.D.yeT OT-
6HpaTb ,lJ,BOHHOH 06"bCM np06bl: .D.J1S1 HCnblTaHHH, xpaHeHHSI H nOBTopHO-
ro KOHTpOJISI B cnopHblX CJIY4aSlX.
nepCOHQJl
3aKJIlO4eHHe 0 Ka4eCTBe MaTepHaJIOB, BceH mraHTCKOH pa60Te no
npOH3BO.D.CTBY, nOCTaBKe H KOHTpOJlIO MaTepHaJIOB 3aBHCHT OT npaBHJIb-
HOCTH oT60pa H aHaJIH3a np06. B paBHOH CTeneHH 3TO OTHOCHTCSI H K
roTOBOH npO.D.YKUHH. OWH6Ka npH oT60pe np06 MO)l(eT CTOHTb .D.Oporo.
Ellle xY)l(e, eCJlH npH oT60pe np06bl 3arpSl3HeHHSI nonallyr B MaTepHaJI.
FDA 06palllaeT npHCTaJIbHOe BHHMaHHe Ha nOpSl.D.OK oT60pa H aHa-
JIH3a np06, JIa60paTopHble oWH6KH H TO, 4TO nopoH cnHCbIBaeTCSI Ha
HHX (rJlaBa 20).
nepCOHaJI, oT6HpalOwHH np06bl, 1I0JI)I(eH npOXOlIHTb Ha4aJIbHOe H
CHCTeMaTH4eCKoe 06Y4eHHe nOpSI.D.KY oT60pa np06 B COOTBeTCTBHH C
npHJIO)l(eHHeM 8 K rOCT P 52249-2009. OH .D.OJI)I(eH nOHHMaTb JlJ1LIHYIO
OTBeTCTBeHHOCTb 3a CBOfO pa60TY, nOHHMaTb, 4TO OH SlBJlSleTCSI O.D.HHM HJ
KJlI04eBblX 3BeHbeB B npOH3BOlICTBe H KOHTpOJle KalleCTBa.
Tpe606allUH cGMP ClllA K om60py U aHQJlU3Y np06 UcXOOHblX U yna-
K060llHblX MamepUQJl06
*211.84 cGMP CiliA, 21 CFR [16] COlIep)l(HT CJlelIYlOlllHC Tpe60B<1-
HI11 K oT60py np06 (B CiliA HCnOJIb3yeTcSI TepMHH c «omponell1» , S1B11S1IO-
IllHHCSI CHHOHI1MOM el3pOneHcKoro TepMHHa «startin!; material,) - «HCXOlI-
HblH MaTepHLU1»):

flpOU360dcm60
95
(a) Ka)I(1laSl cepl1S1 I1CXOllHblX 11 ynaKOB01.JHblX M3Tepl1aJlOB 1l0JI>KHa
6bITb 113"bHTa 113 06pallleHI1S1 110 Tex nop, nOKa 113 Hee He 6Y1lYT oT06paHbI 11
npOBepeHbl npo6bI 11 BbI1laHO pa3peWeHI1e OTlleJIOM KOHTpOJISI Ka4eCTBa;
(b) 1-13 Ka)I(1l0H cepl1l1 nOJIY1.JeHHbIX MaTepl1aJ10B CJIellyeT oT06paTb
npellCTaBI1TeJlbHbIe np06bI. '-II1CJIO ynaKOBOK. 113 KOTOpbIX oT611palOTCSI npo-
6bl, 11 06"beM npo6bl 113 Ka>K1loi1 ynaKoBKI1 onpe1leJlSlIOTCSI no onpe1leJleHHO-
MY Kpl1Tepl1lO, Hanpl1Mep, CTaTI1CTI11.JeCKOMY, C Y1.JeTOM 113MeH1.JI1BOCTI1 MaTe-
pl1 aJla , 1l0Bepl1TeJlbHbiX npe1leJlOB 11 >KeJlaeMOH T01.J, HOCTI1 I1H4>opMaUI1I1 0
Ka1.JeCTBe MaTepl1aJ10B OT 1laHHoro nOCTaBllll1Ka B npOlliJlOM, He06xo1lI1MOM
KOJll11.JeCTBe MaTepHaJlOB LUISI npOBelleHI1S1 aHaJll13a 11 pe3epBHOM 06"bCMe
np06bl cornaCHO 211.170;
(c) npl1 oT6ope npo61l0JI>KHbl 6blTb BbInOJlHeHbl CJlellYlOllll1e YCJlOBI1S1:
(I) YnaKOBKI1, 113 KOTOpblX oT611palOTCSI np06bl. 1l0Jl>KHbl 6blTb, npl1
He06xo1lI1MOCTI1, 01.JI1WeHbl; cnoc06 01.JI1CTKI1 1l0JI>KeH I1CKJl101.JaTb nona1la-
HHe 3arpSl3HeHI1H B MaTepl1aJl;
(2) OTKpbIBaHl1e, oT60p np06 11 repMeTl13aUI1S1 1l0Jl>KHbl BblnOJlHSlTbCSI
TaK, 1.JT06bl npe1l0TBpaTI1Tb 3arpSl3HeHI1e I1X C01lep)l(I1Moro 11 3arpSl3HeHI1e
1lpymx I1CX01lHbIX 11 ynaKOBOLJHblX MaTepl1aJ10B;
(3) npl1 He06xo1lI1MOCTI1 CJIe1lyeT I1CnOJIb30BaTb CTepl1J1bHOe o60pY1lo-
BaHl1e 11 aCenTI14eCKI1e MeT01lbl oT60pa np06;
(4) ECJlI1 Tpe6YeTcSI oT611paTb npo6bl CBepxy, 113 Cepe1lI1Hbl 11J111 113
HI1>KHeH 1.JaCTI1 ynaKOBKI1, TO cJlellyeT I1CKJl101.Jl1Tb I1X CMeWI1BaHl1e;
(5) Tapa C np06aMI1 1l0Jl>KHa I1MeTb MapKMpoBKY C HaHeCeHl1eM cJle1lY-
10111I1X 1laHHbIX: HaI1MeHOBaHI1S1 MaTepHaJla np06bl, HOMepa Cepl1l1, HOMepa
ynaKOBKI1, 113 KOTOpoH oT06paHa npo6a. 1laTbl oT60pa npo6, 4>aMI1J11111 JII1-
ua, oT06paBwero npo6y;
(6) YnaKoBKa, 113 KOTOpOH oT06paHa npo6a, 1l0Jl)l(Ha 6bITb MapKHpo-
BaHa C YKa3aHl1eM, 1.JTO 113 Hee oT06paHa npo6a;
(d) AHaJll13 npo6 BbInOJlHSleTCSI B CJIe1lYlOllleM nOpSl1lKe:
(I) npOB01lHTCSI KaK MI1HI1MYM 01lI1H aHaJll13 Ha l11leHTI11.JHOCTb Ka)I(1l0-
ro I1CX01lHOro MaTepl1aJ1a. Cne1lyeT BbIn011HSlTb cneUH4>J1LleCKl1e TeCTbl Ha
l11leHTI11.JHOCTb, eCJlI1 OHI1 CYllleCTBYIOT;
(2) Ka>K1lblH I1CX01lHbIH MaTepl1aJl 1l0Jl>KeH 6blTb npoBepeH Ha COOTBeT-
CTBl1e BceM nOKa3aTeJISlM CneUI14>I1KaUI1H Ha 1.JI1CTOTY, aKTI1BHOCTb
(strength *) 11 Ka1.JeCTBO. npol13BOllHTeJlb JIeKapCTBeHHoro cpellCTBa MO>KeT
BMeCTO npoBe1leHI1S1 3TI1X aHaJll130B I1CnOJlb30BaTb npOTOKOJl (oTLJeT) 06 I1X
npOBe1leHI1I1 nOCTaBllll1KOM MaTepl1aJla npl1 YCJlOBI1 11 , 1.JTO KaK MI1HI1MYM
01lI1H CneUI14>I1LJeCKI1H TeCT Ha l11leHTI11.JHOCTb LUISI 1laHHoro MaTepl1aJla Bbl-
nOJlHeH np0I13B01lI1TeJleM JleKapcTBeHHoro cpellCTBa 11 1.JTO OH n01lTBep>K1laeT
1l0CTOBepHOCTb aHaJlI130B nOCTaBIllI1Ka nYTeM aTTeCTaUl111 I1X pe3YJIbTaTOB,
npOBOlll1MOH C onpe1leJleHHOH nepI1011I11.JHOCTblO;
(3) YnaKOB01.JHble MaTepl1aJlbl (B T.1.J. YKynop01.JHble) 1l0Jl)f(Hbl 6blTb
npOBepeHbl Ha COOTBeTCTBl1e BceM CneUI14>I1KaUI1S1M. npOH3BOlll1TeJlb Jle-
KapCTseHHoro cpellCTBa MO>KeT BMeCTO npoBe1leHI1S1 3TI1X aHaJll130B I1CnOJlb-
30saTb npOTOKOJI I1cnblTaHI1H (npoBepKI1) OT nOCTaBllll1Ka MaTepl1aJ1a npl1
YC110BI1I1, 1.JTO np0l13BOlll1Te11b BbInOJlmleT, KaK MI1HI1MYM, BI13yanbHYlO npo-
BepKY 3TI1X MaTepl1aJ10B 11 1.JTO OH nOllTBep>K1laeT 1l0CTosepHOCTb aHaJlI130B
nOCTaBWI1Ka nYTeM aTTeCTaUl111 I1X pe3Y11bTaTOB, npOB01lI1Moi1 C onpelleJleH-
HOi1 nepI1011I11.JHOCTblO;

96
f.!laBa 4
(4) npl1 He06xOlll1MOCTI1 CJle1lyeT npoBOlll1Tb aHaJlI13 I1CXOllHblX MaTe-
pl1aJ10B nOlI MHKpOCKonOM;
(5) Ka>K1laSl cepl1S1 I1CXOllHblX 11 ynaKOB01.JHblX MaTepl1aJ10B, B KOTOpOH
MOryr 6bITb rpSl3b, HaceKOMble 11 np01.Jl1e 3arpSI3HeHI1S1, 1l0Jl>KHa 6bITb npo-
BepeHa Ha 1.JI1CTOry;
(6) Ka>K1laSl cepl1S1 I1CXOllHblX 11 ynaKOB01.JHblX MaTe pl1 aJlOB , B KOTOpoi1
MOryr npl1CYTCTBOBaTb MI1KpOOpraHI13Mbl, He1l0nYCTI1Mble, HCX01lSl 113
Ha3Ha1.JeHI1S1 MaTepl1aJlOB, 1l0Jl>KHa 6bITb npoBepeHa Ha MI1Kpo6110JIOrH1.Je-
CKYIO 1.Jl1CTOry 110 I1X I1CnOJlb30BaHI1S1;
e) Cepl1S1 I1CXOllHblX 11 ynaKOB01.JHblX MaTepl1aJlOB, COOTBeTCTBYlOlllaSI
Tpe60BaHHSlM K l11leHTI11.JHOCTI1. aKTI1BHOCTI1, Ka'leCTBY 11 1.Jl1CTOTe 11 ycnew-
HO npowellwaSl I1cnblTaHI1S1 comaCHO n. d, MO>KeT 6blTb 1l0nYllleHa K I1C-
nOJlb30BaHI1IO.
* strength - 3mom mepMUH UMeem d6a 3Ha'teHUR ('tacmb 2/0 CFR ClllA):
- KOHlI,eHmpall,UR aKmU6HOi?O 6eUl,eCmBa (HanpUMep, 6ec/6ec, 6ec/o6beM
UAU iJo3upo6aHHaR eiJuHulI,a/o6beM), U/UJ1U
- 3rjJrjJeKmu6Hocmb, nOHUMaeMaR KaK mepane6mu'tecKaR aKmU6Hocmb J/e-
Kapcm6eHHOi?O cpedcm6a, nOdm6epJICdeHHaR ucnblmaHURMU 6 J/a6opamopuu UJ/U
KJ/UHu'teCKUMU ucnblmaHURMU, pa3pa6omaHHbIMU U 6btnOJ/HeHHbIMU HaiJJ/eJICa-
Ul,llM o6pa30M (6blpaJICeHHbl,MU, HanpUMep, 6 mepMuHax edUHUlI, co CCb/J/KOU Ha
cmaHdapm).
4.4 3THKeTKH H MapKHpoBKa
MapKHpOBKe nO.D.Jle)l(HT Bce: ynaKoBKH C MaTepHaJIaMH, npOMe)l(Y-
T04HaSi H rOTOBaSi npO.D.YKUHSI, nOMellleHHSI H OCHOBHoe 060pY.D.OBaHHe.
0603Ha4eHHSI (MapKHpoBKa) .D.OJI)I(Hbl CO.D.ep)l(aTb. KaK MHHHMYM,
HaHMeHOBaHHe npO.D.YKUHH HJIH MaTepHaJIa, ero .D.03HpOBKY (eCJIH Tpe6y-
eTCSI) H HOMep cepHH.
npH He06xo.D.HMOCTH CJIelIyeT YKa3bIBaTb CTa.D.HfO TeXHOJIOrH4ecKoro
npouecca 11 CTaTYC MaTepHaJIa (np0,lJ,YKUHH).
MapKHpOBKa MO)l(eT BbInOJIHSlTbCSI 3THKeTKaMH HJlH .D.PYrHM cnoc060M.
0603Ha4eHHSI (MapKHpOBKa) Ha ynaKoBKe, 060PY.D.OBaHHH HJlH nOMellleHH-
fiX .D.OJI)I(Hbl 6bITb 4eTKHMH, 01IH03Ha4Hb1MH, ycraHOBJleHHOH <!:>OPMbl.
BHympunpoU3600cm6eHHbie :JmUKemKU
PeKoMeHlIyeTcSI npHMeHSlTb BHyrpHnpoH3BOlICTBeHHble 3THKeTKH
(rOCT P 52550-2006 [3]) .D.J1S1:
- HCXOlIHblX MaTepHaJIOB;
- npOMe)l(yr04HoH H roTOBOH npOlIYKUHH;
- 060PYlIoBaHHSI, nOMellleHHH H T. .D..
BHyrpHnpoH3BolIcTBeHHble 3THKeTKH .D.eJIITCSI Ha lIBa BHlIa:
- H.D.CHTH<!:>HKaUHoHHble;
- CTaTYCHble.

flPOU360dcm60
97
B uiJeHmuqJUKau.UOHHOii 3THKeTKe YKa3bIBaIOTCSI:
- HaHMeHOBaHHe (KOlI) MaTepHaJIa HJIH npO.D.YKTa;
- HOMep cepHH;
- lIaTa HaHeceHHSI 3THKeTKH (MapKHpOBKH);
- nOlInHCb.
CmamYCHaH 3THKeTKa COlIep)l(HT HH<!:>opMaUHIO 0 TOM, me HaXOlIHTCSI
MaTepHaJI (npOlIYKUHSI, e.D.HHHua 060PYlIOBaHHSI, nOMellleHHe H np.) HJIH
KaKYIO CTMHIO B npOH3BO.D.CTBeHHOH uenH OH npOllleJl (<<KapaHTHH»,
«l1cnblTaHHSI», «Pa3peweHO», «OTKJlOHeHO H np.). Ha HeH TaK)I(e CJIelIyeT
YKa3blBaTb HaHMeHOBaHHe (KO.D.) MaTepHaJIa, HOMep cepHH H .D.aTY.
CTaTYC MaTepHaJIa (KapaHTHH, pa3peweHO, OTKJlOHeHO) MO)l(HO 060-
3Ha4aTb UBeTOM 3TH KeTKH. 3TH UBeTa 1I0Jl)l(Hbl 6bITb JIerKO pa3JlH4HMbl H
3anOMHHaTbCSI nepCOHaJIOM. B KHHre 153] npHBO.D.SlTCSI BapHaHTbl UBeTO-
BOro peweHHSI (pHC. 4.2):
- «KapaHTHH» - 4epHblH WPHQrr Ha )l(eJITOM <!:>oHe;
- «Pa3pellleHo» - 3eJleHblH WPH<!:>T Ha 6eJIOM <!:>oHe;
- «OTKJlO HeHo» - KpacHblH WPH<!:>T Ha 6eJIOM <!:>oHe.
Nlb«1>AMEll.OAO
KOll
Ccpml
MaTCpHaJl
n po6y B3HJl
!laTa oT6opa npo6bl
KAPAHTH H
a) CTaTYCHaSl 3TI1KeTKa «KapaHTI1H»
Nlb«1>AME!l.OAO
KOll
MaTcpH<U]
CCpItH----.JlaTa CJ1Cll. KOHTpOJ1H
!laTa «1>. H.O.
PA3PEWEHO
b) CTaTycHaSl 3TI1KeTKa <,PaJpeWeHo»
Nlb«1>AME!l.OAO
KOll
CCplt}!
!laTa «1>.H.O.
MaTcpHarJ
OTKJlOHEHO
c) CTaTYCHaSl 3TI1KeTKa <,OTKJlOHeHo»
PI1C. 4.2. CTc1TycHble 3TI1KeTKH

98
IJw6a 4
,[lJISi HCKJlI04eHHSI nepenyrblBaHHSI MaTepHaJIOB CTa-rYCHYIO 3THKeTKY
CJIe.D.yeT HaHOCHTb Ha Ka)l(1lYIO ynaKoBKY. 3THKeTKH 1I0Jl)J(Hbl 6blTb 4eT-
KHMH, SlCHblMH H He H3MeHSlTbCSI C Te4eHHeM BpeMeHH.
npH HCnOJIb30BaHHH KOHTeHHepoB C KpbllllKOH 3THKeTKY CJIe.D.yeT
HaHOCHTb Ha CllM KOHmeiiHep HJlH Ha KOHTeHHep H KPblWKY O.D.HOBpe-
MeHHO. HeJIb3S1 HaHOCHTb 3THKeTKY TOJlbKO Ha KPbIWKY.
flepenymb/6aHue KpblUieK - pacnpocmpaHeHHaR npUIJUHa HeOJICUdaHHo-
cmeu, nocJ1YJICu6U1aR OCH060U clOJlCemoe U e KpuMuHaJ/bHoM JlCaHpe (U3-
eecmHb/u pOMaH Ai'amb/ Kpucmu 06 3. flyapo).
OcpopMJleHHe 3THKeTKH .D.OJl)l(HO 6bITb TaKHM, 4T06bl OHa 6blJIa Jler-
KO Y3HaBaeMa Jl106blM pa60THHKOM. D.nSl 3TOro MO)l(eT HCnOJIb30BaTbCSI
JIoroTHn (3M6JleMa) npe.D.npHSlTHSI HJIH lIPYrHe npHeMbl, HCKJlI04alOIllHe
nepenyrblBaHHe «CBoeM» 3THKeTKH C nOCTopOHHeM, KOTopaSi MO)l(eT OKa-
3aTbCSI Ha ynaKOBKe.
3THKeTKH .lI.OJl)l(Hbl 6bITb np04HO npHKpenJIeHbl K ynaKoBKe, B npo-
THBHOM CJIY4ae OHH ,lJ,OJI)I(Hbl 6blTb 3aMeHeHbl. CTapble 3THKeTKH CJIe.D.yeT
Y.D.aJISlTb, 4T06bl HCKJlI04HTb nepenyrblBaHHe MaTepHaJIOB H npO.D.YKUHH.
YCJIOBHSI xpaHeHHSI 3THKeTOK .D.OJI)I(Hbl HCKJlI04aTb .D.OCTyn nOCTO-
pOHHHX JIHU H npe.D.YCMaTpHBaTb Mepbl npelIOCTOpO)l(HOCTH OT nepeny-
TbIBaHHSI H nO.D.MeHbl. Pa3pe3aHHble 3THKeTKH H .D.pYrHe pa3p03HeHHble
ne4aTHble MaTepHaJIbl CJle.D.yeT xpaHHTb H TpaHcnopTHpOBaTb pa31IeJlbHO B
3aKpbITOM Tape, HCKJlI04alOIlleH HX nepenyrbIBaHHe.
3THKeTKH ueJIeC006pa3HO ne4aTaTb B pYJIOHaX H pa3pe3aTb HX Heno-
Cpe.D.CTBeHHO nepe.D. HaHeceHHeM Ha roTOBYIO npO.D.YKUHIO. C ueJIblO 3a-
IllHTbl OT HenpaBHJIbHOH MapKHpOBKH peKOMeH,lJ,yeTcSI ne4aTaTb 4HCJlO
3TH KeTOK, paBHoe 4HCJIY e.D.HHHU npO.D.YKUHH B cepHH, H cpaBHHBaTb
4HCJIO H3paCXO.D.OBaHHbIX 3THKeTOK C H3roTOBJleHHbIMH, He .D.OnYCKaSi He-
KOHTpOJIHpyeMblx H3JlHlllKOB, nOTepb H HCnOJlb30BaHHSI 3THKeTOK He no
Ha3Ha4eHHIO.
HeHCnOJIb30BaHHble 3THKeTKH CJIe.D.yeT YHH4TO)l(aTb C o<!:>opMJleHHeM
npOTOKOJIa.
MapKup06Ka 060pyiJ06allUH
OCHOBHoe 060pY.D.OBaHHe (TeXHOJlOrH4eCKHe JIHHHH, peaKTopbl,
MHKcepbl H np.) .D.OJI)I(Hbl HMeTb MapKHpOBKY C YKa3aHHeM KO.D.a HJlH
HHoro 0603Ha4eHHSI, KOTopoe 1I0Jl)l(HO 6blTb BHeceHO B npOTOKOJl cepHH.
ECJlH B npOH3BOlICTBe HCnOJIb3yeTcSI TOJlbKO OlIHa e.D.HHHua 060pY.D.OBa-
HHSI lIaHHoro Ha3Ha4eHHSI, TO BMeCTO KOlIa MO)l(eT HCnOJIb30BaTbCSI ero
HaHMeHOBaHHe.
0603HalleHUH nOMew,eHuii
Bce nOMellleHHSI 1I0Jl)l(Hbi 6blTb 0603Ha ' leHbl C YKa3aHHeM HaHMeHO-
BaHHSI nOMe IlleH, HSI ero HOMepa, 30Hbl no GMP (KJlacca 4HCTOTbl) H
lIpyrl1x lIaHHblX, npH He06xolIUMOCTI1. 0603Ha4eHHc CJlelIyeT HaHCCTH Ha
lIBCpb CO CTOpOHbl BXOlIa B nOMellleHHe.

flPOU36odcm60
99
4.5 npOH3BO,lJ,CTBO npOJJYKU,HH
4.5.1 npHeM MaTepH3JlOB B npOH3BO,lJ,CTBO
nOCJIe nOJIY4eHHSI pa3peweHHSI OT OT,lJ,eJla KOHTpOJlSl Ka4eCTBa MaTe-
pHaJIbl MOryr 6bITb nepe.D.aHbl B npOH3BOlICTBO. MaTepHaJIbl H3 30Hbl Ka-
paHTHHa nepeMelllalOTCSI B 30HY, Bbl.D.eJleHHYIO .D.JlSl 1I0nYIlleHHblX MaTepH-
aJIOB (30HY xpaHeHHSI MaTepHaJIOB), KOTopaSl 0603Ha4eHa COOTBeTCTBYIO-
IllHM 06pa30M. MO)l(eT BbInOJIHSlTbCSI BH3YaJIbHOe pa3rpaHJ1LleHHe HJIH
YCTaHaBJlHBaTbCSI BpeMeHHble 6apbepbl.
B npOH3BOlICTBO MOryr nepelIaBaTbCSI TOJlbKO MaTepHaJIbl C HeHC-
TeKWHM CpOKOM ro.D.HOCTH H .D.OnYllleHHble OT.D.eJIOM KOHTpOJISI Ka4eCTBa.
CKJla.D. MaTepHaJIOB BbI.D.aeT B npOH3BO.D.CTBO MaTepHaJIbl Ha cepHIO
npO.D.YKUHH. BbI.D.a4a MaTepHaJIOB npOH3BO.D.HTCSI TOJIbKO CneUHaJIbHO
Ha3Ha4eHHblMH JlHuaMH B COOTBCTCTBHH C nHCbMeHHOH HHCTPYKUHeH.
MaTepHaJIbl .D.OJI)I(Hbl 6bITb T04HO B3BeweHbl, OTMepeHbl HJlH nOC4HTaHbl
H nOMellleHbl B 4HCTYIO H MapKHpOBaHHYIO Tapy.
npH BbI.D.a4e (OTMepHBaHHH, B3BeWHBaHHH, C4eTe) MaTepHaJIOB B
npOH3BO.D.CTBO CJle.D.yeT BbInOJIHSlTb .D.BOHHOH KOHTpOJlb C .D.OKYMeHTaJIb-
HblM o<!:>opMJIeHHeM.
B03MO)l(Hbl .D.Ba BapHaHTa o<!:>opMJIeHHSI BbI.D.a4H MaTepHaJIOB B npo-
H3BO.D.CTBO 153]:
1. B BH.D.e OT.D.eJIbHoro .D.OKYMeHTa, B KOTOpOM YKa3bIBalOTCSI .D.aHHble
o MaTepHaJIe, .D.aTa Bbl.D.a4H, nOJIyYaTeJlb (uex, Y4aCTOK), <!:>aMHJIHH, HHH-
lJ.HaJIbl H nO.D.nHCH JIHU, BbI.D.aBlllHX H nOJIY4HBWHX MaTepHaJI;
2. DOJlee pacnpOCTpaHeHHblM SlBJlSleTCSI BHeceHHe .D.aHHbIX 0 nOJIY4e-
HHH MaTepHaJIa B npOTOKOJI cepHH, B caMOM ero Ha4aJIe.
Ba)l(HO, 4T06bl B .D.OKYMeHTaUHH 6blJIH He TOJIbKO nO.D.nHCH, HO H HX
paCWH<!:>pOBKH C YKa3aHHeM <!:>aMHJIHH H HHHUHaJIOB. 3TO YHHBepCaJIb-
Hoe H 06S13aTeJIbHOe npaBHJIO o<!:>opMJIeHHSI Jl1060ro .D.OKYMeHTa. B npo-
THBHOM CJlY4ae B03MO)l(Hbl He.D.Opa3YMeHHSI, oc06eHHo B KOH<!:>JlHKTHbIX H
cnopHblx cHTyaUHSlX. JIHUO, nO.D.nHCbIBalOlllee .D.OKYMeHT, .D.OJI)I(HO BH.D.eTb
CBOIO <!:>aMHJlHIO. 3TO nOBblwaeT OTBeTCTBeHHOCTb nepCOHaJIa 3a CO.D.ep-
)KaHHe BbInOJIHSleMOH pa60Tbl H ee pe3YJlbTaTbl.
MaTepHaJIbl, nOJIY4eHHble .D.JlSl Ka)I(.D.OH cepHH, CJle.D.yeT xpaHHTb Ha
npOH3BO.D.CTBeHHoM Y4aCTKe B onpe.D.eJleHHOM MeCTe, KOTopoe .D.OJI)I(HO
6bITb 4eTKO 0603Ha4eHo.
4.5.2 TeXHOJlOrHlfeCKHe npOl.{eCCbl npoH3BO,lJ,CTBa
npoueccbl, B XO.D.e KOTOpblX H3 HCXOlIHblX MaTepHaJIOB nOJIY4alOT ro-
TOBoe JIeKapCTBeHHoe cpelICTBO, Ha3bIBalOTCSI TeXHOJIOrH4eCKHMH npo-
ueccaMH npOH3BOlICTBa (TeXHOJlOrJ1LleCKI1MH npoueccaMH). B EBpone .D.J1S1
I1X 0603Ha4eHHSI npHMeHSleTCSI TepMHH «production», B CiliA
«processing». K HHM OTHOCSlTCSI npHeM M<nepHaJIOB, npOH3BO.D.CTBO H
ynaKoBKa roTOBOro npOlIYKTa.

100
IJw6a 4
nOlI ynaK06Koii nOHHMalOTCSI Bce onepaUHH, B T. 4. HanOJIHeHHe H
MapKHpOBKa, npOBO.D.HMble C Hepac<!:>aCOBaHHblM npOlIYKTOM lIJlSl nOJlY-
4eHHSI roTOBOro npOlIYKTa. OnepaUHH HanOJIHeHHSI B npOH3BOlICTBe CTe-
pHJIbHblX JIeKapCTBeHHblX Cpe.D.CTB, KaK npaBHJIO, He CJlelIyeT paCCMaTpH-
BaTb KaK 4aCTb npouecca ynaKOBKI1. B 3TOM CJlY4ae Hepac<!:>aCOBaHHblM
npOlIYKTOM C4HTalOTCSI HanOJlHeHHble nepBH4Hble ynaKoBKH (aMnYJIbl,
<!:>JlaKOHbl H np.) 6e3 OKOH4aTeJIbHOH ynaKOBKH.
Ha HeKOTopblX npOH3BOlICTBax OTCyrCTBYIOT CTMHH nOJlY4eHHSI HC-
XOlIHblX MaTepHaJIOB H HX 06pa60TKH, a nepBOH CTMHeH S1BJlSleTCSI npHeM
HepacrjJaC06aHHOlO lom060l0 npOOYKma HJlH 6aJIK-npOlIYKTa, no.D. KOTO-
pblM nOHHMaeTCSI npOlIYKT, npowelIWHH Bce npOH3BOlICTBeHHble CTMHH,
3a HCKJlI04eHHeM OKOH4aTeJIbHOH ynaKOBKH. Ha TaKOM npOH3BOlICTBe
BbInOJIHSleTCSI TOJlbKO 3aBepwalOIllaSi CTa.D.HSI - ynaKOBKa.
YaCTH4HO nepepa60TaHHblH MaTepHaJI, KOTOpblH npOXO.D.HT Bce CTa-
.D.HH npOH3BO.D.CTBa, npe)I(.D.e 4eM OH CTaHeT Hepac<!:>aCOBaHHblM roTOBblM
npO.D.YKTOM, Ha3bIBaeTCSI npoMe:JICymollllblM npooYKmoM (intermediate
product).
npHeM npOMe)l(yr04HoH H Hepac<!:>acoBaHHoH npO.D.YKUHH npOBO.D.SIT
B COOTBeTCTBHH C npaBHJIaMH, .D.eHcTBYIOIllHMH .D.J1S1 HCXO.D.HbIX MaTepHa-
JIOB. nOpSl.D.OK 06paweHHSI H YCJlOBHSI xpaHeHHSI npOMe)l(yr04HoH H
Hepac<!:>acoBaHHoH npOlIYKllHH .D.OJI)I(Hbl COOTBeTCTBOBaTb YCTaHOBJleH-
HblM Tpe60BaHHSlM.
nOMellleHHSI H 060PYlIoBaHHe nepell Ha4aJIOM BbInOJlHeHHSI JII060H
TeXHOJIOfH4eCKOH onepaUHH .D.OJl)l(Hbl 6bITb 4HCTbIMH. npH He06xo.D.HMO-
CTH CJle.D.yeT npOBO.D.HTb .D.e3HH<!:>eKuHfO (CTepHJIH3aUHIO). BbInOJlHeHHe
3THX pa60T .D.OmKHO 6blTb nO.D.TBCp)I(.D.eHO .D.OKYMeHTaJIbHO.
CJle.D.yeT y6elIHTbcSI B TOM, 4TO B 30He npOH3BO.D.CTBa OTCyrCTBYIOT
nOCTopOHHHe MaTepHaJIbl H npe.D.MeTbl: OCTaTKH I1CXO.D.HbIX H ynaKoB04-
HblX MaTepHaJIOB H npO.D.YKUHH, MaTepHaJIbl H HHBeHTapb.D.J1S1 y60pKH, He
OTHOCSllllaSiCSI K lIaHHOMY npoueccy 1I0KYMeHTaUHSI H np.
TexHoJlorH4eCKHH npouecc BbInOJIHSleTCSI B COOTBeTCTBHH C TeXHO-
JIOrH4eCKHMH HHCTPYKUHSlMH. B npe.D.YCMOTpeHHbIX CJlY4aSlX nOCJle
OnpelIeJIeHHblX 3TanOB npOBOlIHTCSI BHyrpHnpOH3BO.D.CTBeHHbIH KOHTpOJIb
(n. 4.5.3 KHHrH).
BbInOJlHeHHe Ka)l(1loro 3Tana npouecca O<!:>0pMJlSleTCSI 3anHCblO B
npOTOKOJIe cepHH (n. 4.5.7). nOcJle OKOH4aHHSI npouecca CJIe.D.yeT:
a) 3anHcaTb 3aMe4eHHble OTKJlOHeHHSI H npOBeCTH HX aHaJIH3;
b) YKa3aTb He06bl4Hble C06bITHSI;
c) y6elIHTbcSI, 4TO Bce onepaUHH BbInOJlHeHbl B COOTBeTCTBHH C I1H-
CTPYKUHSlMH, H Bce napaMeTpbl COOTBeTCTBOBaJIH HopMe, 3a HCKJlI04eHH-
eM BblWenpHl3elIeHHblX CJlY4aeB a) H b);
d) OTlIeJlY KOHTpOJlSl KalleCTBa nOlITBeplIl1Tb npaBH11bHOCTb ynaKOBKH.

flPOU360dcm60
101
TeXHOJlOlUlleCKue MamepUaAbl
3TH MaTepHaJIbl He BXO.D.SlT B COCTaB npOlIYKUHH, a CJIY)I(aT lIJlSl Bbl-
nOJlHeHHSI TeXHOJlOrH4ecKoro npouecca. npHMepOM S1BJlSleTCSI BO.D.a 04H-
UleHHaSl, HCnOJlb3yeMaSi .D.J1S1 MOHKH <!:>JIaKOHOB. TepMHH «TeXHOJIOm4e-
CKHe MaTepHaJIbl» OTcyrcTByeT B G M P EC, HO OH HaWeJl npHMeHeHHe H
OTpa)l(aeT Cyrb Bonpoca.
OlpaHUlleHUH no 6peMeHU 6 xoiJe npou360iJcm6a
npaBHJIa cGMP CiliA 21 CFR  211.111 116] YKa3blBalOT, 4TO npH
He06xOlIHMOCTH CJlelIyeT YCTaHOBHTb orpaHH4eHHSI Ha BpeMSI BbInOJlHe-
HHSI OTlIeJlbHblX onepaUHi-L OTKJlOHeHHSI OT YCTaHOBJleHHoro BpeMeHH He
.D.OJI)I(Hbl YXY.D.WaTb Ka4eCTBO npOlIYKUHH. 3Ha4eHHSI OTKJlOHeHHH 1I0Jl)l(-
Hbl YKa3blBaTbCSI B npOTOKOJle cepHH.
KOllmpOJlb MUKp061lblX 3alpH31lellUii
B npOH3BO.D.CTBe HeCTepHJIbHOH npO.D.yJ<UHH .D.Oll)l(Hbl 6bITb npHHSlTbl
Mepbl no npe.D.OTBpallleHHIO ee MHKp06HOro 3arpSl3HeHHSI C .D.OKYMeH-
TaJIbHblM o<!:>opMJIeHHeM. B npOH3BOlICTBe CTepHJIbHblX JIeKapCTBeHHblX
Cpe.D.CTB MHKp06HaSi HarpY3Ka MaTepHaJIOB H npOMe)l(yr04HoH npO.D.YK-
UHH .D.OJl.>KHa 6bITb CBe.D.eHa K MHHHMYMY.
MeTO.D.bl 06ecne4eHHSI CTepHJIbHOCTH B npOH3BO.D.CTBe CTepHllbHblX
JleKapCTBeHHblX Cpe.D.CTB ,lJ,OJI)I(Hbl 6bITb aTTeCTOBaHbl KaK .D.JlSl acenTH4e-
CKHX npoueCCOB, TaK H .D.J1S1 npOlIYKUHH, nO.D.J1e)l(allleH <!:>HHHWHOH CTe-
pHJIH3aUHH (CTepHJIH3aUHH B nepBH4HOH ynaKoBKe).
4.5.3 BHYTpunpOH3BO,lJ,CTBeHHbIH KOHTpOJlb
rOCT P 52249-2009 H .D.Pyme .D.OKYMeHTbl npe.D.YCMaTpHBaIOT npOBe-
.D.eHHe BHyrpHnpoH3BOlICTBeHHoro KOHTpOJISI.
OH npOBOlIHTCSI nOCJle OnpelIeJleHHblX CTMHH npouecca .D.J1S1 npOBepKH
O.D.HOpOlIHOCTH npOlIYKUHH H COOTBeTCTBHSI ee 3a.D.aHHbIM Tpe60BaHHSlM.
BHyrpHnpOH3BolICTBeHHblH KOHTpoJIb BbInOJlHSleTCSI .D.J1S1 Ka)l(1l0H cepHH
npO.D.YKUHH. Ero CO.D.ep)l(aHHe onpeD.eJlSleTCSI COOTBeTCTBYlOllleH .D.OKYMeHTa-
UHeH (MeTO.D.HKOH BHyrpHnpOH3BO.D.CTBeHHOro KOHTpOJlSl).
KOHTPOJlb npe.D.YCMaTpHBaeTCSI nOCJle CTa.D.HH TeXHOJIOrH4ecKoro
npouecca, KOTopble Moryr BJlHSlTb Ha xapaKTepHCTHKH npOMe)l(YT04HOH H
rOTOBOH npOlIYKUHH, HX BbIXO.D. 3a npelIeJlbl 1I0nYCTHMbiX 3Ha4eHHH.
npl1Mepbl KOHTpOJIHpyeMblx napaMeTpOB:
- Bec Ta6JleTOK H KanCYJI;
- TBeplIOCTb Ta6JIeTOK, HX TOJlWHHa (pa3Mepbl) H xpynKocTb;
- paCTBopHMOCTb (pacnalIaeMocTb);
- O.D.HOpOlIHOCTb (roMoreHHocTb) MaCCbl nOCJle CMeWHBaHHSI;
- BpeMSI H CKOpOCTb paCTBopeHHSI;
- np03pa4HOCTb, paCTBOpl1MOCTb Hl1l1 pH paCTBopa;
- H,UlJ1LIHC MHKpOOpraHHJMOB.

102
1J1Q6a 4
Pe3YJlbTaTbl BHyrpHnpoH3BolIcTBeHHoro KOHTpOJlSl MaTepHaJIOB Ha
HlIeHTH4HOCTb, 3<!:><!:>eKTHBHOCTb, Ka4eCTBO H 'IHCTOry MOryr CJlY)I(HTb oc-
HOBaHHeM .D.J1S1 HX .aonYCKa HJIH OTKJlOHeHHSI, HanpHMep, nepe.a Ha4aJIOM
MJIH 3aBepweHHeM OTBeTCTBeHHblX onepauHH HJIH nOCJIe .D.J1HTeJlbHoro
xpaHeHHSI.
KaK MHHHMYM, CJIelIyeT BbInOJlHSlTb KOHTpOJlb B Ha4aJIe, cepelIHHe 11
KOHue npouecca. nepHOlIH4HOCTb KOHTpOJISI 1I0JI)I(Ha 6blTb YKa3aHa B
HHCTPYKUHH. Pe3YJIbTaTbl BHyrpHnpoH3BOlICTBeHHoro KOHTpOJlSl 1I0Jl)l(Hbl
BXOD.HTb B npOTOKOJI cepHH.
He D.OnYCKaeTCSI B03BpawaTb B cepHIO MaTepHaJIbl, HCnOJIb3yeMble
.D.J1S1 BHyrpHnpoH3Bo.acTBeHHoro KOHTpOJISI.
OTKJlOHeHHble no pe3YJIbTaTaM BHyrpHnpoH3BOlICTBeHHoro KOH-
TpOJISI MaTepHaJIbl .aOJI)I(Hbl 6bITb H3"bSlTbl H3 06pallleHHSI .ao npHHSlTHSI
peweHHSI no HHM.
KOHTpOJIb napaMeTpOB oKPY)I(alOllleH cpe.abl HJIH 060Py.aoBaHHSI
TaK)I(e OTHOCHTCSI K BHyrpHnpOH3Bo.aCTBeHHOMY KOHTpOJIIO. npHMepaMH
CJlY)I(aT KOHTpOJIb KOHueHTpaUHH 4aCTHU B B03.ayxe npH npOH3Bo.aCTBe
CTepHJlbHblX JIeKapCTBeHHblX Cpe,lJ,CTB, KOHTpOJlb TeMnepaTypbl H BJla)l(HO-
CTH B nOMellleHHSlX.
4.5.4 YnaKoBKa npOJ],yKl\HH
CJIe.ayeT HCKJlI04HTb pHCK nepeKpecTHoro 3arpSl3HeHHSI, nepenyrbl-
BaHHSI HJIH nOlIMeHbl npo.aYKUHH B npouecce ee ynaKOBKH. He .aonyc-
KaeTCSI ynaKoBblBaTb npo.aYKUHIO pa3JlH4HblX BH.aOB B Henocpe.aCTBeH-
HOH 6JIH30CTH .apyr OT .apyra npH OTCyrCTBHH <!:>H3H4ecKoro pa3.aeJIeHHSI
30H.
nepell Ha4aJIOM onepauHH no ynaKoBKe CJIe.ayeT y6elIHTbcSI B TOM,
4TO pa604aSl 30Ha, ynaKoB04Hble JlHHHH, ne4aTHble MaWHHbl H .apyroe
060pYlIOBaHHe Haxo.aSlTCSI B 4HCTOM COCTOSlHHI1 H He co.aep)l(aT MaTepHa-
JIOB, npo.aYKUHH HJIH 1I0KYMeHTOB. npH nOCTynJleHHH npo.aYKUHH H yna-
KOB04HblX MaTepH<lJIOB Ha Y4aCTOK ynaKoBKH CJle.ayeT npOBepHTb HX KO-
JIH4eCTBO, nO.D.J1HHHOCTb H COOTBeTCTBHe HHCTPYKUHSlM no ynaKOBKe.
nepBH4HaSi ynaKoBKa nepell Ha4aJIOM onepaUHH HanOJIHeHH1
.aOJI)I(Ha 6bITb 4HCTOM. CJIelIyeT y.aaJISlTb JII06ble 3arp13HeHHSI (OCKOJIKI1
CTeKJIa, MeTaJIJIH4eCKHe lIaCTHUbl H np.).
MapKHpOBKY npo.aYKUHH nOCJle HanOJIHeHHSI H YKynopHBaHHSI CJle-
.ayeT BbInOJlHSlTb KaK MO)l(HO 6blCTpee.
npaBHJIbHOCTb BbInOJIHeHHSI Jl106blX nellaTHblX onepaUHH (HanpH-
Mep, HaHeceHHSI KOlIOB HJIH cpOKa rolIHOCTH) npH ymlKoBKe H nOCJIe HCC
CJIelIyeT TlllaTeJlbHO KOHTp011HpOBaTb H ml>opMJlSlTb .aOKYMeHT<lllbHO.
Oc060e BHHMaHHC CJlelIyeT YlIeJlSlTb PY'IHOH MapKHpOBKe, KOTOPYIO CJle-
.ayeT KOHTpOJll1pOBaTb 4epe3 OnpelIeJIeHHble HHTCpmlJlbl BpeMCHH.

[JPOU3600cm60
103
npH KOHTpOJIe npouecca ynaKoBKH npOlIYKUHH Ha JIHHHH CJIelIyeT
npOBepSlTb, KaK MHHHMYM, CJIelIYlOlllee:
a) 061llHH BHll ynaKoBKH;
b) KOMnJIeKTHOCTb ynaKoBKH;
c) npaBHJlbHOCTb HCnOJIb30BaHHSI ynaKoB04HbIX MaTepHaJIOB B co-
OTBeTCTBHH C Tpe60BaHHSlMH .D.OKYMeHTaUHH Ha lIaHHYIO npOlIYKUHIO;
d) npaBHJIbHOCTb HaHeceHHSI ne4aTHblX HalInHceH;
e) npaBHJIbHOCTb pa60Tbi YCTPOHCTB KOHTpOJlSl Ha JIHHHH.
He .D.OnYCKaeTCSI B03BpaT Ha JIHHHIO oT06paHHblx C Hee 06pa3uoB
npolIYKuHH.
YnaBwHH C JlHHHH <!:>JlaKOH HeJlb3S1 nOlIHHMaTb H CTaBHTb CHOBa
Ha JIHHHIO! 3TO npoCToe npaBHJIO HapywaeTcSI 04eHb 4aCTO. HY)l(Hbl
opraHH3aUHoHHble H .D.HCUHnJIHHapHble Mepbl, 4T06bl 3TO KOHTpOJlH-
pOBaTb nOCTOSlHHO H HaKa3blBaTb BHHOBHbIX, B TOM 4HCJIe PYKOBO.D.H-
TeJIeH.
npHMep
npl1 aTTeCTaUl111 aCenTH1.JeCKoro np0I13B01lCTBa HaM 1leMOHCTpl1pOBa-
JII1 COBpeMeHHblH ypOBeHb KOHTpOJISI npouecca HanOJIHeHI1S1 C nOMOlllblO
BI11leOHa6J1I01leHI1S1. CHa1.JaJla npouecc HanOJIHeHI1S1 weJI HOpMaJlbHO, 3£1-
TeM nYCTOM CTepl1J1bHblH 4>JIaKOH CJlY1.JaHHO ynaJl C JII1HI1I1 Ha nOJI, onepa-
TOp n01lHSlJI ero H nOCTaBI1J1 Ha JlHHI1IO LUl5I HanOJlHeHH5I. n01l1.JepKI1BaeM,
3TO 6WJI npouecc HanOJIHeHI1S1 peaJIbHOH Cepl1l1, npe1lHa3Ha1.JeHHOM llJISI
np01la>Kl1, npl11.JeM aCenTl11.JeCKI1H npouecc, 6e3 cj:JI1HI1WHOH CTepl1J1113aUl111.
Ha1.JaJlbHI1K np0I13B01lCTBa 3TO BI11leJI Ha 3KpaHe 11 HI1KaK He OTpeampo-
BaJI. BI11leOHa6J1I01leHl1e OKa3aJ10Cb 6eCnOJle3HbIM. 3TO He e1lI1HI11.JHbIH
npl1Mep.
KaK 6blTb?
nepBoe, 1.JTO HY>KHO C1leJlaTb, 3TO BBeCTI1 BI11le03anl1Cb npouecca
HanOJlHeHI1S1 11 npl1KJ1a1lblBaTb ee K npoTOKOJIY cepl1l1. Ha4aJlbHI1K OT1leJIa
KOHTpOJlSl Ka1.JeCTBa (ynoJlHOM01.JeHHOe JII1UO) 1l0JI>KeH npOCMaTpl1BaTb 3TH
3anl1CI1. )],a>Ke YCKopeHHblH npoCMOTp n03BOJlSleT 06HapY>KI1Tb MHoroe. )],11-
peKTOpy TO>Ke He MeWaJlO 6bl nepI101lI11.JeCKI1, B nOpSl1lKe KOHTpOJlSl, npo-
CMaTpl1BaTb I1X. 06 3TOM 1l0Jl>KHbl 3HaTb Bce onepaTopbl 11 PYKOB01lI1TeJlI1
ECJlI1 PYKOBOlll1TeJIb nepBblM He OTpeampoBaJl Ha HapyweHl1e, 11 nOTpe60-
BaJlOCb BMeWaTeJlbCTBO Bblcwero PYKOB01lCTBa, 3£1 3TO HY>KHO OTBe1.JaTb.
BTopoe 11 06S13aTeJIbHOe YCJIOBl1e 34>cj:JeKTI1BHoro KOHTpOJISI - 3TO
HeMI1HyeMa51 OTBeTCTBeHHOCTb 3£1 HapyweHI1S1
Ka)I(1lblM 1l0Jl>KeH 3HaTb, 1.JTO OH HaXOlll1TCSI n01l KOHTpOJleM.
nOCJle 3aBepweHHSI onepauHH no ynaKoBKe JII06ble OCTaBWHecSi
ynaKOBOLJHble MaTepHaJIbl C HaHeceHHblM Ha HHX HOMepoM cepHH 1I0Jl)l(-
Hbl 6bITb YHH4TO)l(eHbl C nOCJIelIYIOWHM COCTaBJleHHeM npOTOKOJla. B03-
BpaT Ha CKJlall HeMapKHpoBaHHblx ynaKoB04HblX MaTepH<lJIOB npoH3BolISiT
B COOTBeTCTBl111 C YTBep)l(1leHHoH HHcTpYKuHeH.
nOJlHblH C13011 Tpe60BaHHH K npoueccaM ynaKoBKH .D.aH n.n. 5.44-
5.57 YacTH I rOCT P 52249-2009.

104
1J1Q6a 4
4.5.5 COnOCTaBJIeHHe
no OKOH4aHHH npoH3BolIcTBeHHoro UHKJla CJlelIyeT Cpal3HHTb O)l(H-
.D.aeMblH H <!:>aKTH4eCKHH BblXOlI (06"beM) npOlIYKUHH. 3Ta onepaUHSI
Ha3bIBaeTCSI conOCma6JleHUeM (reconciliation). Pac4eT O)l(H.D.aeMoro BbIXO.D.a
BbInOJIHSleTCSI no 3a.D.aHHoMY pacxo.D.Y MaTepHaJIOB B COOTBeTCTBHH C
npOMblWJIeHHblM pernaMeHToM. CJIe.D.yeT TaK)l(e cpaBHHBaTb pac4eTHblM
H <!:>aKTH4ecKHH pacxo.D. HCXO.D.HbIX H ynaKoB04HblX MaTepHaJIOB (Hepac-
<!:>acoBaHHoH npolIYKuHH), ne4aTHblX MaTepHaJIOB H roTOBOH npolIYKUHH.
npH cYlllecTBeHHoM HJIH He06bl4HOM paCXO)I(.D.eHHH, YCTaHOBJleHHOM
npH conOCTaBJleHHH KOJlH4eCTBa Hepac<!:>acoBaHHoH npolIYKUHH, ne4aT-
HblX H ynaKoB04HblX MaTepHaJIOB H roTOBOH npO.D.YKUHH, CJlelIyeT npoBe-
CTH paCCJIe.D.OBaHHe H YCTaHoBHTb npH4HHY 3TOro paCXO)l(1leHHSI .D.O no-
JIY4eHHJI pa3pellleHHSI Ha peaJIH3aUHIO .D.aHHOH npolIYKuHH.
npaBI1J1a cGMP CiliA, 21 CFR  210.3 116] llalOT CJle1lYlOllll1e onpe-
1leJIeHI1S1 TepMI1HaM, OTHOCSlllll1MCSI K BbmYCKY npOllYKUI1I1:
- TeOpeTH1JeCKHH (HJlH O)KH.lJ:aeMbIH) BbIXO)J. (theoretical yield): KOJII11.Je-
CTBO, KOTopoe 1l0Jl>KHO 6bITb np0113Be1leHO Ha JlI060H CTa1l1111 npoI13B01lCTBa
I1JII1 ynaKoBKH llaHHoro JleKapCTBeHHoro cpe1lCTBa, I1CX01lSl 113 KOJIHLJeCTBa
I1CnOJlb30BaHHblX MaTepI1aJlOB npH OTCYTCTBI1I1 nOTepb 11J111 OWI160K B npo-
113B01lCTBe;
- aKTH1JeCKHH BbIXO)J. (actual yield): 4>aKTI11.JeCKI1 npol13Be1leHHOe KO-
JIl11.JeCTBO Ha JII060H CTa1lI1H np0I13B01lCTBa I1JIH ynaKoBKI1 1laHHoro JleKap-
CTBeHHoro cpellCTBa;
- npoueHT aKTH1JeCKOrO BbIXO,lJ,a (percentage of actual yield): OTHowe-
Hl1e 4>aKTH1.JeCKoro BbIX01la (Ha JlI060H CTa1l1111 npol13BOllCTBa HJlI1 ynaKoBKH
1laHHoro JleKapCTBeHHoro cpe1lCTBa) K TeopeTl11.JeCKOMY BbIX01lY Ha TOH >Ke
CT31lI1I1, Bblpa>KeHHOe B npoueHTaX.
ComaCHO npaBI1J1aM cG M P CWA, 21 CFR  211.103 CJle1lyeT onpelle-
JII1Tb 3Tanbl npoI13B01lCTBa, ynaKOBKI1 11J111 06pallleHI1S1 JIeKapcTBeHHoro
cpellCTBa, nocJle KOTOpblX HY>KHO CBepSlTb 4>aKTI11.JeCKI1H BbIX01l npo1lYKTa
(npoMe>KYT01.JHoro 11J111 roTOBOro) C O>KI11laeMbIM BbIX01l0M. 3Ta CBepKa
1l0Jl>KHa BbInOJlHSlTbCSI OllHI1M JIHUOM, npaBI1J1bHOCTb ee 1l0JI>KHa 6blTb n01l-
TBep>K1leHa 1lPYrHM JII1UOM, 3£1 I1CKJl101.JeHl1eM CJlY1.JaSI npl1MeHeHI1S1 aBTOMa-
TI11.JeCKoro 060PYllOBaHHSI (CM. Bblwe).
4.5.6 fOTOBaH npOD,yKUHJI
KapaHmuH U KOHmpOJlb lom060U npooYKu.UU
UeJlblO npOH3BOlICTBa SlBJlSleTCSI nOJlY4eHHe roToBoH npOlIYKUHH (ro-
TOBoro npolIYKTa), T.e. JIeKapCTBeHHoro cpelICTBa, npowellwero Bce 3Ta-
nbl TeXH0110rH4ecKoro npouecca, BKJlIO'!aSl OKOH4aTeJlbHYIO ynaKoBKY
(nepBJ1LIHYIO H BTOPH4HYIO). rOTOBa1 npOlIYKUHSI nOMewaeTCSI B KapaH-
THH, H3 Hee oT6HpalOTcSI np06bl OTlICJlOM KOHTpOJlSl Ka4eCTBa, H npOlIYK-
UI1S1 HaXOlIHTCSI B KapaHTHHe 110 3aBcpweHISI aHaJIH30B H Bbllla'iH pa3pe-
weHH1 Ha peaJlH3aUHIO ynOJlHOMOllCHHblM 11HUOM.

flp01l360dcm60
105
nOCJle BbllIa4H pa3peweHHSI Ha peaJIH3aUHIO roToBaSl npOlIYKUHSI
.D.OJI)I(Ha xpaHHTbCSI Ha cKJlane roToBoH npOlIYKUHH B YCJlOBHSlX, YCTaHOB-
JIeHHblX npOH3BOlIHTeJIeM. YCJIOBHSI xpaHeHHSI 1I0JI)I(Hbl COOTBeTCTBOBaTb
YCTaHOBJleHHblM Tpe60BaHHSlM. Pa3Hbie cepHH npOlIYKUHH CJIelIyeT xpa-
HHTb pa31IeJIbHO. nOpSilIOK xpaHeHHSllIOJI)I(eH Y4HTbIBaTb YCJlOBHSI 060po-
Ta npOlIYKUHH (nepBblM npHWJIO. nepBblM YWJIO).
BbliJalla pa3peUleHUH Ha peaJlU3au.ulO
nOCJIe 3aBepweHHSI npOH3BOlICTBa roTOBOH npOlIYKUHH H KOHTpOJISI
ee Ka4eCTBa CJIe.D.yeT nOJlY4HTb pa3peweHHe Ha peaJIH3aUHIO npO.D.YKUHH.
no rOCT P 52249-2009 (GMP EC) pa3peweHHe Bbl.D.aeTCSI ynOJlHOMO-
LJeHHblM JlHUOM (maBa 16 KHHrH). B CiliA 3TY <!:>YHKUHIO BbInOJIHSleT
omeJI KOHTpOJISI Ka4eCTBa (Quality cOnTrol unit).
Pa3peweHHe Ha peaJIH3aUHIO Bbl.D.aeTCSI nOCJIe nOJIY4eHHSI nOJlO:JICU-
meJlbHblX pe3YJlbmam06 Bcex HCnbITaHHH cepHH roTOBOro JIeKapCTBeHHoro
cpelICTBa, npOBepKH npOmOKOJl06 cepuu (c nOJIO)l(HTeJlbHblM pe3YJIbTaTOM)
H cOnOCma6JleHUH.
nOpSilIOK oueHKH Ka4eCTBa rOToBoH npO.D.YKUHH H .D.OKYMeHTaUHSI,
He06xOlIHMaSi .D.J1S1 nOJIy<IeHHSI pa3pellleHHSI Ha peaJIH3aUHIO, .D.OJl)l(Hbl CO-
OTBeTCTBOBaTb Tpe60BaHHSlM pa3.D.eJIa 6 YaCTH I npaBHJI GMP (rOCT P
52249- 2009). B OmeJIbHblX CJIY4aSlX .D.OnYCKaeTCSI Bbl.D.a4a pa3pellleH HSI
Ha peaJIH3aUHIO npO.D.YKUHH no napaMeTpaM TeXHOJlOrH4ecKoro npouecca
.D.O 3aBepweHHSI HcnbITaHHH (BbmycK no napaMeTpaM, n. 4.10 KHHm).
XpaHeHue U omlpY3Ka lom06blX JleKapCm6eHIlbiX cpeiJcm6
nOCJIe nOJlY4eHHSI pa3peweHHSI Ha peaJIH3aUHIO npOlIYKUHSI nepelIa-
eTCSI Ha CKJla.D. roTOBOH npO.D.YKUHH, ynaKoBblBaeTCSI B TpaHcnopTHYIO Ta-
PY (eCJIH 3TO He BbInOJlHSleTCSI B npOH3BO.D.CTBeHHOM uexe) H OTrpy)l(aeT-
CSI B YCTaHOBJleHHOM nOpSl.D.Ke. XpaHeHHe .D.OJI)I(HO 6bITb opraHH30BaHO B
YCJIOBHSlX, YCTaHOBJleHHblX npOH3BOlIHTeJIeM C C06JllOlIeHHeM Tpe60BaHHH
K TeMnepaTYPC, BJla)l(HOCTH, OCBellleHHOCTH TaK, 4T06bl HCKJllOllHTb BJlH-
SlHHe OKPY)I(alOllleH cpelIbl Ha COCTaB, 3<!:><!:>eKTHBHOCTb, Ka4eCTBO H 4H-
CTOTY JIeKapCTBeHHblX cpelICTB.
4.5.7 npOTOKOJl H3 cepHIO np0J],yKl.(HH
npOTOKOJIOM Ha cepHIO (record) Ha3bIBaeTCSI 1I0KYMeHT, OTpa)l(alO-
IllHH npouecc npOH3BOlICTBa cepHH npOlIYKUHH, B T. 4. pa3peweHHe Ha
ee peaJIH3aW11O, H Bce <!:>aKTopbl, HMelOlllHe OTHoweHHC K Ka4eCTBY ro-
TOBOH npOlIYKUHH. OH COCTaBJlSleTCSI Ha Ka)I(.D.YIO cepHIO npO.D.YKUHH.
O<!:>OpMJlSlTb BbInOJIHeHHe pa60Tbl, T. e. COCTaBJlSlTb npOTOKOJl HY)I(HO
cpa3Y nocJle 3a6epUleHUH onepaUHH. HH B KoeM CJIY4ae HeJIb3S1 3TO OT-
I<J1a.D.blBaTb «Ha nOTOM», «Ha 4epe3 nSlTb MHHyr». Y)I(e 'lepe3 MHHYTY MO-
ryr B03HHKHyrb HeOTJIO)l(Hble lIeJla, KOTopble OTBJleKYT HCnOJlHHTeml, H
pa60Ta OCTaHeTCSI Hco4>opMJlCHHOH.

106
f.w6a 4
rOBOpSlT, 4TO HeOfpOpMJleHHaH pa60ma - 3mo lle6btnOJl1leHHaH pa60-
ma. 3TO He BnOJlHe T04HO, lIeikTBHTeJlbHOCTb xy)I(e. Heo<!:>opMJIeHHaSl
pa60Ta - 3TO HenOHSITHO, KaKaSl pa60Ta. JlY4we pa60TY He BbInOJIHHTb,
4eM BbInOJIHHTb H He O<!:>OPMHTb, a nOTOM He HMeTb OCHOBaHHSI .D.OKa-
3aTb, 4TO H KaK 6blJIO Ha caMOM lIeJIe C.D.eJIaHO.
HeJlb3S1 OTBJleKaTb 4eJlOBeKa, 3aHSIToro pa60TOH H ee o<!:>0pMJIeHHeM.
BbInOJlHHTb pa60TY H ee O<!:>0PMHTb - maBHaSl 3a.D.a4a, panH KOTOpOH OH
npHllleJl Ha npe.D.npHSlTHe. OCTaJIbHOe nOlIO)l(1leT.
BbInOJlHeHHe JII060H pa60Tbl 1I0J])I(HO 6bITb nO.D.TBep)l(lIeHO .D.OKYMeH-
TaJIbHO. D.nSl TaKHX pa60T, KaK TeXHH4eCKoe 06CJlY)I(HBaHHe H y60pKa no-
MellleHHH, MO)l(HO ClIeJIaTb 3anHCb B )l(ypHaJIe HJlH rpa<!:>HKe C YKa3aHHeM
.D.aTbl, nO.D.nHCH, <!:>aMHJlHH H HHHUHaJIOB HCnOJIHHTeJlSl.
B npOH3BO.D.CTBe npolIYKUHH Bce OKa3bIBaeTCSI CJlO)l(Hee.
D.nSl nOJIY4eHHSI pa3peUlellUH Ila 6btnycK npoiJYKu.uu HY)l(HO npe.D.CTa-
BHTb nOJlHblU KOMTl./leKm iJoKYMeHm06, OTpa)l(alOlllHX <!:>aKTH4eCKOe Bbl-
nOJlHeHHe TeXHOJIOrH4ecKoro npouecca H pe3YJlbTaTbl KOHTpOJlSl.
Ha ceMHHapax no GMP HHoma 3a.D.a1OT BOnpocbl: 3aIJeM HYJfCHbl
npomoKoJlbl Ha cepUlo npOdYKu,UU, eCJ1U .Mbl 6 melJeHUe deCflmUAemuu pa60-
maAU 6e3 HUX, U HUlJeZO He npoUCXOOUAO? Mbl 3HaeM C60e deAo, Rbi IJmo,
HaM He eepume?
PaCCMOTpHM 3TO nO.D.p06Hee.
Bo-nep6blX, JIeKapCTBeHHoe Cpe.D.CTBO - 3TO OC06blH BH.D. npOlIYK-
UHH. OHO He MO)l(eT 6blTb npOBepeHO Hepa3pywalOIllHMH MeTO.D.aMH.
3Ha4HT, 0 Ka4eCTBe cepHH MO)l(HO CY.D.HTb TOJIbKO no OT.D.eJIbHbIM 06pa3-
uaM npO.D.YKUH H.
A B KaKOM CJIyYae 3TO MO)l(HO C.D.eJIaTb?
TOJIbKO B TOM CJIY4ae, Koma npouecc npOH3BOlICTBa a6COJllOmHO no-
6mopHeM u HeU3.MeHeH. 1l0Ka3aTeJIbCTBOM CJlY)I(HT .D.OKYMeHTaUHSI 0 <!:>aK-
TH4eCKOM BblnOJlHeHHH npouecca, nOKa3aHHSI npH60pOB (KOTopble 3anH-
caHbl H coxpaHeHbl), pe3YJIbTaTbl aHaJIH3a.
ComaCHO G M P KOllmpOJlb lom060U npoiJYKu.UU He H6JlHemCH lapall-
mueu ee Kallecm6a. Ka4eCTBO 1alCJlaiJbl6aemCH meXHOJlOlueu. KJ1104eBble
napaMeTpbl TeXHOJlOrH4ecKoro npouecca Hy)I(HO KOHTpOJlHpOBaTb.
rOBOpHTb, 4TO C npOlIYKUHeH He 6blJIO np06JleM, 3Ha4HT roBOpHTb
HeT04HO. MHOrHe np06JleMbl Bbl60p04HblM KOHTpOJleM BblSlBHTb HeB03-
MO)l(HO. He Bcema MO)l(eT 6bITb OnpelIeJleHa npH4HHa Ylllep6a, HaHeceH-
HOro 60JIbHOMY. 04eHb 4aCTO OHa HOCHT CKpblTblH xapaKTep. nopoH
Tpe6yeTcSI MHOro BpeMeHH H cpelIcTB, 4T06bl HaHTH npH'IHHY.
n03TOMY ueJlblO G M P S1BmICTCSI HeiJonyw,eHue iJeljJeKma B npolIYK-
UHH H 1I0Ka3aTeJIbCTBO npaBH11bHoCTH TeXH0110rHH BbInYCKa cepHH 3£1
C4eT nOJlHoH npOcJle:JICU6QeMOCmU Bcero npouecca OT npHeMa HCXOlIHblX
H ynaKoBo'IHblX MaTcpH<lJIOB 110 KOHTpoml roToBoH npolIYKUHH.
1l0Ka3<neJlbcTBoM lBmICTC1 npOTOKOJl Ha cepHIO npOlIYKUHH.

flPOU360dcm60
107
BO-6mopblX, nOHSlTHSI «Bepa» H «npOH3BOlICTBO OTBeTCTBeHHOH npo-
,lJ,YKUHH» - 3TO nOHSlTHSI HeCOBMeCTHMble. npH npHHSlTHH peweHHSI 0
BbInYCKe cepHH npO.D.YKUHH pe4b H.D.eT He 0 .nOBepHH, a 0 npOBepKe 110-
Ka3aTeJIbCTB TOro, 4TO:
- np0.D.YKUHSI npOH3Be.D.eHa H3 XOPOWHX MaTepHaJIOB;
- nO.D.roToBKa 060PY.D.OBaHHSI H nOMellleHHH, BKJlI04aH O'IHCTKY H
CTepHJIH3aUHIO 060PY.D.OBaHHSI, npOBelIeHa TaK, KaK npe.D.YCMOTpeHO;
- TeXHOJIOrH4eCKHe onepaUHH BbInOJlHeHbl B COOTBeTCTBHH C HH-
CTPYKUHSI M H;
- napaMeTpbl TeXHOJlOrWlecKoro npouecca H napaMeTpbl OKpY)I(alO-
llleH cpelIbl COOTBeTCTBYIOT HopMe, H 3TO nOlITBep)l(1leHO pacne4aTKOH
nOKa3aHHH npH60pOB;
- pe3YJIbTaTbl BHYTpHnpOH3Bo.nCTBeHHoro KOHTpOJISI nOlITBep)l(1lalOT
npaBHJlbHOCTb BbInOJIHeHHSI TeXHOJlOrH4ecKoro npouecca;
- KOHTpOJIb roTOBOH npO.D.YKUHH nO.D.TBep.D.HJI ee COOTBeTCTBHe 3a-
.D.aHHbIM Tpe60BaHHSlM.
B-mpembUX, KTO KOMY .D.OJl)l(eH BepHTb? Om6emcm6eHHocmb nepeiJ
.JaKOHOM 3a Ka4eCTBO npOlIYKUHH HeceT ynOJlHOMOlleHHoe JlUU.O HJIH
Ha4aJIbHHK OTK, eCJlH eMY 3TO nOPY4eHO. npH 06HapY)I(eHHH .D.e<!:>eKTa
3TO JIHUO HeceT OTBeTCTBeHHOCTb, BnJIOTb.D.O yroJIOBHOH.
npHHHMaSl pellleHHe 0 BbInYCKe npO.D.YKUHH, 3TO JlHUO nOJlalaemCH
Ha npOmOKOJl cepuu. A eCJIH npOTOKOJI HenOJlOH HJlH He.D.OCTOBepeH? To-
r.aa ynOJIHOM04eHHoe JIHUO He HMeeT npaBa .D.aTb pa3pellleHHe Ha BbmYCK
npO.D.YKUHH.
B-lIem6epmblX, B npOH3BOlICTBe B03MO)l(Hbl OTKJlOHeHHSI OT Tpe60Ba-
HHH cneUH<!:>HKaUHH. B03MO)l(Hbl peKJIaMaUHH H OT3blBbl cepHH npO.D.YK-
UHH.
KaK HaHTH npH4HHY? ECTb TOJIbKO O.D.HH nYTb - npOBeCTH aHaJIH3
.D.OKYMeHTaUHH Ha cepHIO. YT06bl aHaJIH3 .D.aJI pe3YJlbTaT, .D.OKYMeHTaUH1
,lJ,OJI)I(Ha 6bITb nOJIHOH.
Be.D.eHHe .D.OKYMeHTaUHH nOBblwaeT OTBeTCTBeHHOCTb H lIHCUHnJlHHY
nepCOHaJIa, KOTOpblH .D.OJI)I(eH 3HaTb, 4TO ero oWH6Ka HJlH He6pe)l(HOCTb
6Y.D.eT HaHlIeHa. 3TO He06xo.D.HMaSi 06pamllaH C6H3b B npOH3BO.D.CTBe.
Ha npelInpHSlTHH .D.OJI)I(Ha 6bITb pa3pa6OTaHa UHcmpYKu.UH no OfjJOPM-
JlellUIO npOmOKOJl06 Ha Ka)I(.D.blH BH.D. npO.D.YKUHH, KOTopaSl YCTaHaBJlHBaeT
Tpe60BaHHSI K COlIep)l(aHHIO H <!:>opMe npOTOKOJIa.
npOH3BOlICTBeHHHKH 06maHbi ee BbInOJIHSlTb, ynOJlHOM04eHHoe
JIHUO HJlH OTlIeJl KOHTpOJISI Ka4eCTBa 06S13aHbl npHHHMaTb cepHIO npo-
.D.YKUHH no ::nOH HHCTPYKUHH. OHH HC HMelOT npam1 .D.aTb pa3peWeHI1C
Ha BbInYCK, eCJlH npOTOKOJI OTKJlOHSleTCSI OT Tpe60BaHHH HHCTPYKUHH.
BBelISi TaKOH nopSilIOK, npelInpHSITHe nepeH.D.eT OT paccY)l(.D.eHHH K
pa60Te no 'leTKoH CHCTeMe.

108
IJw6a 4
Cyrb GMP COCTOHT B TOM, 4TO Ha CMeHY mpaiJuu.UHM, MHeHUHM U
iJ06epuIO npHXOlIHT lIemKaH HOpMamU6HaH CUCmeMa, KOTopaSl HCKJlI04aeT
B03MO)l(HOCTb OWH6KH (HJIH He BblSlBJleHHoH oWH6KH) H CTaBHT Ka)I(1l0rO
B YCJlOBHSI, Koma OH .D.OJl)l(eH pa60TaTb TaK, KaK npelIycMoTpeHo, H Bbl-
nOJlHeHHe caMoH pa60Tbl 1I0Jl)l(HO 6bITb 1I0KYMeHTaJIbHO nOlITBep)l(1leHo.
3TO 3aKOH BbInycKa oTBeTcTBeHHoH npolIYKUHH, me MeCTa fJlaroJlaM
«X04Y» H «.D.YMalO» HeT, a eCTb elIHHCTBeHHaSi cxeMa pa60Tbl:
- iJoA:JICeH ClIeJlaTb;
- 3HalO, KaK lIeJIaTb (no HHCTpYKUHH);
- 6btnOAHUJl pa60TY;
- noiJm6epOUJl ee BbInOJlHeHHe npOTOKOJlOM Ha cepHIO npO.D.YKUHH.
06"beM 1I0KYMeHTaUHH Ha cepHIO onpe.D.eJISleTCSI cneuH<!:>HKoH npo-
H3BO.D.CTBa. HanpHMep, B npOH3BO.D.CTBe CTepHJIbHblX JleKapCTBeHHblx
cpelIcTB, nO.D.J1e)l(alllHX <!:>HHHwHoH CTepHJlH3aUHH, K npOTOKOJlY cepHH
CJIe.D.yeT npHKJla.D.bIBaTb pacne4aTKH .D.HarpaMM 3anHCH Bcex TepMO.D.aT4H-
KOB.D.J1S1 UHKJla CTepHJIH3aUHH H T. .D..
B npOMblWJleHHOCTH eCTb .D.Be cxeMbl Bbl.D.a4H pa3peweHHSI Ha Bbl-
nycK npO.D.YKUHH (pHC. 4.3):
- no pe3YJIbTaTaM HcnblTaHHH (KOHTPOJlSl);
- no .D.OKYMeHTaUHH Ha cepHIO npO.D.YKUHIO H pe3YJlbTaTOB Bb160p04-
HOro KOHTpOJISI.
nepBblH no.D.XO.D. npHMeHSleTCSI Toma, Koma Bce elIHHHUbl npOlIYK-
UHH MOryr 6bITb npOBepeHbl Hepa3pywafOIllHMH MeTO.D.aMH (aBTOM06HJlb,
MHKpocxeMa, 3JIeKTpH4ecKHH npH60p H T. .D..).
100% KOHTpoIlb
B03MO>KeH
AOCTaT04HO I1MeTb
aKT I1CnblTaHl11i1 Bcex
eAI1HI14 npoAY K 4 1111
06bl'tHblM
nOJ:\xoJ:\
100% KOHTpOIlb
HeB03MO>KeH, --I>-
npoBepeTc TOIlbKO
He60Ilbwa Bbl60pKa
nOIlHa AOKYMeHTa411
Ha BeCb npo4ecc
npol13BOACTBa
+ I1CnblTaHI1
oTAeIlbHblx 06pa340B
<:;::::> G M P 1
PHC. 4.3. llBa BapHaHTa npHHSlTI1S1 pellleHHSI 0 BbmYCKe npO.D.YKUHH
K JIeKapCTBeHHblM CpelICTB<lM :no He OTHOCHTCSI. OHH He MoryT
6bITb npOBepCHbl HepaJpywalOlllHMH MCTOlIaMH. npOBepeHHaSl elIHHHua
npOlIYKW1 11 , HanpHMep, Ha CTepH11bHOCTb, HC npHrolIHa K HCnOJlb30Ba-
HHIO. lleJlo ycyry6JlSleTCSI TeM, liTO JleKapCTBeHHoe cpelICTBO .D.OJI)I(HO
6bITb He npOCTO .;)(tJ(peKTHBHbIM. OHO 1I0JI>KHO 6bITb 6eJOnaCHbIM.

flp0U360ikm60
109
Tpe60BaHHSI K npOH3BOlICTBY TaKoH npO.D.YKUHH pe3KO B03paCTaIOT.
D.J1S1 Hee pe4b HlleT He 0 CHU:JICeHUU 6epOHmHocmu 6paKa, a 06 UClCJllOlle-
IlUU elO 603.M0:JICHOcmu. Ll06HTbCSI 3TOro MO)l(HO TOJlbKO 4eTKOH TeXHOJlO-
fHeH H opraHH3auHeH npOH3BO.D.CTBa, BKJlI04aSl n011Hoe ,lJ,OKYMeHTaJIbHOe
o<!:>0pMJleHHe BbInOJIHeHHOH pa60Tbl.
n03TOMY peweHHe 0 BbInYCKe cepHH JleKapCTBeHHoro Cpe.D.CTBa MO-
)l(eT npHHHMaTbCSI TOJIbKO Ha OCHOBe BTOpOro nOlIXOlIa - .D.OKYMeHTaUHH
Ha cepHIO npOlIYKUHH C BbI60pO'IHbIM ee KOHTpOJleM.
npOH3BO.D.HTeJIb JIeKapCTBeHHblX cpelICTB 1I0JI)I(eH He TOJIbKO BbInYC-
KaTb 6e30naCHYIO H 3<!:><!:>eKTHBHYIO npOlIYKUHIO, COOTBeTCTBYlOlllYIO 3a-
.D.aHHbIM Tpe60BaHHSlM. OH .D.OJI)I(eH YMeTb iJoKa3amb C6010 npa60my B
CJlY4ae peKJIaMaUHH HJlH TSI)I(eJIblX nOCJlelICTBHH (eCJlH OH npaB). nOJIHaSl
.D.OKYMeHTaUHSI Ha cepHIO npO.D.YKUHH SlBJlSleTCSI OCHOBOH 3alllHTbl.
4.6 CepHH npOJ],yKll.HH
nOHSITHe cepHH npO.D.YKUHH SlBJlSleTCSI O.D.HHM H3 KJlf04eBblX B npo-
H3BOlICTBe JleKapCTBeHH blX cpelICTB. rOCT P 52249-2009 (n paBHJIa
GMP EC) .D.aeT CJIe.D.YIOIllHe onpe.D.eJIeHHSI:
cepHH; napTHH (batch; or lot): Onpe1leJIeHHOe KOJIl11.JeCTBO 01lHOp01lHbIX
HCX01lHbIX 11 ynaKOB01.JHblX MaTepl1aJ10B I1JII1 OllHOp01lHOH npOllYKUI1I1, 06pa-
60TaHHOH B XOlle 01lHOH 11J111 HeCKOJIbKJ.1X nOCJle1l0BaTeJlbHbIX TeXHOJlOrH1.Je-
CKI1X CTa1lI1H.
n p 11 M e 'I a H 11 e - npl1 He06xo1lI1MOCTI1 Ha onpe1leJleHHblX CTa1lI1-
SIX np0I13B01lCTBa cepl1S1 MO)l(eT 6blTb pa31leJleHa Ha nOllCepl1l1, 06"be1lI1HSle-
Mble BnOCJIe1lCTBI1H B 01lHOp01lHYIO cepl1lO np01lYKUI1I1. npH HenpepblBHOM
np0I13B01lCTBe nOHSlTl1e cepl1l1 1l0Jl>KHO OTHOCI1TbCSI K onpe1leJIeHHOH 4aCTH
np01lYKUI1I1, xapaKTepl13yeMoH OllHOP01lHOCTblO.
C T04KI1 3peHI1S1 KOHTpoJlSl roTOBOH np01lYKUI1I1 cepl1S1 npo1lYKUI1I1
BKJl101.JaeT B ce6S1 cOBoKynHocTb elll1HI1U 1l03I1poBaHHOH 4>oPMbl JleKap-
CTBeHHblX Cpe1lCTB (JleKapCTBeHHOH 4>OPMbl), 113roTORJIeHHbiX 113 01lHOro
06"beMa I1CX01lHOro MaTepl1aJ1a 11 npowe1lwl1x e1lI1HYIO nOCJle1l0BaTeJIbHOCTb
np0l13BOllCTBeHHblX onepaUI1H 11J111 elll1HblH UI1KJ1 CTepl1J1113aUI1J.1; npl1 He-
npepblBHoM np0I13B01lCTBe - Bce e1lI1HI1UbI, np0l13BelleHHble B 3a1laHHbIH
J.1HTepBaJl BpeMeHI1.
HOMep cepHH; HOMep napT"H (batch number or lot number): Onpe1leJleH-
Hoe C01.JeTaHl1e UI14>P 11/11J111 6YKB, 0603Ha1.JalOlUee cepl1lO np01lYKUJ.1I1.
AHaJIorH4Hoe OnpelIeJleHHe .D.aHO B cG M P CiliA. 21 C FR, Parts
210,211:
cepHH (batch): OnpelleJleHHOe KOJlI1 ' leCTBO JIeKapCTBeHHoro Cpe1lCTBa
111111 llPYroro MaTepl1aJla, KOTopoe I1MeeT 01lHOp01lHble CBOHCTBa 11 Ka1.Je-
CTBO B npelle11ax YCTaHOBJleHHblX 3Ha ' leHI1H, J.1 np0113Be1leHHOe B COOT-
BeTCTBI1H C OllHI1M 3aKa30M Ha np0l13BOllCTBO B X01le 01lHOro np0I13B01l-
CTBeHHoro UI1KJ1a.

110
rJla6a 4
UeJlblO npoH3BolIcTBa SlBJlSleTCSI BbInYCK npO.D.YKUHH 3a.D.aHHoro
HaHMeHOBaHHSI H B HY)I(HOM KOJlH4eCTBe C BbInOJlHeHHeM Tpe60BaHHH K
H.D.eHTH4HOCTH, aKTHBHOCTH (3<!:><!:>eKTHBHoCTH), Ka4eCTBY H 4 HCTOTe.
(cGMP,  211.100).
CepHH npOlIYKUHH .D.OJl)l(Ha 6blTb OlIHOpOlIHOH BO BceM ee 06"beMe.
3TO CBOHCTBO 3aBHCHT OT O.D.HOpOlIHOCTH HJIH H.D.eHTH4HOCTH:
- HCXO.D.HbIX H ynaKoB04HblX MaTepHaJIOB;
- 060PYlIoBaHHSI;
- npoueCCOB;
- nOpSl.D.Ka BbInOJlHeHHSI Bcex onepauHH;
- nepCOHaJIa;
- .D.OKYMeHTaUHH.
B OnpelIeJIeHHH cepHH KJlI04eBblMH nOHSlTHSlMH S1BJlSlIOTCSI:
- O.D.HH 06"beM HJIH OlIHa cepHSI HcxOlIHOro MaTepHaJIa;
- OlIHH npOH3BO.D.CTBCHHbIH UHKJI (.D.J1S1 HenpepblBHoro npOH3BO.D.CTBa -
npO.D.YKUHSI, BbInYllleHHaSi B Te4eHHe onpe.D.eJIeHHoro BpeMeHH, HJlH
OnpelIeJIeHHOe KOJIH4eCTBO npO.D.YKUHH).
OCTaHoBHMcSI Ha 3THX nOHSlTHSIX nO.D.p06Hee.
nOlI «OlIHHM 06"beMOM HCXO.D.HOro MaTepHaJIa» nOHHMaeTCSI TO, lITO
Bce HCXO.D.Hble H ynaKoB04Hble MaTepHaJIbl .D.OJI)I(Hbl 6blTb B3S1Tbl H3 0,lJ,-
HHX H Tex )l(e cepHH MaTepHaJIOB, npOWe.D.WHX BXOlIHOH KOHTpOJlb H .D.O-
nYllleHHblX B npOH3BO.D.CTBO.
3TO CJIe.D.yeT OTpa3HTb B npOTOKOJIe cepHH roTOBOH npOlIYKUHH.
B HeM 1I0Jl)l(Hbl 6bITb YKa3aHbl HOMepa cepHH Bcex HCXO.D.HbIX H yna-
KOB04HblX MaTepHaJIOB, HCnOJIb30BaHHblX npH npOH3BO.D.CTBe .D.aHHOH ce-
pHH roTOBOH npO.D.YKUHH.
B onpe.D.eJleHHH cepHH .D.aeTCSI YKa3aHI1e Ha «eiJuHYIO nOCJleiJ06ameJlb-
Hocmb npou36oiJcm6eHHblX onepau.uii.) H «e.D.HHbIH UHKJI CTepHJIH3aUHH».
3TH nOHSlTHSI CBSl3aHbi C IaTpaTaMH Ha 060PY.D.OBaHHe, BbI.D.eJIeHHCM
npOH3BO.D.CTBeHHblx nJIOIlla.D.eH H np.
TexHoJIorH4eCKHe cxeMbl Moryr HMeTb pa3BeTBJleHHSI C nOCJIelIYIO-
IllHM 06"belIHHeHHeM B OlIHH npouecc. OnpelIeJIeHHe cepHH B TaKHX CJIY-
4aSlX MO)l(eT Bbl3bIBaTb KOH<!:>JlHKTbl HHTepeCOB.
HeKOTopble PYKOBO.D.HTeJlH npe.D.npHSlTHH CTpeMSlTCSI 06"be.D.HHSlTb B
O.D.HY cepHIO Bce, 4TO BbInYCKaeTcSI H3 O.D.HOrO 06"beMa HCXOlIHblX MaTe-
pHaJIOB, He3aBHCHMO OT cxeMbl npouecca H KOJIH4eCTBa 060PY.D.OBaHHSI
O.D.Horo Ha3Ha4eHHSI.
Bcer.aa JIH 3TO 1I0nYCTHMO? PaCCMOTpl1M 3TO Ha npHMepax.

npOU3floocm60
111
1I0cJleiJ06ameJlbHoe npou360iJcm60
npouecc He HMeeT pa3BeTBJleHHH, H BCSI npOlIYKUHSI npOXOlIHT
CTpOro OlIHY nOCJIelIOBaTeJIbHOCTb 4epe3 OlIHO H TO )l(e 060PY.D.OBaHHe
(pHC. 4.4). npH 06HapY)I(eHHH OTKJlOHeHHH B cepHH, CBSl3aHHblX C 060-
PYlIOBaHHeM, MO)l(HO 01IH03Ha4HO HaHTH HX npH4HHY.
-1
H
 ............... . 1

PHC. 4.4. nOCJIe.D.OBaTeJlbHaSi cxeMa npOH3BO.D.CTBa
3TO caMblH Y.D.06HbIH BapHaHT. HY)I(HO TOJIbKO C06JIIOCTH Tpe60Ba-
HHSI K O.D.HOpO.D.HOCTH MaTepHaJIOB, O.D.HOpO.D.HOCTH BbInOJlHeHHSI npouec-
ca (B O.D.HY CMeHY O.D.HHM nepCOHaJIOM). C T04KH 3peHHSI GMP 31IeCb Bee
XOpOlllO.
Ho C T04KH 3peHHSI 3KOHOMHKH 3Ta cxeMa MO)l(eT 6bITb 04eHb He-
Bbl, rO.D.HOH eCJIH npOH3BO.D.HTeJIbHOCTb pa3HblX e.D.HHHU 060PY.D.OBaHHSI
pe3KO pa3JIH4aeTCSI: pa3Mep cepHH 6y.neT onpe.D.eJISlTbCSI caMblM Y3KHM
MeCTOM, T. e. e.D.HHHUeH 060PY.D.OBaHHSI C HaHMeHbweH npOH3BO.D.HTeJlb-
HOCTblO.
lIpou360iJcm60 c pa36em6JleHUeM Ila 3a6epUlalOlIl,eii cmaiJuu
npHMepoM MO)l(eT CJlY)I(HTb BbInYCK HH<!:>Y3HOHHbIX paCTBopOB Ha
OlIHOH JIHHHH C <!:>HHHWHOH CTepHJIH3aUHeH B HeCKOJlbKHX CTepHJIH3aTO-
pax (pHC. 4.5).
-i
H
 ........
CTepI1JlHJ<lTOP
NQl
CTepl1JlHJaTOp
NQ
PHC. 4.5. CxeMa npouecca C pa3BeTBJleHHeM Ha 3aBeplllalOIlleH CTa.D.HH
B 3TOM CJlYllae elIHHaSi cepHSI nOCJle HanOJIHeHHSI H repMeTH3aUHH
pa31IeJISleTCSI Ha HeCKOJlbKO nOlIcepHH no 4HCJlY CTepHJlH3aTOpOB (nolIce-
PHI - 3TO 'IaCTb cepHH, npowelIwaSl CTepHJIH3aUHIO B lIaHHOM CTepHJlH3a-
TOpe). B 0603Ha ' leHHH cepHH YKa3bIBalOTCSI HOMepa cepHH H nOlIcepHH.

112
1J1Q6a 4
3T0 n03BOJIleT HaHTH np06JleMY, eCJlH 06HapY)I(eHa HeCTepHJlbHOCTb npo-
.D.YKUHH, T. e. no HOMepy nOlIcepHH YCTaHOBHTb, B KaKOM CTepHJIH3aTOpe
npouecc HeYlIOBJleTBOpHTeJIeH.
B 3TOM 3aKJIlO4aeTCSI pOJlb npaBHJIbHoro OnpelIeJleHHSI cepHH H nOlI-
cepHH npO.D.YKuHH: HeCMOTpSl Ha TO, 4TO B npouecce eCTb pa3BCTBJleHHe,
MO)l(HO HaHTH npH4HHY npH OTKJlOHeHHSlX npOlIYKUHH OT 3a.D.aHHbIX Tpe-
60BaHHH.
llapllJlJleJlbllble 6em6U 6Hympu npou.ecca
npHMepOM MO)l(eT CJly)l(HTb npOH3BOlICTBO Ta6JIeTOK: Bce CTa.D.HH
(npHeM MaTepHaJIOB, B3BeWHBaHHe, npoceHBaHHe, rpaHYJIHpOBaHHe H
np.) H.D.yr no nOCJIe.D.OBaTeJIbHOH cxeMe, 3aTeM pa3BeTBJlSllOTCSI Ha .D.Ba
HJlH TPH Ta6JIeTnpeCca, nOCJIe 4ero CHOBa 06"be.D.HHSlIOTCSI B O.D.HY JIHHHIO
H HanpaBJlSlIOTCSI Ha ynaKOBKY B 6JlHCTepbl (pHC. 4.6).
Ta6Jlempecc
NI
Ta6Jlempecc
N2
PHC. 4.6. CxeMa C napaJIJIeJIbHblMH 3BeHbSlMH BHyrpH npouecca
3TO - HeO.D.H03Ha4HbIH BapHaHT.
Pa3.D.eJlHTb cepHIO Ha nOlIcepHH B .D.aHHOM CJlY4ae He BCema B03-
MO)l(HO, Y4HTblBaSl, 4TO Hy)I(HO HCKJlI04HTb nepenyrblBaHHe pa3HblX nOlI-
cepHH H nepeKpeCTHble 3arpSl3HeHHSI H .D.OKa3aTb, 4TO OHH HCKJlI04eHbl B
.D.eHCTBHTeJlbHOCTH, nOHHMaSi 3TO KaK YCJIOBHe 06ecne4eHHSI O.D.HOpO.D.HO-
CTH.
YT06bl cepHSI 6blJla OlIHOpOlIHOH, pa60TalOIllHe napaJIJleJlbHO Ta6-
JIeTnpeCCbl .D.OJl)l(Hbl 6blTb HlIeHTH4HbIMH.
nOHSlTl1e cepHH npOlIYKUHH 1I0Jl)l(HO 6bITb OnpelIeJleHO Ha caMbl)\,
paHHHX CTMHIX C031IaHHSI npOH3BOlICTBa - CTMHSlX npoeKTa H .D.a)l(C
KOHuenUHH npoe, KTa nOCKOJIbKY OT 3TOro 3aBHCHT BCI opraHH3aUH1
npOH3BOlICTBa, no-rpe6HOCTH B 060pY.D.OBaHHH H, B KOHe'IHOM HTore, HC-
06XOlIHMbiX 3aTpaTax.

flp01l3600cm60
113
4.7 3aUJ,HTa OT 3arpH3HeHuH H nepeKpeCTHblX 3arpH3HeHHH
B paMKax llaHHoH TeMbl eCTb .D.Ba OCHOBHblX TepMHHa:
- 3arpH3HeHHe: nonalIaHHe B npOlIYKT nOCTopOHHHX BellleCTB (4a-
CTHU, CMa304HblX MaTepHaJIOB, XHMH4eCKHX coelIHHeHHH, MHKpoopra-
HH3MOB H np.);
- nepeKpeCTHOe 3arpSl3HeHHe: 3arpSl3HeHHe MaTepHaJIOB H npO.D.YK-
UHH lIPYrHMH MaTepHaJIaMH HJIH npO.D.YKUHeH.
npH4HHOH nepeKpeCTHblX 3arpSl3HeHHH MOryr 6blTb:
- HeY.D.OBJleTBOpHTeJIbHaSi 04HCTKa 060PYlIoBaHHSI, H3-3a 4ero Ha HeM
OCTaeTCSI npe.D.bl.D.YIllHH npO.D.YKT HJIH MaTepHaJIbl (rJIaBa 10);
- nblJIb, ocelIalOlllaSi Ha <!:>HJlbTpaX, B03.D.YXOBO.D.aX H np.;
- HenpaBHJlbHaSi opraHH3aUHSI npHT04HOH H BbITSI)I(HOH BeHTHJlSlUHH
H np.
Oc06yIO onaCHOCTb npe.D.CTaBJlSlIOT nopOWKH H TBep.D.ble <!:>OpMbl B
ueJlOM, nOCKOJIbKY HX 4aCTHUbl JIerKO nepeHOCSlTCSI nOTOKaMH B031Iyxa H
nepCOHaJIOM H OCe.D.aIOT Ha nOBepXHOCTSlX, MaTepHaJIaX H npOlIYKUHH.
Tpe60BaHHSI K 3alllHTe OT 3arpSl3HeHHH, B TOM 4HCJle nepeKpeCTHblX
3arpSl3HeHHH, YCTaHOBJleHbl rOCT P 52249-2009, 4aCTb I:
5.9 He 1l0nYCKaeTCSI OllHoBpeMeHHoe I1JII1 nOCJlellOBaTeJIbHOe npoBelle-
Hl1e onepaUI1H C pa3J1I11.JHblMI1 npo1lYKTaMI1 B 01lHOM 11 TOM >Ke nOMellleHl111
npl1 OTCYTCTBI1H 3allll1Tbl OT pl1CKa nepenYTblBaHI1S1 HJII1 nepeKpecTHoro 3a-
rpSl3HeHI1S1.
5.10 npO.ayKUHSI 11 MaTepHaJlbl 1l0JI>KHbl 6blTb 3alUl1111eHbl OT MI1Kp06-
HOro J.1 1lpymx BH1l0B 3arpSl3HeHI1H Ha Bcex 3Tanax npoH3B01lCTBa.
5.11 npl1 pa60Te C CYXI1MI1 MaTepl1aJ1aMI1 11 npOllYKTaMI1 He06xo1lI1MO
npl1HI1MaTb oc06b1e Mepbl npellOCTOpo>KHOCTI1 no npellOTBpallleHl11O 06pa-
30BaHI1S1 11 pacnpoCTpaHeHI1S1 nblJll1, oc06eHHO npH pa60Te C CI1J1bH01leH-
CTBYlOlUJ.1MH 11 CeHCH611J111311PYIOlUI1MI1 BelUeCTBaMI1.
npe1l0TBpameHHe nepeKpeCTHoro 3arpH3HeHHH upH npoH3B01lCTBe
5.18 CJle1lYeT J.1CKJlI04I1Tb B03MO>KHOCTb 3arpSl3HeHI1S1 I1CX01lHbIX MaTe-
pl1aJ10B 11J111 npo1lYKTOB 1lPymMI1 MaTepl1aJ1aMI1 11J111 npollYKTaMI1. B npouec-
ce npoI13B01lCTBa pl1CK CJIY1.JaHHoro nepeKpeCTHOro 3arpSl3HeHI1S1 B03HI1KaeT
npl1 HeKOHTpoJIl1pyeMoM BbI1leJleHI1H nblJlH, ra30B, I1CnapeHI1H, a3po30JIeH
HJII1 MI1KpOOpraHI13MOBI13 MaTepl1aJ10B (npollYKUI1I1) 11 OT OCTaT01.JHblX 3£1-
rpSl3HeHI1H Ha 060PYllOBaHI111 H 01le>K1le JII01leH. CTeneHb pl1CKa 3aBI1CI1T OT
nlna 3arpSl3HeHI1S1 11 npo1lYKTa, n01lBep>KeHHoro 3arpSl3HeHI1IO.
K Hal160JIee onaCHblM 3arpH3HSlI01lll1M BellleCTBaM OTHOCSlTCSI CeHCI1-
611JII1311PYI01lll1e BellleCTBa, 6110JlOm1.JeCKI1e npenapaTbl, C01lep>Kallll1e >KI1Bble
MI1KpoopraH113Mbl, HeKOTopbIe ropMOHbl, UI1TOTOKCI1Hbl 11 1lpyme CI1J1bHO-
1leHCTBYlOllll1e BellleCTBa. OC06eHHO onaCHO 3arpH3HeHI1e I1H"bCKUI10HHbIX
npenapaTOB, a TaK>Ke npenapaTOB, npe1lHa3Ha1.JeHHblX LUISI npl1eMa B 60Jlb-
WI1X 1l03ax 11/11JI11 B Te1.JeHl1e npOllOJI>KI1TeJIbHoro BpeMeHI1.
5.19 D.nSl npellOTBpaweHI1S1 nepeKpeCTHoro 3arpSl3HeHI1S1 CJle1lyeT
npellycMoTpeTb He06xo1lI1Mble TeXHl11.JeCKl1e 11 OpraHI13aUI10HHbIe Mepbl,
Hanpl1Mep:

114
£106a 4
a) np0I13B01lCTBO B BbllleJleHHblX 30Hax (06S13aTeJlbHOe LUISI TaKI1X npo-
1lYKTOB KaK neHI1UI1JlJlI1H, >KI1Bble BaKUI1Hbl, 6aKTepl1aJlbHble npenapaTbl 113
>KI1BbIX MI1KpOOpraHI13MOBI1 HeKOTopble llpyme 6110JlOrH1.JeCKI1e 11eKap-
CTBeHHble cpellCTBa) 11J111 pa31leJleHl1e UI1KJ10B npol13BOllCTBa BO BpeMeHI1 C
COOTBeTCTBYlOllleH y60pKOH nOMellleHI1S1 11 060pYllOBaHI1S1 Me>K1lY UI1KJ1aMI1;
b) OpraHl13aUI1S1 B031lYWHbIX WJlI030B 11 BbITSI>KHbIX YCTPOHCTB;
c) CBe1leHl1e K MI1HHMYMY pl1CKa 3arpSl3HeHI1S1, BbI3blBaeMoro peUl1p-
KYJISlUl1eH I1JII1 nOBTopHblM nocTynJleHl1eM He06pa60TaHHoro 11J111 He1l0CTa-
T01.JHO 06pa60TaHHoro B031lyxa;
d) XpaHeHl1e 3allll1THOH (cneUl1aJ1bHoH) 01le>K1lbl B npelleJIaX 30H npo-
113B01lCTBa npo1lYKUI1I1 C BblCOKI1M pl1CKOM nepeKpecTHoro 3arpSl3HeHI1S1;
e) I1CnOJIb30BaHl1e BblcoK034>4>eKTI1BHbIX MeT01l0B 01.JI1CTKI1 11 06pa-
60TKI1 C UeJlblO I1CKJl101.JeHI1S1 He1l0CTaT01.JHOH 01.JI1CTKI1, 1.JaCTO S1RJ1S1I0111eHCSI
npl11.Jl1HOH nepeKpecTHoro 3arpSl3HeHI1S1;
f) I1CnOJlb30BaHI1e «3aKpblTbIX CI1CTeM» np0I13B01lCTBa;
g) KOHTpOJlb HaJlI1411S1 OCTaTKOB npellbl1lYlllero npo1lYKTa I1JII1 MOIO-
lUHX Cpe1lCTB 11 MapKHpoBKa 060pY1l0BaHI1S1 C YKa3aHI1eM cTaTyca 1.JI1CTOTbI.
5.20 CJle1lYCT nepl101lI11.JeCKI1 npoBepSlTb 34>4>eKTI1BHOCTb Mep no
npe1l0TBpallleHI1IO nepeKpeCTHOro 3arpSl3HeHI1S1 B COOTBeTCTBl111 C YTBep-
)I(1leHHblMI1 11 HCTPYKUI1S1M 11.
PaCCMOTpHM HeKoTopble npHMepbl nepeKpecTHbIx 3arpSl3HeHHH H
MeTO.D.bl 60pb6bl C HHMH.
BblmH:JICHaH 6eHmUJlHu.UH
npaBHJIbHaSi opraHH3aUHSI BblTSI)I(HOH BeHTHJISlUHH (MecTHblx OTCO-
COB HJIH CHCTeM acnHpaUHH) HMeeT KpHTH4eCKoe 3Ha4eHHe. OpraHH3a-
UHSI BblTSI)I(KH pa3JlH4aeTCSI .D.J1S1 omKpblmblX H 3aKpblmblX npOUeCCOB.
Oc06eHHO 4YBCTBHTeJIbHblMH S1BJlSlIOTCSI OTKpblTble npOueCCbl.
BblTSI)I(HaSi BeHTHJISlUHSI .D.OJI)I(Ha Y.D.aJISlTb 3arpSl3HeHHSI 3a npe.D.eJIbl
3.D.aHHSI HJIH OCa)l(.D.aTb HX Ha BblTSI)I(Hble <!:>HJIbTpbl, a He nO.D.aBaTb 3a-
rpSl3HeHHSI B .D.PYrHe 4aCTH nOMellleHHSI HJlH «BTSlrHBaTb» 3arpSl3HeHHSI CO
Bcero nOMellleHHSI B pa604YIO 30HY.
D.nSl MHomx onepaUHH BbITSI)I(HaSi BeHTHJISlUHSI HrpaeT KpHTH4eCKYlO
pOJIb. HanpHMep, .D.J1S1 HCKJlI04eHHSI nOna.D.aHHSI 3arpSl3HeHHH B MaTepHall
npH B3BeWHBaHHH Moryr C03.D.aBaTbCSI B031IYWHble JaBeCbl C nOMOlllblO
O.D.HOHanpaBJleHHoro (JlaMHHapHoro) nOTOKa B03lIyxa. BbITSI)I(HaSl BeHTH-
JISlUHSI .D.OJI)I(Ha npe.D.YCMaTpHBaTbCSI .D.J1S1 OTKpblTblX npoueCCOB, Hanpl-
Mep, npH npOBelIeHHH onepauHH CMeWHBaHHSI nopOlllKOB, H3MeJIb ' leHHSI.
npoceHBaHHSI H np.
HenpaBHJlbHble pellleHHSI no BeHTHJISlUHH WHpOKO pacnpOCTpaHeHbl.
npHMep H3 npaKTHKH
npl1 nOCellleHl111 npellnpl1S1TI1S1, BbInYCKalOlllero (jmJlbTpbl LUISI KpOBl1
no «HaHOTeXH0110rl1S1M», HaM 6blJl 3a1laH Bonpoc: KaK 1136aBI1TbCSI OT 3a-
rpSl3HeHI1H npOllYKUI1I1? Ha roTOBblX 4>11J1bTpaX eCTb nOCTOpOHHl1e BKJlIO'le-
HI1S1. BpOlle 6bl Bce Clle11aHO npaBH11bHO, nOMeweHl1e BbIn011HeHO nO'ITl1
lII1CTbIM, JIlOlll1 ncpeOllCBalOTC1 B nOCTl1paHHYIO OllC>K1lY, pa60TaeT OTllC11

flpOU360()cm60
115
KOHTpOJlSl Ka1.JeCTBa, Bce wKa4>bl 3anOJlHeHbl 1l0KYMeHTaUl1eiL npHrnaweH-
HblH KOHCYJlbTaHT npOBeJl (,aHaJll13 PI1CKOB') 11 peKOMeH1l0BaJl YCTaHOBI1Tb
30HT - MeCTHYIO BbITSI>KKY Ha1l Ka>K1lblM pa601.JI1M MeCTOM no c60pKe 4>11J1b-
TpOB. B pe3YJlbTaTe 3arpSl3HeHI1H B npo1lYKUI1I1 CTaJlO ellle 60Jlbwe.
B 1.JeM lleJlo?
A 1leJlO OKa3aJlOCb BOT B 1.JeM: BbITSI>KKY HY>KHO CTaBI1Tb TaM, me Bbille-
JISIIOTCSI JarpSl3HeHI1S1, 1.JT06bI He 1l0nYCTI1Tb I1X pacnpoCTpaHeHI1S1 B OKPY-
>KalOlllYIO cpe1lY, B nOMellleHl1e 11 Ha 1lPyroe 060PY1l0BaHl1e. ECJlI1 1leJlaTb
BbITSI>KKY Ha1l 1.Jl1CTblM pa601.JI1M MeCTOM, me Bbl1leJleHI1S1 3arpSl3HeHI1H HeT,
TO OHa 6Y1leT BTSlrHBaTb 3arpSl3HeHI1S1 113 Bcero nOMellleHI1S1, 1l0CTaBJlSISI I1X
no nYTI1 Ha 1.Jl1CTOe pa601.Jee MeCTO, KOTopoe pacnOJlO>KeHO Me>K1lY nOMellle-
Hl1eM 11 MeCTHblM OTCOCOM (BbITSI>KKOH). 3TO 11 np0l130WllO Ha npe1lnpl1S1-
TI1I1-113roTOBI1TeJle B BblcweH CTeneHI1 OTBeTCTBeHHOH npo1lYKUI1I1 - 4>1111b-
TpOB LUISI KpoBI1.
HaMI1 6bl11 1laH COBeT:
I. Y6paTb BbITSI>KKI1;
2. YCTaHOBI1Tb Ha1l Ka)I(1lblM pa601.JI1M MeCTOM 30HT, HO He 6blmRlU6alO-
UU B03.llYX, a noiJalOU(uu 'lUCmbIU 603iJyX 'lepe3 tjJUJlbmp B pa601.JYIO 30HY.
3TO peWeHl1e 01.JeBI11lHO 110 npl1MI1TI1BHOCTI1 11 Tpe6yeT JII1Wb BHI1Ma-
TeJIbHOH pa60Tbl caMoro npe1lnpl1S1TI1S1. HHKaKl1x CneUl1aJlbHblX 3HaHI1H
31leCb He HY>KHO.
BblmH:JICKa U3 060pyiJ06aHUH .D.OJI)I(Ha 6bITb BbInOJlHeHa TaK, 4T06bl
HCKJlI04HTb HaKanJIHBaHHe oceBwero npO.D.YKTa H nepeKpeCTHble 3arpSl3-
HeHHSI. 3TO - HenpOCTOH H He04eBH.D.HbIH Bonpoc.
BCTpe4alOTCSI peKOMeH.D.aUHH opraHH30BbIBaTb npHMblKaHHe B03.D.Y-
XOBO.D.OB K 060PY.D.OBaHHIO ropH30HTaJIbHblMH Y4aCTKaMH, 4T06bl oceB-
lllHe Ha HX CTeHKax 4aCTHUbl npOlIYKTa He ynaJIH BHH3. 3TO HeBepHblH H
onacHblH no.D.XO.D.. '-IacTHUbl MOryT HaKanJIHBaTbCSI, pa3JlaraTbCSI H nona-
.LI.aTb Ha3a.D. B 060PY.D.OBaHHe 06paTHblM nOTOKOM B03.D.yxa npH nepexo.D.-
HblX npoueccax (BKJlf04eHHe/BbIKJII04eHHe BeHTHJISlUHH), npHBO.D.SI K ne-
peKpecTHblM 3arpSl3HeHHSlM.
PacnpOCTpaHeHHe 4aCTHU H OCa)I(.D.eHHe HX Ha nOBepxHocTSIX 3aBH-
CSIT OT MHOrHX <!:>aKTopoB: pa3MepoB H Beca 'IaCTHU, CKOpOCTH .D.BH)I(eHH
B031Iyxa, 06"beMa H KOHCTPYKUHH 060PYlIoBaHHSI. YnpollleHHblH nOlIXO.D.
MO)l(eT YBecTH B CTOPOHY.
npaBHJIbHOe peweHHe - YCTaHoBKa BblTSI)I(HblX <!:>HJIbTpOB. Ba)l(HO
BbInOJIHSlTb 06pa60TKY 060PY.D.OBaH, HSI a npH nepexolle C npo.D.YKTa Ha
npO.D.YKT MeHSlTb <!:>HJIbTp.
npHMeHIOTCSI TaK)I(e m6KHe B03.D.YXOBO.D.bl THna «X060T CJIOHa», KO-
Topble Y.D.ep)l(HBaIOT nblJlb 3Ha4HTeJlbHO JIY4we, 4eM ma.D.KHe B03.D.YXOBO-
.LI.bl, Moryr JIerKO .D.eMOHTHpoBaTbcSI, MeHSlTbCSI H O'IHlllaTbCSI.
f/JUJlbmpbl
BblTSI)I(HOH <!:>HJlbTP YCTaHaBJlHBaeTCSI B 30HC coelIHHeHHSI B031IYXO-
BOlla C 060PYlIOBaHHeM. ilil1pOKO pacnpOCTpaHeHO BepTI1KaJIbHOe COClIH-
HeHHC, HanpHMCp, B cywHJlKaX nCeBlIOO)l(H)I(eHHoro CJIOSI. n pelIYCM,lT-

116
rJ/a6a 4
pHBaeTCSI BCTpSlxHBaHHe <!:>HJIbTpa, PY4Hoe HJlH aBTOMaTH4eCKoe, B Te4e-
HHe npouecca H no ero OKOH4aHHH.
BblTSI)I(Hble <!:>HJIbTpbl .aOJI)I(Hbl YlIep)l(HBaTb nblJIb, He 1I0nYCKaSi ee
pacnpOCTpaHeHHSI B .aPYrHe MeCTa. cDHJIbTpbl CJlelIyeT CBoeBpeMeHHO 3a-
MeHSlTb. I1x 3aMeHa .aOJl)l(Ha BbInOJlHSlTbCSI aKKypaTHo, He .aonYCKaSl Bbl-
.aeJIeHHSI 3arpSl3HeHHH B OKpY)I(alOlllYIO cpe.ay.
npH npOH3Bo.aCTBe BbICOK03<!:><!:>eKTHBHbIX, ceHCH6HJlH3HPYIOIllHX H
.aPyrHx aHaJIOrH4HblX BHlIOB npo.aYKUHH 1I0Jl)l(Hbl HCnOJlb30BaTbCSI TOJIbKO
HH.aHBHlIYaJIbHble <!:>HJIbTpbl. Ka)I(1lblH TaKoH <!:>HJIbTP CJIelIyeT MapKHpo-
BaTb, ero HCnOJIb30BaHHe H yrHJIH3aUHIO CJle.ayeT O<!:>0PMJISlTb .aOKYMeH-
TaJIbHO.
no.aa4a B03.ayxa B 060pYlIOBaHHe BbInOJIHSleTCSI 4epe3 HEPA
<!:>HlIbTp.
OplaHu3au.UH 6bliJeJleHHblX U lIucmblX 3011
npH pa60Te C onaCHblMH BellleCTBaMH opraHH3YlOTCSI BbI.D.eJIeHHble
30Hbl C nOHH)I(eHHblM .aaBJleHHeM B03.ayxa, npenSlTCTBYlOlllHe pacnpo-
CTpaHeHHIO 3arpSl3HeHHH 3a npelIeJIbl pa604ero nOMellleHHSI.
3<!:><!:>eKTHBHbIM cpe.aCTBOM SlBJlSleTCSI npHMeHeHHe 3aKpblmblX cxeM H
U30JlHmOp06. npaBHJIbHaSi KOM6HHaUHSI nepenaiJ06 iJa6JleHUH B03.ayxa
TaK)l(e n03BOJISIeT pa31IeJISlTb 30Hbl, He 1I0nYCKaSi nepeKpeCTHblX 3arpSl3-
HeHHH H 06eCne4HBa51 4HCTOTY npo.aYKUHH.
OTBeTCTBeHHble onepaUHH B npOH3Bo.aCTBe CTepHJIbHblX JIeKap-
CTBeHHblX cpe.aCTB .aOJI)I(Hbl BbInOJlHSlTbCSI B lIucmblX nOMelU,ellURX II].
npaKTHKOH no.aTBep)I(.D.eHa 3<!:><!:>eKTHBHOCTb npHMeHeHHSI 4HCTblX nOMe-
llleHHH H B npOH3Bo.aCTBe HeCTepHJIbHOH npOlIYKUHH.
Ta6JlemOllHbie npeCCbl
Ta6JIeT04Hble npeCCbl (Ta6JleTnpeCCbl), eCJlH OHH He BbInOJIHeHbl B
BH.ae H30JISITOpOB, 1I0Jl)l(Hbl pa3MelllaTbCSI B OT.aeJIbHbIX nOMellleHHSlX HJIH
30Hax, 4T06bl HCKJlI04HTb nepenyrblBaHHe npo.aYKUHH H nepeKpeCTHble
3arpSl3HeHHSI. OHH 1I0Jl)l(Hbl 6bITb cHa6)1(eHbl 3<!:><!:>eKTHBHbIMH BbITSI)I(Ka-
MH. npHMepbl pellJeHHSI nOKa3aHbl B maBe 3 .D.J1S1 npOH3Bo.aCTBa aKTHB-
HbIX <!:>apMaueBTH4ecKHx cy6cTaHUHH.
)J(uiJKocmu
D.nSl pSilIa npoueCCOB, HanpHMep, rpaHYJlHpOBaHHSI H 06BOJIaKHBa-
HHSI peKoMeHlIyeTcSI HCnOJIb30BaTb TOJlbKO CBe)l(enpHroTOBJleHHble pac-
TBOpbl HH.D.HBHlIYaJIbHO.D.J1S1 Ka)I(.D.OH cepHH.
npH npHroTOBJleHHH paCTBopOB lIJlSl pa3HbiX cepHH H HX xpaHeHHH
B Te4eHHe .D.J1HTeJIbHoro BpeMeHH B03HHKaeT pHCK XHMH4ecKoro H MHK-
P06HOro 3arpSl3HeHHSI.

npOU360dcm60
117
3alpH3HeHUH om 060pyiJ06aHuH
CJIelIyeT opraHH30BaTb TeXHH4eCKoe 06CJlY)I(HBaHHe, B T. 4. OCMOTpbl
nOBepXHOCTeH 060PYlIOBaHHSI Ha npe.aMeT HaJIH4HSI TpeIllHH, H3JlOMOB,
H3Hoca. HY)I(HO HCKJlI04HTb nona.aaHHe 06JlOMKOB nyaHcoHoB Ta6JleT04-
HblX npeccoB, BbllIeJleHHH OT 060PYlIOBaHHSI, CMa304HblX MaTepHaJIOB H
np. B npolIYKUHIO. D.OJI)I(Hbl 6blTb npelIycMoTpeHbl Mepbl, npelIoTBpallla-
IOIllHe nOna.D.aHHe B npolIYKUHIO 4aCTHU MeTaJIJIa, CTeKJIa, .aepeBa H np.
4.8 OTKJlOHeHHble, nOBTopHO HCnOJlb30BaHHbIe H B03Bpal.l\eHHble
MaTepHaJlW H npOAYKHH
OmlCJlOHeHHaH MamepUaJlbl U npoiJYKu.UH
OTKJlOHeHHble MaTepHaJIbl H npo.aYKUHSI .aOJI)I(Hbl HMeTb 4eTKYIO
MapKHpOBKY H xpaHHTbCSI pa3.aeJIbHO B 30Hax C orpaHH4eHHblM 1I0CTY-
nOM. OHH nO.D.J1e)l(aT B03BpaTY nOCTaBWHKY, nepepa60TKe (eCJIH 3TO 110-
nYCTHMO) HJlH YHH4TO)/(eHHIO C .aOKYMeHTaJIbHbIM o<!:>opMJIeHHeM.
npH OTKJlOHeHHH ynOJlHOM04eHHblM J1HUOM cepHH npo.aYKUHH OHa
B03BpalllaeTCSI B nepepa60TKY HJIH yrHJlH3HpyeTCSI.
no.a nepepa60mKoii (reprocessing) nOHHMaeTCSI nOBTopHaSl 06pa60TKa
cepHH HJlH 4aCTH cepHH npo.aYKUHH, He COOTBeTCTBYlOllleH 3a.D.aHHbIM
Tpe60BaHHSlM, Ha4HHaSi C onpe.aeJleHHOH CTa.D.HH npOH3Bo.aCTBa, .D.J1S1 no-
JIY4eHHSI npo.aYKUHH Tpe6yeMoro Ka4eCTBa nOCJle npOBelIeHHSI O.aHOH
HJIH HeCKOJIbKHX .aonOJIHHTeJlbHbIX onepaUHH. OTlIeJlOM KOHTpOJISI Ka4e-
CTBa MOryT 6bITb YCTaHOBJleHbl .aonOJIHHTeJlbHble Tpe60BaHHSI no KOH-
TpOJIIO nepepa60TaHHOH npo.aYKUHH.
nepepa60TKa OTKJlOHeHHOH npo.aYKUHH .aonYCKaeTCSI B HCKJlI04H-
TeJIbHblX CJIy<IaSix npH YCJlOBHH OTCyrCTBHSI yxy.aweHHSI Ka4eCTBa roTOBOH
npo.aYKUHH H BbInOJlHeHHSI Bcex Tpe60BaHHH cneUH<!:>HKaUHH. nepepa-
60TKY OCYllleCTBJlSlIOT B COOTBeTCTBHH C yrBep)I(.D.eHHblMH HHCTPYKUHSIH
nOCJIe oueHKH B03MO)l(HOro pHCKa C nOCJIelIYlOlllHM .aOKYMeHTaJIbHbIM
o<!:>opMJIeHHeM. ECJIH nOKa3aTeJlH npo.aYKUHH HaCTOJIbKO He COOTBeT-
CTBYIOT Tpe60BaHHSlM cneUH<!:>HKaUHH, 4TO ee nepepa60TKa HelIonYCTHMa,
BCSI cepHSI no.aJle)l(HT YHH4TO)l(eHHIO, Tpe60BaHHSI K KOTOPOMY .aOJI)I(Hbl
6bITb YCTaHOBJleHbl CneUHaJIbHOH HHCTPYKUHeH.
ll06mopHoe UCnOJlb306aHue
ECJIH cepHSI npOlIYKUHH y.aOBJleTBOpSleT Tpe60BaHHHM, TO OHa (HJlH
ee 4aCTb) MO)l(eT 6bITb BKJlI04eHa B .aPyrylO cepHIO npOlIYKUHH Ha onpe-
.aeJleHHOH CTa.aHH npOH3Bo.aCTBa, T. e. HCnOJIb30BaHa nOBTopHO. nopl-
1I0K nOBTopHOro HCnOJlb30BaHHSI (recovelY) H nOJIY4eHHSI Ha 3TO pa3pe-
weHHSI 1I0JI)I(eH 6bITb YCTaHOBJleH cneUHaJIbHOH HHCTPYKUHeH. nOBTOp-
Hoe HCnOJlb30BaHHC npOlIYKUHH .aonYCKaeTCSI TOJIbKO nOCJle oueHKH
B03MO)l(HOro pHCKa (B T. 4. ero BJlHSlHHSI Ha CpOK rolIHOCTH cepHH) no
YTBep)l(1leHHOH HHCTPYKUHH C 1l0KYMeHTaJIbHblM O<:}>opMJleHHeM.

118
IJw6a 4
B036paw,eHHaH npooYKu.UH
B03BpallleHHaSl npo.aYKUHSI, Hall KOTOpOH 6blJl yrpa4eH KOHTpOJlb CO
CTOpOHbl npOH3BOlIHTeJlSl, nO.D.J1e)l(HT YHH4TO)l(eHH10, eCJIH He no.aTBep-
)l(.D.eHO COOTBeTCTBHe ee Ka'leCTBa YCTaHOBJleHHblM Tpe60BaHHSlM. Pewe-
HHe 0 nOBTOpHOH npOlIa)l(e, nepeMapKHpOBKe HJIH nOBTopHOM HCnOJIb-
30BaHHH MO)l(eT 6blTb npHHSlTO TOJlbKO nOCJle CneUHaJIbHoro aHaJIH3a,
npOBe.aeHHoro OT.aeJIOM KOHTpOJlSl Ka4eCTBa B COOTBeTCTBHH C nHCbMeH-
HOH HHCTPYKUHeH.
CJIe.ayeT Y4HTbIBaTb xapaKTep npo.aYKUHH, ee npe.ablCTOpHIO H CO-
CTOSlHHe, C06JIIOlIeHHe YCJlOBHH xpaHeHHSI H BpeMSI, npOllle.awee C MO-
MeHTa BbInYCKa. npH JII06blX COMHeHHSlX B OTHoweHHH Ka4eCTBa npo-
.aYKUHH He .aonYCKaeTCSI ee nOBTopHoe HCnOJIb30BaHHe HJIH nOBTopHblH
BbInYCK, HO B03MO)l(Ha ee XHMH4eCKaSl nepepa60TKa C ueJlblO pereHepa-
UHH aKTHBHblX HHrpe.aHeHTOB. Bce BbInOJIHSleMble .aeHCTBHSI .aOJl)l(Hbl
6bITb o<!:>opMJIeHbl 1I0KYMeHTaJIbHO.
4.9 Pa60Ta no KOHTpaKTaM
npaBHJIa GMP .aonYCKaIOT pa60TY no KOHTpaKTaM (pa3.aeJl 7 YacTH I
rOCT 52249-2009). Pa60Ta no KOHTpaKTY HJlH .aOroBOpy - eCTeCTBeH-
Hoe CJleD.CTBHe pa3BHTHSI pa3.aeJIeHHSI TpY,lJ,a H CneUHaJIH3aUHH npOH3-
BO.aCTB. OHa OC06eHHO aKTYaJIbHa .D.J1S1 He60JIbWHX npelInpHSITHH, Koma
OTlIeJIbHble 3Tanbl npouecca ueJleC006pa3HO nepelIaTb Ha cy6noD.pSI.D.
(BbInOJlHeHHe CTOpOHHeH opraHH3aUHeH), He BKJla.D.blBaSi cpelICTBa B CO-
3.aaHHe .aOpOroCTOSlIllHX H MaJIO JarpY)I(eHHblX pa6OTOH no.apa3.aeJIeHHH.
npHMepaMH Moryr CJIY)I(HTb npOBe.aeHHe aHaJIH30B H pa.aHaUHOHHaSi
CTepHJIH3aUHSI.
CJleD.yeT HMeTb B BH.ay, 4TO cxeMa pa60Tbl no KOHTpaKTY .aOJI)I(Ha
6blTb np03pa4HOH H JIerKO npOBCpSieMOH. B maBe 19 KHHrH npHBe.aeH
npHMep CJlHWKOM CJlO)l(HOH cxeMbl pa60Tbl no KOHTpaKTY, Koma pSl.a
OCHOBHblX onepaUHH 6blJl nepe.aaH pa3HblM opraHH3aUHSlM. I1HcneKuHSI
CnpaBe.D.J1HBO C04Jla 3TY cxeMY HenpHeMJleMoH.
npOH3BOD.HTeJlb JleKapCTBeHHoro cpe.aCTBa HeceT OTBeTCTBeHHOCTb
3a ero Ka4eCTBO, B TOM 4HCJle 3a pa60TY Bcex cOHcnoJIHHTeJIeH. 3Ta OT-
BeTCTBeHHOCTb He .aOJl)l(Ha HOCHTb D.eKJIapaTHBHbIH xapaKTep, OHa .aOJI)I(-
Ha 6bITb SlCHOH H .aOKa3yeMOH. KOHTpaKTOM .aOJI)I(Ha 6blTb onpe.aeJIeHa
OTBeTCTBeHHOCTb CTOpOH (3aKa34HKa H HCnOJIHHTeJlSl) 3a BbInOJlHSleMblC
HMH pa60TbI, npOH3Bo.aCTBO H KOHTpOJIb npOlIYKUHH.
B KOHTpaKTe .aOJI)I(HO 6blTb YKa3aHO, KaKHM 06pa30M ynOJlHOMO-
4eHHoe JlHUO, OTl3eTCTBeHHoe 3a BbInYCK cepHH npOlIYKUHH, MO)l(eT y6c-
.aHTbCSI B TOM, 4TO Ka)l(1laSl cepl1S1 npOlIYKUHH 6blJla H3rOTOBJleHa 11 npo-
WJla KOHTpOJlb B COOTBeTCTI3HH C YCTaHOBJleHHblMH Tpe60I3aHHSlMH.
npOTOKOJlbl npOHJI301ICTBa, aHaJIH30B H peaJIH3aUHI1 npOlIYKUHH, a
TaK)I(C COOTI3CTCTBYIOWHC KOHTpOJlbHble 06paJUbi .aOJl)l(Hbl xpaHHTbC1 Y

flpOU3600cm60
119
3aKa34HKa. nepe4eHb .aOKYMeHTOB, OTHOCSlIllHXCSI K oueHKe Ka4eCTBa
npo.aYKUHH H CBSl3aHHblX C peKJIaMaUHSlMH HJlH B03HHKHOBeHHeM CO-
MHeHHH B Ka4eCTBe npo.aYKUHH, .aOJI)I(eH 6bITb onpe.aeJIeH 3aKa34HKOM B
HHCTPYKUHSlX no OTKJlOHeHHIO (OT3bIBY) npOlIYKUHH.
KOHTpaKTOM .aOJl)l(HO 6blTb npelIYCMOTpeHO npaBO 3aKa34HKa Ha no-
cellleHHe npOH3Bo.aCTBa HCnOJIHHTeJISI. npH 3aKJIlO4eHHH KOHTpaKTa Ha
npOBelIeHHe aHaJIH30B B03MO)l(HO HHcneKTHpOBaHHe HCnOJlHHTeJlSl
Ha1l30pHbIMH opraHaMH.
4.10 BbrnycK no napaMeTpaM
B OT.aeJIbHbIX CJlY4aSlx .aonYCKaeTCSI 6btnYCK cepHH no napllMempllM
TeXHOJIOrH4ecKoro npouecca .ao 3aBepweHHSI HcnblTaHHH Ha CTepHJIb-
HOCTb (npHJIO)l(eHHe 17 npaBHJl G M P - rOCT P 52249-2009).
Ha OCHOBe pe3YJIbTaTOB KOHTpOJISI cepHH npo.aYKUHH H npOBepKH .ao-
KYMeHTaUHH ynOJlHOM04eHHoe JIHUO npHHHMaeT peweHHe 0 BbInYCKe ce-
pHH B peaJIH3aUHIO HJlH ee OTKJlOHeHHH, llaB He06xo.aHMoe 060CHOBaHHe.
BbInYCK no napaMeTpaM oc06eHHO Ba)l(eH .D.J1S1 npOH3Bo.aCTBa npena-
paTOB Ha OCHOBe KOPOTKO)l(HBYIllHX H30TonOB, C nepHOlIOM nOJIypacnalIa,
H3MepSleMblM 4acaMH. B 3TOM CJlY4ae CpOK ro.aHOCTH npenapaTa BO MHO-
ro pa3 MeHbwe BpeMeHH npOBe.aeHHSI HcnblTaHHH Ha CTepHJIbHOCTb.
npenapaT BBO.aHTCSI .ao 3aBepllleHHSI HcnblTaHHH Ha CTepHJIbHOCTb, HO
HCnblTaHHSI npOBo.aSlTCSI .D.J1S1 no.aTBep)I(.D.eHHSI CTepHJlbHOCTH HJIH BbISlB-
JIeHHSI OTKJlOHeHHH OT HOpMbl.
BbmycK no napaMeTpaM HCnOJlb3yeTcSI H npH KPynHocepHHHoM npo-
H3Bo.aCTBe HH<!:>Y3HOHHbIX paCTBopOB. COBpeMeHHble CTepHJIH3aTOpbl n03-
BOJlSlIOT rapaHTHpOBaTb CTepHJIbHOCTb. npaBHJIbHaSl pa3pa60TKa npouecca
CTepHJIH3aUHH H HenpepblBHblH .aBOHHOH KOHTpOJlb TeMnepaTypbl B KPH-
TH4eCKHX T04Kax CTepHJIH3aTOpa rapaHTHpYIOT CTepHJIbHOCTb npo.aYKUHH.
BbInYCK no napaMeTpaM npouecca CTepHJIH3aUHH .ao nOJIyYeHHSI pe3YJIbTa-
TOB KOHTpOJISI CTepHJlbHOCTH (14 .aHeH H 60Jlee) pe3KO COKpalllaeT nOTpe6-
HOCTb B nJIOIlla.D.SIX .D.J1S1 KapaHTHHHoro xpaHeHHSI roTOBOH npo.aYKUHH.
BbInYCK no napaMeTpaM 1l0nYCKaeTCSI .aJlSl XopOWO pa60TalOlllHx
npoH3BOlICTB, nOlITBeplIHBWHX Ka4eCTBO CBoeH npo.aYKUHH H COOTBeT-
CTBHe npOH3BOlICTBa Tpe60BaHHSlM GMP. B 4aCTHOCTH, CJle.ayeT nOKa-
3aTb cTa6HJIbHOCTb H 3<!:><!:>eKTHBHoCTb npouecca CTepHJIH3aUHH, KOHTpO-
nHpoBaTb 6HoHarpY3KY nepell cTepHJlH3aUHeH, HCKJlI04HTb B03MO)l(HOCTb
nepenyrblBaHHSI npOlIYKUHH, npowelIweH H He npowellweH CTepHJlH3a-
UHIO H T. .a.
nO.ap06Hee BbmycK no napaMeTpaM paccMOTpeH B KHHre [10].

120
fJIaBa 5
)J:OKYMEHTAll.H»
5.1 Ha3HalfeHHe ,lJ,OKYMeHTau,HH
LIOKYMeHTaUHSI BbInOJIHSleT .aBe rJIaBHble <!:>YHKUHH:
I) YCTaHaBJlHBaeT mpe606aHuH KO BCeMY, 4TO HCnOJlb3yeTcSI HJlH
BbInOJIHSleTCSI npH npOH3Bo.aCTBe H KOHTpOJle;
2) OTpa)l(aeT tjJaKmullecKoe 6binOJlHeHUe pa60Tbl.
B nep60M CJlYllae .a0KYMeHTaUHSI YKa3bl6aem, 4TO, KaK, Koma H KTO
.aOJI)I(eH .aeJIaTb, KaKHe Tpe60BaHHSI npe.a"bSlBJlSlIOTCSI K MaTepHaJIaM H
npo.aYKUHH, MeTo.aaM KOHTpOJISI H T. .a. 3TO - perJIaMeHTHpYIOIllaSi .ao-
KYMeHTaUHSI. OHa OXBaTblBaeT BCIO npOH3BOlICTBeHHYfO uenb, .aOJI)I(Ha
6bITb npaBHJIbHOH H COOTBeTCTBOBaTb nepe.aOBOMY ypOBHIO TeXHOJIOrHH.
Ha npe.anpHSlTHH Bce .aOJI)I(HO 6blTb no.a KOHTpOJleM. 3TOT npHHUHn
onpeD.eJlSleT COCTaB H CTeneHb .aeTaJIH3aUHH 1I0KYMeHTaUHH, BKJlI04aSl:
- nOJIY4eHHe H KOHTpOJlb MaTepHaJIOB;
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- BbInOJIHeHHe TeXHOJIOrH4eCKHX npoueCCOB;
- nOpSI.D.OK 3KCnJ1yaTaUHH nOMellleHHH H 060Py.aoBaHHSI;
- BHYTpHnpOH3Bo.acTBeHHbIH KOHTpOJlb;
- KOHTpOJIb roTOBOH npo.aYKUHH;
- aHaJIH3 OTKJlOHeHHH OT cneuH<!:>HKauHH;
- aHaJIH3 peKJIaMaUHH;
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- 06Y4eHHe nepCOHaJIa H np.
Bo 6mopOM CJlYllae 1I0KYMeHTaUHSI KOHcmamupyem, 4TO, KaK, Koma
H KTO c.aeJlaJI H KaKHe nOJIY4eHbl pe3YJIbTaTbl.
«To, limo He 3anucaHO, mo He COeJlaHO» - 3TO <!:>YH.aaMeHTaJIbHbIH
npHHUHn KOHTpOJISI HCnOJIHeHHSI. 113 3TOro npHHUHna HCXO.aSlT Ha.a30p-
Hble opraHbl Bcex CTpaH npH npOBepKe npe.anpHSITHH.
YeTKaSi D.OKYMeHTaUHSI lIaeT OCHOBY .D.JISI CTaHlIapTHoro npOH3BO.a-
CTBa npo.aYKUHH C HeH3MeHHblMH CBOHCTBaMH, n03BOJlSleT npOCJlelIHTb
HCTOpHIO H3roTOBJleHHSI cepHH npOlIYKUHH H BblSlBHTb npH4HHbl OTKJlO-
HeHHH. 3TO, B CBOIO 04epelIb, lIaeT B03MO)l(HOCTb BHeCTH HCnpaBJleHHSI B
npouecc H npelIOTBpaTHTb OTKJlOHeHHSI B 6YlIYllleM.
Pa60Ta B CTpOroM COOTBeTCTBHH C 1I0KYMeHTaUHeH n03BOJlSleT HC-
KJlI04HTb OWH6KH, B03MO)l(Hbie npH YCTHOM 061lleHHH H3-3a HenpaBHJlb-
HOro TOJlKOBaHHSI CJ10B, HenOJlHOH HJIH 3a6blToH HH<popMaUI1H OHa
n03BOJlSleT 3aMKHyrb Kpyr OTBeTCTBeHHOCTH H HaHTH BHHOBHOro.

jI,oKYMeHmau,UR
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UHOHHblX 1I0KYMeHTOB, npOMblWJleHHblX perJlaMeHTOB, lIaHHblX 3aBO.aOB-
H3roToBHTeJIeH 060Py.aOBaHHH, anp06HpOBaHHbiX MeTOlIOB, nOlITBep-
)l(.D.eHHblX c06CTBeHHbiM HJIH 3aHMCTBOBaHHblM OnblTOM pa60Tbl.
5.2 CnJlOlliHOe ,lJ,OK)'MeHTHpOBaHHe - OCHOBHOH npHHWfD GMP
«CaMble 6J1edHble LfepHUJlO Jl)'LfUIe CGMoii c06epUleHHoii naMRmu» - 3Ta
KHTaHcKaSi My.aPOCTb OTpa)l(aeT Cyrb no.axo.aa GMP K opraHH3aUHH npo-
H3Bo.aCTBa, Koma Bce npe.aYCMOTpeHO .aOKYMeHTaMH H HeT MeCTa npOH3-
BOJIbHblM .aeHcTBHSlM.
06S13aTeJIbHbIMH Tpe60BaHHSlMH K npOH3BOlICTBY JIeKapCTBeHHblX
cpe.acTB SlBJlSlIOTCSI:
- uiJellmulIlloe, cmalloapmHoe BbInOJIHeHHe Bcex onepauHH;
- npOCJle:JICU6aeMOCmb npouecca npOH3BOlICTBa Ka)l(1l0H cepHH npo-
LlYKUHH;
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ynaKOB01..JHbIX MaTepHaJIOB, npOMe)l(Yf04HOH H roTOBOH npOlIYKUHH 3a-
iJaHHblM mpe606allUHM.
C 3TOH ueJlblO B OCHOBY GMP 3aJIO)l(eHbl CJle.aYIOIllHe npOCTble npa-
BHJIa:
- JII060e .aeHcTBHe .aOJI)I(HO BbInOJlHSlTbCSI B COOTBeTCTBHH C ym6ep-
JlCiJeHHblM iJoKYMellmoM (uHcmpYKu.ueii):
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Ha nllMHmb;
- He .aonYCKaeTCSI CJle.aOBaHHe ycmHblM paCnOpH:JICeHUHM, Bce .aOJl)l(-
HO O<!:>0PMJISlTbCSI iJoKYMellmaJlbHO H .aOBO.aHTbCSI .ao HCnOJlHHTeJIeH 6
ycmaH06JleHIlOM nopHiJKe;
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HO, 6y.ab TO BbInYCK cepHH npo.aYKUHH, npOBe.aeHHe y60pKH nOMellleHHH
HJIH JII060e lIPyroe C06bITHe.
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meXHOJlOlUlleCKoii iJoKYMeHmau.uu H 4eTKoro HCnOJlHeHHSI ee Tpe60BaHHH.
JII06aSl .aeSlTeJIbHOCTb, CBSl3aHHaSi C nOBblweHHOH OTBeTCTBeHHOCTblO
J.1JlH 06eCneLJeHHeM 6e30naCHOCTH, pernaMeHTHpyeTcSI HHCTPYKUHSlMH H
npaBHJIaMH. 3a HX BbInOJIHeHHeM YCTaHaBJlHBaeTCSI KOHTpOJlb (HHoma
D.BOHHOH, He3aBHCHMblMH opraHaMH HJIH JIHUaMH). npH OTKJlOHeHHH OT
J.1HCTpYKUHH BHHOBHblH npHBJleKaeTCSI K OTBeTCTBeHHOCTH, He .aO)l(H.aa-
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npH'IHHe HapyweHH1 HHCTPYKUI1I1.

122
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- KOllmpOJlUp06amb BbInOJIHeHHe pa60Tbl CTpOro no 1I0KYMeHTaUHH;
- BBeCTH H peaJIH30BaTb cHCTeMY om6emcm6eHHocmu 3a OTKJlOHeHHe
OT Tpe60BaHHH .aOKYMeHTallHH.
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5.3.1 06UJ,He nOJlmKeHHH
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OT.aeJIbHbIH nYHKT HY)I(HO OCMbICJlHTb, c.aeJIaB naY3Y. 3HaL.JHTeJIbHO y.a06-
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pe4HCJleHHe nOCJle .aBoeT04HSI, Ha4HHaSl Ka)I(.D.blH nYHKT C HOBOH CTpOKH.
513b1K H CTHJIb .aOKYMeHTa, 060POTbl pe4H 1I0Jl)l(Hbl 6bITb CTaH.aapT-
HbIMH. HeJIb3S1 Ha3bIBaTb OlIHO H TO )l(e pa3HblMH CJlOBaMH. O.aHH H TOT
)l(e npelIMeT, H3JlO)l(eHHblH HHa4e, MO)l(eT 6blTb BocnpHHSlT KaK .aPyroH
npelIMeT. 3Toro .aonYCKaTb HeJIb3S1. YeJIOBeK 1I0JI)I(eH nOHSlTb KpaT4aH-
WHM nyreM TO, 4TO HanHcaHO B TeKCTe, a He np06HpaTbCSI CKB03b 4alllY
CJlOBeCHblX nOCTpoeHHH H BblBepTOB. TeKcT HY)I(HO nOHSlTb, 3anOMHHTb,
4TO HY)l(HO, H 4eTKO CJle.aOBaTb eMY B pa60Te.
HYMepau.UH U 6bliJeJleHUH
D.nSl pa3.aeJleHHSI pa3HblX npe.aMeTOB H y.a06CTBa CCblJIOK CJle.ayeT
npHMeHSlTb HYMepaUHIO UH<!:>paMH HJIH 6YKBaMH. ECJlH npHMeHSIIOTCSI
6YKBbl, TO JIY4we HCnOJIb30BaTb JlaTHHCKHe 6YKBbl. C .aOKYMeHTaUHeH
MO)l(eT 3HaKOMHTbCSI HHOCTpaHHblH CneUHaJIHCT, OHa MO)l(eT nepeBO-
.aHTbCSI Ha lIPyroH Sl3bIK, B aJI<!:>aBHTe KOTOpOro HeT KHpHJIJlHUbl.
D.nSl pa3rpaHH4eHHSI pa3HblX MblCJleH nOJIe3HO HCnOJlb30BaTb OTCTY-
nbl H np06eJ1bl, a .D.J1S1 no.a4epKHBaHHSI HaH60Jlee Ba)l(HblX - BbI.D.eJIeHHe
)KHPHbIM lllPH<!:>TOM HJIH KypCHBOM.
IlocJleiJ06ame.rlbHocmb U3.rlO:JICeHUH
B HHCTPYKUHSlX H MeTo.aHKax nOCJIe.aOBaTeJIbHOCTb .aeHCTBHH .aOJl)l(-
Ha COOTBeTCTBOBaTb peaJIbHOH XpOHOJIOrHH HX BbInOJIHeHHSI. Ka3aJIOCb
6bl, 3TO 04eBH.aHoe Tpe60BaHHe. Ho BCTpe4alOTCSI TPy.aHOCTH H nyraHHua
TaM, me Tpe6yeTcSI 1I0KYMeHTaJIbHOe o<!:>opMJIeHHe lIeHCTBHSI. TaKHe 3a-
nHCH MOryr .aeJlaTbCSI HeCKOJIbKO pa3 no Xo.ay BbInOJlHeHHSI HHCTPYKUHH.
CBOlIHTb HX K OlIHOMY nYHKTY: «O<!:>OpMHTb Ha1lJle)l(alllHM 06pa30M»
HeJlb3S1. HY)I(HO YKa3aTb, 4TO KOHKpeTHO 3anHCbIBaTb nOCJle BbInOJlHeHHSI
KaKoro-JlH60 nYHKTa HHCTPYKUHH.

126
IJw6a 5
TOIIHocmb U HCllocmb
HY)I(HO H36eraTb Bblpa)l(eHHH THna «1I0CTaT04Hoe KOJIJ1LleCTBO» HJIH
«COOTBeTCTBYlOlllaSl MeTOlIHKa». CJIelIyeT YKa3aTb uH<!:>poH Maccy HJlH
06"beM, HanpHMep, I MJl, HJIH MeTOlIHKY C YKa3£1HHeM HaHMeHOBaHHSI.
J10lullecKaH 3a6epUlellHocmb
D.oKYMeHT 1I0JI)I(eH HMeTb JlOrH4eCKoe laBepweHHe ,lJ,eHCTBHH BO
B3aHMOCBSl3H C .aPYrHMH HHCTPYKUHSlMH. HanpHMep, B HHCTpYKUHH no
KOHTpOJIIO nepenalIOB .aaBJleHHSI Me)I(.D.Y nOMellleHHSlMH He.aOCTaT04HO
HanHcaTb, Me)I(.D.Y KaKHMH nOMellleHHSlMH KOHTpOJIHpyeTcSI .aaBJleHHe,
KaKHM OHO 1I0Jl)l(HO 6blTb H KYlIa 3anHCbIBalOTCSI pe3YJIbTaTbI. ECJIH .aaB-
JIeHHe BbIXO.aHT 3a 1I0nYCTHMble npe.aeJIbl (npe.aeJlbl npe.aynpe)I(.D.eHHSI),
TO .aOJI)I(HO 6bITb YKa3aHO, KOro H KaK CJIe.ayeT nOCTaBHTb B H3BCCTHOCTb
.D.J1S1 npHBelIeHHSI nepena.D.a .aaBJleHI1S1 B HOPMY HJlH KaKHe npe.anpHHSlTb
.aeHCTBHSI.
YKa3bl6alOlU,uii cmUJlb
I1HCTPYKUHH H .aPyme pemaMeHTHpYlOlllHe .aOKYMeHTbl .aOJI)I(Hbl
M3JlaraTbCSI B HMnepaTHBHOM, YKa3bIBalOIlleM CTHJIe.
5.4 nOpH,lJ,OK pa3pa60TKH ,lJ,OKYMeHTOB
5.4.1 nOCJle,lJ,OBaTeJlbHOCTb pa60Tbl
Ha caMOM nepBOM 3Tane C03.aaeTCSI CTpYKTypa CHCTeMbl .aOKYMeHTa-
UHH H nepe4HH .aOKYMeHTOB no pa3JlH4HblM pa31IeJIaM (cneuH<!:>HKauHH,
HHCTPYKUHH, MeTOlIHKH H np.).
3aTeM OnpelIeJISleTCSI HaHMeHOBaHHe Ka)I(.D.oro .aOKYMeHTa H ero CO-
.aep)l(aHHe, .aaJIee rOTOBHTCSI nepBaSl pe.aaKUHSI .aOKYMeHTa. Ee nHweT
O.aHH 4eJlOBeK, JIH60, eCJIH .aOKYMeHT 60JIbWOH, OT.aeJlbHble pa31IeJIbl MO-
ryr nHcaTb pa3Hble JlIO.aH (Ka)I(.D.bIH - CBOH pc:l3lIeJI).
Kmo iJO.ll:JICeH nucamb iJoKYMeHm?
JlY4WHH aBTOp - 3TO TeXHOJlOr, B03MO)l(HO, Henocpe.aCTBeHHblH
HCnOJIHHTeJlb, HH)I(eHep HJlH COTPYlIHHK OTK. CneUHaJlHCTbl no CTaH-
.aapTH3aUHH HJIH no GMP B JIY4weM CJIY4ae MorYT KOOPlIHHHpOBaTb
pa60TY no nOlIroToBKe .aOKYMCHTaUHH, npOBepSlTb HCnOJlHeHHe, HO
nHcaTb OHH Moryr TOJIbKO TO, 4TO 3HalOT caMH H 4eM BJlalIelOT Ha
npaKTHKe.
MHorHe JllOlIH He JII06S1T nHcaTb H BCSl4eCKH H36eralOT 3TOH pa60TbI.
nOlIroToBKa nHCbMeHHblX MaTepHaJIOB Tpe6yeT KBaJIH<!:>HK£1UHH H CT£1p£1-
HHSI. 3T£1 pa60Ta, a T£1K>Ke YCTHble BblcTynJIeHHSI 6e3 TeKCTa Ha 6YMarc
OTHOCITCSI, no MHCHHIO aBTopa, K caMblM TPYlIHblM BH.aaM .aeSlTeJIbHOCTH.

j/,OKYMeHmau,UR
/27
TeM He MeHee, nHcaTb 1I0KYMeHTbl HY)I(HO, H JIY4WHH aBTOp - TOT, KTO
.aaHHbIH npelIMeT 3HaeT.
HY)I(HO YCTaHoBHTb cpOK noOlomo6Ku 1I0KYMeHTa, )l(eCTKHH, HO pe-
aJlbHblH. PacTSlHyrble CpOKH He HY)I(Hbl. D.nSl cpelIHeH HHCTPYKUHH Tpe-
6yeTcSI .aBa-TpH ,lJ,HSI, MaKCHMYM HelIeJlSl. ECJlI.1 Ha 3TY pa60ry lIaTb TPH
MeCSlua, TO HCnOJlHHTeJlb OTJIO)l(HT ee B 1I0JlrHH S1IllHK, a TO H BOBce 3£1-
6y.aeT npo Hee.
nOCJIe nOlIroToBKH nep60ii peiJaKu.uu aBTOpy 1I0KYMeHTa CJIe.ayeT ca-
MOMY BbInOJIHHTb pa60ry no HeMY H BHeCTH HCnpaBJleHHSI. 3aTeM ero
Hy)I(HO .aaTb HeCKOJlbKHM flHuaM .D.J1S1 BHHMaTeJIbHoro np04TeHHSI 11 npaK-
TH4eCKOH pa60Tbl, B TOM 4HCJIe onepaTopaM, .D.J1S1 KOTOpblX .aOKYMeHT
npe.aHa3Ha4eH. Ha 3TOM 3Tane npOBepSleTCSI, npaBHJIbHO JIH nOHHMalOT
.aPYrHe JlHua TO, 4TO HanHCaJI aBTOp.
nOCJle 3TOro roTOBHTCSI 6mopaR peiJaKu.UH 1l0KYMeHTa .D.J1H npelICTaB-
JIeHHSI PYKOBOlICTBY H CneUHaJIHCTaM .D.J1S1 OKOH4aTeJIbHoro pe.aaKTHpOBa-
HHSI.
D:oKYMeHT C rpy6blMH npOC4eTaMH HY)I(HO BepHyrb Ha 1I0pa60TKY.
YTBep)I(.D.aTb nJIOXOH 1I0KYMeHT HeJIb3S1. 3TO npHBe.aeT K <!:>OpMaJIH3MY H
nOTepe CMbICJla. YeTKaSi pa60Ta no HenpaBHJIbHoMY .aoKYMeHTY HaHeceT
60JIblllOH Bpe.a.
npaKTH4eCKaSl npoBepKa .aoKYMeHTa - HCKJlI04HTeJlbHO Ba)l(HblH
3Tan. OHa BblSlBflSleT oWH6KH H He.a04eTbl H nOKa3blBaeT, nOHHMaeT JlH
HCnOJIHHTeJIb .a0KYMeHT H 6y.aeT JIH pa60TaTb no HeMY. ECJIH He nOHH-
MaeT HJIH He BocnpHHHMaeT, TO .aOKYMeHT HY)I(HO nepelIeJIaTb H He OCT£1-
HaBJlHBaTbCSI 110 Tex nop, nOKa OH He CTaHeT nOJIe3HblM H He06xo.aHMb1M
pa604HM HHCTpYMeHTOM.
(/)0PMaJlU3.M - CllMblii cmpaUlHblii 6pal GMP U Jl1060l0 iJeJla 6006lU,e
He cJIY4aHHo HHCneKTOpbl B nepBYIO 04epe.ab 06palllalOT BHHMaHHe Ha
cHcTeMY 1l0KYMeHTaUHH npe.anpHSITHSI, BJla.D.eHHe elO nepCOHaJIOM H pe-
aJIbHYIO pa60TY no HeH.
5.4.2 nOpHJJ.OK pa3pa60TKH, cornaCOBaUHH H YTBep}Kj),eHHH
3TOT nopSl.aOK .aaH B rOCT P 52550-2006:
I-1HCTPYKUI1S1 pa3pa6aTbIBaeTcSI KOMneTeHTHblM COTPY1lHI1KOM. llaHHblH
COTPY1lHHK MO>KeT BX01lI1Tb 11J111 He BXOlll1Tb B nepe1.JeHb JII1U, Ha KOTOpblX
6Y1leT pacnpoCTpaHSlTbCSI I1HCTPYKUI1S1.
Pa3pa60TKa I1HCTPYKUI1I1 Be1leTCSI B CJle1lYlOllleM nOpSl1lKe:
- nOJlY1.JeHl1e HOMepa pa3pa6aTbIBaeMOH I1HCTPYKUI1I1 B OT1leJIe, KOH-
TPOJlHpYlOllleM Be1leHl1e 1l0KYMeHTaUI1H;
- pa3pa60TKa npoeKTa I1HCTPYKUI1I1;
- 06CY>K1leHl1e I1HCTPYKUI1I1 11 pa60Ta B COOTBeTCTBl111 C HeH B onblTHOM
nOpSl1lKe C Y1.JaCTl1eM Tex, KTO 6YlleT no Hei1 pa60TaTb; npl1 3TOM oc060e
BHHMaHl1e CJle1lyeT YllellSlTb n011HOTe I1HCTPYKUI1I1 11 S1CHOCTI1 ee 113J10>KeHI1S1;
- 1l0pa60TKa I1HCTPYKtil111 C y'leTOM npeLUlO)f(eHI1H 11 3aMe l JaHI1H;
- nOBTopHoe 06cY>K1leHl1e I1HCTPYKUI1I1 (npl1 He06xOllI1MOCTI1);

128
1J106a 5
- npoBepKa He06xo1lI1MOCTI1 113MeHeHI1S1 1lpymx 1l0KYMeHTOB B cJlY1.Jae
YTBep>K1leHI1S1 llaHHOH I1HCTPYKUI1I1 (npl1 BHeCeHl111 113MeHeHI1H B I1HCTPYK-
UI1IO - npoBepKa He06xOlll1MOCTI1 113MeHeHI1H 1lpymx pa3.lleJlOB llaHHOH I1H-
CTPYKUI1I1 11J111 llpymx 1l0KYMeHToB);
- COfJIaCOBaHl1e I1HCTPYKUI1I1 C COOTBeTCTBYlOllll1MI1 CJlY>K6aMI1 (oT1le-
JIaMI1), B TOM 1.Jl1CJle CJJY>K60H KOHTpo11Sl Ka1.JeCTBa 11 nOllpa31leJIeHl1eM, OT-
BeTCTBeHHblM Ja Be1leHl1e 1l0KYMeHTaUI1I1;
- YTBep>K1leHl1e I1HCTPYKUI1I1;
- nOMellleHl1e I1HCTPYKUI1I1 B 311eKTpOHHYIO 6a3Y llaHHbIX npe1lnpl1S1TI1S1
(eCJlI1 3TO npe1lYCMOTpeHO);
- H3roTORJIeHI1e He06xo1lI1MOro 1.Jl1CJla KOnl1H HHCTPYKUI1H C YKa3aHI1eM
HOMepa KOnl111 I1HCTPYKUI1I1 11 nOCTaHOBKa I1X Ha y1.JeT;
- 06Y1.JeHI1e nepCOHaJla cpa3Y >Ke nocJle YTBep>K1leHI1S1 11 HCTPYKUI1 11.
5.4.3 llp3BHJl3 p33p36oTKH ,lJ,OKYMeHTOB
npaKTHKOH Bblpa60TaH pM npOCTblX npaBHJl, KOTopble .aalOT opHeH-
THp npH pa3pa60TKe .aOKYMeHTaUHH:
llp3BHJlO I
D.oKYMeHT .aOJI)I(eH 6blTb nOJIe3HbIM, Hy)I(HbIM, COCTaBJleHHblM .lI,JlSl
pa60TbI, a He .D.J1S1 nOKa3a KOMY-JIH60.
llp3BHJlO 2
nOHHMaTb caMoMY, 4TO H 3a4eM nHweTCSI. D.oKYMeHT .aOJI)I(eH 6bITb
nOHSITeH BceM, B TOM 4HCJIe ero aBTOpy. I1Ha4e OH 6eCnOJle3eH, 60Jlee
TOro - Bpe.aeH, nOCKOJlbKY C03.aaeT HJlJl103HIO .aeJla BMeCTO caMoro .aeJla.
llp3BHJlO 3
J.13JlaraTb SlCHO, KpaTKO, 6e3 nOBTopOB, HenOHSITHblX CJlOB H YKpa-
WaTeJIbCTB. UeJIb 1I0KYMeHTa - 1I0HeCTH HH<!:>0pMauHIO 0.aH03Ha4HO, B
npocToH <!:>opMe TaK, 4T06bl 4eJlOBeK ee nOHSlJI, H MO)l(HO 6blJlO npOBe-
pHTb HCnOJlHeHHe.
B 3TOM OTJIH4He .aOKYMeHTa OT XYlIO)l(eCTBeHHoro npoH3Be.aeHHSI,
me MOryT .aOMHHHpOBaTb rHpJlSlH.abl CJIOB H npe.D.J10)l(eHHH, ueJIb KOTOpO-
ro He nepe.aa4a CMbICJIa, a C03.aaHHe xy.aO)l(eCTBeHHoro 06pa3a H <!:>OPMH-
pOBaHHe 3MOUHH.
np3BHJlO 4
D.oKYMeHT 1I0JI)I(eH HMeTb npOCToe HaHMeHOBaHHe, He.aBycMbICJleHHO
OTpa)l(alOlllee ero co.aep)l(aHHe.
np3BHJlO 5
D.oKYMeHT .aOJI)I(eH BocnpHHHMaTbCSI 01IH03Ha4HO H He COlIep)l(aTb
.aBYCMbICJIeHHOCTeH. I1cnoJIHHTeJlb He .aOJl)l(eH .aOlIYMblBaTb COlIep)l(aHHC
.aOKYMeHTa. 31"0 MO)l(eT YBeCTH lIaJIeKO B CTOPOHY OT TOro, 4TO HMeJI B
BHlIY aBTOp 1I0KYMeHTa.

,Il,oKYMeHmau,UR
129
np3BHJlO 6
no B03MO)l(HOCTH CJIelIyeT npHBeCTH np£1KTJ1LleCKHe npHMepbI.
np3BHJlO 7
HaKOHeu, HY)I(HO nOHHMaTb, KaK pa60TaeT HanHcaHHblH TeKCT, 11
anp06HpOBaTb ero Ha npaKTHKe C pa3HblMH HCnOJIHHTeJlSlMH.
5.5 OCHoBHble BH)J,b1 ,lJ,0KYMeHTOB
npaBHJIa GMP (rOCT P 52249-2009 [I]) YCTaHaBJlHBalOT CJle,lJ,YIO-
IllHe OCHOBHble BHlIbl .aOKYMeHTOB:
- cneu,mlmK3u,HH (specification): D,oKYMeHT, co.aep)l(alllHH Tpe60Ba-
HHSI K MaTepHaJIaM H npo.aYKTaM, HCnOJlb3yeMblM HJlH nOJIY4aeMbiM npH
npoH3BolIcTBe, SlBJlSlIOIllI1HCSI OCHOBOH DJlSl oueHKH Ka4eCTBa JleKap-
CTBeHHblX cpe.aCTB;
- npOMblWJIeHHblH pefJI3MeHT, TeXHOJlOfHlfeCK3H HHCTPYKl\HH H HH-
CTPYKl\HH no yn3KoBKe (manufacturing formulae, processing and packaging
instruction): D,oKYMeHTbl, onpe.aeJISIIOIllHe Bce HCnOJlb3yeMble HCXOlIHble
MaTepHaJIbl H onepaUHH no npoH3Bo.aCTBY H ynaKoBKe npolIYKUHH;
- HHCTPYKU,HH, MeTO,lJ,HK3, npou.eJ],yp3 (procedure, standard operation
procedure): D,oKYMeHT, co.aep)l(alllHH YKa3aHHSI no BbInOJIHeHHIO OTlleJIb-
HblX BH.aOB onepaUHH; HanpHMep, no 04HCTKe, nepeo.aeBaHHIO, KOHTpO-
JIIO OKpy)l(alOllleH cpelIbl, oT60PY np06, npOBe.aeHHIO HcnbITaHHH, 3KC-
nJIyaTaUHH H TeXHH4eCKOMY 06CJIY)I(HBaHHIO 060Py.aoBaHHSI.
- npOTOKOJl Ha cepHIO (record): D,oKYMeHT, OTpa)l(alOlllHH npouecc
npOH3Bo.aCTBa Ka)I(.D.OH cepHH npo.aYKUHH, B T. 4. pa3peweHHe Ha ee pea-
JIH3aUHIO H Bce <!:>£1KTopbl, BJ1HSlIOIllHe Ha K£14eCTBO roToBOH npo.aYKUHH.
D,aHHble 0 npoBelIeHHH OCHOBHblX TeXHOJIOrH4eCKHX onepaUHH, HC-
nOJlHHTeJISlX H np. MorYT O<!:>0PMJISlTbCSI B BH.ae MapwpYTHblX KapT.
- YlfTeHHble KonHH: KonHH .aoKYMeHToB, HaXOlISlIllHecSi Ha Y4eTe B
nOlIpa31IeJleHHH, KOHTpOJIHpYlOllleM Be,lJ,eHHe .aoKYMeHTaUHH, H B KOTO-
pble BHOCSlTCSI J1106ble H3MeHeHH1 .D.J1 nO.D..D.ep)l(aHHSI HX COOTBeTCTBHSI
OpHrHHaJIY.
B 2010 r. B p£131IeJI B «D,oKYMeHTaUHSI» npaBHJl G M P EC BHeceH pSl.a
H3MeHeHHH:
I. YCTaHOBJleHbl CJIe.aYIOIllHe BH.D.bl .aOKYMCHTOB:
- «I1H<!:>opMauHSI 0 npe.anpHSlTHH» (Site Master File);
- pemaMeHTHpYlOwHe 1I0KYMeHTbl (cneuH<!:>HKauHH, npOMbIWJleH-
HblH perJlaMeHT, TeXHOJIOrHlleCKHe HHCTPYKUHH, HHCTPYKUI1H no yna-
KOBKe H KOHTpOJlIO, HHCTPYKUHH H MeTOlIHKH, TeXHJ1LleCKHe corJl£1we-
HHSI);
- OT'leTHble 1I0KYMeHTbi (npoTOKOJlbl cepHH, npOTOKOJIbl HcnblTa-
HI1i1, CCpTI1)J1K£1Tbl npoBelIeHHSI £1H<lJIH3£1 H np.).

130
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2. lI.oKYMeHT «I1H<!:>0pMaUHSI 0 npelInpHSlTHH» HCnOJIb3yeTcSI Ha
npaKTHKe .aaBHO. BBelIeHHe ero B G M P SlBJlSleTCSI KOHcTaTaUHeH 3TOro
<!:>aKTa. npHBe.aeHbl Tpe60BaHHSI K «I1H<!:>opMauHH 0 npelInpHSlTHH». ne-
peBO.a 3TOro 1I0KYMeHTa .aaH B npHJIO)l(eHHH I K KHHre.
3. BBelIeHbl TepMHHbl:
- TeXHH4eCKoe cornaweHHe (Technical Agreements): cornaweHHe
Me)I(.D.Y 3aKa34HKOM H CTOpOHHHM HCnOJlHHTe11eM;
- CepTH<!:>HKaT npOBelIeHHSI aHaJIH3a (Certificates of Analysis): .aOKY-
MeHT, co.aep)l(alllHH pe3YJIbTaTbl aHaJIH3a np06 npo.aYKUHH HJlH MaTepHa-
JIOB H oueHKY HX COOTBeTCTBHSI cneuH<!:>HKauHH.
4. YKa3aHo Ha B03MO)l(HOCTb Be.aeHHSI .aOKYMeHTaUHH B 3JIeKTpOH-
HOH <!:>opMe. npH 3TOM ClIelI,yeT onpe.aeJIHTb, 4TO SlBJlSleTCSI nepBH4HblMH
.aaHHbIMH. KaK MHHHMYM, Bce .aaHHble, no KOTOpblM npHHHMaeTCSI pe-
llleHHe 0 Ka4eCTBe, .aOJI)I(Hbl paCCMaTpHBaTbCSI KaK nepBH4Hble.
5. no aHaJIOrHH C cGMP CiliA BBe.aeHO nOHSITHe «Master Docu-
ments» (OPHrHHaJI, llla6JIOH) H «Working Documents» (pa604He HJIH HC-
nOJIHHTeJlbHble .aOKYMeHTbl, 3anOJIHSleMble Wa6JIOHbl HJIH <!:>OPMbl). Ha
PYCCKOM Sl3blKe CMblCJl 3THX TepMHHOB COCTOHT B CJIe.aYlOllleM:
- .ao Ha4aJIa pa60Tbl HCnOJIHHTeJIb 6epeT <!:>OPMY, T. e. .aOKYMeHT, B
KOTOpOM YKa3aHbl Bce onepaUHH B nOCJle.aOBaTeJIbHOCTH BbInOJIHeHHSI,
napaMeTpbl C npe.aeJIaMH HX H3MeHeHHSI H np.;
- B npouecce pa60Tbl <!:>opMa 3anOJlHSlTCSI, OTMeLJaeTCSI <!:>aKTH4eCKOe
BbInOJIHeHHe onepauHH, 3Ha4eHHSI napaMeTpOB H np.);
- 3anOJIHeHHaSi <!:>opMa BXO.aHT B COCTaB npOTOKOJIa cepHH.
6. lI.aHbl YKa3aHHSI no xpaHeHHIO .aOKYMeHTOB:
- MeCTO xpaHeHHSI .aOKYMeHTOB .aOJI)I(HO 6bITb 4eTKO on pe.aeJIeHO,
06ecne4eHbi coxpaHHOCTb H ueJlOCTHOCTb 1I0KYMeHTOB;
- npOTOKOJIbl cepHH .aOJI)I(Hbl xpaHHTbCSI B Te4eHHe cpOKa rolIHOCTH
nJIIOC O.aHH rolI, HJIH He MeHee 4eM B Te4eHHe nSiTH JIeT nOCJIe BbInYCK£1
cepHH ynOJIHOM04eHHblM lIHUOM (BbI6HpaeTCSI HaH60JlblllHH CpOK); .aJlSl
JIeKapCTBeHHblX cpe.aCTB, npe.aHa3Ha4eHHblX .D.J1S1 KJlHHH4eCKHX HCCJIe.ao-
BaHHH, npOTOKOJIbl cepHH .aOJl)l(Hbl xpaHHTbCSI He MeHee 4eM B Te4eHHe
nSiTH JIeT nOCJle nOCJlelIHero KJlHHH4ecKoro HCCJIe.aOBaHHSI, B KOTOpOM
HCnOJlb30BaJICSI npenapaT, BXO.aSlIllHH B cepHIO; .aJlSl OTlIeJlbHblX BHlIOB
npenapaTOB MOryr 6bITb YKa3aHbl lIPYrHe Tpe60BaHHSI.
lI.eSlTeJIbHOCTb npelInpHSITHSI TaK)I(e pernaMeHTHpyeTcSI oplaHu3au.u-
Ollllo-pacnopHiJumeJlbHblMU iJoKYMeHmllMU, B KOTOpblX <!:>HKCHPYIOTC1 pe-
llleHHSI MMHHHCTpaTHBHblX BonpOCOB, a TaK)I(e BonpOCOB ynpaBJleHH1 II
B3aHMo.aeHCTBHSI C .aPYrHMH npelInpHSlTHSlMH H opraHH3aUHSlMH.
Tpe60B£1HHSI K 0plaHu3au.uoIlIl0-meXHOJlOlUlleCKUM iJoKYMeHmllM npll
npoH3BolIcTBe JleKapCmeHHblx cpelIcTB YCTaHOBJleHbl B rOCT P 52550-
2006 [3]. BHlIbl opraHH3auHoHHo-TeXHOJlOrWleCKoH .aOKYMeHTaUHH H H'\
Ha3Ha'leHHe nOK,uaHbl B Ta611Hue 5.1.

j]OKy"teHmau,UfI
131
Ta6J1Uu,a 5.1
BH.D.bl opraHH3aUHOHHO-TeXHOJIOrWleCKHX 1I0KYMeHTOB no G M P
2
HaHMeHOBaHHe .IIOKYMeHTa
I-1HQJOPM3U1UI 0 npellnplUITI1I1, pcm-
CTpaUI10HHOC 1I0CbC, J1I1UCH311f1 H3
np0l13BOllCTBO 11 np.
CnCUI1QJI1KaUI1f1
3
npOMblWJlCHHblH pcrmiMCHT, TCXHO-
JlOrl1'lCCKaSi I1HCTPYKUlUI, I1HCTPYK-
UI1S1 no ynaKoBKC
I-1HCTPYKUI1f1 (MCTOllI1Ka)
4
5
npOTOKOJl H3 CCpl1l0
6
BHyrpl1np0I13BOlICTBCHH3S1 3TI1KCTK3
HaJHa'leHHe
06waSi 1I0KYMCHT3UI1H npClInpmlTl1H
LlOKYMCHT, COllcp)f(3WI1H TpC60IlaHI1f1 K
M3TCpl1aJJaM 11J111 npOllYKUl111
LlOKYMCHTbl, YCTIlHaBJlI1BalOWI1C Tpc6o-
BaHI1H K npoucccaM np0l13BOllCma KOH-
KpCTHOH npOllYKUl111
J]OKYMCHT, YCTaHaBJIl1B31OWI1H Tpc6oBa-
HI1f1, o6wI1c llJISi npm13BOllCTB pa3J111'J-
HbIX BI1110B npOllYKUl111
J]OKYMCHT. OTpa)f(aIOWI1H )3KTI1'ICCKI1C
113HHble 0 np0l13BOllCTBC KOHKpCTHOH
CCpl111 npOllYKUl111
J]OKYMCHT, I111CHTI1QJI1UI1PYIOWI1H M3TC-
pl1aJJbl 11J111 npOllYKUI1IO, COllCP)f(3WI1H
YK333HI1C I1X CTIlT)'C3 B np0l13BOllCTBC
Ha npe.D.npHSlTHH TaK)I(e .D.OJI)I(Hbl HCnOJIb30BaTbCSI MeTOlIHKH aTTe-
CTaUHH KpHTH4ecKoro 060PYlIOBaHHSI H npoueCCOB, npOTOKOJIbl aTTeCTa-
UHH, lI.OKYMeHTbl 0 npOBelIeHHH aY.D.HTOB (caMOHHcneKUHH), .D.OJI)I(HOCT-
Hble HHCTPYKUHH H np.
5.6 l1uclJOpM3UHH 0 npe,lJ,UpHHTHH
CO.D.ep)l(aHHe HH<!:>opMaUHH 0 npe.D.npHSlTHH pemaMeHTHpYIOTCSI
rOCT P 52537-2006 [2].
B «I1H4>opMaUI1I1 0 npe1lnpl1TI1I1» npI1B01lSlTCSI CJle1lYlOllll1e 1laHHble:
- Hal1MeHOBaHl1e 11 a1lpec npe1lnpl1S1TI1S1;
- HOMeHKJlarypa BbInycKaeMoH np01l}'KUI1H (ecJlI11l0nYCTI1Mo);
- 1laHHble 0 1.Jl1CJleHHOM COCTaBe (ecJlI11l0nycTI1Mo):
- OpraHI13aUI10HHaSI CTpYKTypa npellnpl1S1TI1S1;
- OTBeTCTBeHHOCTb PYKoB01lI1TeJleH CJlY>K6bl KOHTpOJlSl Ka'leCTBa;
- nepe1.JeHb OCHOBHWX CTaH1laPTOB, Ha KOTOpWX OCHOBaHa CI1CTeMa
06ecne'leHI1 Ka1.JeCTBa;
- CI1CTeMaTI1311pOBaHHblH nepe1.JeHb 1l0KYMeHTOB, no KOTOpblM BelleTCSI
pa60Ta npe1lnpl1S1TI1S1, n01lpa311e11eHI1H 11 OT1leJIbHbIX I1CnOJlHI1TeJleH, npOBO-
llSlTCSI aTTeCTaUI1S1 11 I1cnblTaHI1S1 060pY1l0BaHI1S1, BelleTCSI 06Y1.JeHI1e nepco-
HaJla 11 np.; npl1 6oJlbWOM KOJll11.JeCTBe 1l0KYMeHTOB MOryT npI1B01lI1TbCSI BI1-
1lbl (HaHMeHOBaHI1S1 rpynn) 1l0KYMeHTOB.
npI1JIO>KeHI1S1MI1 K «I1H4>opMaul1l1 0 npellnpI1S1TI1I1» MOryT 6blTb:
- nOJlI1TI1Ka npe1lnpl1S1Tml B 06J1aCTI1 KalleCTBa (He06I3aTeJlbHbIH 1l0-
KYMeHT);

132
DW6a 5
- CBOllHblH nepe'leHb Bcex 1l0KYMeHTOB Ha npellnpl1S1Tl111 (I1HCTPYKUI1I1,
MeTOllI1KI1, npI1Ka3bl 11 np.) C CI1CTeMOH KOlll1poBaHI1S1 1l0KYMeHTOB (npl1
He06xo1l11 MOCTI1).
KOHKpeTHoe C01lep>KaHl1e «MH4>opMaul1l1 0 npellnpI1S1TI1I1» onpe1leJlSl-
eTCSI CaMI1M npe1lnpl1S1Tl1eM.
«MH4>opMaul1S1 0 npellnpI1S1TI1I1» 1l0Jl>KHa 6blTb, no B03MO>KHOCTI1,
KpaTKoH 11 Hanl1CaHHOH B S1CHOH 4>opMe. llaHHblH 1l0KYMeHT 1l0Jl>KeH 6blTb
nOJle3HblM LUISI COTPY1lHI1KOB 11 PYKoBOlll1TeJleH npe1lnpl1S1TI1S1 11 I1CIl011b30-
BaTbCSI B npaKTI11.JeCKoi11leSlTeJlbHOCTI1.
«MH4>opMaul1S1 0 npe1lnpl1S1TI1I1» 1l0JI>KHa 6blTb OTKpbITblM 1l0KYMeH-
TOM, 1l0crynHblM LUlH nOJlb30BaHHSI (3a I1CKJl101.JeHl1eM 1laHHbIX LUISI cJIY)I(e6-
HOro 1l0JIb30BaHI1S1).
«I1H<!:>opMaUHSI 0 npelInpHSlTHH» - KpaTKHH 1I0KYMeHT, 06"beMOM He
60JIee 20 c. nOlIp06HOCTH MOryT .aaBaTbCSI B npHJIO)l(eHHSlX.
HOBblH pa31IeJI III npaBHJI G M P EC co.aep)l(HT 60JIee no.ap06Hble
Tpe60BaHHSI K «I1H<!:>opMauHH 0 npe.anpHSlTHH» (npHJIO)l(eHHe I K KHHre).
OplaHu3au.UOHHaH cmpYKmypa npeonpUHmUH
«I1H<!:>0pMauHSI 0 npelInpHSlTHH» .aOJI)I(Ha BKJlI04aTb opraHH3aUHOH-
HYIO CTPYKTYPY, KOTopaSl .aaeT B03MO)l(HOCTb Ka)I(.D.OMY nOHSlTb cxeMY
ynpaBJleHHSI, B3aHMOCBSl3H, no.a4HHeHHOCTb H CBoe MeCTO B HeH.
OpraHH3aUHOHHaSi CTpYKTypa npelInpHSITHSI no rOCT P 52550-2006
HMeeT HeCKOJIbKO YPoBHeH:
- PYKOBo.aHTeJIb npelInpHSITHSI;
- 3aMeCTHTeJIH PYKOBo.aHTeJISI (maBHblH HH)I(eHep, 3aMeCTHTeJIH no
npOH3BOlICTBY, Ka4eCTBY, KOMMep4ecKoH pa60Te, KanHTaJIbHOMY CTPOH-
TeJlbCTBY, 061llHM BonpocaM, pa3BHTHIO H .ap.);
- Ha4aJIbHHKH no.apa3.aeJleHHH (uexoB, OT.aeJlOB, JIa60paTOp11H,
CJIY)I(6 H IIp.), 3aBelIYIOIllHe CKJla.D.aMH H rJlaBHble CneUHaJIHCTbl (maBHblH
TeXHOJlOr, maBHblH MexaHHK H np.);
- CTpYKTypHble elIHHHUbl nOlIpa31IeJleHHH (omeJIbl, 61Opo H np.):
- HCnOJlHHTeJIH.
OpraHH3aUHoHHaSi CTpYKTypa .aOJI)I(Ha OTpa)l(aTb B3aHMOCBSl3H Me)I(.D.Y
pa3JlH4HblMH ypOBHSlMH ynpaBJleHHSI H nOlIpa31IeJIeHHSlMH npe.anpHSITHSI.
CJIe.ayeT onpe.aellHTb, KTO BbInOJlHSleT <!:>YHKUHH ynOJlHOM04eHHoro JlHua.
PyKoBolIHTeJlb npelInpHSITHSI, ero 3aMeCTHTeJIH, PYKOBOlIHTeJlH no.a-
pa3.aeJIeHHH, CTpYKTypHble elIHHHUbl H HCnOJlHHTeJlH .aOJI)I(Hbl HMeTb onpe-
.aeJIeHHble <!:>YHKUHH (06maHHOCTH) H OTBeTCTBeHHOCTb, KOTopble H3Jlara-
IOTCSI B 1I0Jl)l(HOCTHbiX I1HCTPYKUHSlX, KOHTpaKTaX I1JlH lIpyrHx .aOKYMeHTax.
He 1I0nYCKaeTCSI lIy6JIHpOBaHHe OTBeTCTBeHHOCTH.
Ll.JHI nOlIp£131IeJIeHHH H CTPYKTYPHblX elIHHI1U 1I0JI)I(Hbl 6blTb p,up£1-
60T<lHbl nOJIO)l(eHHI, B KOTOpblX OnpelIeJleHbl CTPYKTypa, 3Ma ' IH, <!:>YHK-
UHH, np£1B£1, B3£1HMOOTHOWeHI1H C lIPYrHMH nOlIp£131IeJleHHSlMH H OTBeT-
CTBeHHOCTb. OpraHH3aUHOHH<H1 CTpYKTyp£1 H .a011)l(HOCTHbIC HHCTPYKUHI1
onpelIeJIIIOT n01I411HeHHOCTb nOlIp£131le11CHI1H H pa60THI1KOB.

jI,oKYMeHmau,Ufl
133
5. 7 Cneu.HHK3UHH
CneLm<!:>HKaUHH COCTaBJlSlIOTCSI .D.J1S1 CJle.aYIOIllHX MaTepHaJIOB H npo-
JIYKUHH:
- HCXOlIHbIX, BcnOMOraTeJIbHblX H ynaKoB04HblX MaTepHaJIOB;
- npOMe)l(YT04Horo npOlIYKTa (npH ero HaJIH4HH);
- roTOBOH npOlIYKUHH.
B cneUH<!:>HKaUHH YKa3blBaIOTCSI:
- HaHMeHOBaHHe MaTepHaJIa (npOlIYKUHH) co CCblJlKOH Ha BHYTpeH-
HHH KO.a npelInpHSITHSI (npH He06xOlIHMOCTH);
- CCblJIKa Ha <!:>apMaKoneHHYIO CTaTblO HJIH .apyroHlIOKYMeHT;
- OCHOBHble xapaKTepHCTHKH MaTepHaJIa (npo.aYKUHH);
- nopSllIOK oT60pa np06 H npOBelIeHHSI HCnblTaHHH (CCbIJIKH Ha Me-
TO.aHKY HCnblTaHH5I);
- YCJIOBHSI xpaHeHH5I H Mepbl npe.aOCTopmKHOCTH (CCbIJIKH Ha HH-
CTPYKUHIO);
- CpOK ro.aHOCTH (xpaHeHHSI) H nepHo.aH4HOCTb nOBTOpHblX HCnblTaHHH;
- .aPYrHe .aaHHble.
OpHMep <!:>OpMbl cneUH<!:>HKaUHH Ha MaTepHaJIbl
Cnel\H!fiHKal\HH HOMep CTp._ H3_
HaHMeHoBaHHe
!fiHPMbl nOJ{pa3JI.eJleHHe: )J,aTa HOMep
OTJ{eJl KOHTpOJlH Ka'leCTBa BBeJI.eHHH peJI.aKl\HH _
Hal1MCHOBaHl1c I1HCTPYKUI1I1!MCTOJ{I1KI1 I
Hal1MCHOBaHl1c MaTCpl1aJ1bl
TY, mCT, <J>C
nOCTaBWI1KI1 nCpC'ICHb nOCTaBWI1KOB
(111111 npl1110)l(CHI1C c ncpCtlHCM)
YnaKOBKa 11 YClIOBI1H XpaHCHI1H Hanpl1MCp, nllOTHO JaKpblTbIii KOH-
TciiHCP, KOMHaTHaH TCMncparypa
MeTOlI oT60pa np06
Hal1MCHOBaHI1C PCJYlIbTaT MCTOll OUCHKII nOKaJaTClIH
nOKaJaTClIH
BHCWHl1ii Bl1l1 Hanpl1MCp: 6ClIblii Kpl1CTalllll1- CCblllKa Ha MCTOlll1KY
'1CCKl1ii nopOWOK 111111 6ClIblC
nllOCKI1C Kpl1CTaJllIbI
COCTaB
(<!JopMYlIa)
COllCp)l(allllC Hc MCHCC - % 11 HC 601lcc CCblllKa Ha MCTOlll1KY
- % no OTHOWCHI1IO K CY-
XOMY nCWCCTBY
OnpClIClICHI1C KO- CCblllKa Ha MCTOlll1KY
1I11'1CCTBCHHbIX xa-
paKTCpl1CTlIK
PaJpa60Tall CorllaCOlJall <1>.1-1.0.. YTIICPlll1l1 <1>.1-1.0.,
<1>.1-1.0.. nOllnllCb, }laTa nOllnl1Cb, llaTa
1I011nI1Cb. ll<lTa

134
F.,/Q6a 5
npHMep <!:>OPMbl cneuH<!:>HK£1uHH
Ha npOMe)l(YT04HYIO H roTOBYIO np0.D.YKUHIO
HaHMeHOBaHHe npe.ll.- CneI{H4JHKaI{HH HOMep I CTp._ H3 _ CTp.
npHHTHH non:pallleJleHHe: )laTa BBen:eHHH BepcHH
OTn:eJl KOHTpOJlH
K3'1eCTBa
Hal1 MeHOBaH l1e Ta6J1eTKI1, 50 Mr (npI1Mep)
NQ napaMeTpbl HopMbl no <1>C CCblllK3 H3
n/n (TY 11 T. n:.) MCTOn:I1KY
I Onl1CaHl1e
2 COCT3B
3 Bec
4 nOIlllI1HHOCTb
5 P3CTBOpl1 MOCTb
6 pH
7 nOCTOpOHHl1e npl1MeCI1
8 MI1Kpo61101l0rH'1eCKaSl 'II1CTOTa
9 YnaKOBKa
10 MapKl1pOBKa
II XpaHeHl1e
12 CpOK ron:HOCTI1
WTPI1XOBOi1 KOn:
Oroop n po6
Pa3pa6oTaJI <1>. M. 0., I Cor1l3COBaJI <1>.1-1.0., I YTBepn:l1l1 <1>.11.0.,
non:nI1Cb, n:aTa non:nI1Cb, n:aTa non:nI1Cb, n:aTa
K CneUH<!:>HKaUHH Ha MaTepHaJIbl .D.OJI)I(eH npHJlaraTbCSI nepelleHb
nOCTaBIllHKOB H npOH3BO.D.HTeJIeH MaTepHaJIOB.
5.8 npOMblUlJleHHble pern3MeHTbl, TeXHOJlOfHlfeCKHe HHCTpYKLl.HH H
HHCTPYKLl.HH no yn3KoBKe
npOMblWJIeHHblH pernaMeHT OXBaTblBaeT Bce acneKTbl TeXHOJlOrWle-
CKOro npouecca, Tpe60BaHHSI K Ka4eCTBY CblpbSl, BHYTpHnpOH3BO.D.CTBeH-
HOMY KOHTpOJIIO, KOHTpOJIIO Ka4eCTBa, 6e30naCHOCTH TpYlIa, yrHJIH3aUHH
OTXO.D.OB H np. HapSI.D.Y C 3THM TepMHHOM HCnOJIb3yeTcSI TCpMHH «TeXHO-
JlOrH4eCKI1H pernaMeHT».
3TH .D.OKYMeHTbl npelIHa3H£14eHbl .D.J1S1 cepHHHoro npoH3BOlICTBa u
CO.D.ep)l(aT onHcaHHe TeXHOJIOrWlecKoro npouecca C YKa3aHHCM CTalIHi1.
BbInOJlHSleMblX onepaUHH, 060PYlIOB£1HHI, MaTCpHaJIOB, MeTO.D.OB KOH-
Tpoml H np. MoryT p.npa6aTblBaTbcSl JI£160p£1TopHble, onblTHo-
npOMblWJlCHHblC H nycKoBblC pern£1MeHTbI.

jI,oKYMeHmau,UR
135
LJ.;ISI Ka)I(.D.oro paJMepa cepHH npOlIYKUHH p£13pa6aTbIB£1eTCSI npo-
MblWJIeHHblH HJIH HHOH pemaMeHT C TeXHOJIOrH4eCKHMH HHCTPYKUHSlMH,
B TOM 4HCJIe no <!:>aCOBKe H ynaKoBKe, yrBep)l(1leHHblMH B YCTaHOBJleH-
HOM nopSilIKe.
5.9 MHCTPYKUHH H MeTOlI.HKH
I1HCTPYKUHH H MeTo.aHKH OXBaTblBalOT Bce c<!:>epbl npOH3BOlICTBa H
KOHTpOJlSl Ka4eCTBa H pemaMeHTHpYIOT .aeHcTBHSI, He OTHOCSlIllHecSi K Tex-
HOJIOrH4eCKHM onepaUHSlM. OHH He BKJlI04alOT Tpe60BaHHSI K npOH3BO.a-
CTBY KOHKpeTHOH npOlIYKUHH, KOTopble H3JlO)l(eHbl B npOMblWJIeHHOM
perJlaMeHTe.
I1HCTPYKUI1H H MeT01lI1K11 pernaMeHTHpYIOT (fOCT P 52550-2006):
- nOJIY1.JeHl1e H KOHTpoJlb Ka1.JeCTBa HCX01lHbIX 11 ynaKOB01.JHblX MaTepl1aJlOB;
- KOHTpOJIb Ka1.JeCTBa npOMe>KYT01.JHOH 11 roTOBOH np01lYKUI1I1;
- pa60TY JIa60paTOpHH;
- aTTeCTaUl110 KpHTH1.JeCKI1X npoueCCOB 11 060pY1l0BaHI1S1;
- pa60TY CKJla1l0B, 06pallleHI1e MaTepHaJlOB, npOMe>KYT01.JHOH H rOTOBOH
np01lYKUHI1;
- TeXHOJlOm4eCKoe 11 I1H>KeHepHOe 060pYlloBaHI1e (CI1CTeMbl OTOnJleHI1S1,
BeHTI1JISlUl111 H KOH1lI1UI10Hl1poBaHI1S1 B0311yxa, n01lroToBKI1 BOllbl, napa, Tex-
HOJlOrl11.JeCKI1X >K111lKOCTeH 11 ra30B, C>KaToro B031lyxa, 1.JI1CTble nOMellleHI1S1,
3KCnJIyaTaUHIO, TeXHl11.JeCKOe 06CJI}')Kl1BaHHe 11 peMOHT 060pY1l0BaHI1S1, Ka-
J1116poBKY npl160poB 11 T. 1l.);
- Tpe60BaHI1S1 K nOBe1leHI1IO, mmeHe 11 COCTOSlHI1IO 31l0pOBbSl nepCOHaJla;
- nOpSl1l0K Be1leHI1S1 1l0KYMeHTaUI1I1 11 T. 1l.
nepCOHaJI .aOJI)I(eH 3HaTb HHCTPYKUHIO H YMeTb OTBeTHTb Ha Jl1060H
Bonpoc, KacalOIllHHcSI ee. I1HcTPYKUHH He .aOJI)I(Hbl co.aep)l(aTb JlHWHHe
.aaHHble, He HCnOJlb3yeMbie B pa60Te. OHH He TOJlbKO BHOCSIT nOMeXH, HO
H MOryr CTaTb npH4HHoi1 npH3HaHHSI HeCOOTBeTCTBHSI .aOKYMeHTaUHH
Tpe60BaHHSlM GMP.
11 HCTPYKUHH, BKJlI04aSl H3MeHeHHSI K HHM, .aOJI)I(Hbl COOTBeTCTBO-
BaTb Tpe60BaHHSlM HopMaTHBHblX .aOKYMeHTOB, npOMblWJleHHblX pema-
MeHTOB, TeXHJ1LleCKOH .aOKYMeHTaUHH Ha npoueCCbl H 060Py.aOBaHHe.
I1HCTPYKUHH pa3pa6aTbIBalOTCSI B CJIe.aYIOIllHX CJlY'taSlX:
- opraHH3aUHH HOBora npOH3BOlICTBa;
- peKOHCTpYKUHH npOH3Bo.aCTBa;
- BBe.aeHHSI HOBOro 060Py.aOBaHHSI H npoueCCOB HJIH BHeceHHSI B
HHX H3MeHeHHi1;
- H3MeHeHHSI HopM£1THBHblX .aOKYMeHTOB, Tpe6YIOIllHX pa3pa60TKH
HOBOH HHCTPYKUHH.

136
"'106a 5
CoiJep:JICaHUe UHcmpYKu.uu
HH)I(e npHBolISlTCSI 061llHe Tpe60BaHHSI K COlIep)l(aHHIO H <!:>opMe HH-
CTPYKUHH no fOCT P 52550-2006. KOHKpeTHble Tpe60BaHHSI onpe.D.e-
JISIIOTCSI caMHM npelInpHSlTHeM C Y4eTOM TOro, lITO HHCTPYKUHSI .D.OJI)I(Ha
HOCHTb HC4epnbIBalOIllHH xapaKTep.
npH 60JIbWOM 06"beMe HHCTPYKUHH, HanpHMep, HHCTPYKUHH no
TexHH4ecKOMY 06CJlY)I(HBaHHIO, .D.OnycKaeTcSI CCblJlKa Ha .D.PYrHe .D.OKY-
MeHTbl. B 3TOM CJIY4ae .D.OJI)I(eH 6bITb opraHH30BaH KOHTpOJlb H3MeHeHHH
B .D.OKYMeHTax, Ha KOTopble C.D.eJIaHa CCbIJlKa.
PeKOMeH1lyeTcSI BKJlIOLJaTb B HHCTPYKUI1IO CJle1lYlOllll1e pa31leJIbl:
a) 06111l1e 1laHHble:
- Hal1MeHOBaHl1e npe1lnpHSlTH5I;
- Hal1MeHOBaHl1e n01lpa31leJIeHI1S1;
- Hal1MeHOBaHl1e HHCTPYKUHH;
- HOMep HHCTPYKUI1I1;
- 1laTY YTBep>K1leHHSI HHCTPYKUI1I1;
- 1lary 11 HOMep BHeCeHI1S1 113MeHeHI1S1 (npl1 He06xo1lI1MOcm);
- CpOK 1lCHCTBI1S1 HHCTPYKUI1I1;
- 1laHHble no HCTOpl111 I1HCTPYKUI1I1 (HoMep 11 1lary npe>KHero Bapl1aHTa
H HOMepa 11 1laTbl BHeCeHI1S1 Bcex 113MeHeHI1i1);
b) CneUl1aJ1bHble 1laHHble:
- 06J1aCTb npl1MeHeHHSI I1HCTPYKUHH (npl1 He06xo1lI1MOCm, YKa3aHl1e
Ha 06J1aCTI1, Ha KOTopble OHa He pacnpoCTpaHSleTCSI);
- nepe1.JeHb JII1U (llOl1)l(HOCTeH, n01lpa31leJleHI1H), Ha KOTopble pacnpo-
CTpaHSleTCSI I1HCTPYKUI1S1;
- Tpe60BaHI1S1 K oxpaHe OKpY)l(alOlllei1 Cpe1lbl (npl1 He06xo1lI1MOcm) C
YKa3aHl1eM Mep 3allll1Tbl I1JII1 co CCbIJIKOH Ha COOTBeTCTBYlOllll1e 1l0KYMeHTbl;
- Tpe60BaHI1S1 TeXHI1KI1 6e30naCHOCTI1 11 npoI13B01lCTBeHHOH CaHI1Tapl111
C YKa3aHI1eM Cpe1lCTB I1H1lI1BI11lYaJlbHOH 3allll1Tbl;
- nepe1.JeHb 1l0KYMeHTOB, CBSl3aHHblX C 1laHHOH I1HCTpYKUHei1;
- TepMI1Hbl 11 onpelleJIeHI1S1 (npl1 He06xOllI1MOcm);
- COllep>KaHl1e I1HCTPYKUI1I1 (LUISI I1HCTPYKUI1H 60JlbWOrO 06"beMa);
c) OCHOBHoe C01lep>KaHI1C I1HCTPYKUI1I1 B 4>oPMe npoHYMepoBaHHOIt
nOCJlellOBaTeJIbHOCTI1 llCHCTBI1H C YKa3aHI1eM Tpe6yeMbix MaTepl1aJ10B, 060-
pY1l0BaHI1S1, npl160poB 11 1l0KYMeHTaUI1I1;
d) npo1.Jl1e llaHHbIe, Hanpl1Mep, nepH01lI11.JHOCTb 06pa60TKI1 060pY1lo-
BaHI1S1 H nOMellleHI1H 11 np.;
e) 4>aMI1JII1I1, I1HI1Ul1aJlbl 11110JI>KHOCTH:
- pa3pa60T1.JI1KoB I1HCTPYKUI1I1;
- JII1U, cornaCOBaBWI1X 11 YTBep1lI1BWI1X I1HCTPYKUI1IO;
f) npl1J10>KeHI1S1 K I1HCTPYKUI1I1.
npl1 HaJll11.Jl1l1 B I1HCTPYKUI1I1 rpa4>HKoB (pI1CYHKOB) H Ta6J1I1U OWl
1l0Jl>KHbl I1MeTb CKB03HYlO HYMepaUl110 11 HaI1MeHOBaHI1S1.
11l1ua, Ha KOTopble pacnpoCTpaHSleTCSI I1HCTPYKUI1S1, 1l011)l(Hbl npoHTlI
06Y1.JeHI1e pa60Te no llaHHOH 11 HCTPYKUI1I1. npl1 pa3pa60TKe I1HCTPYKtil1H
peKoMeHllyeTcH roTOBI1Tb y'le6Ho-MeTOlll11.JeCKI1H MaTepHaJI, KOTOpblH MO)f(CT
npl111araTbC1 K I1HCTPYKtil1l1.

JIoKYMeHmau,UR
137
(/)opMa UHcmpYKu.UU
<DopMa HHCTPYKUHH OnpelIeJISleTCSI CaMHM npelInpHSITHeM. B npelIe-
JIax OlIHOro npelInpHSlTHSI CJIelIyeT HCnOJIb30BaTb elIHHYIO £pOPMY.
I1HCTPYKQHH no nOBe,lJ,eHHIO B IfHCTbIX nOMemeHHHX (npHMep)
HaHMeHOBaHHe npellnpHHTHH
I1HCTPYKuHH N!!_ OT «_» 2012 r.
nOBe1leHHe nepCOHana B 'IHCTbIX nOMemeHHSlX
N!! lm/Ol Bepcl1S1 I llaTa 01.02.2011
nO.apa31leJleHHe
Pa3pa60TaH3
Ha3Ha'leHHe
YCTaHOBI1Tb Tpe60BaHI1S1 K nOBe1leHI1IO nepCOHaJla B 1.Jl1CTblX nOMellleHI1S1X C
ueJlblO CBe1leHI1S1 K MHHHMYMY ero OTpl1uaTeJlbHoro BJlI1S1HI1SI Ha np01lYK-
UI1IO 11 npoueCCbl
MeCTo H BpeMSI npHMeHeHHSI
MecTo npl1MeHeHI1S1 - lll1CTble nOMellleHI11.
BpeMSI npoBelleHI1S1 - BbInOJIHeHl1e Bcex pa60T B 1.JI1CTOM nOMellleHI1I1,
BKJl101.JaSl npoI13BOllCTBO, y60PKY, TeXHI14eCKOe 06CJlY>Kl1l3aHl1e, KOHTpoJlb
napaMeTpOB 11 np.
I1cnoJlHHTeJlb
Bce JIl1ua, BXOllSlllll1e B 1.Jl1CTOe nOMellleHl1e
Tpe60BaHHH
nepell BXOllOM B lll1CTOe nOMellleHl1e CJIe1lyeT:
- nOllroTOBI1TbCSI KO BXOllY B 1.Jl1CTOe nOMellleHl1e B COOTBeTCTBHH C
HHCTPYKUl1eH no mmCHe LUISI 1.Jl1CTblX nOMellleHI1H 1laHHoro
KJlacca 1.JI1CTOTbl;
- nepell BXOllOM B 1.Jl1CTOe nOMCllleHl1e nepeOlleTbCSI B KOMnJleKT 01le>K1lbl
LUlSlllaHHoro KJlacca 1.JI1CTOTbl, BbInOJlHSISI Tpe60BaHI1S1 HHCTPYKUl1H no
nepeOlleBaHI1IO;
- BX01lI1Tb B lll1CTOe nOMCllleHI1C 11 I3bIX01lI1Tb 113 HCro TOJlbKO 1.Jepe3 KOMHa-
TY nepeOlleBaHI1S1 11 HH B KoeM cJlY1.Jae He 1.Jepe3 MaTepl1aJlbHbli lliJI103;
- He npOHOCI1Tb B 1.Jl1CTOe nOMCllleHl1e e1lY, nl1Tbe, )KeBaTeJIbHYIO peJI1HKY,
nOCTopOHHHe JIeKapCTBeHHble CpC1lCTBa, He CBSI3aHHbie C npe1lMeTOM
npOl13BOllCTBa, 'IaCbl, IOBel1l1pHble 1131lel1l1S1, Cnl11.JKI1 11 Ta6a l lHbie 11311e-
JII1S1, 1lPyme nOCTOpOHHl1e npe1lMeTbl:
- nepell Ha1.JaJlOM pa60Tbi 06pa60TaTb PYKI1 B nep'IaTKaX CTpYHKOi-i paCTBO-
pa 113 6ecKoHTaKTHoro 1l03aTopa, nocJle llero He KacaTbCSI PYKaMI1 OllC)K-
llbl 11 11106b1X npCllMeTOB, 3a I1CKJlIO'leHl1eM npC1lYCMOTpeHHbIX TeXHOJlO-
m1.JCCKoi-i I1HCTPYKUl1ei-i:
- BbIn011HSlTb pa60TY T011bKO B COOTBeTCTBI1H C I1HCTPYKtil1ei-i:
- He llonYCKaTb pCJKI1X 11 HeHY>KHbIX llBI1>KCHHi-i, Bbl3blBalOllll1X HapyweHHc
llBI1)KCHI1H nOTOKOB B0311yxa;

138
IJwfla 5
- He 1.JI1XaTb, He KaWJIHTb, npl1 He06xOlll1MOCTI1 KaWllSlHYTb 11J111 1.Jl1XHYTb -
Clle11aTb 3TO B CaJlcjJeTKY, 3aTeM l3epHYTbCSI B KOMHaTY nepeOlleBaHI1S1, no-
JlO>KI1Tb CaJl4>eTKY B KOHTeHHep LUISI OTXOllOB (l1cnOJlb30BaHHOH Olle>K1lbl),
3aMeHI1Tb nep1.JaTKI1, BepHYTbCSI Ha pa60 ' lee MeCTO; npl1 nOBTOpeHl111 llO-
110>KI1Tb PYKOBOllI1Te111O LUISI npl1HSlTI1S1 peWeHI1S1 0 3aMeHe pa60THI1Ka 11
oueHKe COCTOSlHI1S1 ero 31l0pOBbSl;
- He 1l0nYCKaTb HeHY>KHbIX pa3roBopoB;
- He pa3roBapl1BaTb, HaX01lSlCb Ha1l npOllYKTOM 11J111 pa60TaSl B Jlal\lI1HapHblX
JOHaX nOMellleHI1H NQ_,
- nOCJIe CJIY1.JaHHoro 11J111 BbIHy)I(1leHHoro KaCaHI1S1 KaKOrO-l1l160 npellMeTa
nOBTOpJ.1Tb 06pa60TKY PYK;
- 0 JlI06blX HapyweHI1S1X 1l0KJIa1lblBaTb PYKOB01lCTBY no pa1l110TeJIe4>oHY.
11HI.(O, KOHTpOJlHpYlOmee BbmOJlHeHHe HHCTPYKLlHH
YTBep>K1leHa (nOllnHCb)
llaTa BBelleHI1S1 B 1leHCTBl1e B3aMeH
CTp. 113
npelInpHSITHe .D.OJI)I(HO pa3pa60TaTb HHCTPYKUHH no BceM BonpocaM,
He OCTaBJlSlSl HH4ero 6e3 BHHMaHHSI. KOMnJIeKT HHCTPYKUHH .D.J1S1 Ka)l(1l0-
ro npe.D.npHSITHSI HH.D.HBH.D.YaJIeH, HO onblT pa60Tbl n03BOJISIeT .D.aTb 06-
IllHe COBeTbl.
PeKOMeH.D.yeMbIH nepeLJeHb HHCTPYKUHH, MeTO.D.HK H CTaH.D.apTOB
npelInpHSITHSI npHBe.D.eH B npHJlO)l(eHHH E K fOCT 52550-2006 [3].
PeKOMeHJ],yeMbIH nepelfeHb
HHCTPYKI.(HH, MeT01I.HK H CT3H.D.apTOB npe,lJ,npHHTHH
I-1HCTPYKUJ.1S1 no pa3pa60TKe, YTBep>K1leHI1IO, pacnpOCTpaHCHI1IO, I1C-
n011b30BaHI1IO 1l0KYMeHTOB, BHeCeHl110 B HI1X 113MeHeHHi1 11 np.
2 I-1HCTPYKUI1S1 no BJBeWI1BaHl11O 11 BbI1la1.Je CblpMI.
3 I-1HCTPYKUI1S1 no 3KCnJlyaTaUI111 060PYlloBaHI1S1.
4 I-1HCTPYKUI1S1 no BHYTpl13aBOllCKoH MapKl1pOBKe.
5 I-1HCTPYKUI1S1 no npe1l0TBpallleHI1IO nepeKpeCTHOro 3arpSl3HCHI1H.
6 I-1HCTPYKUI1S1 no np0I13B01lCTBY pa3J1I11.JHOH npo1lYKUI1I1 B OllHOH 30He.
7 I-1HCTPYKUI1S1 no I303BpalllCHI1IO Ha CKJla1l OCTaTKOB CblpbSl 11 MaTe pl1 aJlOfl.
8 I-1HCTPYKUI1S1 no nepepa60TKe 3a6paKoBaHHoH npOllYKUI1I1.
9 I-1HCTPYKUI1S1 no cjJopMl1poBaHl11O 1l0Cbe Ha cepl1lO roTOBOH npOllYKUJ.1H.
10 I-1HCTPYKUI1S1 no Y1.JeTY OTKJlOHCHI1H H BbInOJlHeHl11O KOppCKTl1pYlOlllHX
1leHCTBI1H B npouecce npoI13B01lCTBa.
II I-1HCTPYKUI1S1 no OT3bIBY np01lYKUI1J.1 C pblHKa 11 pa60Te C pCKJlaMaUHHMI1
12 I-1HCTPYKUI1S1 no YHJ1LITO)j(eHI1IO 3a6paKoBaHHoH, B03BpawcHHoH
11 OT03BaHHOH npOllYKUI1I1.
13 1-1 HCTPYKUI1S1 no Y1.JeTY llBI1)j(CHHH npOI\.JapKl1pOBaHHblX ynaKOflO1.JHblX
M.lTepH<\JlOB.
14 I-1HCTPYKUI1SI no YHI1'ITO>KeHHIO ynaKOB01.JHblX 11 MapKllpOI!aHHbIX
MaTCpl1aJ10B.
15 I-1IICTPYKUIIH no OtiCHKC 3110poBbH ncpCOH.\Jla.

jI,()KYMeHmau,UfI
139
16 MHCTPYKW1S1 no 11I11.JHOH rHrHeHe nepCOHaJla.
17 MHCTPYKUI1S1 no nepeolleBaHl11O 11 HOWeHl11O Olle)l(1lbl.
18 M HCTPYKUI1S1 no 06pa60TKe 01le>K1lbl.
19 M HCTPYKUI1S1 no BXOllY B 1.Jl1CTbIe nOMellleHI1S1.
20 MHCTPYKUI1S1 no O'Il1CTKe, y60pKe, 1le3I1H4>eKul1l1 nOMellleHI1H.
21 MHCTPYKUI1S1 no YllaJIeHl110 OCTaTKOB 1le3I1H4>l1uI1PYI01llI1X Cpe1lCTB C 06-
pa60TaHHblx nOBepxHocTeH.
22 M HCTPYKUI1S1 no 01.JI1CTKe 11 CaHI1TapHOH 06pa6oTKe Tpy60npoBolloB.
23 MHCTPYKUI1S1 no 6opb6e C napa3l1TaMI1, HaceKOMblMI1 11 >KI1BOTHbIMI1.
24 MHCTPYKUI1S1 no 06Y1.JeHI11O nepCOHaJla.
25 MeT01lI1KI1 no aTTeCTaUl111 npoueCCOB 11 060pY1l0BaHI1S1.
26 MHCTPYKUI1S1 no TeXHl1'leCKOMY 06cJlY>KI1BaHI1IO 06oPY1l0BaHI1S1.
27 MHCTPYKUI1S1 no 01.JI1CTKe 060pYlloBaHI1S1.
28 MHCTPYKUI1S1 no CTepl111113aUI1I1 060pY1l0BaHI1S1.
29 MHCTPYKUI1S1 no 01.JI1CTKe ynaKoBo'IHblX JlI1HI1H.
30 MHCTPYKUI1S1 no MOHTa>KY.
31 M HCTPYKUI1S1 no aY1lI1TY nOCTaBlllI1KOB.
32 M HCTPYKUI1S1 no npl1eMKe I1CX01lHbIX MaTepl1aJlOB.
33 MHCTPYKUI1S1 no npl1eMKe ynaKOB01.JHblX MaTepl1aJ10B.
34 MHCTPYKUI1S1 no KapaHTI1HHOMY XpaHeHI1IO.
35 MHCTPYKUI1}) no XpaHeH1110 I1CX01lHbIX H ynaKOB01.JHbIX MaTepl1aJ10B.
36 MHCTPYKUI1S1 no l111eHTI14>I1KaUI1I1 I1CXOllHblX 11 ynaK0I304HblX MaTepl1aJ10B.
37 MHCTPYKUI1S1 no 06pallleHI11O C >KI1BOTHbIMI1.
38 MHCTPYKUI1S1 no KOHTpoJlIO oKpY>KalOllleH Cpellbl.
3TOT nepe4eHb He SlBJlSleTCSI HC4epnb1Ba101llHM. OH MO)l(eT CJlY)I(HTb
cnpaB04HblM MaTepHaJIOM npH nO.D.roToBKe .D.OKYMeHTaUHH, onpe.D.eJIeHHH
ee CO.D.ep)l(aHHSI H 06"beMa.
llOPHdoK npeOcma6JlellUH U xpaHeHuH ullcmpYKu.uii
I1HCTPYKUHH MOryT 6bITb npe.D.CTaBJleHbl B 6YMa)l(HOM H/HJlH B 3JIeK-
TpOHHOM BH.D.e.
llocTyn K HHCTPYKUHSlM B 3JIeKTpOHHOH <!:>opMe .D.OJI)I(Hbl HMeTb Bce
JIHua, Ha KOTOpblX OHH pacnpocTpaHSIIOTcSI: cooTBeTcTBYlOlllHC PYKOBO-
.D.HTeJlH H COTPYlIHHKH nO.D.pa3.D.eJleHHH.
OpHrHHaJIbl (KOHTpOJlbHble 3K3eMnJISIpbl) xpaHSlTcSI B OT.D.eJIe 06ec-
ne4eHHSI Ka4eCTBa HJlH .D.PyroM nOlIpa3.D.eJleHI1H, OTBeTCTBeHHOM 3a KOH-
TpOJIb BC.D.eHHSI .D.OKYMeHTaUHH.
nOJIb30BaTeJIb .D.OJI)I(eH HMeTb TOJIbKO .D.eHCTBYIOIllHe Y4TeHHble KO-
nHH, He 1I0nYCKaeTCSI HaXO)l(1leHHe Y nOJlb30BaTeJlSl npoeKTOB .D.OKYMeHTOB.
npOeKTbllIOKYMeHTOB .D.OJl)l(Hbl HMeTb rpH<!:> «npOEKT».
nO.D.pa3.D.eJIeHHe, KOHTpOJIHpYlOlllee BelIeHHe .D.OKYMeHTaUHH, .D.OJI)I(HO
CJIelIHTb 3a He.D.OnYllleHHeM .D.y6JIHpOBaHHSI HHCTPYKUHH H npoTHBope4HH B
HHCTPYKUHSlX, npHBJlCKaSI .D.J1S1 3TOro He06xo.D.HMble nO.D.pa3.D.eJIeHHSI.

140
1J106a 5
5.10 Be,lJ,eHHe ,lJ,OKYMeHT3HH H BHeceHHe H3MeHeHHU
nOpSllIOK BelIeHHSI 1I0KYMeHTaUHH 1l0JI)I(eH 6bITb OnpelIeJIeH cneUH-
aJIbHOH HHCTPYKuHeH (CTaHlIapTOM npe.D.npHSITHSI), pemaMeHTHPYlOllleH
nOpSI.D.OK pa3pa60TKH, yrBep)l(1leHHfI, pacnpOCTpaHeHHSI, HCnOJlb30BaHHSI
.D.OKYMeHToB, BHeceHHSI B HHX H3MeHeHHH H np. nepBblM waroM npH
pa3pa60TKe opraHH3auHoHHo-TeXHOJlOrH4eCKOH .D.OKYMeHTaUHH, COOT BeT-
CTBYlOllleH Tpe60BaHHSlM fOCT P 52249-2009, .D.OJI)I(Ha 6bITb pa3pa60TKa
HHCTPYKUHH no BelIeHHIO .D.OKYMeHTaUHH (CTaH.D.apTa npelInpHSITHSI).
3ra HHCTPYKUHSI YCTaHaBJlHBaeT nOpSl.D.OK pa3pa60TKH, pacnpOCTpa-
HeHHSI, nepeCMOTpa, yrBep)l(1leH, HSI OTMeHbl H HCnOJlb30BaHHSI Bcex He06-
XO.D.HMbIX .D.OKYMeHTOB, B TOM 4HCJle HHCTPYKUHH, TeXHOJIOrH4eCKHX pe-
maMeHTOB npOH3BOlICTBa, TeXHOJIOrH4eCKHX HHCTPYKUHH, HHCTPYKUHH no
<!:>aCOBKe H ynaKoBKe, a TaK)l(e Be.D.eHHSI npOTOKOJla Ha cepHIO roTOBOH
npO.D.YKUHH. npH He06xOlIHMOCTH MOryT pemaMeHTHpOBaTbCSI Tpe60BaHHSI
K CO.D.ep)l(aHHIO, <!:>opMe, nOpSl.D.KY comaCOBaHHSI, yrBep)I(.D.eHHSI H HCnOJIb-
30BaHHSI (pacnpOCTpaHeHHSI, npHMeHeHHSI, H3"bSiTHSI) KOHKpeTHblX BH.D.OB
.D.0KYMeHTOB.
npOMbllllJleHHble perJlaMeHTbl npOH3BOlICTBa, TeXHOJlOrH4eCKHe HH-
CTPYKUHH H HHCTPYKUHH no <!:>aCOBKe H ynaKoBKe, KaK npaBHJIO, pa3pa-
6aTbIBalOTCSI Ha CTa.D.HH pa3pa60TKH H nOCTaHOBKH npO.D.YKUHH Ha npo-
H3BO.D.CTBO H KOppeKTHpYlOrcSi B XOlIe npaKTH4eCKOro HCnOJIb30BaHHSI B
COOTBeTCTBHH C npHHSlTblM nOpSI.D.KOM BHeceHHSI H3MeHeHHH.
BHeceHue U3.MeHeHUii
B npouecce pa60Tbl MO)l(eT B03HHKHyrb nOTpe6HOCTb B H3MeHeHHH,
YJIY4111eHHH HHCTpYKUHH. I1HHUHaTHBY nepCOHaJIa no COBepweHCTBOBa-
HHIO HHCTpYKUHH CJIelIyeT nOOlllpSiTb. Hy)I(HO C06HpaTb npe.D.J10)l(eHHSI,
06CY)l(.D.aTb HX H B onpaBlIaHHblX CJlY4aSlX BHOCHTb H3MeHeHHSI.
ECJlH npe.D.JlO)l(eHHe He npHHSlTO, TO CJIe.D.yeT 06bSlCHHTb aBTOpy
npe.D.J10)l(eHHSI npH4HHbl OTKJlOHeHHSI H nOCTapaTbCSI y6elIHTb ero. HY)I(HO
BbISlCHHTb, 4eM Bbl3BaHO npe.D.JlO)l(eHHe H3MeHHTb HHCTPYKUHIO. MO)l(er
6blTb, HY)I(HO 113MeHHTb He HHCTPYKUHIO, a npouecc HJlH 060PY.D.OB£1HHC.
npHMep
Ha 01lHOM 113 npellnpl1S1TI1H onepaTopbl HHKaK He XOTel1l1 HaxOlll1TbC1
B YKa3aHHOM I1HCTPYKUl1ei1 MCCTe. OKa3aJlOCb, 1.JTO 3TO MeCTO 6bl110 nOlI
npl1T01.JHblM 4>11J1bTpOM C HenpaBI1JIbHO Bbl6paHHbiM 1l114>4>Y30POM -
ncp4>opl1poBaHHoi1 peweTKOH. HanpaBJlSlBWeH nOTOK B031lyxa npSlMO BHHJ.
Ha onepaTOpa. npOCTaSl 3aMeHa peWeTKI1 Ha 11114>4>Y30P, 4>OPMI1PYlOlllHii
Typ6YJleHTHblH nOTOK, pewl1Jla npo6J1eMY.
MHeHHe p£160THHKOB - 3TO 34>4>eKTHBHbIH HHCTpYMeHT 06p£1THoi-i
CBfl3H H£1 npOH3BOlICTBC.
OTKJlOHeHHSI OT Tpe60B£1HHi-i HHCTPYKU1i1 He 1I0nYCK£1IOTCSI.
Ho >K113Hb HC CTOHT H£1 MeCTe.

/l.oKYJl.leHmau,UfI
/4/
MO)l(eT B03HHKHyrb He06xOlIHMOCTb B H3MeHeHHl1 HHCTPYKUHH.
nOpSilIOK BHeCeHHSI H3MeHeHHH .D.OJI)I(eH 6bITb YCTaHOBJleH OTlIeJIb-
HblM .D.OKYMeHTOM - «I1HcTPYKuHeH no BHeceHHIO H3MeHeHHH».
BBelIeHHaSl B lIeHCTBHe HHCTPYKUHSI MO)l(eT CO.D.ep)l(aTb OWH6KH H
HeT04HOCTH. ECJIH nepCOHaJI TOllHO BbInOJIHSleT Tpe60BaHHSI HHCTPYK-
UHH, TO 3TH OWH6KH OH Tyr )l(e BbISlBHT. ECJlH lIeHCTBYlOlllaSi KaKoe-TO
BpeMSI HHCTPYKUHSI COlIep)l(HT OWH6KH, HeBbInOJIHHMble HJlH npOTHBope-
4HBble Tpe60BaHHSI, TO 3TO 3Ha4HT, 4TO no HHCTPYKUHH HHKTO He pa60-
TaeT. TaKaSi HHCTPYKUHSI SlBJlSleTCSI <!:>OpMaJIbHOH H JIHWb C031IaeT HJlJIIO-
3HIO pa60Tbl no GMP.
I1HcTPYKuHH .D.OJl)l(Hbl nepHO.D.H4eCKH nepecMaTpHBaTbcSI no HCTe4e-
HHH cpoKa HX lIeHcTBHSI, HO He pe)l(e OlIHOro pa3a B .D.Ba rolla. npH H3-
MeHeHHSlX B 060PY.D.OBaHHH HJIH npouecce BHOCSlTCSI H3MeHeHHSI BO Bce
HHCTPYKUHH, HMelOlllHe K HHM OTHoweHHe.
PeKOMeH.D.yeTcSI BBeCTH 3JIeKTpOHHYIO CHCTeMY KOHTpOJISI Be.D.eHHSI
.D.OKYMeHTaUHH, npelIynpe)l(1lalOlllYIO 06 OKOH4aHHH cpOKa .D.eHCTBHSI .D.O-
KYMeHTa, He06xo.D.HMOCTH ero nepeCMOTpa HJIH BHeceHHSI H3MeHeHHH.
D.nSl npaKTH4ecKoro HCnOJlb30BaHHSI C OpHrHHaJIOB CHHMalOTCSI KO-
nHH. KonHH MOryr 6blTb Y4TeHHblMH H HeY4TeHHbIMH.
B nO.D.pa3.D.eJleHHH, OTBe4alOIlleM 3a Be.D.eHHe .D.OKYMeHTaUHH, Bce
}"-ITeHHble KonHH perHCTpHpYfOTCSI B }"-IeTHOM JIHCTe C YKa3aHHeM no.ll.-
pa3.D.eJIeHHSI H pa604ero MeCTa, B KOTOpblX OHH HaXO.D.SlTCSI.
npH BHeceHHH H3MeHeHHH pa3pa6aTbIBaeTcSI HOBblH 3K3eMnJlSlp
OpHrHHaJIa .D.OKYMeHTa, B KOTOpOM npOCTaBJlSleTCSI HOMep H lIaTa BHece-
HHSI H3MeHeHHSI. 3£1TeM H3roTaBJlHBalOTCSI KonHH .D.OKYMeHTa no 4HCJIY
}"-ITeHHblX KonHH. Ha Ka)I(.D.oi1 Y4TeHHoH KonHH npOCTaBJlSleTCSI WTaMn
«YYTEHHA5I KOnl151» C YKa3aHHeM lIaTbl o<!:>0pMJIeHHSI KonHH H JIHUa,
BbI.D.aBwero KonHIO. Y4TeHHaSi KonHSI Bbl.D.aeTCSI B COOTBeTCTBYlOlllee
nO.D.pa3.D.eJIeHHe, npH 3TOM npe)l(HSlSI KonHSI H3bIMaeTCSI. 113"bSiTble KonHH
YHH4TO)l(aIOTCSI. PeKOMeH.D.yeTcSI Ha Ka)I(.D.YfO Y4TeHHYIO KonHIO npOCTaB-
JISlTb WTaMn «LlEI1CTBI1TEJlbHO LlO 20_ r.».
HeY4TeHHble KonHH He Moryr HCnOJIb30BaTbC1 .D.J1S1 p£160Tbi.
B HHCTPYKUHH 1I0Jl)l(Hbl 6bITb npHBelIeHbl .D.aHHble 0 npe)l(HeM BapH-
aHTe HHCTPYKUHH H Bcex H3MeHeHHSlX C YKa3aHHeM HX HOMepOB H lIaT.
OmMeHa iJoKYMeHm06
LloKYMeHT C HCTeKWHM CpOKOM lIeHcTBHSI HJlH 3aMeHeHHblH 1I0KY-
MeHT .lI.OJI)I(Hbl 6blTb H3"bSlTbl H3 06pallleHHSI.
Ha npe.D.npHSlTHH 1I0JI)I(eH 6bITb npelIYCMOTpeH nopSilIOK, HCKJllOltalO-
Ul.HH 06pallleHHe HJIH HCnOJIb30BaHHe OTMeHeHHblX .D.OKYMeHTOB HJlH .D.O-
KYMeHTOB C HCTeKWHM CpOKOM rolIHOCTH.
H£1npHMep, 3TO MO)l(eT 6blTb npelIycMoTpeHO CHcTeMOH KO.D.HpOBaHHSI
H npHcBoeHHeM lIPYroro HOMepa, YKa3aHHeM B KOlle 1I0KYMeHTa HOMepa
113MeHeHHI, aBTOM£1TJ1LleCKOH 3aMeHoH HOMcp£1 (KOlIa) 1I0KYMeHTa no HC-
Te'leHHIO cpOKa ero lIei1cTBH5I H np.

142
FJ/a6a 5
5.11 Oco6eHHocTH ,lJ,0KYMeHT3I.\HH B CIlIA
CMblCJl Tpe60BaHHH K 1I0KYMeHTaUHH B CiliA aHaJIOrHLleH eBponeH-
CKHM Tpe60BaHHSlM, HO eCTb HeKOTopble oc06eHHocTH.
Ko.aeKc cDelIepaJIbHblX npaBHJI CiliA 21 CFR Part 210 and 211 [16]
COlIep)l(HT Tpe60BaHHSI K CJle.aYIOIllHM 1I0KYMeHTaM:
211.180 06111l1e Tpe60BaHI1S1
211.182 )KYPHaJlbl no 01.JI1CTKe 11 3KCnJIyaTaUl111 060PY1l0BaHI1S1
211.184 npOTOKOJlbl Ha I1CX01lHble H ynaKOB01.JHble MaTepl1aJlbl, MaTepl1a-
JlbI LUISI YKynopKI1 11 3TI1KeTKH
211.186 3TaJlOHHbIe npOTOKOJlbI Ha npol13BOllCTBO 11 KOHTpOJlb
211.188 npOTOKOJIbl Ha np0I13B01lCTBO 11 KOHTpOJlb cepl1l1
211.192 npOTOKOJIbl paCCMOTpeHHSI npOI13B01lCTBa
211.194 npOTOKOJIbl JIa60paTopl1H
211.196 D.oKYMeHTaUI1S1 Ha peaJll13aUI11O
211.198 D.oKYMeHTaul1S1 no peKJIaMaUHSlM
HH)I(e npI1Bo.aSITCSI Bbl.aep)l(KH 3THX npaBHlI.
3T3JlOHHble npOTOKOJIbl H3 npOH3BO,lJ,CTBO H KOHTpOJlb
Master production and control records (21 CFR 186)
3TaJlOHHble npoTOKOJlbl CJlY>KaT LUISI KOHTpoJlSl CTaH1lapTHOCTI1 npOllYK-
UI1I1 OT cepl1l1 K cepl1l1 11 pa3pa6aTbIBalOTcSI LUISI Ka>K1loro BI11la np01lYKUI1I1 11
pa3Mepa cepl1l1. OHI1 C01lep>KaT CJle1lYlOllll1e llaHHble (npI1B01lSITCSI C COKpa-
llleHI1S1MI1):
I) Hal1MeHoBaHl1e, 34>4>eKTI1BHOCTb 11 Onl1CaHl1e JleKapCTBeHHoro
Cpe1lCTBa;
2) Hal1MeHoBaHl1e 11 KOJIl11.JeCTBO Ka)I(1l0ro aKTI1BHoro I1Hrpe1ll1eHTa B
e1lI1HI1Ue npo1lYKUI1I1 I1JII1 e1lI1HI1Ue Beca I1JII1 1lpyroH e1lI1Hl1ue H3MepeHI1S1 11
YKa3aHI1e 06 06111eM Bece 111111 1lpyroH KOJll11.JeCTBeHHOH xapaKTepl1CTI1Ke
elll1HI1Ubl np01lYKUI1I1;
3) nOJlHblH nepe1.JeHb KOMnOHeHTOB C YKa3aHl1eM Hal1MeHOBaHI1H I1J1H
K01l0B, OTpa>KalOllll1X CneUI14>I11.JHOCTb;
4) T01.JHble llaHHble 0 Bece Ka)I(1l0ro KOMnOHeHTa C YKa3aHI1eM llony-
CTI1MblX OTKJlOHeHI1H;
5) D.aHHble 0 paC1.JeTHOM npeBbIWeH1111 KOJll11.JeCTBa KOMnOHeHTa;
6) TeOpeTI1'IeCKI1H Bec 111111 1lpyraSl KOJll11.JeCTBeHHaSl xapaKTepl1CTI1Ka
LUISI COOTBeTCTBYlOllll1X CTaLll1H TeXHOJlOm1.JeCKoro npouecca;
7) TeopeTI1 ' lecKl1ti BblXOll npollYKU1111 C YKa3aHI1eM OTKJlOHeHl1ti, npl1
BbIXOlle 3a KOTopble Tpe6yeTcSI npOBe1leHl1e aHaJll13a;
8) Onl1CaHl1e nepBl11.JHblX 11 BTOpl11.JHbIX ynaKoBo'IHblX MaTepHaJlOB H
MaTepl1aJ10B LUISI YKynopKI1 C npl1110)f(eHl1eM 06pa3uoB 111111 KOnl1H 3TI1KeTOK
1111111lpymx CpellCTB MapKlpoBKI1;
9) n011Hblti KOMn11eKT TeXH0110rl1'leCKI1X I1HCTPYKtil1H 11 MCTOlll1K KOH-
Tp011Sl H oT60pa np06, cneUl1cpl1KaUI1H, OC06blX YKa3aHI1H 11 npe1lynpe)f(1lC-
Hl1ti.

J[OKYMeHmau,UJl
143
npOTOKOJlbl H3 npOH3BO,lJ,CTBO H KOHTpOJlb cepHH
Batch production and control records (21 CFR ,'188)
3TI1 npOTOKOJlbl COCTaBJlSlIOTCSI Ha Ka)I(1lYIO cepl1lO BbInYllleHHoro Jle-
KapCTBeHHoro cpe1lCTBa H 1l0Jl>KHbl COllep>KaTb nOJlHYIO 11H4>opMaUI1IO 0 ee
npOJ.13BOllCTBe 11 KOHTpoJIe. OHI1 C01lep>KaT CJle1lYlOllll1e 1laHHble (npI1B01lSlT-
CSI C cOKpallleHI1S1MI1):
a) T01.JHYIO KOnl11O COOTBeTCTBYlOlllero 3TaJlOHHOro npOTOKOJIa np0l13-
BOllCTBa 11J111 KOHTpOJlSl, npOBepeHHYIO 11 n01lnI1CaHHYIO C YKa3aHI1eM 1laTbl;
b) D.oKYMeHTaUI1IO Ha Ka>K1lYIO CYllleCTBeHHYIO CTa1l111O np0I13B01lCTBa,
ynaKOBKI1 I1JII1 o6pallleHI1S1 cepl1l1 npo1lYKUI1I1, BKJlI01.JaSl:
I) D.aTbl;
2) Hal1MeHoBaHl1e Ka)I(1l0H e1l11 HI1 UbI OCHOBHOro 060PYllOBaHI1S1 11 JII1-
HI1I1 C I1X l11leHTI14>I1KatiI10HHbIM HOMepoM;
3) D.aHHble 0 Ka)I(1l0H cepl1l1 I1CX01lHbIX MaTepl1aJ10B 11J111 MaTepl1aJ10B,
HCnOJIb3yeMblx B Te1.JeHl1e TeXHOJlOrH1.JeCKoro npouecca;
4) D.aHHble 0 Bece I1JII1 llpymx KOJIl11.JeCTBCHHblX xapaKTepl1CTI1KaX Ma-
Tepl1aJ10B, Hcno11b3yeMblx B TeXHOJIOrH1.JeCKOM npouecce.
5) Pe3YJIbTaTbl BHYTpl1np0I13B01lCTBeHHoro 11 Jla60paTOpHoro KOHTpOJlSl;
6) D.aHHble 0 npOBepKe 30Hbl ynaKOBKI1 11 MapKHpOBKI1 110 11 nOCJIe pa-
60Tbl;
7) $aKTI11.JeCKHH BbIX01l npo1lYKUI1I1 11 COOTHoweHHe C TeOpeTI14eCKI1M
BbIX01l0M Ha COOTBeTCTBYlOllll1X CTa1lI1S1X npouecca;
8) nOJlHble npOTOKOJIbl KOHTpoJlSl 3TI1, KeTOK BKJlI04aSI 06pa3Ubi 11J111
Komm;
9) Onl1CaHHe nepBI14HblX ynaKOB01.JHblX 11 YKynOpo1.JHblX MaTepl1aJ10B;
10) Bce oT06paHHbie np06bl 11J111 06pa3Ubl;
II) D.aHHble 06 onepaTOpax, I1X HenOCpe1lCTBeHHbIX PYKOB01lI1TeJlSlX 11
JIl1uax, KOHTpoJll1pYlOllll1X Ka)I(1lYIO CYllleCTBeHHYIO CTa1l111O np0I13B01lCTBa;
eCJlI1 TaKaSl CTa1lI1S1 BbInOJIHSleTCSI Ha aBTOMaTl11.JeCKOM 060PY1l0BaHI1I1, TO
npl1B01lSlTCSI 1laHHbIe 0 nepCOHaJle, KOHTpOJll1pYlOllleM CYllleCTBeHHble CTa-
111111 pa60Tbl :noro 060PY1l0BaHI1S1;
12) D.aHHble 0 npOBelleHl11-1 aHaJlI130B CO maCHO 211.192 (paCCMOTpe-
Hl1e npOTOK0110B CepI1H);
13) Pe3Y11bTaTbl KOHTpoJlSl B COOTBeTCTBI1I1 C 211.134 (npoBcpKa ynaKo-
BaHHOH npo.ayKUI1I1 11 BI13yanbHblH KOmpoJlb npaBI1J1bHOCTI1 MapKl1poBKI1).
npOTOKOJI Ha npOH3BO.aCTBO H KOHTpOJlb cepHH ueJleC006pa3HO Bbl-
nOJlHHTb B BHlle llla6JlOHa, B JIeBOH CTopOHe KOTOpOro YKa3aHO, 4TO .aOJl)l(HO
6blTb, a B npaBOH - <!:>aKTH'leCKHe .aaHHble. TaK .aeJIaeTCSI Ha npelInpHSlTHSIX
npOTOKOJlbl p3CCMOTpeHHH npOH3BO,lJ,CTB3
Production record review (21 CFR .9208)
Bce npoTOKOJlbl npoI13B01lCTBa 11 KOHTpoJlR, BKJl101.JaSl npOTOKOJlbl yna-
KOBKI1 11 MapKl1pOBKI1, 1l0Jl>KHbl 6bITb paCCMOTpeHbl 11 YTBep>K1leHbl OTlleJIOM
KOHTpOJlSl Ka'leCTBa C ueJlblO nOllTBep>K1leHI1S1 COOTBeTCTBI1S1 BceM npl1HSI-
TbIM, YTBep>K1leHHbIM nl1CbMeHHblM 1l0KYMeHTaM 110 BbInYCKa cepl1l1 B pea-
JI 11 Jatil1 10. J1106b1C He06"bRCHI1Mble paCXO>K1leHI1S1 (BKJlI01.JaSl npeBblWeHl1e
1l0nYCTI1MbiX OTKJlOHCHI1H B MeHbWYIO 1-11111 6oJlbWYIO CTOpoHY, YCTaHOBJIeH-

144
1J106a 5
HblX 3TaJlOHHblMI1 npOTOKOJIaMI1 npol13BOllCTBa 11 KOHTp011Sl) 111111 HeCOOT-
BeTCTBl1e cepl1l1 11J111 JlI060ro BxollSllllero B Hee KOMnOHeHTa CneUI14>I1KaUI1-
S1M 1l0JI>KHbl TWaTeJIbHO paCCJle1l0BaTbCSI He3aBI1CI1MO OT TOro, onpY>KeHa
cepl1S1 I1JII1 HeT. B paCCJlellOBaHl1e CJle1lyeT BKJllO l ll1Tb llpyme cepl1l1 TOH >Ke
npOllyKUl111 11J111 1lpyroH np01lYKUI1I1. K KOTOpOH 1laHHbIH OTKa3 11J111 pac-
XO)l(1leHl1e MOryT I1MeTb OTHOWeHl1e.
no pe3YJlbTaTaM paCCJIe1l0BaHI1S1 HY>KHO 04>OPMI1Tb npOTOKOJl C BbIBO-
1laMI1 11 npellnpHHI1MaeMblMI1 MepaMI1.
KaK CJIelIyeT H3 npHBe.aeHHblX Bbl.aep)l(eK, npaBHJIa cG M P CiliA
.aalOT 4eTKYlO npoue.aypy oueHKH COOTBeTCTBHSI cepHH npo.aYKUHH:
- OCHOBOH .aJlSl oueHKH SlBJlSlIOTCSI 3TaJIOHHble npOTOKOJlbl, B KOTO-
pblX YKa3aHbl Tpe60BaHHSI K npo.aYKUHH C 1I0nYCTHMblMH OTKJlOHeHHSlMH;
- .D.J1S1 Ka)I(.D.OH cepHH npo.aYKUHH COCTaBJlSlIOTCSI npOTOKOJlbl, B nep-
BOH 4aCTH KOTOpblX KOHCTaTHpYIOTCSI Tpe60BaHHSI, B3S1Tble H3 3TaJIOHHblX
npOTOKOJlOB, a BO BTOpOH - nOlIp06Hble lIaHHble 0 npOH3Bo.aCTBe cepHH
npo.aYKUHH H ee xapaKTepHCTHKax, nOJIY4eHHblX npH KOHTpOJIe;
- 3aBeplllalOIllHM .aOKYMeHTOM S1BJlSleTCSI npOTOKOJl paCCMOTpeHHSI
npOH3Bo.aCTBa, npH COCTaBJleHHH KOTOpOro npOBOlIHTCSI aHaJIH3 npOTO-
KOJIOB Ha cepHIO npo.aYKUHIO H lIeJIaeTCSI 3aKJIlO4eHHe 0 ee COOTBeTCTBHH
I1JIH HeCOOTBeTCTBHH 3a.D.aHHbIM Tpe60BaHHSlM.
npH COOTBeTCTBHI1 npo.aYKUHH 3THM Tpe60BaHHSlM .aaeTCSI pa3pewe-
HHe Ha peaJIH3aUHIO.
5.12 ,l],oKYMeHTaI\HH B 3J1eKTpOHHOH c1JopMe
Be.aeHHe H xpaHeHHe .aoKYMeHTaUHH B 3JleKTpOHHOH <!:>opMe, 3JIeK-
TpOHHble no.anHCH H .aPYrHe aTpH6yrbl KOMnbIOTepH3aUHH BOWJIH B
npaKTHKY npOH3BOlICTB JleKapCTBeHHblX cpe.aCTB. fJlaBHOe Tpe60BaHHe K
KOMnblOTepHblM CHCTeM£1M C T04KH 3peHHSI 6e30nacHocTH - OHH He
.aOJI)I(Hbl HapywaTb BbInOJIHeHHe np£1BHJI GMP. 3TO npelIYCMOTpeHO p£1J-
.aeJIOM 4 'taCTH I H npHJlO)l(eHHeM II «CHcTeMbl C KOMnblOTepHbl1\l
ynpaBJleHHeM H KOHTpOJleM» K npaBHJIaM GMP (fOCT P 52249-2009).
YT04HeHHSI :noro npHJlO)l(eHHSI BHeceHbl B GMP EC B 2011 r.
n. 4.9, 'IaCTb I rOCT P 5249-2009
3anl1Cb 1laHHbIX MO>KeT BbIn011HSlTbCSI C I1CnOJlb30BaHl1eM 3J1eKTpoHHoii
TeXHI1KI1, 4>oTorpa4>l1poBaHI1H I1JII1 1lpymx CpellCTB, 06eCne ' II1BaJOWIJ\
Ha1le>KHOe XpaHeHI1C I1H4>opMaUI1I1 B COOTBeTCTBl111 C I1HCTPYKUI1S1MI1 no I1C-
n011b30BaHI1IO 3TI1X cpellCTB. CJIellyeT npOBepSITb TOlJHOCTb 3anl1CeH. npl!
BeneHl111 1l0KYMeHTaUl111 B 3J1eKTpOHHOM BI111e npaBO 1l0cryna 111111 113MCHC-
HI1S1 llaHHblX B KOMnblOTepe MOryr I1MeTb T011bKO Jll1ua C cooTBeTcTBYIOW l 1
MH nOllHOM01.JI1S1MI1. npl1 3TOM CJlellYCT BeCTI1 npOTOKOJl 113MeHeHI1H 11 113NI
TI1H. .lI.nSl orpaHI1 ' leHI1H 1l0CTYna K 311eKTpoHHOH 6a3e 1laHHbIX cJlellyeT HC-
nOJlb30BaTb CI1CTeMY napo11cH 111111 llpymx cpellCTB; BHeCeHl1e oco60 Ba)l(HblX
llaHHblX llOl1>KHO npoRepITbCH HC3alll1CI1MbiM cnoc060M. npl1 xpaHeHlli1

j1,oKYMeHmau,UfI
145
npOTOKOJIOB Ha cepl1l1 npo1lYKUI1I1 B 311eKTpOHHOM BI11le LUISI 3allll1Tbl I1H-
4>opMaUI1I1 He06xOlll1MO C0311aBaTb pe3epBHble KOnl111 Ha MarHl1THblX HOCI1-
TeJISlX, MI1Kpo4>l1J1bMaX, 6YMare 11J111 I1HblX Ha1le>KHbIX Cpe1lCTBax. B nepl101l
XpaHeHI1S1 3TI11laHHble 1l0Jl>KHbl 6bITb 1l0crynHbIMI1.
KOMnblOTepHble CHCTeMbl, npe.D.YCMaTpHBalOIllHe 3JIeKTpOHHblH 06-
MeH lIaHHblX C lIPYrHMH CHCTeMaMH, .D.OJI)I(Hbl HMeTb BCTpoeHHblH KOH-
TpOJlb npaBHJlbHOCTH 11 6e30nacHocTH BBOlIa H 06pa60TKH lIaHHblX.
npH PY4HOM BBOlIe lIaHHblX CJIelIyeT npe.D.YCMaTpHBaTb npOBepKY
.D.aHHbIX. 3Ta npOBepKa MO)l(eT BbInOJIHSlTbCSI .D.pyrHM onepaTopOM HJIH C
nOMOlllblO aTTeCTOBaHHblX 3JIeKTpOHHblX Cpe.D.CTB.
CJIe.D.yeT 06ecne4HTb 3alllHTY .D.aHHbIX OT nOBpe)I(.D.eHHH C nOMOlllblO
KaK <!:>H3H4ecKHx, TaK H 3JIeKTpOHHblX Cpe.D.CTB. CJIelIyeT npOBepSlTb ,lJ,0-
cTynHocTb, llHTaeMOCTb H T04HOCTb coxpaHSIeMblX .D.aHHbIX.
D.OJI)I(Ha 6bITb 06ecne4eHa B03MO)l(HOCTb nOJlY4eHHSI 4eTKHX pacne-
4aTOK, a .D.J1S1 .D.aHHbIX, OTHOCSlIllHXCSI K npOTOKOJlaM cepHH - pacne4aTOK
C YKa3aHHeM TOro, 6blJIH JlH BHeceHbl H3MeHeHHSI B nepBOHa4aJIbHO BBe-
.D.eHHble .D.aHHble.
3JleKmpOHHbie noonucu
D.aHHble, npe.D.CTaBJleHHble B 3JIeKTpOHHOH <!:>opMe, MOryT HMeTb
3JIeKTpOHHble nO.D.nHCH, KOTopble:
- BHyrpH npe.D.npHSITHSI HMelOT ry )l(e CHJIY, 4TO H «pY4Hble»;
- Hepa3pbIBHO COClIHHeHbl C LlOKYMeHTOM, KOTOpblH OHH Y.D.OCTOBepSiIOT;
- HMelOT .D.ary H BpeMSI, Koma OHH nOCTaBJleHbl.
5.13 THnHlfHble He,lJ,OCT3TKH B ,lJ,OKYMeHT3lU1H
npH npOBC.D.eHHH aY.D.HTa npOH3BO.D.CTB H 03HaKOMJIeHHH C .D.OKYMeH-
TaUHeH npelInpHSlTHH aBTopOM H ero KOJIJIeraMH OTMe4eHbl nOBTOpSlIO-
IllHeCSI He.D.OCTaTKH. HH)I(e npHBOlISlTCSI npHMepbl HaH60Jlee pacnpOCTpa-
HeHHbIX, THnH4HblX He.D.OCTaTKOB.
npHMep I
Hal1MeHOBaHHe 1l0KYMeHTa He COOTBeTCTByeT ero C01lep>KaHI1IO.
Hanpl1Mep, I1HCTPYKUI1S1 Ha3BaHa "nOBe1leHl1e nepcOHaJla B 1.Jl1CTbIX
nOMellleHI1S1X'>, a B 1leHCTBI1TeJIbHOCTI1 C01lep>KI1T 06111l1e TPe60BaHI1S1 K Tex-
HI1Ke 6e30naCHOCTI1. CaMI1 >Ke Tpe60BaHI1S1 K nOBe1leHI1IO 1laHbI B I1HCTPYK-
UI1I1 «OOpSl1l0K nepe01leBaHI1S1'), KOTOpaSI, B CBOIO 01.Jepe1lb, BMeCTO KpaTKoro
11 S1CHOro nepe1.JHSI lleHCTBI1H npl1 nepeOlleBaHl111 npellCTaRJISleT C060H c60p-
HI1K BbI1lep>KeK 113 CTaHllapTOB 11 ny611I1KaUI1H.
npHMep 2
COllep>KaHl1e I1HCTPYKUI1I1 COOTBeTcTByeT HaI1MeHOBaHHIO, HO nopSlllOK
I3bInOJlHeHI1S1 pa60Tbl paCKpblT He n011HOCTblO, JII160 COllep>KI1T HeBbIn011HI1-
MbIe 111111 HeHY>KHbIe lleikTBI1SI.

146
1:106a 5
npHMep 3
J..1HCTPYKUI1IO BbIn011HI1Tb HeB03MO>KHO, TaK KaK nepCOHaJI HaX01lI1TCSI
B aCenTl11.JeCKOH 30He, a npl160pbl, KOTopble OH 1l0Jl)l(eH BKJlI01.JaTb, YCTa-
HORJIeHbl 3£1 npe1le11aMI1 411CTOro nOMellleHI1R.
npHMep 4
B I1HCTPYKUI1I1 roBOpI1TCSI, 'Iero HeJIb3S1 lleJlaTb, BMeCTO OnI1CaHI1S1 TO-
ro, KaK HY>KHO BbInOJlHI1Tb pa60TY. Hanpl1Mep, B I1HCTPYKUI1I1 no y60pKe
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147
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LJeCTBa H np. paCCMaTpHBalOTCSI B .D.PYrHX maBax.
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CTaH.D.apT ASTM E2500 H PYKOBO.D.CTBO FDA «Guidance for Industry. Pro-
cess Validation: General Principles and practices» (CiliA) [15; 33]. AHaJIH3
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150
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Ta MO)l(eT 6bITb Ha4aT 3aKa3 060py.aOBaHHSI.
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CKHX npoueCCOB;
- YKPynHeHHble nJIaHHpOB04Hble pellleHHSI;
- nepe4eHb OCHOBHOro 060py.aoBaHHSI;
- peweHHSI no 4HCTblM nOMellleHHSlM H pa31IeJIeHHIO 30H;
- npHHUHnHaJIbHble peweHHSI no BeHTHJlSlUHH H KOH.aHUHOHHpOBa-
HHIO;
- oueHKY nOTpe6HocTH B 3Hepropecypcax H np.
COCTaB KOHuenUHH OnpelIeJlSleTCSI .aOroBOpOM Me)l(1ly 3aKa34HKOM H
HCnOJIHHTeJIeM. Pe3YJIbTaTOM KOHuenUHH SlBJlSleTCSI 3alIaHHe Ha npoeKTH-
pOBaHHe (yr04HeHHoe 3a.D.aHHe).
Coom6emcm6ue npoeKma npa6UJlllM GMP
npOeKTHaSi .aOKYMeHTaUHSI nO.D.J1e)l(HT comaCOBaHHfO B HaiJ30pHblX
oplaHax. CJle.ayeT HMeTb B BH.ay, 4TO npH 3TOM npOBepSifOTCSI mO.tlbKO
Tpe60BaHHSI npOMbIWJIeHHOH, caHHTapHoH, 3KOJIOrH4eCKOH 6e30nac1l0-
cmu H np.
Ha.D.30pHble opr£1Hbl He npOBepSlIOT COOTBeTCTBHe npoeKTa ero Ha3Ha-
4eHHIO, B TOM 4HCJle npaBHJlaM GMP. 3TO MO)l(eT nOKa3aTbCSI napa.D.OK-
CaJIbHblM: TO, Pa.D.H 4ero C03.aaeTCSI npoeKT, H KaK BbInOJlHSlIOTCSI Tpe60Ba-
HHSI K npOH3BO.aCTBY JIeKapCTBeHHblX cpe.aCTB, He np06epHemCH HUKeM.
Bo BceM MHpe H B POCCHH COOTBeTCTBHe npOH3Bo.aCTBa npaBHJlaM
GMP npOBepSleTCSI HHcneKUHeH, Koma 06beKm lom06 K 3KcTl.Ilyamau.uu.
ECJIH npoeKT oWH604eH H npOH3Bo.aCTBO He COOTBeTcTByeT GMP, TO 3TO
pHCK 3aKa34HKa H ero nJlaTa 3a nOBepXHOCTHblH no.axo.a Ha CTa.D.HH npo-
eKTHpOBaHHSI.
D.nSl 4acTHoro ceKTopa 3a60Ta 0 Ka4eCTBe npoeKTa - .aCJlO caMoro
4acTHoro ceKTopa. A.D.J1S1 rocy.aapCTBeHHblX 3aKa30B HenOHSlTHO, n04eMY
rocy.aapcTBo, BbllleJISISI 3Ha4HTeJIbHble cpelICTBa Ha CTpOHTeJIbCTBO H pe-
KOHCTPYKUHIO npOH3Bo.aCTB JleKapCTBeHHblX cpelICTB, He KOHTpOJIHpyeT HX
COOTBeTCTBHe Tpe60BaHHSlM GMP, Ha4HHaSi C npoeKTa. ECJlH npoeKT
oWH604eH H npOH3BOlICTBO He COOTBeTcTByeT GMP, ero HY)l(HO 6y.aeT ne-
pe.aeJlbIBaTb 3a 6101I)I(eTHble cpe.aCTBa.
CTpOHTeJIbHble HOpMbl H npaBHJIa (CHHnbl), caHHT£1pHO-
3nH.D.eMHOJIOrH4eCKHe np£1BHJIa H HOpMaTHBbl (CaHnHHbl) H lIpyrHe 06S1-
3aTeJIbHble 1I0KYMeHTbl YCTaHaBJlHBalOT MHHHMaJIbHblH COCTaB 1I0KYMeHTa-
UHH .D.J1S1 npelICTaBJleHHSI B HM30pHble opraHbl (apXHTeKTypHO-
nJIaHHpOBO'IHoe ynp£1BJleHHe, opraHbl C£1HHTapHoro H nO)l(apHoro Ha.D.JOpa,
oxpaHbl OKPY)I(alOllleH cpelIbI H np.).

flOOlom06KO npOU3600cm60
153
Ho OHH He OTpa)l(alOT cneu.utjJUKU npOH3BOlICTB C OC06blMH Tpe60Ba-
HHSlMH K meXIlOJlOlUU, KaKHMH S1BJlSlIOTCSI npOH3BOlICTBa JleKapCTBeHHblX
cpe.aCTB, H He Y4HTbIBalOT Tpe60BaHHH GMP.
npoeKT MO)l(eT npoHTH Bce npe.aYCMOTpeHHble nOCTaHOBJleHHeM npa-
BHTeJlbCTBa, CHHnaMH H lIPYrHMH .aoKYMeHTaMH comaCOBaHHSI, HO He
COOTBeTCTBOBaTb GMP. nOJIY4HB comaCOBaHHSI, 3aKa34HK CTpOHT 06"beKT
H TOJlbKO nOTOM npelI"bSlBJlSleT ero HHcneKUHH, KOTopaSl npOBepSleT ero
COOTBeTCTBHe GMP. ECJlH :noro COOTBeTCTBHSI HeT, HY)I(HO Ha4HHaTb Bee
CHa4aJIa.
HaJIHUO pa3pbl6 Me)l(1lY Tpe60BaHHSlMH, BbInOJIHeHHe KOTOpblX npo-
BepSleTCSI npu :JKcnepmU3e npoeKma, H Tpe60BaHHSlMH GMP, npOBepSle-
MblMH .aJlSl Y:JICe lom060lO 06beKma.
PHCK nonaCTb B 3TOT pa3pbIB H nOCTpOHTb He COOTBeTCTBYlOlllee
Tpe60BaHHSlM G M P npOH3BOlICTBO no 6JIaronOJlY4HO comaCOBaHHOMY
npoeKTY BeJIHK. MHOrHe npe.anpHSITHSI nOna.D.alOT B 3TOT pa3pbIB H Hecyr
CYllleCTBeHHble nOTepH.
KaK 3TOro H36e)l(aTb?
npe)I(.D.e Bcero, HY)I(HO S1CHO nOHHMaTb, 4TO Tpe60BaHHSI CHHnOB
He.aOCTaT04Hbl .D.J1S1 npOH3BOlICTBa JIeKapCTBeHHblX cpe.aCTB. OHH He Y4H-
TblBalOT maBHoro - meXHOJlOlUU npOU3600cm6a.
TeXHOJlOrHSI He TOJlbKO 06ecne4HBaeT COOTBeTCTBHe npOlIYKUHH
CBoeMY Ha3Ha4eHHIO H Tpe60BaHHSlM GMP. B npOH3BOLlCTBe
JIeKapCTBeHHblX cpe.aCTB npaBHJlbHaSi TeXHOJIOrHSi - e.aHHCTBCHHaSI
B03MO)l(HOCTb rapaHTHH HX 6e30naCHOCTH.
6.4 TeXHOJlOmlfeCKHH p33,lJ,eJl - OCHOB3 npoeKT3
OCHOBOnOJlaralOWHM pa3.aeJIOM npoeKTa S1BJlSleTCSI pa3.aeJI «TeXHOJlO-
lUlleCKue peUleIlUH».
OH Bcer.aa pa3pa6aTbIBaJICSI nepBblM H LlOJl)l(eH HlITH nepBblM Bcema.
HeJIb3S1 CHa4aJIa .aaTb nJIaHHpOB04Hble peweHHSI nOMellleHHH, a nOTOM
.aYMaTb, pa3MeCTSlTCSI JlH B HHX TeXHOJIOrH4eCKHe JIHHHH H 060Py.aoBa-
HHe, HeJIb3S1 CHa4aJIa npOJlO)l(HTb ceTH 3JIeKTpOCHa6)1(eHHSI, a nOTOM pe-
maTb, KaKHe MOIllHOCTH H HanpSl)l(eHHSI .aOJI)I(Hbl 6blTb.
TexHoJlor Ha OCHOBe npe.aCTaBJleHHOrO eMY npOMblUlJlellHOlO (meXHO-
JlOlUlleCKOlO) pelJlllMeHma pa3pa6aTbIBaeT CJle.aYIOIllI1C .aOKYMeHTbl:
- TeXHOJIOrH4eCKHe cxeMbl C YKa3aHHeM Bcex 3TanOB npOH3BOlICTBa,
I1CXOlIHblX H npOMe)l(yr04Hblx MaTepHaJIOB, Tpe60BaHHH K BOlle, C)I(aTOMY
B031IYXY, ra3aM H np.;
- cneUH<!:>HKaUHH TeXHOJIOrH4ecKoro 060PYlIOBaHHSI;
- n11£1HHpOB04Hble peweHHSI C Y4eTOM Tpe60BaHHH GMP, YK£13aHH-
eM KJl£1CCOB 'IHCTOTbl nOMeweHHH H paccTaHoBKoH 060py.aoBaHHSI;

154
FJl060 6
- nJIaHHpOB04Hble peweHHSI C HaHeceHHeM nOTOKOB MaTepHaJIOB,
nepCOHaJIa, npOMe)l(yr04HoH H roToBoH npOlIYKUHH;
- nopSlllOK Bxo.aa B nOMellleHHSI H BblXOlIa H3 HHX, nOlIa4H MaTepHa-
JIOB H T. .a.;
- OCHOBHble Tpe60BaHHSI K 3KCnJIyaTauHH 4HCTblX nOMellleHHH
(06ecne4eHHe OlIe)I(.D.OH, y60pKa, 06pa60TKa H np.);
- cxeMbl no.aroToBKH BO.abl 04HllleHHoH, BO.abl .D.J1S1 HH"beKUHH, c)I(a-
TOro B03lIyxa H np.;
- 6aJIaHC MOIllHoCTeH npOH3BOlICTBa (YBSl3Ka npOH3BOlIHTeJlbHOCTH
060PYlIoBaHHSI Ha pa3JlH4HblX TeXHOJlOrH4eCKHX CTa.D.HSlX);
- MaTepHaJIbHblH 6aJIaHC;
- BpeMeHHble'.aHarpaMMbl npOH3Bo.aCTBa;
- UlTaT npOH3BOlICTBa H MHoroe .aPyroe.
Ha OCHOBe 3TOro TeXHOJlOr 6bliJaem 3aiJaHuH lIpyrHM CneUHaJIHCTaM
.aJlSl pa3pa60TKH pa3.aeJIOB:
- apXHTeKTYpHO-CTpOHTeJIbHoro;
- OTOnJIeHHSI, BeHTHJISlUHH H KOH.aHUHOHHpOBaHHSI B03.ayxa;
- Bo.aocHa6)1(eHHSI H Bo.aOOTBe.aeHHSI;
- 3JleKTpocHa6)1(eHHSI;
- aBTOMaTH3aUHH;
- oxpaHbl oKpY)l(alOllleH cpe.abl H T. .a.
Bce 3TO o<!:>0pMJlSleTCSI B BHlle nOSlCHHTeJIbHOH 3anHCKH C
He06xo.aHMb1M rpa<!:>H4ecKHM MaTepHaJIOM.
UeHTp npoeKTa H 3aJIOr ero ycnexa 3TO npaBHJIbHble
TeXHOJIOrH4eCKHe pellleHHSI.
HenOHHMaHHe 3TOH npOCTOH HCTHHbl BelIeT K nOTepSlM, BnJlOTb.ao
HeB03MO)l(HOCTH BbInYCK£1 npo.aYKUHH no Y)I(e peaJIH30BaHHOMY npoeKTY.
3a oWH6KH OTBe4aeT CBOHM KapMaHOM TOJIbKO caM JaKa34HK. Pa3-
pa60T4HKH CHHnOB, CaHnHHoB, nOCTaHOBJleHHH H 3aKOHOB HH 3a lITO
He OTBe4alOT H He OTBe4aJIH HHKor.aa.
n03TOMY OWH6KH, HelI04eTbl, ynYllleHHSI H HeCTblKOBKH B HopMa-
THBHblX .aOKYMeHTax HY)l(HO 3HaTb H HY)I(HO .aeJIaTb npoeKT TaK, 4T06bl
OH OTBC4aJl Tpe60BaHHSlM, B TOM 4HCJIe H npaBHJlaM GMP.
ECJlH npoeKT Y)I(e roTOB H eCTb XOTb MaJIeHWee COMHeHHe, HY)I(HO
OT.aaTb npoeKT Ha aTTeCTaUHIO CneUHaJIHCTY, KOTOpblH BbInOJlHHT ee
KOMneTeHTHO H, eCJlH HY)I(HO, .aaCT He06xo.aHMble peKOMeH.aaUHH.
06e 3TH 3a.D.a4H - HenpOCTble.
Pe3YJlbTaTbl HenpaBHJIbHoro no.axo.aa Mbl BHlleJIH MHoroKpaTHo, npo-
BOlISi aTTeCTaUHIO npoeKTOB H Y)I(e nOCTpoeHHblX npOH3Bo.aCTB. 3aKa34HKII
3THX 06"beKTOB ynYCTHJlH, 4TO npoeKT - 3TO cPYH.aaMeHT GMP, H 3aJ10-
)l(HTb ero HY)I(HO rpaMOTHO H HMOJlro.

nOdcom06KO npOU360dcm60
/55
6.5 Y KOro 33K333Tb npoeKT?
KOHe4HO, y TOro, KTO MO)l(eT ero C.aeJIaTb H npe.aJlO)l(HT npHeMJIe-
Mble YCJIOBHSI, He 3aBbiCHT ueHY. A KaK 3TO OnpelIeJlHTb? 3TO Tpy.aHblH
Bonpoc. HHKaKHe JIHUeH3HH, 4JIeHCTBO B CPO (caMoperyJlHpyeMoH op-
raHH3aUHH) H peKJIaMa He SlBJlSlIOTCSI CBH.aeTeJIbCTBOM KOMneTeHTHOCTH.
Y Hac 3a npOeKTHpOBaHHe 6epeTCSI JI1060H.
Ha pblHKe .aeHCTByeT MHO)l(eCTBO opraHH3aUHH, KpynHblx H MeJI-
KHX, KOTopble He npe.aCTaBJlSlIOT ce6e H MaJIOH TOJIHKH TPYlIHocTeH, HO
caMOYBepeHHO H BHeWHe y6elIHTeJIbHO paCCY)I(.D.aIOT 0 GMP.
I1Horna 3TH <!:>HpMbl 6e3 CTeCHeHHSI HCnOJlb3YlOT npoeKTbl, paHee
pa3pa60TaHHble npo<!:>eCCHOHaJIaMH, nepeKpaHBalOT HX nOlI CBOIO 3a.D.a4Y,
KpaCHBO O<!:>0PMJISIIOT H BbllIalOT 3aKa34HKY. EblBalOT H Kpai1HoCTH.
01lHa)I(1lbl K HaM Ha aTTeCTaUl110 nocTynl1J1 npoeKT, «BbInOJlHeHHbIH»
HeH3BeCTHOH HaM 110 3TOro OpraHI13aUl1eH. OTKpblB ero, Mbl YBI11leJII1 CBOH
c06CTBeHHblH npoeKT, npl11.JeM aTTeCTOBaHHblH paHee 3ana1lHblM CneUHaJll1-
CTOM. Ero npoCTO CKOnl1pOBaJll1, 3aMeHHJlH yrnoBble WTaMnbl 11 nOMeCTl1JI11
HOBblH TI1TYJIbHbIH JII1CT C YKa3aHI1eM 1lPYroro 31laHI1S1 11 1lpyrl1x Tpe60Ba-
HI1H. HI1 01lHa CTpoKa B TeKCTe 11 HI1 01lHa JII1HI1S1 B 1.JePTe>Kax He 6blJll1 113-
MeHeHbI.
I1HTepecHo, 1.JTO npoeKT 6blJI cornaCOBaH (caHI1TapHbIH, nO>KapHblH
Ha1l30p 11 1lp.) 11 n01l Hero 6bIJIO 3aKa3aHO o60pY1loBaHl1e. I1HBecTop n04YB-
CTBOBaJl HeJla1lHOe 11 peWI1J1 OT1laTb npoeKT Ha aTTeCTaUl110 HaM. npl1 aTTe-
CTaUl111 6blJl0 YCTaHoRJIeHo HeCOOTBeTCTBl1e npOeKTa 3a1laHI1IO Ha npOeKTI1-
pOBaHl1e 11 1leHCTBI1TeJIbHOCTI1. Ero c01lep>KaHl1e 6blJIO He TOJlbKO HeBepHblM
LUISI 1laHHoro npoI13BO.aCTBa, HO 11 HepeaJIl13yeMblM.
HTaK, Jl1060e .aeJIO Ha4HHaeTCSI C npoeKma.
6.6 ArreCT3u,HH H 3KcnepTH33 npoeKT3
KaK y)l(e OTMe4aJIOCb, 06S13aTeJIbHoi1 3KcnepTH3bl npoeKTOB Ha co-
OTBeTCTBHe GMP HeT. npoeKTbl peaJIH3YIOTCSI, H TOJIbKO nOTOM rOTOBoe
np0I13Bo.aCTBO oueHHBaeTCSI HHcneKUHeH Ha COOTBeTCTBHe Tpe60BaHHSlM
GMP. HaCKOJlbKO caM npoeKT COOTBeTcTByeT GMP, He oueHHBaeT HH-
KTO, eCJlH TOJIbKO caM 3aKa34HK He peWHT OT.aaTb ero Ha aTTeCTaUHIO.
TaKoe nOJlO)l(eHHe xapaKTepHO He TOJIbKO.D.J1S1 POCCHH. B EBpone H
AMepHKe HHcneKUHSI nponepSieT y)l(e roToBoe npOH3Bo.aCTBO. KaK ero
C.lI,eJlaTb Ha.D.Jle)l(aIllHM 06pa30M - 3a60Ta H pHCK 3aKa34HKa.
B CTpaHax, HMelOlllHX .D.J1HTeJlbHbIH OnblT pa60Tbl no GMP, 3aKa3-
4HK TlllaTeJIbHO H OCTOpO)l(HO nOlIxo.aHT K Bbl60PY npoeKTHpOBIllHKa H11H
reHnOlIpSl1I4HKa. OH nOHHMaeT, 4TO pHcKyeT CBOHMH .aeHbraMH, BpeMC-
HeM, penyraUHeH H xopowo BbInOJlHeHHblH 06"beKT HY)I(CH TOJlbKO eMY.

156
1J1060 6
.D.aJIee 3aKa34HK no CBoeH HHHUHaTHBe H 1I06pOBOJlbHO OTlIaeT npo-
eKT Ha aTTeCTaUHIO - Design Qualification (DQ). UeJlb aTTeCTaUHH npo-
eKTa - npOBepHTb COOTBeTCTBHe npoeKTa 3alIaHHIO, npaBHJlaM GMP,
.aPymM HopMaTHBHblM 1I0KYMeHTaM H oueHHTb 3KOHOMH ' leCKYIO ueJIeco-
06pa3HocTb npHHSlTblX peweHHH.
ATTeCTaUHIO npOBo.aHT He3aBHCHMaSi opraHH3aUHSI HJIH 3KcnepT, H3-
BeCTHble B .aaHHoH 06JlaCTH H HMelOlllHe nOJIO)l(HTeJIbHYIO penyraUHIO.
B TaKoH CHCTeMe )l(HTb npOllle. B HeH eCTb YCToH4HBaSl cxeMa B3aH-
MOOTHoweHHH H rocnolIaM aBaHTlOpHCTaM waHCOB 3apa60TaTb HeT.
Y Hac Bce CJlO)l(Hee.
1.JTO )l(e .aeJIaTb 3aKa34HKY?
npe)I(.D.e BCero, Hy)I(HO nOMHHTb, 4TO npoeKT HY)I(eH eMY H TOJlbKO
eMY. 3a Bce oWH6KH nJIaTHTb 6y.aeT OH. CaMoe .aeweBoe - 3TO He caMoe
Bblro.aHoe. npo<!:>eCCHOHaJIbHble <!:>HPMbl, pa60TalOIllHe B 06JlaCTH G M P,
BKJla.D.blBalOT cpelICTBa B nOBblweHHe KBaJIH<!:>HKaUHH CBOHX COTPy.aHH-
KOB, B TOM 4HCJIe 3a Py6e)l(OM, H ce6eCTOHMOCTb HX pa60Tbl Bblllle.
HY)I<HO nOHHMaTb, 4TO opraHH3aUHSI, KOTOpOH 3aKa34HK 1I0BepSieT
CBoe 6y.aYlllee, .aOJI)I(Ha OTBe4aTb .aBYM maBHblM Tpe60BaHHSlM:
- KOMneTeHTHOCTH;
- .a06pOCOBeCTHOCTH.
Tyr HHKaKHe JlHueH3HH He nOMoryr.
Ha060poT, eCJlH <!:>HpMa peKJIaMHpyeT, 4TO y Hee eCTb npaBo Ha
npoeKTHpoBaHHe H cTpOHTeJIbCTBO 4HCTblX nOMellleHHH, TO 3TO .aOJI)I(HO
HaCTOpO)l(HTb (4HCTble nOMellleHHSI OT.aeJIbHO He YKa3aHbl B nepe4He
CTpOHTeJIbHblX BHlIOB lIeSlTeJlbHOCTH, T. e. HaJIHUO He4HCTaSi Hrpa). TOT,
KTO npH6eraeT K YJIOBKaMH .aa)l(e B MaJIOM, He 3aCJIy)I(HBaeT .aOBepHSI.
Hy)I(HO nOHHTepecoBaTbcSI nOCJlY)I(HblM cnHCKOM TOro, KTO 6epeTCSI
npoeKTHpoBaTb HJIH npoBo.aHTb aTTeCTaUHIO npoeKTa. Y Hac B 90-e ro.abl
nOSlBHJlaCb apMHSI OKa3aBwHXCSI He Y .aeJI HaY4HbIX pa60THHKOB H no-
.a06Hb1X HM JIHU. OHH He HMelOT OnblTa pa60Tbl, HO 3aTO MOrYT caMOYBC-
peHHO H 6e3aneJIJISlUHOHHO paCCY)I(1laTb Ha JII06yIO TeMY. 3TH JlHua CO-
UHaJIbHO OnaCHbl. OHH BHywalOT .aOBepHe cBoei-i BHewHOCTblO, YMeHHeM
rJIa.aKO, YBepeHHO H MHOro roBOpHTb H npOH3BOlISlT nepBoe HeOTpa3HMoc
Bne4aTJIeHHe.
TaKHe JIlOlIH, nOXO)l(e, HCKpeHHe C llHTa lOT, 4TO MOryr CYlIHTb 060
BceM. OHH C03.aa1OT HCKYCCTBeHHble np06JIeMbl, BHLlSIT Tpy.aHOCTH TaM,
me HX HeT, H He 3aMe4alOT peaJIbHblX H cepbe3HblX 3a.aa ' l.
ECJIH .D.J1S1 aTTeCTaUHH npoeKTa npHmaweH 3apy6e)l(HblH 3KcnepT, TO
HY)l(HO B nepBYIO 04epellb 1I0roBOpHTbCSI 0 TepMHHax. HH)I(e npHBOlIHTC1
COnOCTaBJleHHe Japy6e)l(HblX TepMHHOB C TepMHHaMH, npHHSlTblMH B
OTe4eCTBeHHOH npaKTHKe.

flOOi!Om06KO npOU3600cm60
157
3a1laHl1e Ha npOeKTl1pOBaHl1e
KOHuenUI1S1 (npl1HUl1nl1aJlbHble pewe-
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npoeKTHaSl 1l0KYMeHTaUI1S1 (cTa1ll1S1 n)
flpe.HCHue HG36GHUR: Ymeep.HCOGeMGR
'1GCmb, T30
Pa60 ' JaSl1l0KYMeHTaUI1S1 (CTa1ll1S1 P)
Design Specification
Concept (Feasibility Study)
Basic Design
Detail Design (Working Drawings)
COOTBeTCTBHe GMP 3aKJIa.D.blBaeTCSI Ha CTa.D.HH npoeKTa, H npoBe-
pSlTb ero peweHHSI, Koma npOH3BOlICTBO c.aaeTCSI B 3KCnJIyaTaUHIO,
n031IHO. nOHHMaSi 3TO, B 3apy6e)l(HOH npaKTHKe pa3BHBaeTCSI n03TanHaSl
aTTeCTaUHSI npoeKTHblX pellleHHH, He orpaHH4HBaSiCb npoeKTHOH .aOKY-
MeHTaUHH. HH)I(e nOKa3aHbl B03MO)J(Hble 3Tanbl npoeKTHpOBaHHSI H aTTe-
CTaUHH.
CTa1lIUI n p oeKTa
3a1laHl1e Ha npoeKTI1-
pOBaHl1e
KOHuenUHSI (eCJlI1 OHa
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npoeKTHaSl1l0KYMeHTa-
UI1S1
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BHeceHl1e 113MeHeHI1H
3Tan aTTeCTaLlHH
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3a.aaHI1S1 Ha npoeKTl1poBaHl1e
111111 KOHuenUl111
(Specification Qualification -
SQ)
ATTecTaUI1S1
npOeKTHOH 1l0KYMeHTaUHI1
(Design Qualification I -
DQI)
ATTecTaUI1S1
pa601.JeH 1l0KYMeHTaUI1I1
(Design Qualification 2 -
DQ2)
KOHTpOJlb 113MeHeHI1H
(Change Control)
Qenb aTTeCTau.HH
npOBepKa npaBI1J1bHO-
CTI1 pa3pa6oTKI1 3a1la-
HI1S1 Ha npOeKTl1pOBa-
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npoBepKa COOTBeTCTBI1S1
npoeKTHoH 1l0KYMeHTa-
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HH)I(e npHBOlISlTCSI TOJlbKO 061llHe Tpe60BaHHSI .D.J1S1 Bcex npOH3Bo.aCTB.
7.2.1 Tpe6oB3HHH fOCT P 52249-2009
Tpe60BaHHSI GMP K nOMellleHHSlM lIaHbl B 4aCTH I rOCT P 52249-
2009 [I].
nJlaHHpOB04Hble peweHHSI nOMellleHHH .aOJl)l(Hbl npe.aYCMaTpHBaTb:
- JIOrH4HYIO nOCJle.aOBaTeJIbHOCTb BbInOJIHeHHSI onepauHH;
- HCKJlI04eHHe nepenyrblBaHHSI MaTepHaJIOB H np0,lJ,YKUHH;
- OTcyrcTBHe nepece4eHHSI MapwpyroB JlBH)I(eHHSI (noToKoB) nepco-
HaJIa, HCXO.aHbIX H ynaKoB04HblX MaTepHaJIOB, npOMe)l(YT04HOH H rOTO-
BOH npOlIYKUHH, eCJlH HHoe He npe.aYCMaTpHBaeTCSI pa3.aeJIeHHeM nOTO-
KOB BO BpeMeHH, HanpHMep, .D.J1S1 He60JIbWlIX npOH3BO,lJ,CTB;
- pa3rpaHH4eHHe npOH3Bo.aCTBeHHbIX 30H H 30H npHeMa nHIllH;
- BbInOJIHeHHe OC06blX YCJlOBHH .D.J1S1 npoH3Bo.aCTB TOKCH4HbIX,
CHJIbHo.aeHCTBYIOIllHX, BaKUHHHblX H lIPyrHx npenapaToB co CneUHaJIb-
HblMH Tpe60BaHHSlMH;
- B03MO)l(HOCTb nOlI.Llep)l(aHHSI nepena.D.OB .aaBJleHHSI B03.ayxa Me)I(.D.Y
nOMellleHHSlMH (npH He06xo.aHMOCTH):
- nopSl.aoK Bxo.aa H BbIXO,lJ,a H3 nOMellleHHH, nepeO,lJ,eBaHHSI nepco-
HaJIa, nepeMellleHHSI MaTepHaJIOB H npolIYKUHH;
- 06ecne4eHHe 3a.D.aHHbIX KJlaCCOB 4HCTOTbl;
- B03MO)l(HOCTb paUHOHaJIbHoro pa3MellleHHSI 060PYlIoBaHHSI C .ao-
cTaT04HblMH nJIOlllalISlMH .D.J1S1 3KCnJIyaTaUHH, TeXHH4ecKoro 06CJIY)I(HBa-
HHSI H peMoHTa;
- y.a06CTBO no.aBOlIa H TeXHH4ecKoro 06CJlY)I(HBaHHSI KOMMYHHKa-
UHH, 3HeproHocHTeJleH, TeXHOJIOrH4eCKHX cpell H np.
nOMHMO 061llHX Tpe60BaHHH npaBHJIa GMP KOHKpeTH3HpYIOT Tpe-
60BaHHSI K pa3JlH4HblM 30HaM:
- npoH3Bo.acTBeHHb1M 30HaM;
- 30HaM CKJlalIHpOBaHHSI;
- 30HaM KOHTpOJISI Ka4ecTBa;
- BcnOMOraTeJIbHblM 30HaM.
K nOMellleHHIM npoH3BolICTB CTepHJIbHblX JleKapCTBeHHblx cpelIcTB
npelI"bSlBmIIOTc1 1I0n011HHTeJIbHble Tpe60mlHHI, KOTOpblC .aaHbl B npl1Jlo-
)l(eHHH I K rOCT P 52249-2009.

178
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CBOIO cneuH<!:>HKY HMeeT npaBHllbHaSi H paUHOHaJIbHaSi opraHH3aUHSI
4HCTblX nOMellleHHH H 4HCTblX 30H.
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JIeHbl B CiliA.
7.2.2 Tpe6oB3HHH CllJA
Ko.aeKc <!:>elIepaJIbHblX npaBHJI CiliA 21 CFR 210, 211 [16] .aaeT
CJle.ayIOWHe Tpe60BaHHSI K 3.aaHHSlM H nOMellleHHSlM (B cOKpallleHHH):
nO.apa31len C
211.42 Tpe60BaHHH K npoeKTY H KOHCTPYKLlHHM
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HblMI1 Cpe1lCTBaMI1 1l0Jl>KHbl HMeTb He06xo1lI1Mble pa3Mepbl. KOHCTPYKUI1IO 11
pacnOJlaraTbCSI TaK, 1.JT06bl o6ecne4l1Tb BbInOJIHeHl1e npe1lYCMOTpeHHbIX
onepaUI1H, OLJI1CTKY H TeXHl11.JeCKOe 06cJlY>KI1BaHHe.
(b) 31laHI151 1l0Jl>KHbl I1MeTb 1l0CTaT01.JHble nJIOllla1l11 1lJISi pa3MellleHHSI
060pY1l0BaHHSI H MaTepl1aJ10B B nOpSl1lKe, npe1l0TBpalllalOllleM nepenYTblB£1-
Hl1e I1CX01lHbIX MaTepHaJlOB, nepBI14HblX ynaKOB01.JHblX M£1Tepl1aJlOB, Cpe1lCTB
1lJISI YKynopKI1, 3TI1 KeTO K, MaTepl1aJlOB, I1cnoJlb3yeMblx B X01le TeXHOJlOrH4e-
CKOro npouecca, I1JII1 rOTOBblX JleKapCTBeHHblX Cpe1lCTB, 11 He 1l0nYCKaTb I1X
3arpSl3HeHI151. npOeKTOM 1l0Jl>KHa 6blTb npe1lYCMOTpeHa TaKaSl OpraHI13aUI1S1
nOTOKOB I1CX01lHbIX 11 nepBH1.JHblX ynaKoB04HbIX MaTepl1aJlOB, cpellCTB LUISI
YK)'nopKI1, 3T11KeTOK, MaTepl1aJlOB. I1CnOJlb3yeMblx B X01le TeXHOJlOm1.JeCKoro
npouecca, 11 rOTOBblX JIeKapCTBeHHblX CpellCTB BHYTpl1 31laHI1S1 I1JII1 Me>K1lY
31laHI1S1MI1, KOTopaSl He 1l0nYCTI1JIa 6bl I1X 3arpSl3HeHI1S1.
(c) TeXHOJIOrH1.JeCKl1e onepaUHI1 1l0Jl}J(Hbl BbInOJIHSlTbCSI BHYTpH cne-
Ul1aJ1bHO Bbl1leJIeHHbIX 30H Tpe6yeMblx p£13MepOB. CJle1lyeT npe1lYCMOTpeTb
OT1leJIbHble 11J111 Bbl1leJleHHble 30Hbl I1JII1 1lpyme Mepbl 3allll1Tbi OT 3arpSl3-
HeHI1H 11J111 nepenYTblBaHI1S1 npl1 BbInOJIHeHl111 CJle1lYlOlllI1X onepaUI1H:
(I) npl1eM, l11leHTI14>I1KaUI1S1, XpaHeHl1e HJlI1 113"bSlTl1e 113 06pallleHI1S1 I1C-
X01lHbIX, nepBl11.JHblX ynaKOB01.JHblX MaTepHaJlOB, cpellCTB LUISI YKynopKI1 11
3TI1KeTOK, Hax01lSl111I1XCSI Ha CTa1l11S1X oT60pa npo6 11 KOHTPOJISI OT1leJIOM KOH-
TpoJlSl Ka1.JeCTBa 110 nepe1la1.J11 I1X B npol13BOllCTBO 11J111 H£1 yn£1KOBKY;
(2) 06pallleHHe C OTKJlOHeHHblMI1 I1CXOllHbIMI1, nepBl11.JHblMH ynaKo-
B01.JHblMH M£1Tepl1aJlaMI1, cpellCTBaMI1 LUISI YKynopKI1 11 3TI1KeTK£1MI1 110 I1X
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ynaKOB01.JHbIX MaTepl1aJlOB, Cpe1lCTB LUISI YKynopKI1 11 3TI1KeTOK;
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JIY1.JeHI1S1 p£13peweHI1S1 H£1 peaJll13aUI1IO;
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peWeHI1S1 Ha peaJIl13aUI1IO;
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3daHUfi U nOMew,eHUfi
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1lJI5I npoI13B01lCTBa 1lPymx JIeKapCTBeHHblX CpellCTB LUISI 1.JeJlOBeKa.
211.48 06eCne'leHHe BOJJ.OH
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mental Protection Agency s Primary Drinking water regulations set forth in 40
CFR part 141). He 1l0nycKaeTcSI nocTynJIeHl1e B01lbl, He COOTBeTCTBYlOweM
3TI1M CTaHllaPTaM, B CI1CTeMbl nl1TbeBOH B01lbI.
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rp1160B, Cpe1lCTB LUlH 4>YMl1raul1l1 (06p£16oTKI1 ra30M), MOlOllll1X 11 1le3I1H4>I1-
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perHCTpl1poBaHHblX B 4>e1lepaJIbHOM aKTe Federal Insecticide, Fungicide, and
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CTBCHHblX cpelICTB 4HCTOTa He HY)I(Ha. YHCTOTa HY)I(Ha Be3.ae, HO Tpe60-
BaHHSI K HeH H MeTOlIbl 06ecne4eHHSI pa3JlH4Hbi.
CmepUJlbHble JleKapCm6eHHbie cpeiJcm6a
rOCT P 52249-2009 (GMP EC), npHJIO)l(eHHe I, YCTaHaBJlHBaCT
Tpe60BaHHSI K llHCTOTe B031Iyxa B npOH3BOlICTBe CTepHJIbHblX JleKap-
CTBeHHblX cpelICTB, a PYKOBOlICTBO FDA CWA - K 4HCTOTe B031Iyxa B
acenTH4eCKOM npOH3BOlICT13e [I, 34].

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onepaUl-1 elspol11 2345 67 e 9 21 0.7 8 9 011 2 3 4 5 16 71B 9 21 23 0-7 B 9 011 2 3 4 5 6 7 6 9 21 0-7890112345 6 7 B 9 122 0-7 11 2 3 4 5 6 7 8 9 21 30.7 89 01 1 2131415
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- COBMeCTI1Tb np0l13Bo.acTBa pa3Hblx npenapaToB B JIHo4>HJlH3HpOBaHHOH 4>opMe HeB03MO)I(H0.
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186
(/la6a 7
nO.ap06HO Tpe60BaHHSI K 4HCTblM nOMellleHHSlM B npOH3Bo.aCTBe
CTepHJIbHblX JIeKapCTBeHHblX cpelICTB paCCMOTpeHbl B KHHre «npOH3BO.a-
CTBO CTepHJIbHblX JleKapCTBeHHblX cpelICTB» [10], KOTopaSi SlBJlSleTCSI npo-
.aOJI)I(eHHeM .aaHHoH MOHorpa<!:>HH.
HeCmepUJlbHble JleKapcm6eHHbie cpeiJcm6a
npaBHJIa G MP He YCTaHaBJlHBalOT KOHKpeTHblX KOJIH4eCTBeHHblX
Tpe60BaHHH K 4HCTOTe nOMellleHHH .D.J1S1 npOH3BOlICTBa HeCTepHJIbHblX
JIeKapCTBeHHblX Cpe,lJ,CTB. B TO )l(e BpeMSI Ha HHX pacnpOCTpaHSIIOTCSI
061llHe nOJIO)l(eHHSI 06ecne4eHHSI «MHHHMaJlbHoro pHcKa 3arpSl3HeHHSI
MaTepHaJIOB H npolIYKUHH».
nOBepxHOCTH npoH3Bo.aCTBeHHblx nOMellleHHH «.aOJl)l(Hbl 6bITb
rJIa.D.KHMH, 6e3 TpelllHH H OTKpbITblX CTbIKOB». D,omKHa 6bITb 06ecne-
4eHa «3<!:><!:>eKTHBHaSi CHCTeMa BeHTHJISlUHH, 060Py.aOBaHHaSi YCTPOH-
CTBaMH KOHTpOJISI B03.ayxa». MHome npe.anpHSITHSI, 4T06bl BbInOJIHHTb
3TH Tpe60BaHHSI, HCnOJIb3YIOT .D.J1S1 HeCTepHJIbHoro npOH3Bo.aCTBa 4H-
CTble nOMellleHHSI, XOTSI B HopMaTHBHblX .aOKYMeHTax 3TOro Tpe60Ba-
HHSI HeT.
3TO HenpHBbl4HaSi .D.J1S1 Hac nOCTaHOBKa .aeJIa: npSlMblX HOpM Ha 4H-
CTOT)' HeT, KOHTpOJISI 3a BbInOJIHeHHeM 3THX YCJIOBHH HeT, a npe.anpHSI-
THSI .a06pOBOJIbHO BKJla.D.blBalOT cpe.aCTBa B 06ecne4eHHe 4 HCTOTbl H no-
BceMeCTHO CTpeMSlTCSI 06ecne4HTb 4HCTOTY npH npOH3Bo.aCTBe HeCTe-
pHJIbHblX JIeKapCTBeHHblX cpe.aCTB.
3a4eM 3TO Hy)I(HO? 3TO HY)J(HO ,lJ,JlSl 06ecne4eHHSI cTa6HJlbHOCTH
npenapaTa Hero .D.J1HTeJIbHOrO cpOKa rolIHOCTH, nOCKOJlbKY 4HCTble no-
MellleHHSI SlBJlSlIOTCSI Halle)l(HblM cpelICTBOM 3alllHTbl npo.aYKUHH OT 3a-
rpSl3HeHHH, B TOM 4HCJIe MHKpoopraHH3MaMH. 3TO .aaeT rapaHTHIO Bbl-
nOJlHeHHSI Tpe60BaHHH K MHKp06HOllOrH4eCKOH 4 HCTOTe.
B npOH3BO,lJ,CTBe TBep.ablX <!:>OpM Ha MHomx npe.anpHSlTHSIX HC-
nOllb3YIOTCSI 30Hbl D (KJlacc 8 I1CO B OCHallleHHOM COCTOSlHHH), a
)l(H.aKHX HeCTepHJlbHblX CpeLlCTB - 30Hbl C (KJlacc 7 I1CO). D.nSl )l(H.a-
KHX HeCTepHJIbHblX npenapaTOB HY)I(Ha 60JIee BblCOKaSi 4 HCTOTa, no-
CKOJIbKY BJlara S1BJlSleTCSI 6JlaronpHSITHOH cpe.aOH ,lJ,JISI pa3MHO)l(eHHSI
MHKpoopraHH3MOB. 6JlarolIapSi 4HCTOTe CpOK ro.aHOCTH npenapaTa .ao-
CTHraeT 3-5 JIeT.
TOHKocTb Bonpoca COCTOHT B TOM, 4TO npH lIeKJIapHpOBaHHH
KJlacca 4 HCTOTbl HJIH THna 30Hbl CJIe.ayeT BbInOJIHHTb Bce Tpe60BaHH1
KOMnJIeKCa CTaHLlapTOB rOCT P I1CO 14644-1 «YHcTble nOMeweHH1
H CBSl3aHHble C HHMH KOHTpOJIHpyeMble cpelIbl» 11 rOCT P 52249-
2009 K nJIaHHpOB04HblM peweHHSlM H KOHCTPYKUHSlM 4HCTblX nOMe-
llleHHH, KOMHaTaM nepeOlIeBaHHSI, MaTepHaJlbHblM WJII03aM, CHCTeMC
BeHTHJlSlUHH H np.
ECJIH :noro He lIeJIaTb, TO MO)l(HO BBeCTH HeCTaHlIapTHble KJlaCCbl
4 HCTOTbl (HanpHMep, F, E, K), cneuH4>HUHpoBaB He06xOlIHMble na-
paMeTpbl (KOHueHTpaUHIO 'laCTHU, nepena.D. LlaBJIeHI1S1 H np., HCXO.aSl

30aHUfi U nOMew,eHUfi
187
H3 KOHKpeTHOH 3alIa4H). B TaKHX nOMellleHHSlX MO)l(eT 6bITb 06ecne-
4eHa HY)I(HaSi 4HCTOTa B031Iyxa npH ynpollleHHblX TeXHH4eCKHX pellle-
HHSlX, HanpHMep, 6e3 KOMHaT nepeo.aeBaHHSI H MaTepHaJIbHblX lllJIIO-
30B.
3Ta MblCJIb 3aJIO)l(eHa B rOCT P 52896-2007 «npOH3BO.aCTBO Jle-
KapCTBeHHblX cpelICTB. TexHoJlorH4ecKoe 060Py.aoBaHHe .aJISI npOH3-
BOlICTBa TBeplIblX JIeKapCTBeHHblX <!:>0pM. 061llHe Tpe60BaHHSI» H PYKO-
BOJ],CTBO ISPE no npOH3BOllCTBY TBep.ablX <!:>OpM H [4, 42].
rOCT P 52896-2007 YCTaHaBJlHBaeT CJIellYlOlllHe Tpe60BaHHSI K
ypOBHSlM 3alllHTbl pa3JlH4HblX 3TanOB TeXHOJIOrH4ecKoro npouecca
(Ta6JIHua 7.1):
ypOBCHb I - 060Py.aoBaHHe H 30Hbl, K KOTOpblM He npelI"bSlBJlSl-
IOTCSI CneUHaJIbHble Tpe60BaHHSI;
ypOBeHb 2 - 060Py.aoBaHHe H 30Hbl, B KOTOpblX CJle.ayeT npH-
HSlTb Mepbl no 3alllHTe OTKpblTOro npo.aYKTa H MaTepHaJIOB, BXO.aSlIllHX
B npo.aYKT;
ypOBCHb 3 - o60Py.aoBaHHe H 30Hbl co CneUHaJIbHblMH Tpe60Ba-
HHSlMH K OKpy)l(alOllleH cpe.ae H cpe.aCTBaM ee KOHTpOJISI .D.J1S1 npe.aOTBpa-
llleHHSI 3arpSl3HeHHSI npo.aYKTa Ii MaTepHaJIOB, BXOllSlIllHX B npo.aYKT, a
TaK)l(e npe.aOTBpallleHHSI yrpaTbl HM CBOHX CBOHCTB.
YKa3aHHble Tpe60BaHH npe.a"bSlBJlSlIOTCSI .D.J1S1 pa604Hx 30H 060PY.a0-
BaHHSI (me BbInOJIHSlIOTCSI onepaUHH C npo.aYKTOM) HJIH nOMellleHHSI, me
pa3MellleHO 060PYlloBaHHe.
3alllHTa npoueCCOB H npo.aYKTa OT 3arpSl3HeHHH, B TOM 4HCJle OT
nepeKpeCTHblX 3arpSl3HeHHH, 06ecne4HBaeTCSI 3a C4eT npHMeHeHHSI:
3aKpbIToro 060PYJ],OBaHHSI;
CHCTeM MOHKH Ha MeCTe (WIP - «Wash-In-Place») HJIH 04HCTKH
Ha MeCTe (CIP - «Clean-In-Place»);
<!:>HJlbTpauHH B03.ayxa, nocTynalOlllero B 060Py.aoBaHHe, B COOT-
BeTCTBHH C Tpe6yeMblM ypOBHeM 3a1llHTbl;
4 HCTOTbl nOMellleHHSI, B KOTOpOM HaXOlIHTCSI 060PYlIOBaHHe;
4HCTOTbl TeXHOJlOrH4eCKHX cpe.a;
KOHTpOJISI napaMeTpOB H np.
CHCTeMbl MOHKH H 04HCTKH Ha MeCTe npelIYCMaTpHBalOT aBTOMaTH-
4eCKYIO 06pa60TKY 060Py.aOBaHHSI no 3aMKHyroH cxeMe, 6e3 KOHTaKTa
06pa6aTbIBaeMblX nOBepXHOCTeH C OKPY)I(alOllleH cpe.aOH H nepCOHaJIOM.
D.nSl o.aHoro H TOro )l(e BH.D.a 060py.aOBaHHSI MOryr nOTpe60BaTbCSI
pa3JlH4Hble ypOBHH 3alllHTbl B 3aBHCHMOCTH OT CJlelIYlQIllHX <!:>aKTopOB:
nJIOIlla.aH nOBepXHOCTH MaTepHaJIOB (npOMe)l(yr04Horo HJIH roTO-
Boro npOlIYKTa), KOHTaKTHPYlOllleH C OKPY)I(alOllleH cpe.aOH;
CneUHallH3aUHH 060PYllOBaHHSI .D.JISI .aaHHoro npo.aYKTa HJIH HC-
nOJIb30BaHHSI 060Py.aOBaHHSI .D.J1S1 pa3JlH4HblX BH.D.OB npOlIYKUHH;
npHcnoc06JIeHHOCTH 060PYlIOBaHHSI K 3<!:><!:>eKTHBHOH 04HCTKe;
CTeneHH rHrpOCKonH4HOCTH npOlIYKTa H BJlHSlHHSI Ha Hero BJlarH.

188
F-w6a 7
Ta6JlUl(a 7.1
PeKoMeHlIyeMble ypOBHH 3alllHTbl npH npOH3Bo.aCTBe TBep.ablX <!:>OpM
Hal1MeHOBaHl1e 3Tana YpoBeHb JaIllI1Tbl 06opy-
TeXHOJIOrl1 ' lecKoro npOtieCca 1I0BaHI1S1 I1J1H nOMellleHI1H
I npl1eM MaTepl1aJlOB I
2 CKJla1lCKl1e nOMellleHI1S1 I
3 83BeWI1BaHI1e 11 pacnpelIeJleHl1e:
- 30Ha B3BeWI1BaHI1S1 LUISI OTKpblTblX MaTepl1a- 3
110B
- oKpY>KalOlllaSl cpe.aa 2
4 CMeWI1BaHl1e OT 2 lIO 3 BKJl101.Jl1TenbHO
5 H3MeJIb1.JeHI1e 3
6 fpaHYJIl1poBaHl1e:
- nOJlHOCTblO 3aKpbITaSl CI1CTeMa, BKJlIOLJaSl 3£1- I
rpY3KY;
- OTKpblTaJl I1JII1 1.JaCTl11.JHO 3aKpbITaSI 3arpY3Ka aT 2 .ao 3 BKJl101.JHTeJIbHO
7 Ta6J1eTHpoBaHl1e 11 KanCYJll1pOBaHl1e 2
8 HaHeceHl1e 060JlO1.JKI1 2
9 n011l1poBKa, copmpoBKa, KOHTpoJIb, ynaKoBKa aT 11I0 2 BKJl101.Jl1TeJIbHO
11 np.
Dpl1Me1.JaHI1S1
I. YpoBeHb 3allll1Tbl 3 OTHOCI1TCSI TOJlbKO K o60py.aoBaHI1IO, ypOBHI1 1112
- K 060pYlIoBaHI11O 11 nOMellleHI1S1M.
2 .lJnSl 06eCne1.JeHI1S1 ypoBHSI 33111I1Tbl 2 MOryT I1CnOJIb30BaTbCSI 1.Jl1CTble no-
MellleHI1S1 C 3OHOH 0 no faCT P 52249-2009 (KJlacc 1.Jl1CTOTbl 8 Hca B
OCHallleHHOM COCTOSlHI1I1 no faCT Hca 14644-1).
Tpe606allUH K tjJUJlbmpau.uu 603iJyxa
D.nSl 060PYLloBaHHSI C 3alllHTOH )-ro ypOBH5I Tpe60BaHHSI K <!:>HJlbTpa-
LlHH B031Iyxa He npelI"bSlBJlSlIOTCSI.
B pa604YIO 30HY o60py.aoBaHHSI C 3alllHTOH 2-ro Ii 3-ro ypoBHeH .aOJl-
)l(eH no.aaBaTbCSI B03LIYX, npowe.awHH 4epe3 BblcoK03<!:><!:>eKTHBHble <!:>HJIb-
TPbl (HEPA <!:>HJlbTpbl) CJlelIYlOlllHX KJlaCCOB no rOCT P EH 1822-1-2010:
Ell -.D.J1S1 3alllHTbl 2-ro ypOBHSI (He HH)I(e);
H 14 - .D.J1S1 3aWHTbl 3-ro ypOBHSI.
D.nSl 060pYlIoBaHHSI C 3alllHToH 2-ro ypOBHSI 3Ha4eHHSI Ta6JlHUbi 7.1
MOryT pacnpoCTpaHSlTbcSI Ha B031IYX nOMellleHHSI. B KOTOpOM YCTaHOBJle-
HO 060PYLloBaHHe. B pa604YIO 30HY C 3alllHTOH 3-ro ypOBHSI B031IYX 1I0Jl-
)l(eH nOlIaBaTbCSI Henocpe.aCTBeHHO 4epe3 cooTBeTcTBYlOlllHH <!:>HJlbTp.
UeJIOCTHOCTb H EPA-<!:>HJIbTpOB CJIelIyeT npOBepSlTb npH aTTeCTaUHH
060pYlIoBaHHSI nepell BBOlIOM ero B 3KCnJIyaTaUHIO, 3aTeM He pe)l(e O.aHO-
ro pa3a B roJ], JIH60 nOCJle 3aMeHbl <!:>HJIbTpOB.
KOHCTpYKUHeH <!:>HJIbTpOB 1I0Jl)l(HO 6bITb 06ecne'leHO y.a06CTBO I1X
3aMeHbl H, npH He06xOlIHMOCTH, O'IHCTKH.

3dOHUfi U nOMeU(eHUfi
189
KOHmpOAbHble Jla6opamopuu
KOHTpOJlbHble JIa60paTOpHH HMelOT npuHu.unUaJlbHOe OmAUlIue OT
npOH3BOlICTBa B nJlaHe Tpe60BaHHH K 4HCTOTe.
3arpSl3HeHHe npOlIYKUHH B npoU36oiJcm6e 6eiJem K 6pQ1(Y, CKpblTOMY
HJlH SlBHOMY. 3arpSl3HeHHe npo6bl B Jla6opamopuu BelIeT K JlO:JICHOnOAO:JICU-
meJlbHOMY pe3YJIbTaT)', T. e. xopowaSl cepHSI MO)l(eT 6bITb OTKJlOHeHa H3-3a
3arpSl3HeHHH, npHBHeceHHblX B npo.aYKT npH KOHTpOJle npo6bl. 3To HHKaK
He BJlHSleT Ha Ka4eCTBO cepHH npo.aYKUI1H, KOTopaSi Y)I(e H3roTOBJleHa, yna-
KOBaHa, HaXOlIHTCSI B KapaHTHHe H O)l(HllaeT peweHHSI: 6bITb BbmYllleHHOH B
peaJIH3aUHIO HJIH OTKJlOHeHHOH. Ho 3TO peweHHe BJlHSleT Ha 3KOHOMHKY.
3alllHTa OT 3arpSl3HeHHH B Jla60paTOpHH MO)l(eT 6bITb caMOH pa3HOH.
Moryr npelIYCMaTpHBaTbCSI JIaMHHapHble lllKa<!:>bl, YCTaHaBJlHBaeMble B 4H-
CTblX nOMellleHHSlX C 30HaMH D, C, B HJlH HeKJIaCCH<!:>HUHPyeMblx nOMellle-
HHSlX. Moryr npHCBaHBaTbCSI HeCTaH.aapTHble KJlaCCbl no peweHHIO npe.a-
npHSITHSI HJlH npOeKTHOH opraHH3aUHH. Moryr HCnOJlbJOBaTbCSI H30JlSlTOpbl,
YCTaHaBJlHBaeMble B HeKJIaCCH<!:>HUHPyeMblx nOMellleHHSlX. D.nSl HCKJlI04eHHSI
pHCKa MHKpo6HOro JarpSl3HeHHSI MO)l(eT npe.aYCMaTpHBaTbCSI CTepHJIH3aUHSI
nOMellleHHH H nepelIaT04HblX KaMep napaMH nepeKHCH Bo.aopo.aa.
UeHa 3THX peweHHH MO)l(eT COCTaBJlSlTb COTHH TblCSl4 EBpo. 3TO
He.aeweBO, HO 3TO JlY4we, 4eM TepSlTb cepHH npo.aYKUHH, CTOHMOCTb KO-
TOpOH cpaBHHMa C 3TOH BeJIH4HHOH.
7.5 CHCTeMbl BeHTHJlHQlfH H KOIl)l,Hll,HOHupOBaHiUl
CHCTeMbl BeHTHJISlUHH H KOHlIHUHOHHpOBaHHSI BOJlIyxa BbInOJlHSlIOT
CJle.aYIOIllHe <!:>YHKUHH:
- o6ecne4eHHe nOMellleHHH .aOCTaT04HbIM KOJIH4eCTBOM HapY:JICHOlO
B03.ayxa no caHHTapHblM HopMaM lIJlSl lIblxaHHSI 4eJIOBeKa;
- YlIaJIeHHe H36bITKOB meTl./lOmbl U 6AalU;
- KOMneHcaUHSI y.aaJIeHHSI BOJ.ayxa 3a npe.aeJIbl 31IaHHSI MeCmHblMU
omCOCllMU H o61lleo6MeHHoH BeHTHJISlUHeH;
- KOMneHcaUHSI nOTepb B03.D.yxa H3-Ja :JKctjJUJlbmpau.uu (nepeTOKa) B .aPY-
fHe nOMellleHHSI H 3a npe.aeJlbl 3.aaHHSI H Ha C03.D.aHHe nepenaiJ06 iJa6JleIlUH;
- o6ecne4eHHe 3a.aaHHoro KJlacca 4HCTOTbl 4HCTblX nOMellleHHH.
CHcTeMbl BeHTHJlSlUHH H npaBHJIbHaSl opraHH3aUHSI nOTOKOB B031Iyxa
BJlSlIOTCSI 3<!:><!:>eKTHBHbIMH cpe.aCTBaMH npelIOTBpallleHHSI nepeKpecmHblX
3alpH3HeHuii.
rOCT P 52249 (GMP EC), lJacmb 1
3.12 B np0l13BOllCTBeHHbiX 3OHax, B 3aBI1CI1MOCTI1 OT BbmycKaeMoH
np01lYKUI1I1, BbInOJIHSleMblX onepaUI1H 11 Tpe60BaHHH K oKPY>KalOllleH cpe1le,
c11ellyeT npe1lYCMaTpl1BaTb 34>4>eKTI1BHYIO CI1CTeMY BeHTI111S1UI1I1 C o6ecne1.Je-
Hl1eM Tpe6yeMoH TeMnepaTYPbl 11, npl1 Heo6xOllI1MOCTI1, RJla>KHOCTI1 B031lyxa
11 ero <j)I1JIbTpaUI1I1.

190
1J106Q 7
Tpe606aHUH CiliA
KOlIeKc <!:>elIepaJIbHblX npaBHJl CiliA 21 CFR Parts 210 and 211
YCTaHaBJlHBaeT CJlelIYlOlllHe Tpe60BaHHSI K BeHTHJISlUHH H KOHlIHUHOHH-
pOBaHHIO [16]:
211.46 BeHTHJlHLlHH, HJlbTpaLlHH, n01l0rpeB H OXJIIDK,lJ.eHHe B03.ayxa
(a) CJle1lyeT 06eCne1.JHTb Heo6xo1lHMYIO BeHTI1J1S1UI1IO.
(b) npl1 npoI13B01lCTBe, ynaKoBKe 11 o6pallleHI111 JIeKapCTBeHHblX
Cpe1lCTB CJle1lyeT, npl1 Heo6xo1lI1MOCTI1, npellYCMOTpeTb KOHTpOJIb 1laBJleHI1S1
B031lyxa, MI1KpOOpraHI13MOB, 3anbIJleHHOCTI1, BJIa>KHOCTI1 11 TeMnepaTypbI.
(c) CnellyeT npe1lYCMOTpeTb CI1CTeMbl clJl1JIbTpaUl111 B031lyxa, BKJl101.JaSl
npe1l4>I1JIbTpbl 11 clJl1JIbTpbI 01.JI1CTKI1 B031lyxa OT 1.JaCTI1U B npl1T04HbIX CI1CTe-
Max npoI13B01lCTBeHHbIX 30H TaM, me 3TO Heo6xo1lI1MO. ECJlI1 B np0I13B01l-
CTBeHHblX 30Hax npe1lYCMOTpeHa peUI1PKYJISlUI1S1 B031lyxa, TO CJle1lyeT npl1-
HSlTb Mepbl no npe1l0TBpallleHI1IO pacnpoCTpaHeHI1S1 nblJll1 OT npo1lYKUI1I1. B
30Hax, me MO>KeT npoI1CX01lI1Tb 3arpSl3HeHI1e B031lyxa B npouecce np0l13-
B01lCTBa, CJIe1lyeT npe1lYCMOTpeTb BblTSI)I(Hble CHCTeMbl I1JIH 1lpyme CpellCTBa.
npe1l0TBpalllalOlllHe pacnpoCTpaHeHHe 3arpSl3HeHI1H.
(d) CI1CTeMbl n01lroToBKI1 B031lyxa LUISI np0I13B01lCTBa, ynaKoBKI1 11 06-
pallleHI1S1 C neHI1UI1JIJII1HOM llOJl)l(Hbl 6blTb nOJIHOCTblO OT1leJIeHbl OT CI1CTeM,
o6ecne1.JI1BaIOWI1X pa60ry Y1.JaCTKOB, Ha KOTOpbIX npoH3Bo1lSITCSI 1lpyme JIe-
KapCTBeHHble cpe1lCTBa LUISI 1.JeJlOBeKa.
Ha caMOM paHHeM 3Tane HO npHHSlTb peweHHe 0 B03MO)l(HOCTH
peUHpKYJISlUHH B03LI.yxa, npHMeHIDI ee Be3.ae, me 3TO B03MO)l(HO no HopMaM
6e30nacHoCTH H caHHTapHblM HopMaM. PeUHPKYJISlUHSI B03.ayxa SlBJlSleTCSI
3<!:><!:>eKTHBHbIM Cpe.aCTBOM 3Heproc6epe)l(eHH5I. TaM, me peUHpKYJlSlUHSI
B03L1.yxa He.aonycTHMa, ueJIeCOO6pa3Ho npHMeHSlTb peKYnepaUHIO TenJla.
Pa31IeJI npoeKTa no BeHTHJISlUHH H KOHllHUHoHHpoBaHHIO .aOJl)l(eH
co.aep)l(aTb;
- npHHUHnHaJIbHble cxeMbl BeHTHJlSlUHH H KOH.aHUHoHHpoBaHHSI C
YKa3aHHeM pacxolIoB B031Iyxa, THnOB <!:>HJIbTPOB, cxeMbl KOHlIHUHoHepoB,
KJlaCCOB 4HCTOTbl nOMellleHHH, nepena.aoB .aaBJIeHHSI, MeCTHblX OTCOCOB:
- Ta6JIHUbl 6aJIaHCOB B03.ayxoo6MeHa;
- pellleHHSI no o6ecne4eHHIO napaMeTpoB MHKpOKJIHMaTa;
- nJIaHbl nOMellleHHH C HanpaBJleHH}JMH .aBH)I(eHHSI nOTOKOB B03.ayxa
H3 O.aHOro nOMellleHHSI B lIpyroe (npH HX HaJIH4HH);
- .aPYrHe npe.aycMoTpeHHble HopMaMH pa3.aeJIbI.
CJlelIYeT nOJ],4epKHYTb pOJlb npHHUHnHaJlbHblX cxeM H Ta6J1HU 5aJIaHcoB
B03lIyxoo6MeHa, nOCKOJlbKY B HHX CBOllSITCSI OCHOBHble peweHHSI, H OHH CJlY-
)l(aT lIOKaJaTeJlbCTBOM npaBHJlbHOCTH BbInOJlHeHHSI TPC60BaHHH TeXHOJlOrHll
H HOpM HJlH n03BOJISlIOT HaHTH Y3KHe Mecra H HelI04eTbl B npoeKTe.
nOlIpo6Hoe COlIep)l(aHHe pa31IeJIa no BeHTHJlSlUHH H KOHlIHUHOHHpO-
BaHHIO B031Iyxa .aaHO B KHHre «YHcTble nOMellleHHSI') [12].

191
r JIaBa 8
OEOPY)J:OBAHlfE If ClfCTEMbI
8.1 TeXHOJlOmlfeCKoe o60PYJ],oB3HHe
CYlllecTByeT MHO)l(eCTBO BH.aOB o6opy.aoBaHHSI .D.J1S1 npOH3Bo.aCTBa
JIeKapCTBeHHblX cpelICTB. 3TO SlBJlSleTCSI CJIe.aCTBHeM pa3Hoo6pa3HSI JIe-
KapCTBeHHblX <!:>OpM H Tpe60BaHHH K HHM. TeM He MeHee, eCTb OCHOB-
Hble Tpe6oBaHHSI, KOTopble .aOJI)I(Hbl BbInOJlHSlTbCSI .D.J1S1 JII06blX npoueCCOB
H BH.aOB o6opy.aOBaHHSI. B .aaHHOH rJlaBe paCCMaTpHBalOTCSI 061llHe Tpe-
60BaHHSI. B Ka4eCTBC npHMepOB lIaHbl oco6eHHocTH o6opy.aOBaHHSI no
npOH3Bo.aCTBY TBep.ablx <!:>0PM, Tpe60BaHHSI K BOlle H C)I(aTOMY BOJ.ayXY.
06opy.aOBaHHe .D.J1S1 npOH3BOlICTBa CTepHJIbHblX JIeKapCTBeHHblX cpelICTB
no.apo6HO He paCCMaTpHBaeTCSI, nOCKOJIbKY 3TOMY nOCBSlllleHa OT.aeJlbHaSi
KHHra 110]. 061llHe MaTepHaJIbI no Ha.ae)l(HOCTH TeXHH4eCKHX cpe.aCTB
.aaHbl B npHJlO)l(eHHH 3.
TexHoJIorH4ecKoe o6opy.aoBaHHe .aOJI)I(HO BbInOJIHSlTb <!:>YHKUHH,
npe.aYCMOTpeHHble TeXHOJIOrH4eCKHM npoueCCOM, H COOTBeTCTBOBaTb
Tpe60BaHHSlM GMP. 3TH Tpe60BaHHSI nOCTOSlHHO COBepllleHCTBYIOTCSI,
.aeTaJIH3HpYIOTCSI H B onpe.aeJIeHHOH CTeneHH y)l(eCT04a IOTCSI, HO o61llaSi
JIOrHKa Tpe60BaHHH OCTaeTCSI HeH3MeHHOH. HH)I(e .aaHbl Tpe60BaHHSI
rOCT P 52249-2009 (GMP EC) H Tpe60BaHHSI npaBHJl cGMP CiliA.
TaKHe Tpe60BaHHSI CnpaBe.D.J1HBbl .D.J1S1 JIf06oro npOH3BOJ],CTBa, HO .D.J1S1
npe.anpHSlTHH <!:>apMaueBTH4ecKoH H Me.aHUHHcKOH npOMblWJIeHHOCTH
OHH KaTeropH4ecKH 06S13aTeJIbHbI.
8.1.1 06UJ.He Tpe6oB3HHH
npaBHJIa GMP (rOCT P 52249) YCTaHaBJlHBalOT CJIe.aYIOIllHe Tpe6o-
BaHHSI K TeXHOJIOrH4eCKOMY o6opy.aoBaHHIO:
- o6opy.aoBaHHe .aOJI)I(HO COOTBeTCTBOBaTb CBoeMY Ha31lalleHUIO;
- 06opYlIoBaHHe .aOJI)I(HO 6bITb npHcnoco6JleHO K OllucmKe H meXHU-
lIecKOMY 06CJlY:JICU6aHUIO;
- caMO o6opy.aoBaHHe, HHBeHTapb H MaTepHaJIbl .D.J1S1 04HCTKH He
iJOJl:JICHbl 6blTb ucmOllllUKllMU 3alpH3HeHUH H HaKaTl./lU6amb 3alpH3HeHUH;
- KOHCTPYKUHSI H pa3MellleHHe o6opy.aOBaHHSI .aOJI)I(Hbl, no B03MO)l(-
HOCTH, UClCJllOllamb 3alpH31lellUH HJlH oUlu6ollHbie iJeiicm6UH;
- 060pYlIOBaHHe He iJOJl:JICHO YXYOUlamb Ka4eCTBO npOlIYKUHH H npe.a-
CTaBJlSlTb KaKYIO-JIH60 onaCHocmb;
- mOIlHocmb npH6opOB H WKaJIa H3MepeHHH lIOJI)I(Hbl COOTBeTCTBO-
BaTb Tpe60BaHHSlM K napaMeTpaM, KOTopble OHH KOHTpOJlHPYIOT;

192
1J1060 8
- '!aCTH TeXHOJlOrH4ecKoro 06oPYlIoBaHHSI, KOHTaKTHpYIOWHe C npo-
.aYKUHeH, He iJOJl:JICHbl BCTynaTb C HeH B peaKu.ulO, 6bliJeJlHmb HJIH a6cop-
6up06amb (HJII1 aiJcop6up06amb) BellleCTBa, OKa3bIBalOIllHe BJlHSlHHe Ha
Ka4eCTBO npOlIYKUHH.
A6cop6u.HH - 06"bCMHOe nOrnOweHl1e BeweCTB >K1111KOCTblO 11J111 TBep-
1lblM BeweCTBOM (£16cop6eHTOM).
AaCOp6L1.HH - cnoco6HOCTb TBeplloro BeweCTBa I1JII1 >K111lKOCTI1 Y1lep-
)l(I1B£1Tb H£1 CBoeH nOBepXHOCTI1 'taCTl1tibl llPYroro BeweCTBa.
B YaCTH II npaBHJl GMP lIaHbl 60JIee lIeTaJIbHble Tpe60BaHHSI K
o6oPy.aOBaHHIO no npOH3Bo.aCTBY aKTHBHblX <!:>apMaueBTH4eCKHX cy6-
CTaHUHH. OHH pacnpOCTpaHSIIOTCSI Ha KOHCTpYKUHIO H MOHTa)l( o6oPY.ao-
BaHHSI, TeXHH4eCKoe 06CJly)l(HBaHHe H 04HCTKY, KaJIH6pOBKY (nOBepKY),
CHCTeMbl C KOMnblOTepHblM ynpaBJleHHeM 11 KOHTpOJleM.
8.1.2 Tpe6oB3HHH CllJA
AHaJIorH4Hble Tpe60BaHHSI C HeKOTopblMH yro4HeHI1S1MH YCTaHOBJle-
Hbl KOlIeKcoM <!:>e.aepaJIbHbIX npaBHJI CiliA 21 CFR, Parts 210 and 211
(npaBHJIa cGMP) [16]:
Pa31leJI D - 06oPY1l0BaHHe
21l.65 KOHCTpYKLlHH o6oPY)J.oBaHHH, ero pa3MepbI H pa3MemeHHe
(a) KOHCTPYKUI1S1 060PY1l0B£1HI1S1 1l0Jl>KH£1 npellYCM£1Tpl1B£1Tb T£1Koe I1C-
nOJlHeHl1e nOBepxHocTeH, I1MelOllll1X KOHT£1KT C I1CX01lHbIMI1 M£1Tepl1aJl£1MI1,
I1cnoJlb3yeMbIMI1 B X01le TeXHOJlOfI11.JeCKoro npouecc£1, I1JII1 roTOBblMI1 Jle-
K£1pCTBeHHbIMI1 cpellCTB£1MI1, 1.JTo6bI OHI1 He BCTynaJll1 B pe£1KUI1IO, He BbI1le-
JISlJlI1 11 He £16cop611POBaJll1 BellleCTBa 11 He 1l0nYCKaJll1 OTKJlOHeHI1H nOK£13£1-
TeJIeH 6e30n£1CHOCTI1, l11leHTI11.J, HOCTI1 34>4>eKTI1BHOCTI1, K£11.JeCTBa I1JII1 '111-
CTOTbl JleK£1pCTBeHHbIX Cpe1lCTB OT 04>I1Ul1aJlbHbIX 11J111 1lpyrl1x YCT£1HOBJleH-
HbIX Tpe60B£1HI1H.
(b) J1106ble BellleCTB£1, I1CnOJlb3yeMbie B p£16oTe, CM£1301.JHbIe 11J111 oXJIa-
)I(1lalOllll1e M£1Tepl1aJlbI He 1l0Jl>KHbI Bcryn£1Tb B KOHT£1KT C I1CX01lHbIMH MaTe-
pl1aJ1aMI1, nepBI1'IHbIMI1 ynaKoB04HbIMI1 M£1Tepl1aJ1£1MI1, cpellCTB£1MH lUI1
YKynopKI1, M£1Tepl1aJ1£1MI1, I1CnOJIb3yeMbIMI1 B X01le TeXHOJlOfI11.JeCKoro npo-
uecc£1, 111111 roTOBbIMI1 JleKapCTBeHHbIMI1 cpe1lCTB£1MI1 11 1l0nYCKaTb OTKJlOHC-
HI1H nOK£13£1TeJleH 6e30n£1cHOCTI1, l11leHTI1 ' IHOCTI1, 34>4>eKn1BHOCTI1, Ka'leCTBa
11J111 411CTOTbI JIeK£1pCTBeHHbIX Cpe1lCTB OT 04>I1Ul1aJlbHbIX I1JII1 1lPYfI1X yCTa-
HORJIeHHblX Tpe6oBaHI1H.
npaBHJIa cG M P YCTaHaBJIHBalOT TaK)I(e Tpe6oBaHH1 K aBTOMaTU-
4eCKOMY, MeXaHJ1LIeCKOMY H 3JleKTpOHHOMY 060PYlIOBaHHIO, O'IHCTKC
H TeXHH'IeCKOMY 06CJIY)I(HBaHI11O 060PYlIOBaHHSI H <!:>HJIbTpaM. npo-
ueCCbl O'IHCTKH paCCMOTpeHbl B rJIaBe 10 KHHrH, )J1JIbTpaUHH - B
KHHre 1101.

06opydo6oHue u CUCmeMbl
193
8.2 KOHTpOJlb napaMeTpOB
npaBJ.'lJIa GMP YCTaHaBJlHBalOT Tpe60BaHHSI K KOHTpOJIIO 060PYlIO-
BaHHSI, npH4eM 3TH Tpe60BaHHSI YCHJIHBaIOTCSI. XOpOWHe <!:>HPMbl-
H3roToBHTeJIH Onepe)l(alOT Tpe60BaHHSI HOpMaTHBHblX .aOKYMeHTOB H
npe.aYCMaTpHBaIOT:
- KOHTpOJlb napaMeTpOB npOueCCOB H 060Py.aOBaHHSI;
- aBTOMaTH3aUHIO pa60Tbl 060Py.aOBaHHSI;
- aBTOMaTH4eCKYIO 04HCTKY H CTepHJIH3aUHIO 060PYlIOBaHHSI.
KOHmpOJlb napllMemp06 n03BOJISleT CJIe.aHTb 3a KpHTH4eCKHM npo-
ueCCOM B pe)l(HMe peaJIbHoro BpeMeHH, HenpepbIBHO. OH .aaeT 06"beK-
THBHoe npelICTaBJleHHe 0 npouecce H Ka4eCTBe npo.aYKUHH. npH OTKJlO-
HeHHH xapaKTepHCTHK npo.aYKUHH OT Tpe60BaHHH cneUH<!:>HKaUHH OH
nOMoraeT HaHTH HX npH4HHY. Pacne4aTKa nOKa3aTeJleH napaMeTpOB B
xo.ae npouecca, npHJIO)l(eHHaSi K npOTOKOJlY cepHH npOlIYKUHH, CJIy)I(HT
.aOKYMeHTaJIbHbIM no.aTBCp)I(.D.eHHeM COOTBeTCTBHSI napaMeTpOB 3a.aaH-
HblM Tpe60BaHHSlM.
UeJIblO KOHTpOJISI napaMeTpOB SlBJlSleTCSI 06HapY)I(eHHe OTKJlOHeHHH
OT HOpMbl H npOrH03HpOBaHHe OTKa30B, T. e. HeCOOTBeTCTBHSI 060PY.a0-
BaHHSI HJlH npouecca 3a.aaHHbIM Tpe60BaHHSlM. D.nSl npelIynpe)I(.D.eHHSI
OTKa30B YCTaHaBJlHBalOTCSI ypOBHH npe.aynpe)l(1leHHSI H .aeHCTBHSI, KOTO-
pble n03BOJISIIOT 3a6JIaroBpeMeHHO BblSlBHTb H YCTpaHHTb npH4HHY OTKa-
3a. nO.ap06Hee 3TOT Bonpoc paCCMOTpeH B npHJIO)l(eHHH 3 no HalIe)l(HO-
CTH 060Py.aoBaHHSI.
A6moMamu3aquH npoqecca CHH)I(aeT HJIH HCKJlI04aeT BJlHSlHHe 4eJIO-
BeKa Ha npouecc. YeJIOBeKY CBOHCTBeHHO 01llH6aTbCSI H pacnpOCTpaHSlTb
3arpSl3HeHHSI. OrpaHH4eHHe Y4aCTHSI 4eJIOBeKa B npouecce HJlH ero HC-
KJlI04eHHe Bo061lle COOTBeTcTByeT lIYXY GMP H, HaBepHoe, 6y.aeT B nep-
cneKTHBe BHeceHO B npaBHJIa GMP.
B COBpeMeHHOM 060Py.aOBaHHH npe.aYCMaTpHBaeTCSI a6mOMamUlle-
CKaH OllucmKa nOBepXHOCTeH, conpHKacalOlllHXCSI C npOlIYKTOM, H, npH
He06xo.aHMOCTH, UX CmepUJlU3aqUH fie3 pa3fiopKU 060pyiJ06alluH, npSlMO Ha
Mecme elO UCnOJlb306aHUH.
3TO CHCTeMbl:
- MOHKH Ha MeCTe - Wash-In-Place (WI P),
- 04HCTKH Ha MeCTe - Clean-In-Place (CIP),
- CTepHJIH3aUHH Ha MeCTe - Sterilization In Place (51 p).
Y HCTOTa (cTepHJIbHOCTb) 060Py.aomlH HSI S1BJISleTCSI KpHTH4eCKHM
YCJIOBHeM. npoueccbl 04HCTKH H CTepHJIH3aUHH no.aJle)l(aT aTTeCTaUHH.
D.nSl TOro 4T06bl npouecc MO)l(HO 6blJlO aTTeCTOBaTb, OH 1I0JI)I(eH
6bITb CTpOro nOBTopSleMblM H He 3aBHceTb OT nOBe.aeHHSI HJlH OWH60K
4eJlOBeKa.

194


1J1060 8


KOHmpOJlbHO-U3.MepUmeJlbHble npu60pbl
CJIe.D.yeT pa3JII1'-JaTb H3MepHTeJIbHble npH60pbl 06lU,elO Ha3Halle1lUH,
H3MepHTeJIbHble npH60pbl, BXOLUllllHe B COCTaB TeXHOJIOm4ecKoro 060-
PY.D.OBaHHSI, H KOHTpOJIbHble npH60pbl (KaJIH6pbl).
113MepHTeJIbHble npH60pbl 061llero Ha3Ha4eHHSI (TepMoMeTpbl, mr-
pOMeTpbl, aHeMOMeTpbl, BOJlbTMeTpbl H .D.p.) nO.D.Jle)l(aT nOBepKe B YCTa-
HOBJleHHOM nopSilIKe B MeTpOJIOm4eCKHX opraHH3aUHSlX.
H3.MepUmeJlbHble npu60pbl, ycmaH06JleHHbie 6 meXHOJlOlUlleCKOM 060-
pyd06aHuu, He nO.D.J1e)l(aT .D.eMOHTa)l(Y H nepelIa4e Ha «nOBepKY» MeTpOJIO-
raM. 3TO 04eHb Ba)l(HaSi MbICJIb. Bo-nepBblx, .D.eMOHTa)l( npH60pa npHBo-
.D.HT K HapyweHHIO ueJlOCTHOCTH 060PYlIOBaHHSI H Tpe6yeT ero nOCJle.D.Y-
IOllleH aTTeCTaUHH. BO-BTOPbIX, MeTpOJlOm MOryT nonpoCTY HcnopTHTb
OTBeTCTBeHHblH npH60p H 3a ::no OTBe4aTb He 6y.D.yr. B-TpeTbHX, MeTpo-
JIom He HMelOT HH MeTO.D.HK, HH Cpe.D.CTB .D.J1S1 KOHTpOJISI MHomx COBpe-
MeHHblX npH60pOB, pOJIb CBO.D.HTCSI K B3HMaHHIO nJlaTbl 3a CBOH «YCJIym»
H <!:>OpMaJIbHOH BbI.D.a4e 6eCCMblCJIeHHblX .D.OKYMeHTOB.
KOHTpOJIbHO-H3MepHTeJIbHble npH60pbl, BXO.D.SlIllHe KaK elIHHoe ue-
JIoe B 060PY.D.OBaHHe, KaJIH6pYIOTCSI no HHCTPYKUHH H3roToBHTeJISI.
TaKOH nopSilIOK npHHSlT BO BceM MHpe H COOTBeTcTByeT Tpe60BaHH-
SlM GMP.
MHome KOllmpOJlbHble npu60pbl He SlBJlSlIOTCSI cpelICTBaMH H3Mepe-
HHSI, nOCKOJIbKY HH4ero He H3MepSifOT, a JIHWb npOBepSiIOT COOTBeTCTBHe
napaMeTpOB 3a.aaHHbIM BeJIH4HHaM, JIH60 BbInOJlHSlIOT <!:>YHKUHfO apH<!:>-
MeTH4ecKoro C4eTa .D.HCKpeTHblx BeJIH4HH (4aCTHU, lllTYK H np.).
npHMep I
C4eT'll1KI1 1.JaCTI1U B B031lyxe H )l(H1lKOCTSlX HH1.Jero He 113MepSlIOT, a
JIHWb C1.JI1TaIOT 1.JHCJIO 4aCTHU, COpTl1pySI I1X no pa3MepaM. TaKl1e npl160pbl
nOlUle>KaT KaJll16poBKe no I1HCTPYKUI1I1 113roTOBI1TeJlSl CaMI1M 113roTOBI1Te-
JIeM, ero npe1lCTaBI1TeJleM, JII160 1lpyroH OpraH113aUl1eH, cnoco6HOH BbInOJl-
HI1Tb :ny pa60ry. 3TOT nOpSl1l0K npl1HSlT 3a py6e>KOM Be31le.


npHMep 2
,lLr!S1 OrpaHI11.JeHI1S1 Ha ra6apl1THYlO BblCOTY aBTOM0611J1S1, Hanpl1Mep,
npl1 npoe31le n01l MOCTOM, Ha onpe1leJleHHOH BblCOTe Ha1l npOe3>KeH 1.JaCTblO
YCTaHaRJII1BaeTCSI nJlaHKa. npl1 3a1leBaHI1I1 KOTOpOH 1laJlbWe 1lBl1raTbCSI HeJIb-
3S1. 3Ta nJIaHKa - npl1Mep KaJlI16pOB, KOTopble I1cnOJlb3YlOTCSI B MaCCOBOM
nOpSl1lKe, He S1BJlSlIOTCSI Cpe1lCTBaMI1 113MepeHI1S1 11 He nOlUle>KaT MeTpOJlOrH-
1.JeCKOMY KOHTpoJlIO.


npHMep 3
,lLr!S1 KOHTpOJlSl '1I1CTOTbl raJaB I1cnOJlb3YlOT I1H1lI1KaTOpHble Tpy6KH,
Hanpl1Mep, (jJl1pMbl Drager, KOTopble MeHSlIOT tiBeT npl1 HaJll11.J1111 onpe1le-
JIeHHblX JarpSl3HeHI1H. 3TO - He cpeiJcm6a U3MepeHUR. Ho MeTpOJlOrH
YMY1lPI1J1I1Cb 11 Ha 3TOM Japa60TaTb, BHecSI UBeToBoH I1H1lI1KaTOp B rocpc-
eCTp CpellCTB 113MepeHI1
i.




060pyiJo60Hue u CUCmeMbl


195


To, 'lTO MeTp0J10fI1 B POCCI1I1 nblTalOTC
1 BBeCTI1 «nOBepKY» 11 rocy-
DapcTBeHHbIH KOHTpOJ1b C'leT'lI1KOB 'laCTI1U 11 llPYfI1X npH60pOB, He 5IB-
J1HlOlllHXC5I cpellCTBaMI1 I13MepeHI1H, He 'lTO I1HOe, KaK He3aKOHHoe HC-
n0J1b30BaHI1e cBoero n0J10)J(eHI15I 11 BbI MOraTeJ1 bCTBO.


8.3 nOK333TeJlU H33H3QeHlUI H 3TTeCT31UfJl (HcnbIT3HUJI)


06
ue mpe60eanUJI
B npaBI1J1aX GMP COllep)J(I1TC5I YHI1BepCallbHOe Tpe60BaHI1e Ha Bce
CJ1Y'laH )J(I13HI1: «KoHcTpYKUI15I, MOHTa)J( 11 nOp5IllOK TeXHJ1llecKoro 06-
CJ1Y)J(HBaHH5I 060pYlloBaHI15I .llOJ1)1(HbI COOTBeTCTBOBaTb ero Ha3Ha'leHI1IO»
(n. 3.34 rOCT P 52249-2009 - GMP EC).
liTO 3TO?
060pY.llOBaHHe 1l0J1)J(HO BbInOJ1H5ITb B03J10)J(eHHbIe Ha Hero
YHK-
UHH. Ero Ha3Ha'leHHe OnpelleJ15IeTC5I TeXH0J10fI1'leCKI1M npoueCCOM (Tex-
H0J10fH'leCKHM pemaMeHTOM). Ka3allocb 6bI, Bce 5ICHO: H
HO nOllO-
6paTb 060PYllOBaHHe, nacnopTHbIe llaHHbIe KOTOpOro COOTBeTCTBYIOT
Tpe60BaHH5IM, YKa3aHHbIM B TeXH0J10fI1'leCKOM pemaMeHTe.
Ho He Bce TaK npOCTO. B TeXH0J10rH'leCKOM perJ1aMeHTe MorYT 6bITb
YKa3aHbI He Bce Tpe60BaHH5I GMP. naCnOPTHbIe llaHHbIe Ha 060PYllOBa-
HHe MOfYT 6bITb OnTHMI1CTH'lHbIMI1 I1J1H He OTpa)J(aTb Tpe60BaHI1H GMP.
ECJ1H 3TO 060PYllOBaHHe - KpHTH'leCKOe, TO ero HY)J(HO HCnbITaTb
(aTTeCTOBaTb) nepe.ll BBO.llOM B 3KCnJ1yaTaUHIO. KaK aTTeCTOBaTb? 3TOT
Bonpoc CTaHOBHTC5I nopoH KaMHeM npeTKHOBeHH5I. B lleHCTBHTeJ1bHO-
CTH OH 5ICeH, Koma eCTb rpaMOTHa5I MeTOllHKa HCnbITaHHM (aTTecTa-
UHH), XOT5I H He Bcema npOCT.
ECJ1H 3TOH MeTOllHKH HeT, TO HH 0 KaKOH aTTeCTaUI1H pe'lH 6bITb
He MO)J(eT, OHa npeBpalllaeTC5I B r3llaHHe H ropbI nYCTbIX 6YMar. To,
'lTO 3TOT Bonpoc DO CI1X nop CYllleCTByeT - CJ1ellCTBHe llecPeKTHOCTI1
HOpMaTI1BHbIX llOKYMeHTOB, HeBe)J(eCTBa 11J1I1 Hell06poCOBeCTHOCTH
Tex, KTO KOMMeHTI1pyeT 11 HaCa)J(DaeT 3TI1 DOKYMeHTbl.
npellnpI15ITH5I-np0I13BOllI1TeJ1I1 J1eKapCTBeHHbIX Cpe.llCTB - He Hay'l-
HO-HCCJ1ellOBaTeJ1bCKI1e HHCTI1TYTbI. OHI1 He MOfYT pa306paTbC5I BO Bcex
TOHKOCT5IX 060PYllOBaHH5I, 'lT06bI OTBeTCTBeHHO pa3pa60TaTb MeTOllI1KY
ero HCnbITaHHH. ECJ1I1 I111TH no 3TOMY nYTI1, TO MeTOllI1K HcnbITaHI1H,
CKa)J(eM, Ta6J1eTnpeCCOB 6YlleT CTOJ1bKO, CKOJ1bKO n0J1b30BaTeJ1eH.
MeTOllI1Ka .llOJ1)J(Ha 6bITb OllHa ll1151 .llaHHoro THna Ta6J1eTnpeCca, 11
elO DOl1)J(Hbl n0J1b30BaTbCH Bce n0J1b30BaTeJ1I1. TOJ1bKO npH 3TOM YCJ10BI1I1
MO)J(eT 6bITb 06ecne l IeHa CpaBHI1MOCTb pa3HbIX np0I13BO.llCTB H 061>eK-
THBHOCTb OueHKI1.
MeTOllI1Ka I1CnbIT<\HI1H (aTTeCTaUI1I1) .llOJ1)1(Ha 6blTb pa3pa60TaHa 113-
rOTOBHTeJ1eM 060pY.llOBaHI15I 11 BXO.llI1Tb B KOMnJ1eKT nOCTaBKI1, npI1'leM B
OCHOBHOH KOMnJ1eKT, a He B onUI1I1. 113roToBI1TeJ1b 060pY.llOBaHHH HeceT
3a Hee OTBCTCTBeHHOCTb.




196
[,1060 8
XOPOWI1H I13roToBHTeJ1b 060PYllOBaHI15I CaM 3aI1HTepeCOBaH B TOM,
'lT06bl ero 060PYllOBaHI1e 6bIJ10 BBe.lleHO B 3KCnJ1yaTaUI1IO 11 pa60TallO
6e3ynpe'lHO. OH caM 3aHHTepeCOBaH 06eCne'lI1Tb 3aKa3'lHKa He06xOllH-
MOH .llOKYMeHTaUI1eH no I1CnbITaHH5IM, 3KCnJ1yaTaUI1I1 11 TeXHH'leCKOMY
06CJ1Y)J(I1BaH 1110.
J[cnbimanUJI (ammecmau,UJI)
rJ1aBHoe. HY)J(HO nOHI1MaTb, 'lTO ne60:JMOJICnO ammecmoeamb 1l.Il0xoe
06opyd06anue U./lU 1l.Il0xoii npou,ecc. I1cnbITaHI15I (aTTeCTaUI15I) - 3TO J1HWb
nOATBep)J(DeHI1e TOro, lITO xopowee 060PYllOBaHHe YCTaHOBl1eHO 11 pa60-
TaeT npaBHJlbHO - TaK, KaK npellYCMOTpeHO ero KOHCTPYKUHeH.
3TO npOCToe H O'leBHllHOe npaBI1J10. Ho ero He 3HalOT MHorHe npo-
H3BOllCTBeHHHKH, KOTopbIe nonallalOTC5I Ha YllO'lKY 3aBepeHI1H nOCTaB-
lllHKOB, 'lTO «Bce 6YlleT OTJ1a)J(eHO H peweHO Ha 3Tane «BallHllaUHH».
nOCTaBlllHK 1l0J1)J(eH BbIllaTb llOKYMeHT (B03MO)J(HO, 3a c06CTBeHHOH
nOllnI1CblO) 0 TOM, 'lTO 060PY.llOBaHHe COOTBeTcTByeT Tpe60BaHH5IM
GMP. nOCTaBlllHK 1l0J1)J(eH llaTb nporpaMMY (MeTOllHKY) aTTeCTaUI1H. B
1l0roBope Ha nOCTaBKY CJlellyeT OnpelleJ1HTb OTBeTCTBeHHOCTb nOCTaBlllH-
Ka Ha CJ1Y'laH, eCJ1H 060PY.llOBaHI1e He npOHlleT I1CnbITaHH5I (aTTeCTa-
lI.HIO). nOp5IllOK aTTeCTaUHH paCCMOTpeH B maBe 9.
B CiliA eCTb Xopowa5I npaKTHKa: CYll npH3HaeT, 'lTO llOJ1)J(HbI BbI-
nOJlH5ITbC5I Tpe60BaHH5I CTaHllapTOB 11 llPYfHX npH3HaHHbIX 1l0KYMeHTOB.
3TO O'leHb YMHO. HeB03MO)J(HO B 3aKOHe I1J1H npaBHJ1aX GMP Y'leCTb Bce
MHO)J(eCTBO TOHKOCTeH. 3TH TOHKOCTI1 3HalOT pa3pa60T'lHKH CTaHllapTOB
H 06111eCTBa I1H)J(eHepOB, KOTopbIe B CBOI1X 1l0KYMeHTax HX nOllp06HO
OnI1CbIBaIOT. nOCTpOHTb npOH3BOllCTBO Ha COBpeMeHHOM ypOBHe, YllO-
BJ1eTBOp5IlOlllee Tpe60BaHH5IM 6e30naCHOCTH H nOKa3aTeJ15IM Ha3Ha'leHmI
H 3cf>eKTHBHOCTH, 6e3 Y'leTa 3TI1X CTaHllapTOB HeJ1b35I.
8.4 060PYAoB3Hue ,1I,JUI npOH3BOACTB3 TBepAblX tJ>oPM
8.4.1 06mHe Tpe60B3HHSI
TexHoJ1ofH'lecKHe npoueCCbI 11 060PYlloBaHHe 1l0J1)J(HbI 06eCne'lHBaTb:
- Tpe6yeMbIH COCTaB npO.llYKTa;
- roMoreHHOCTb (OllHOpOllHOCTb) npOllYKTa;
- 3alllI1TY npO.llYKTa OT pI1CKa 3arp5I3HeHI15I (HanpI1Mep, nYTeM HC-
n0J1b30BaHI15I COOTBeTCTBYlOlllero ypOBH5I 3alllI1TbI);
- npellOTBpallleHI1e nepeKpeCTHblX 3arpH3HeHI1H;
- KOHTpOJ1b napaMeTpOB npouecca (npollYKUI1I1);
- B03MO)l(HOCTb aTTeCT<lUI1I1 KpI1TI1'leCKoro 060PY.llOOaHI1H;
- cTa6I1J1bHOCTb napaMCTpOB 060PY.llOBaHI15I, 06eCne l II1BalOlllYIO
HeI13MCHHOCTb nOKa3aTeJleH npO.llYKUI1I1 B .llOnYCTI1MbIX npe.lleJ1ax;
- Y.ll06CTBO TeXHJ1lIecKoro 06CJlY)I(I1BaHI15I 11 3J<.cnl1yaTaUI1I1.

060pyiJ060Hue u CUCme.Mbl
197
TeXH0110fH'leCKOe 060PYllOBaHI1e .llOJ1)J(HO 06eCne'lI1BaTb COOTBeTCTBI1e
BbInYCKaeMoro npOllYKTa YCTaHOBJIeHHbIM Tpe60BaHH5IM, B TOM 'lI1CJ1e no
CJ1ellYIOUlI1M napaMeTpaM (fOCT P 52896-2007 [4]):
- OllHOpO.llHOCTH;
- pa3MepaM;
- Macce;
- 'lI1CTOTe H .IIPYfHM napaMeTpaM.
Ha Ta6J1eTKaX He 1l0J1)J(HO 6bITb .lleeKTOB pa3Mepa. UBeTa, nOKpbI-
nISI, wpHTa Han.nHCH H pa311eJ1HTeJ1bHoti pHCKH, B TOM 'lHCJ1e:
- BbICTynoB (npHJ1I1nWHX 'laCTI1U nopOWKa);
- yrJly6J1eHI1ti (J1YHOK, BbIKpoweHHbIX 'laCTeH Ta6J1eTOK);
- nbIJ1I1;
- HepaBHOMepHOCTH UBeTa, J10KallbHOro H3MeHeHI15I UBeTa (MpaMOp-
HOCTH);
- CK0J10B;
- CJlI1naHI1H;
- KpoweHHH;
- DeopMaUHH (HapyweHHH oKpymocTH OpMbI);
- uapanHH;
- lleeKTOB nOKpbITH5I, HanpHMep HepaBHOMepHOCTH (pa3J1H'lHOM
TOJllllHHbI) nOKpb1TH5I, ero CMellleHI15I no OTHoweHHIO K 5IllPY.
3aKpblmble U ompblmble cucmeMbl
B 3aBHCHMOCTH OT Tpe60BaHHH K 3alllI1Te npOllYKTa OT BJ1H5IHI15I
OKpy)J(alOllleH cpellbI npoueCCbl (CHCTeMbI) MOfYT 6bITb omKpblmblMU 11
3aKpblmblMU. 3aKpbITbIH npouecc (3aKpbITa5I CI1CTeMa, 3aKpbITOe 060PY-
llOBaHI1e) 03Ha'laeT, 'lTO pa60'la5I 30Ha 11 MaTepI1all (npOllYKUI15I) He KOH-
TaKTHpYIOT C OKpaIOUleH cpen.OH. 6J1aro.llap5I 3TOMY 06eCne'lHBaeTC5I
fjJu3UltecKoe pa3de.llenUe BHYTpeHHero 061>eMa 060PYllOBaHH5I H HaXOll5I-
lllHXC5I B HeM MaTepHallOB H npOllYKTa OT OKPY)J(alOllleH cpellbI, 'leM
06eCne'lHBaeTC5I 60J1ee BbICOKI1ti ypOBeHb 3alllHTbI.
B OTKpbITbIX npoueccax B03MO)J(eH KOHTaKT pa60'leH 30HbI 11 MaTe-
pHallOB (npOllYKUI1H) C OKPY)J(alOllleH cpellOH.
Tpe60eanUR K KoncmpYKu,uu U MamepUQ./lllM
KOHCTPYKUI15I 060PYllOBaHHSI llOJ1)1(Ha 06eCne l lI1BaTb:
- COOTBeTCTBHe 060PYllOBaHI15I CBoeMY na3naltenUIO;
- Tpe6yeMblH ypOBeHb 3aumb' npoiJYKma B 3aBI1CI1MOCTH OT CTene-
HH 3aKpbITOCTI1 060Pyn.OBaHH5I;
- B03MO)J(HOCTb 11 Yll06cTBO OltUCmKU n06epxnocmeii 060PYllOBaHH5I,
conpHKaCalOlllI1XC5I C MaTepHallaMI1 11 npOllYKTaMH;
- MaKCI1MallbHYIO 3aUlI1TY OT OWI160'lHbIX lleHCTBHH nepconQ./la;
- B03MO)J(HOCTb KOnmpO./lR napaMeTpoB;
- B03MO)l(HOCTb meXnU.,eCKOZO 06CJlYJICU6anUR;

198
lJW60 8
- yd06cm60 11 nadeJICnOCmb BbmOJ1HeHI15I np0I13BOllCTBeHHbIX onepa-
UI1H TeXH0J10rI1'leCKoro npouecca;
- 1l0cTynHocTb .llJ15I OCMOTpa;
- HCKJIIO'leHI1e pUCKa 3azpR1HenUR JleKapCTBeHHbIX Cpe.llCTB nbIJ1blO.
ra3aM 11 , napOM 11 np. H nOna.llaHH5I B roTOBbIH npO.llYKT nOCTopOHHHX
MaTepI1allOB, BbIlleJ1eHI1H OT CJ1e.llOB KOpp03I1I1, CMa30'lHbIX MaTepI1allOB 11
llPYfI1X BellleCTB, I1CTO'lHHKOM KOTOpbIX 5IBJ1S1eTC5I 06oPYlloBaHI1e.
MaTepHallbI. npI1MeH5IeMbIe B 060PYlloBaHI1I1:
- He 1l0J1)J(HbI BCTynaTb B peaKII,UIO C npOMe)J(YT0'lHbIM H roTOBbIM
npOllYKTOM H I1CXOllHbIMH MaTepHallaMH;
- He 1l0J1)J(HbI 6blde./lRmb U./lU a6cop6up06amb BellleCTBa, OKa3bIBalO-
lllI1e Bl1I151HHe Ha Ka'leCTBO npOllYKUI1H;
- 1l0J1)J(HbI 6bITb ulnococmoiiKUMU H 06eCneII1BaTb coxpaHeHHe pa60-
Tocnoc06HOCTH 060PYllOBaHH5I B Te'leHHe cpOKa ero CJ1Y)J(6bl npH BbI-
nOJ1HeHHH npellycMoTpeHHbIx pa60T no TeXHI1'leCKoMY 06CJ1Y)J(HBaHHIO;
- He BCTynaTb B peaKUHIO C MOIOUMU U deluntJJUII,UpylOUMU cpell-
CTBaMI1, THnbI KOTOpbIX peKOMeHllOBaHbI np0I13BOllHTeJ1eM I1J1I1 YCTaHOB-
JleHbI HopMaTHBHbIMH llOKYMeHTaMH.
nepe'leHb KpHTH'leCKoro 060PYllOBaHH5I llJ15I npOH3BO.llCTBa TBep.llbIX
OpM, nO.llJ1e)J(alllero aTTeCTaUHH, npHBelleH B maBe 9.
8.4.2 Tpe60B3HIDI K 331l1,11Te npOl\eCCOB H 060PYA0B3HIDI OT 33rpSI3HeHH"
,l],nH Ka)J(,[{oH KpI1TI1'leCKOH ellI1HHUbI 060PYlloBaHH5I CJlellyeT OueHI1-
BaTb pHCK 3arp5I3HeHH5I npOAYKTa 11 MaTepHallOB, BX01l5IlllHX B npOllYKT,
11 npellYCMaTpHBaTb MepbI 3alllHTbI OT 3arp5I3HeHI1H.
CJ1ellyeT oueHHBaTb onaCHOCTb 3arp5I3HeHI1H npOllYKTa H3-3a noCTO-
pOHHHX BKJIIO'leHHH, HaXOll5IlllI1XC5I:
- B HCXO)1HbIX MaTepHallaX;
- Ha nOBepXHOCTH 060PYlloBaHI15I;
- B TeXHOJlOrI1'leCKHX cpellax (c)J(aToM B0311yxe, BOlle, nape H np.);
- B CMa30'lHbIX MaTCpHallaX;
- B OKpalOllleM B0311yxe;
- Ha nepCOHalle 11 np.
npI1 nOllroToBKe np0I13BOllCTBa 11 B npouecce 3KCnJ1yaTaUl1I1 CJ1ellY-
eT aHallH3HpOBaTb npI1'lI1HbI 3arp5I3HeHI1H, onpe.lleJ15ITb KpI1TI1'leCKI1C
TOIIKH, oueHHBaTb pI1CK 3arpSl3HeHI1H, pa3pa6aTbIBaTb H peallI130BbIBaTb
MepbI no npellOTBpallleHI1IO 3arp5I3HeHI1H.
PHCK 3arp5I3HeHHH 3aBI1CI1T OT llJII1TeJ1bHOCTI1 npouecca, KOJ1H'leCTBa
BI1110B npOllYKUI1I1, BbInYCKaeMOH Ha .llaHHOM 060PY.llOBaHI1I1. nepI10.llH'I-
HOCTI1 nepexOlla C BbInYCKa O.llHOro npOilYKTa Ha llpyroH, OT MaTep11 aJ1a,
H3 KOTOpOro H3roTOBJleHO 060PYllOBaHHe 11 np.
,il.n5I CHH)I(eHI1S1 pI1CKa 3arp5I3HCHI15I peKOMeHllYeTC5I npI1MeHSlTb 3aKpbI-
TbIC npoueccbI.

060PY0060Hue u CUCmeMbl
199
Oc06bIe MepbI npellOCTOpO)J(HOCTH CJ1ellyeT npellYCMaTpI1BaTb npI1
npOH3BO.llCTBe ceHcI16I1J1I13I1PYlOlllI1X BellleCTB, aHTH6I10TI1KOB, UI1TOTOK-
CHHOB H CHJ1bHOlleHCTBYlOlllHX J1eKapCTBeHHbIX Cpe.llCTB.
nOBepXHOCTI1 TeXH0J10fH'leCKoro 060PYllOBaHH5I pa3.lleJ15I1OTC5I Ha
TpH rpynnbI:
- COnpHKaCaIOUlI1eC5I C npO.llYKTOM;
- COnpHKaCalOlllI1eC5I C MaTepI1allaMI1, KOTOpbIe BOH.llYT B COCTaB
npO.llYKTa;
- He conpHKaCalOlllI1eC5I C npOllYKTOM H MaTepHallaMH.
COCTaBHbIe 'laCTH 060PYllOBaHH5I B pa60'leH 30He llOJ1)J(HbI 6bITb
rJ1MKI1MH H I13roT0BJ1eHHbIMI1 113 HeTOKCH'lHOro, CTOHKOro K KOpp03HH
MaTepI1alla.
npI1MeHeHHe MaTepI1allOB, COllep)J(alllI1X T5I)J(eJ1bIe MeTallJ1bI (Mellb,
CBHHeu H np.), llJ15I nOBepXHOCTH, conpHKacalOllleHC5I C MaTepHallaMI1
HJ1H npOllYKTOM, HellonYCTHMO.
nOBepXHOCTH pa60'leH 30HbI He llOJ1)J(HbI HMeTb mYXHX «KapMaHOB»,
TeXH0J10fH'leCKH He060CHOBaHHbIX neperopolloK, cTyneHeH, KpOMOK,
pe3KHX CY)J(eHHH nOnepe'lHoro Ce'leHH5I, YXYllwalOlllHX 06pa60TKY HJ1H
CTepHJ1H3aUHIO 3THX nOBepXHOCTeH.
DYHKepbI, eMKOCTH, J10TKI1, )J(eJ106a, HanpaBJ15IlOlllHe llOJ1)J(HbI 6bITb
3aKpbITbI H HMeTb J1erKO O'lHlllaeMYIO mallKYIO nOBepXHOCTb 6e3 llleJ1eH,
3a30pOB, BbIcTynalOlllHx KOHUOB, 3aKJIenOK H llPyrHx 3J1eMeHTOB, 3aTpYll-
H5IIOlllHX caHHTapHYIO 06pa60TKY.
Bce nOBepXHOCTI1 pa60'leti 30HbI 1l0J1)J(HbI 6bITb J1erKO .llOcTynHbI llJ15I
O'lHCTKI1 H KOHTpOJ15I. LlocTynHocTb K CKpbITbIM MeCTaM H HX KOHTpOJ1b
AOJ1)J(HbI 6bITb 06eCne'leHbI B03MO)J(HOCTblO pa360pKH. KOHCTPYKTHBHbIe
3J1eMeHTbI B 3TOM CJ1Y'lae llOJ1)J(HbI 6bITb cHa6)J(eHbI J1erKOpa31>eMHbIMH
coellHHeHH5IMH, 'lT06bI 06eCne'lI1BaTb pa360pKY npeHMYllleCTBeHHO 6e3
npHMeHeHH5I CJ1eCapHoro HHCTpYMeHTa.
8.4.3 KOHTpOJlb n3p3MeTpOB
PeKOMeH.llyeTC5I npellYCMaTpHBaTb HenpepblBHblH KOHTpOJ1b OCHOB-
HbIX napaMeTpOB 060PYlloBaHH5I (npI1 He06xOllI1MOCTI1 no BepXHeMY 11
HH)J(HeMY npe.lleJ1aM), a TaK)J(e .llI1arHOCTHKY npI1 OTKa3e 06oPY.llOBaHI15I.
no B03MO)J(HOCTH ueJ1eC006pa3Ho npellYCMaTpHBaTb pa60TY 060PYlloBa-
HH5I 6e3 npHCYTCTBH5I onepaTopa.
PeKoMeHllyeTC5I npOBOllHTb KOHTpOJ1b CJ1ellYlOlllHX Y3J10B 11
napaMeTpoB:
- pa60TbI OCHOBHOro llBI1raTeJ15I;
- repMeTI1'lHOCTI1 pa60'leH 30HbI;
- n0J10)J(eHI15I OKOH 060PYlloBaHI15I 11 naHeJ1eti B 3aKpbITOM COCT05IHI1I1;
- CKOpOCTI1 nO.lla'lI1 HCXO.llHOro MaTepI1alla;
- YPOBH5I MaTepI1alla B I1CXOllHOM 3arpY30'lHOM 6YHKepe;

200
[;1060 8
- pa60TbI CHCTeMbI MOHKI1 060PY.llOBaHI15I WI P - «Wosh-In-Ploce,)
(MOHKa Ha MeCTe Ta6J1eTnpeCCOB, 06eCnbIJlI1BaTeJ1eH H np.);
- llaBJ1eHI15I C)I(aToro B0311yxa.
napaMeTpbI 060pY.llOBaHI15I (npOllYKTa), CI1fHallbI TpeBOrI1, llaHHbIe 0
HeHCnpaBHOCT5IX .llOJ1)J(HbI pefHCTpI1pOBaTbC5I (HanpI1Mep, B 3J1eKTpOHHOH
OpMe).
npHMepbl
KOHmpOAb napllMemp06 ma6AemnpeCC06
Ta6lleTnpeCCbI KOHTpolll1pYIOT no CJIeJ1YIOUlI1M napaMeTpaM:
- pa60Ta OCHOBHOro J1Bl1raTel151;
- repMeTI1'JHOCTb pa60'Jel1 30Hbl;
- n0110)l(eHI1e OKOH 060PYJ10BaHI151 11 naHel1eH B 3aKpbITOM COCT05lHHI1;
- 6110Kl1poBKa pa60Tbi npl1 OTKJIOHeHl111 napaMeTpoB 111111 BbIKJIIO'JeHI1I1
J1BI1 raTel151;
- 6110Kl1poBKa npl1 OTKpblBaHl111 IIBepeH 33111I1THbIX KOHCTPYKUI1H
- CKOpoCTb nOJ1a'Jl1 Ta611eTO'JHOH MaCCbl;
- ypOBeHb Ta611eTO'lHOH MaCCbI B I1CXOJ1HOM 3arpY30'JHOM 6YHKepe;
- pa60Ta CI1CTeMbl MOHKI1 o60py.nOBaHI151 (WIP - «Wash-In-Place»);
- J1aBlleHl1e C)I(aToro B03J1yxa;
- OTpl1uaTel1bHoe .naBJIeHl1e B 30He Ta611eTl1pOBaHI151 C B03MO)l(HOCTbIO
ero peryl1l1poBaHI151 (c uel1blO 06ecne'JeHI151 6e30naCHOCTI1);
- HaJll1naHl1e Ta611eTO'JH0I1 MaCCbl Ha sePXHl111 nyaHcoH;
- Macca Ta6lleTOK;
- YCI111l1e npeCCOBaHI1H (B MHOroCllOHHblX Ta6lleTKax - DJI51 K3)I(Jl0ro
CJI05l);
- YCl1JIl1e BbITaJlKI1BaHI151 Ta611eTKI1;
- my611Ha Han0l1HeHI151 Ka)l(Jloro C1105l;
- n05lBJIeHI1e 3aTopa Ta611eTOK B pa3rpY30'JHOM YCTpOHCTBe;
- I13JIOM nyaHcoHa;
- UBeT Ta611eTOK.
HY)l(HO npeJ1YCMaTpl1BaTb nOJ1C'JeT Ta611eTOK 11 oropaKOBKY Ta6lleTOK
npl1 HaJll1'Jl1l1 J1e<j)eKTOB, nOCTopoHHI1X BKJIIO'JeHI1H (MeTaJIJIl1'JeCKI1X 11
nl1aCTI1KOBbIX).
Clle.nyeT TaK)I(e npeJ1YCMaTpl1BaTb npeJ10TBpallleHl1e HaJll1naHI151 MaTe-
pl1aJ1a Ha nyaHcoH (HanpI1Mep, 3a C'JeT nOBopoTa nyaHcoHoB B npoTI1BOnO-
110)l(HOM HanpaBlleHl111 cpa3Y)l(e nOClle npeCCOBaHI151, YCTaHOBKI1 llleTOK DJI51
O'JI1CTKI1 nOBepXHOCTI1 nyaHcoHoB 11 np.).
MO)l(eT 6blTb npeJ1YCMOTpeHa OnUI1H CI1CTeMbl nOJ1a'Jl1 CK0l1b351WI1X
BellleCTB Ha BHYTpeHHl1e CTeHKI1 MaTpl1Ubl DJI51 0611er'JeHI151 BbITaJlKI1BaHI11
Ta611eTOK.
KOHmpOAb napllMemp06 KanCYAOHanOAHHIOUI,UX MaWUH
KanCY110Han0l1H5I101ll11e Mallll1Hbl KO HTpol1 11 PY lOT no ClleJ1YIOUlI1M
napaMeTpaM:
- pa60Ta OCHOBHOro J1Bl1raTellH 11 J1Bl1raTel1el1 OCHOBHbIX KOMnOHeHTOB
(BaKYYMHoro Hacoca. nbll1ecoca, nl1TaTelleH 11 np.);
- repMeTI1'JHOCTb pa60'Jei1 30Hbl;
- nOllO)l(CHl1e OKOH 06oPYJ100aHI151 11 naHClleH B 3aKpbITOM COCT05lHI1I1;

060PY0060Hue u CUCmeMb/
201
- 6110Kl1poBKa pa60Tbi npl1 OTKJIOHeHl111 napaMeTpOB 111111 BbIKJIIO'JeHI1I1
OJ1HOro 113 npI1BOJ1HbIX Y3JIOB;
- 6110Kl1poBKa npl1 OTKpblBaHl111 J1BepeH 33111I1THbIX KOHCTPYKUI1H;
- CKOpOCTb nOJ1a'Jl1 nOpOWKa 111111 nel1l1eT 11 TBePJ1bIX )l(ellaTI1HOBbIX
KanCYl1;
- ypOBeHb nOpolllKa 111111 neJlJleT 11 TBepJ1blX )l(ellaTI1HOBbIX KanCYl1 B
3arpY30'JHOM 6YHKepe;
- pa60Ta CI1CTeMbl MOHKI1 060pYJ10BaHI151 (WIP - «Wash-In-Place»);
- J1aBlleHl1e C)I(aToro B03J1yxa;
- 3Ha'JeHl1e BaKYYMa;
- oT6paKOBKa KanCYl1 (HepaCKpblTble nYCTble KanCYl1bl);
- ypOBeHb 33nOllHeHI151 KanCYl1;
- KOlll1'JeCTBO HanOl1HeHHblX KanCYl1.
CllellyeT TaK)l(e npeJ1YCMaTpl1BaTb oT6paKOBKY KanCYl1 npl1 HaJll1'Jl1l1
J1e<j)eKTOB (BM5ITI1H, 3anbIJIeHHOCTI1 11 np.)
8.4.4 KOMOJIeKTHOCTh nOCT3BKU
B KOMnneKT nOCTaBKH 060PYlloBaHH5I 1l0J1)J(HbI BXOllHTb, KaK MHHHMYM:
- 060PYAoBaHHe B COOTBeTCTBHI1 C 3aKa30M;
- 3anaCHbIe 'laCTH Ha COrJ1aCOBaHHbIH nepHOll 3KcnnyaTaUI1I1;
- 3J1eMeHTbl llJI5I coellHHeHH5I 060PYlloBaHHH C BHeWHI1MI1 KOMMY-
HHKaUH5IMH;
- TeXHH'leCKHe llOKYMeHTbI;
- I1HCTPYKUI1I1 no MOHTa)J(Y. 3KCnJ1yaTaUHH H TeXHH'leCKOMY 06cJ1Y-
)J(HBaHI1IO, B TOM 'lHCJ1e no O'lHCTKe 060PY.llOBaHHH;
- 1l0KYMeHTbI no aTTeCTaUHH H HCnblTaHH5IM.
Bce 060PYllOBaHI1e H MaTepI1aJ1bI, BX01l5IlllI1e B KOMnJ1eKT nOCTaBKH,
.llOJ1)J(HbI 6bITb H3ll11e)J(alllHM 06pa30M ynaKoBaHbI B nepBI1'lHYIO ynaKoB-
Ky H TpaHcnopTHYIO Tapy.
K TeXHJ1lleCKI1M 1l0KYMeHTaM OTHOC5ITC5I:
- npHHUI1nl1aJ1bHa5I cxeMa 060PYllOBaHH5I;
- OCHOBHble C60pO'lHbIe 'lepTe)J(I1;
- 'lepTe)J(I1 OCHOBHbIX Y3J10B;
- cneUI1I1KaUHH Ha 060PYllOBaHHe 11 Y3J1bl;
- ::meKTpI1'leCKa5I cxeMa co cneUI1I1KaUI1eH;
- nHeBMaTI1'leCKa5I cxeMa CO cneUI1I1KaUI1eH;
- cxeMa CMa30K 11 nepe'leHb CMa30'lHbIX MaTepI1aJ10B;
- TeXHI1'leCKHe llOKYMeHTbl npOH3BOllI1TeJ15I Ha KOMnOHeHTbI 060PY-
.llOBaHHH (HanpHMep, nbIJ1eCOC, MaWHHY llJI5I nOJ1I1pOBKI1 11 06eCnbIJ1HBa-
HI1H KanCYJ1, CI1CTeMY ynpaBJ1eHHH H np.);
- nepe'IeHb 3anaCHbIX 'laCTeH 11 np.

202
fJ1060 8
K .llOKYMeHTaM no aTTeCTaUI1H H Hcnb1TaHI15IM OTHOC5ITC5I:
- MeTOllI1KI1 aTTeCTaUI1H B nOCTpoeHHOM (ycTaHOBJ1eHHoM), OCHa-
rueHHOM H 3KCnJ1yaTI1pyeMoM COCT05IHI15IX;
- npOTOKOJ1bI npHeMO-CllaTO'lHbIX HCnbITaHHH Ha 3aBO.lle-
H3roTOBI1Tel1e;
- npOTOKOJ1bI npI1eMO'lHbIX I1CnbITaHHH no MeCTY YCTaHOBKI1;
- CepTI1I1KaTbl Ha MaTepI1allbI, COnpI1KaCalOlllI1eCH C npOllYKTOM;
- CepTI1I1KaTbI KallI16pOBKI1 KOHTp0J1bHO-I13MepI1TeJ1bHbIX npI160-
pOB, YCTaHOBJ1eHHbIX Ha 060PYlloBaHHH.
CJ1ellyeT Tpe60BaTb OT 3aBOlla I13rOTOBHTeJ1H npellCTaBHTb lleKJ1apa-
UHIO COOTBeTCTBH5I Tpe60BaHHHM GMP H fOCT P 52896-2007 11 YKa-
3aTb B KOHTpaKTe, 'lTO B CJ1Y'lae HenOllTBep)J(DeHH5I COOTBeTCTBI15I Tpe60-
BaHH5IM G M P npI1 aTTeCTaUHH H Ha'lallbHOM nepI10lle 3KCnJ1yaTaUI1I1
(O.llHH-.llBa rolla) no npI1'lI1He KOHCTPYKUHH H MaTepHallOB 060PYllOBaHH5I
nOCTaBlllI1K KOMneHCI1pyeT Bce 3aTpaTbI.
XOPOWHH npOH3BOllHTeJ1b TaKYIO lleKJIapaUHIO llaCT, nJ10XOH 11 He-
YBepeHHblH Ha'lHeT llI1CKYCCI1IO, 'lTO 3TO He 065I3aTeJ1bHO, 'lTO COOTBeT-
CTBHe Tpe60BaHH5IM GMP 6Y.lleT nOllTBep)J(DeHO nOTOM, npI1 HCnbITaHH-
5IX. C TaKHMH nOCTaBlllI1KaMH J1Y'lwe He I1MeTb lleJ1a.
)J(H3Hb I1lleT Bnepell. 060pYllOBaHHe COBepweHCTByeTC5I, B HeM no-
5IBJ15I1OTC5I HOBbIe YHKUHH H HOBbIe KOHCTPYKTHBHbIe oc06eHHOCTI1, KO-
TopbIe nOTOM MorYT 6bITb nepeHeceHbI B HopMaTHBHbIe .llOKYMeHTbI.
nporpeCCHBHbIe H3MeHeHH5I B 060PYllOBaHHH nOMOfYT J1Y'lwe BbInOJ1-
H5ITb CYllleCTBYlOlllHe Tpe60BaHH5I GMP, 'lTO He ytlneT OT BHHMaHI15I HH-
cneKUHH, eCJ1I1 lla)J(e OHI1 He BHeceHbI B HopMaTHBHbIe llOKYMeHTbI.
B Hllealle 06111I1e Tpe60BaH 1151 G M P K 060PY.llOBaH 1110 CJ1ellOBallO 6bl
KOHKpeTH3I1pOBaTb B CTaHllapTax.
Ho 3TO - Hlleall. I1lleall HellOCTH)J(I1MbIH no OllHOH npOCTOH npI1-
'lHHe: HeT 1l0CTaTO'lHoro KOJ1H'leCTBa CneUHallI1CTOB llOJ1)J(HOH (TOJ1bKO
BbIcweH!) KBallHHKaUHI1, KOTopbIe MOrJ1I1 6bI rpaMOTHO pa3pa6aTbIBaTb
CTaHllapTbI, HllH B HOry C pa3BHTI1eM TeXHHKH.
OT'laCTH MbI nOnbITallHCb 3TY np06J1eMY peWHTb. HaMH pa3pa6OTaH
fOCT P 52896-2007 «np0I13BOllCTBO J1eKapCTBeHHbIX cpellCTB. 060py-
1l0BaHI1e TeXH0J10fH'leCKOe D.115I npOH3BOllCTBa TBepllbIX J1eKapCTBeHHbIX
OpM. 06111I1e Tpe60BaHH5I'),
8.5 Oc06eHHocTH 060PYAOB3HHJI AJlJI npOH3BOACTB3 CTepHJ1bHOn
npOAYKHH
fl1aSHble Tpe60BaHI1H K raKOMY 060PY.llOnaHI11O BbITeKalOl 113 ero
Ha3Ha'leHI15I - np0I13BO.llCTBa CTepI111bHOH npO.llYKUHI1. 3TO Tpe6yeT COB-
MeCTI1MOCTI1 C 'lI1CTbIMI1 nOMeweHI15IMI1, npI1CnOC0611eHHOCTI1 K cTepu-
11 I13aUI1 11 , rapaHTl1pOmlHHoro nbIn0l1HeHI11 CBOHX YHKUI1i1 11 T. .ll.

060PY0060Hue u CUCmeMbl
203
rOCT P 52249-2009 (npl1110)l(eHl1e I, n.n 56-60) YCTaHaBl1l1BaeT
CneUl1aJ1bHble Tpe60BaHI151 K 060pYJ10BaHI1IO, pa60TalOllleMY B np0I13B0J1-
CTBe CTepl111bHblX l1eKapCTBeHHblX CpeJ1CTB, B 'JaCTHOCTI1:
- J1eHTbl KOHBeHepOB He n.Ol1)1(Hbl nepeceKaTb pa3J1el1l1Tel1bHblH 6a-
pbep Me)l(Jly 30HaMI1 A 111111 B 11 np0I13B0J1CTBeHHoH 30HOH C MeHbllleH
'JI1CTOTOH B03J1yxa, eCl1l1 TOllbKO caMa l1eHTa He nOJ1BepraeTCH Henpepbl B-
HOH CTepl111113aUI1I1 (HanpI1Mep, B TYHHel1e CTepl1llI13aUI1I1);
- KOHCTPYKUI151 060pYJ10BaHI151 J1011)1(Ha npeJ1YCMaTpl1BaTb B03MO)l(-
HOCTb paCn0110)l(eHI151 1111ueBOH 'JaCTI1 B 'JI1CTOM nOMellleHl111 11 B03MO)l(-
HOCTb npOBeDeHI151 TeXHI1'JeCKoro 06Cl1Y)l(I1BaHI1H co CTOpOHbl MeHee 'J11-
CTOH 30Hbl;
- Tpe6yeMoe Ka'JeCTBO BOJ1bl DOl1)1(HO 06ecne'JI1BaTbCH npl1 npoeK-
Tl1pOBaHI1I1, Bbl60pe 060pYJ10BaHI1H, MOHTa)l(e 11 TeXHI1'JeCKOM 06Cl1Y)l(I1-
BaHl111 CI1CTeM nOJ1roToBKI1 11 paCnpeJ1el1eHI151 BODbl. He J10nYCKaeTC5I
3Kcnl1yaTaul151 060pYJ10BaHI151 nODroToBKI1 BODbl CBepx npoeKTHoH MOlll-
HOCTI1. npl1roToBlleHl1e, XpaHeHl1e 11 paCnpeJ1el1eHl1e BOJ1bl DJI51 I1H'beK-
UI1H Cl1eJ1yeT BbInOl1H5ITb TaK, 'JT06bl I1CKJIIO'JI1Tb pOCT MI1KpOOpraHI13-
MOB, Hanpl1Mep, 3a C'JeT nOCT05lHHOH UI1PKYl151UI1I1 BOJ1bl npl1 TeMnepa-
Type BbIwe nl1lOC 70T;
- Bce Kpl1TI1'JeCKoe 060pYJ10BaHl1e (CTepl111113aTOpbl, CI1CTeMbl nOJ1-
roTOBKI1 11 <j)1111bTpaUI1I1 B03J1yxa, B03J1YWHble 11 ra30Bble <j)1111bTpbI, CI1-
CTeMbI npl1roToBl1eHI151, XpaHeHI151 11 paCnpeJ1el1eHI1H BOJ1bl 11 np.) J1011)1(HO
6bITb I1CnblTaHO (aTTeCTOBaHO) 11 nOJ1Jle)l(l1T nl1aHOBOMY TeXHI1'JeCKOMY
06Cl1I1BaHI1IO.
nOllp06HO TPe60BaHI15I K 060PYllOBaHHIO llJI5I npOH3BOllCTBa CTe-
pHJ1bHbIX J1eKapCTBeHHbIX cpellCTB paCCMOTpeHbI B KHHre [10].
8.6 Tpe60B3HHJI K BOAe
8.6.1 KrI3CCHHK3U.HJI BH,lI.OB ROAM
PaCCMOTpI1M KJIaCCHHKaUI11O Tpe60BaHHH K BOlle B EBpone, CWA
H POCCI1H.
A) EBponeHcKHH COlO3
B EBpone TPe60BaHH5I K BOlle, HCn0J1b3yeMoH npH npI1roTOBJ1eHI1H
J1eKapCTBeHHbIX cpellCTB, YCTaHOBJ1eHbI EBponeHCKOH apMaKoneeH (EP)
[231. OHa BbIlleJ15IeT CJ1ellYlOlllI1e OCHOBHble BHllbl BOllbl:
- BOlla 0'lHllleHHa5I;
- BOlla BbICOKOO'lI1111eHHa5I;
- BOlla llJl5I I1H1>eKUI1H.
npellYCMaTpI1BaeTC5I I1Cn0J1b30BaHI1e I1llpyrHx BHllOB BOllbI
nOKa3aTeJ1I1 Ka'leCTBa BOllbI H npellellbHbIe 3Ha'leHI15I napaMeTpOB
nOKa3aHbI B Ta6J1I1ue 8.1.

204
r..1060 8
T06J1U1J,0 8.1
CBOllHa5I Ta6J1I1ua
npelleJ1bHbIX 3Ha'leHHH nOKa3aTeJ1eH Ka'leCTBa BO.llbI
N nOKa3aTel1b EJ1. BOJ1a 0'J11- Bona Bbl- BOJ1a DJIH
113MepeHI1H llleHHaH COK00411- I1H'beKUI1H
B 6aJ1K- llleHHa51 B 6aJ1K -
<j)opMe <j)opMe
I MI1Kpo6Hble 3arp5l3HeHI1H KaE* 100 10 10
B I Ml1 B 100 Ml1 B 100 Mll
2 a6111I1H OpraHI1'JeCKI1H yr- Mr/l1 0,5 0,5 0,5
l1epOJ1 (TaC) (ppb*) (500) (500) (500)
3 n pOBOlll1MOCTb MKCM/CM 4,3 1,1 l.l
(CM. Ta6ll. 8.2 11 8.3) npl1 20°C
4 HI1TpaTbl ppm** 0,2 0,2 0,2
5 A11IOMI1HI1H ppb** 10 10 10
6 T 51)1(el1 ble MeTaJll1bl ppm** 0,1 - -
7 EaKTepl1aJ1 bHble EDJMl1 *** < 0,25 < 0,25
(lU/mL) -
3HllOTOKCI1Hbl
*KOE - KOJ1OHueo6p03YIOt«OR eouHuu,o
** ppb - 'tocmeu HO MUJ/J/UOpO, ppm - 'tocmeu HO MUJ/J/UOH
*** < 0,25 npu ucnOJlb30BOHUU BOObl o'tut«eHHou B npou3BoocmBe pocmBopOB
OJ/R OUOJ/U30 6e3 nocJleoYIOUl.ei'o yooJ/eHuR 6oKmepuoJlbHbIX 3HoomoKcuHoB.
Boda oltuennQJI (Purified Water - PW) npellHa3Ha'leHa llJl5I npHro-
TOBJ1eHHH lIeKapCTBeHHbIX cpellCTB, KpOMe Tex, K KOTOpblM npell1>HB1I5I-
IOTC5I Tpe60BaHH5I CTepHJ1bHOCTI1 H anHporeHHOCTH, eCJ1I1 HHoe He oro-
BopeHO H He pa3peweHO (CTp. 3224 Ep).
Pa3J1I1'laIOTC5I BOlla 0'lHllleHHa5I B 6aJ1K-OpMe, T. e. HepaccfJacoBaH-
Ha5I (Hcn0J1b3yeMa5I B np0I13BOllCTBe), H Balla 0'lHllleHHa5I B ynaKOBKe.
MeTOllbl npI1roTOBJ1eHI15I: AI1CTHJ1J15IUI15I, I10HHbIH 06MeH, 06paTHblH
OCMOC HJ1I1 J11060H .IIpyroH npHeMJ1eMblH MeTOll npHrOTOBJ1eHH5I H3 BOllbl,
YllOBJ1eTBOp5IIOllleH Tpe60BaHH5IM llJ15I nOTpe6J1eHI15I 'leJ10BeKOM (nHTbe-
BOH BO.llbI).
npOBOllHMOCTb BOllbI He llOlI)J(Ha npeBbIwaTb YKa3aHHbIX B Ta6J1Hue
3Ha'leHI1H npH COOTBeTCTBYlOlllI1X TeMnepaTypax:
Ta6J1Uu,o 8.2
Tpe60BaHI1H K np0I30J1I1MOCTI1
BOlIbI O'JI1111CHHOH B 3aBI1CI1MOCTI1 OT TeMnepaTypbl
TemepaTYpa, 0 10 20 25 30 40 50 60 70 75 80 90 100
"C
npOBOlIHMOCTb, 2.4 3.6 4,3 5.1 5.4 6.5 7,1 8,1 9,1 9.7 9.7 9,7 10.2
MKCM/cM

06opyo060Hue u cucmeMbl
205
B Ta6J1Hue 8.1 YKa3aHbI nOKa3aTeJ1H Ka'leCTBa BOllbI O'lHllleHHOH B
6allK-opMe. 111151 KOHTpOJ15I 60dbl oltuennoii 6 ynaK06Ke npellYCMOTpe-
HbI TaK)J(e KOHTpOJ1b Ha KHCJ10THOCTb 11 llleJIO'lHOCTb, CO.llep)J(aHI1e OKI1C-
J15IeMbIX BellleCTB, XJ10pl1.ll0B, CYJ1baTOB, aMMOHI15I, KallbUH5I 11 MafHI15I,
OCTaTKOB BellleCTB nOCJ1e HCnapeHI15I.
Boda 6blCOKOOltuw.enHaH (Highl)' Purified Water - H PW)
BOlla BbICOKOO'lI1111eHHa5I - BOlla, npe.llHa3Ha'leHHa5I .llJ15I npI1roToB-
J1eHH5I J1eKapCTBeHHbIX cpellCTB. eCJ111 Tpe6yeTC5I ee BbICOKoe 6I10J1orI1'le-
CKoe Ka'leCTBO, 3a HCKJIIO'leHHeM CJ1Y'laeB, Koma HY)J(Ha BOlla llJ15I I1H1>-
eKUHH (CTp. 3222 Ep).
K MeTOllaM npHroTOBJ1eHH5I OTHOC5ITC5I, HanpHMep, llBOHHOH 06paT-
HbIH OCMOC COBMeCTHO C llpymMH npI13HaHHbIMI1 MeTOllaMI1, TaKHMH KaK
YJ1bTpaHJ1bTpaUH5I H lleI10HH3aUH5I.
T a6-lUu,a 8. 3
Tpe60BaHI1H K npoBOJ1I1MOCTI1 BOJ1bl BbICOKOO'JI1111eHHOH
11 BOJ1bl DJIH I1H'beKUI1H B 3aBI1CI1MOCTI1 OT TeMnepaTypbI
TeMnepm)'pa, 0 5 10 15 20 25 30 35 40 45 50 55 60 65 70 75 80 85 90 95 100
'C
npOBOlIH-
MOCTb, 0,6 0,8 0.9 1.0 1.1 1.3 1.4 1.5 1.7 1.8 1.9 2.1 2,2 2.4 2.5 2.7 2,7 2.7 2.7 2,9 3,1
MKCM/CM
BoiJa iJJIJI unlJeKu.uii (Water for Injections - WFI)
BO.lla .llJ15I I1H1>eKUI1H - BOlla llJl5I npI1rOTOBJ1eHH5I napeHTepallbHbIX
JIeKapCTBeHHbIx cpellCTB, Koma BOlla npellHa3Ha'leHa llJ15I paCTBOpeHH5I
HJ1H pa36aBJ1eHH5I cy6cTaHuHH (eooo OJ1R UHbeKlI,UU 6 60J1K-r/JopMe), J1I160
npenapaTOB .llJ15I napeHTepallbHoro BBelleHI15I (6000 OJ1R UHbeKlI,UU cmepu-
J1U30eOHHOR).
BoiJa iJJIJI unlJeKu.uii 6 6a.1lK-cjJopMe (Water for injections in bulk)
BOlla.llJ15I I1H1>eKUHH B 6allK-cf>opMe - BOlla, nOJ1Y'laeMa5I 113 BOllbI:
- YLlOBJ1eTBOp5IIOllleH Tpe60BaHH5IM K BOlle, npellHa3Ha'leHHOH .llJ15I
nOTpe6J1eHI15I 'leJ10BeKOM, I1J1I1
- H3 BOllbI O'lI1111eHHOH.
MeTOll nOJ1Y'leHI15I - llI1CTI1J1mIUI11 (CTp. 3219 EP).
Boda dJIJI UHlJeKu.uii CmepU./lU30eannaR (Sterilized Water for Injections)
BOlla .llJ15I I1H1>eKUI1H CTepI1J1I130BaHHa5I - BO.lla llJl5I I1H1>eKUI1H B
6allK-OpMe, nOMellleHHa5I B KOHTeHHepbI, YKynopeHHble 11 npOWellWI1e
TenJ10BYIO CTepHJ1I13aUHIO. 111151 KOHTpOJ15I eoiJbl dJIJI unlJe"u.uii CmepU./lU30-
6aHnoii npe.llycMoTpeHbI TaK)J(e KOHTpOJ1b Ha KHCJIOTHOCTb 11 llleJ10'l-
HOCTb, npOBO.llI1MOCTb (MaKCI1MYM 25 MKCM/CM .llJ1H KOHTeHHepoB C HO-
MI1HallbHOH BMeCTI1MOCTblO 10 MJI 11 MCHee 11 MaKCHMYM 5 MKCM/CM 11115I
KOHTeHHepoB C HOMI1HallbHOH BMeCTI1MOCTblO 60JIee 10 MJ1), cOllep)J(aHHC

206
r11060 8
OKI1CJ15IeMbIX BellleCTB, XJ10pl1110B, HI1TpaTOB, cYJlbaTOB, allIOMI1HH5I, aM-
MOHI15I. KallbUI15I 11 MafH 1151 , OCTaTKOB BellleCTB nOCJ1e HCnapeHI15I, KOH-
TpOJ1b HeBHllI1MbIX 'laCTHU, CTepI1J1bHOCTI1 H 6aKTepI1allbHbIX 3H.llOTOKCH-
HOB (MeHee 0.25 Ell/MJ1).
B) CIlIA
(/)apMaKoneR CoeounennbLX llimam06 BbIlleJ15IeT CJ1eilYIOWI1e BHllbI
BOll.bI M5I npHroTOBJ1eHH5I J1eKapCTBeHHbIX cpellCTB (54]:
a) BOlla M5I HH1>eKUHH (Water for injection - WFl), USP 34, c. 4596;
6) DaKTepI10CTaTI1'leCKa5I BOAa M5I HH1>eKUHH (Bacteriostatic water for
injection);
B) CTepHJ1bHa5I BOlla M5I I1HfaJ15IUI1I1 (Sterile water for inhalation);
r) CTepI1J1bHaH BOlla llJ15I I1H1>eKUHH (Sterile water for injection);
A) CTepI1J1bHaH BOlla M5I I1ppI1raUHH (Sterile water for irrigation);
e) BO.lla 0'lHllleHHa5I (Purified water);
)J() BOlla 0'lHWeHHa5I CTepHJ1bHa5I (Sterile purified water).
B Ta6J1I1ue 8.4 npHBe.lleHbI nOKa3aTeJ1H Ka'leCTBa .IIBYX BI1ll0B BOllbI
no cDapMaKonee CoellHHeHHbIx WTaToB USP-34, 2011 r. (B cK06Kax
YKa3aHbl CCbIJ1KH Ha cTaTbH).
Ta6J/uu,a 8.4
npe.llel1bHble 3Ha'JeHI1H nOKa3aTel1eH DJI51 BOJ1bl
nOKa3aTeJIb Bo.aa O'lHllleHHaH Bo.aa )J.JIH HH'beKII.HH
a6111I1H OpraHI1'JeCKI1H 500 ppb 500 ppb
yrl1epoJ1 (no <643» (no <643»
npOBOJ1I1MOCTb no <645> no <645>
MI1Kpo6Hble 3arp5l3HeHI151<645> 100 KaE/Ml1 10 KaE/IOO Ml1
EaKTepl1aJ1bHble 3HJ10TOKCI1Hbl - 0,25 ELl/Ml1
B aHfllHHcKOH TpaHcKpHnUHH 06111I1H OpraHH'leCKHH Yfllepoll 060-
3Ha'laeTC5I KaK TOC (Total Organic Carbon). 3TO COKpallleHHe I1Cn0J1b3Y-
eTC5I B llallbHeHWeM TeKCTe. KOHTpoJ1b TOC H npOBO.llI1MOCTH BBelleHbI B
USP B 1996 r., 11 B EBponeHcKYIO cDapMaKonelO - HeCKOJ1bKO n03)J(e
(TOC - n. 2.2.44, npOBOllHMOCTb - n. 2.2.38).
C) POCCIDI
B HaCT05Illlee BpeM5I B POCCI1I1 lI.eHCTBYIOT llBe apMaKoneHHbIe CTa-
TbH, YTBep)J(DeHHbIe B 1997 r.:
Boda O.,ueHHaR, cDC 42-2619-97
npI1MeH5IeTC5I llJ15I npI1roTOBJleHH5I He I1H1>eKUI10HHbIX J1eKapCTBeH-
HblX Cpe.llCTB, 6eCUBeTHa5I np03pa l IHa5I )J(I1.llKOCTb 6e3 3anaxa 11 BKyca.
YCTaHOBJleHbl Tpe60BaHI11 K:
- pH (OT 5,0 DO 7,0);
- CYXOMY OCTaTKY;

060pyiJ060Hue u cucmeMbl
207
- BOCCTaHaBJ1HBalOlllI1M BellleCTBaM;
- AI10KCI1llY yrJ1epO.lla;
- HI1TpaTaM 11 HI1TpI1TaM;
- aMMI1aKY;
- XJ10pI111aM;
- CYJ1baTaM;
- KallbUI1IO;
- T5I)J(eJ1bIM MeTallJ1aM;
- MHKp06H0J10rH'leCKOH 'lI1CTOTe (He 6arIee 100 MHKpOOpraHH3MOB B I MJ1).
Boda d./lR unlJeKu.uii, <DC 42-2620-97
B Ka'leCTBe MeTOllOB nOJ1Y'leHI15I YKa3aHbI llI1CTI1J1J15IUHH 11 06paTHbIH
OCMOC. Tpe60BaHI15I: llOJ1)J(Ha BbIllep)J(HBaTb HCnbITaHH5I, npHBelleHHbIe B
CTaTbe «Bolla 0'lHllleHHa5I'), 6bITb anI1pOreHHOH, He COllep)J(aTb aHTI1MI1K-
P06HbIX BellleCTB H llpymx 1l06aBOK.
8.6.2 MeTOAbl nOArOTOBKH BO,ll.bI
OCHOBHbIMH BHllaMH BO.llbI 5IBJl5IIOTC5I BO.lla 0'lI1WeHHa5I (PW), BO.lla
BbICOKOO'lHllleHHa5I (HPW) H BOlla ll1151 I1H1>eKUHti (WFI).
BOlla 0'lHllleHHa5I npellHa3Ha'leHa ll1151 npHroTOBJleHH5I HeCTepHJlb-
HbIX OpM, nOJ1Y'leHH5I napa, MbITb5I q)JIaKoHoB H aMnYJ1 (KpoMe nOCJ1ell-
Hero OnOJ1aCKHBaHH5I) H np.
BOlla ll11H I1H1>eKUHH HCn0J1b3yeTC5I ll1151 npHroTOBJ1eHI15I CTepHJlbHblX
cf:>OPM H nOCJ1e.llHero OnOJ1aCKI1BaHI15I nepBI1'lHOH ynaKOBKI1.
EBponeHcKHM areHTCTBOM no oueHKe J1eKapCTBeHHbIx cpellCTB
(EM EA) pa3peweHO HCn0J1b30BaHHe BOllbI BbICOKOO'lHllleHHoti ll1151 I1-
HI1WHOro OnOJ1aCKHBaHI15I npH YCJ10BHH nOCJlellYlOllleH llenI1pOreHH3a-
UHH MaTepI1allOB nepBH'lHOH ynaKOBKI1 11 aTTeCTaUI1I1 npouecca (Note for
Guidance on Quality of Water for Pharmaceutical Use,
CPMP/QWP/158/01, EMEA/CVMP/1I5/01, 20022.). 3TO HMeeT O'leHb
Ba)J(Hoe 3Ha'leHI1e llJ15I npaKTHKI1, nOCKOJ1bKY cYllleCTBeHHo 3KOHOMI1T
KanHTallbHbIe 11 TeKYlllI1e paCXOllbI.
BoiJa iJ.IlJl unlJeKu.uii: iJucmU.ll.llRu.uJl U./lU 06pamnblii OCMOC?
3TOT Bonpoc CTall 6YKBallbHO npI1T'lei1 BO 5I3bluex.
MeTollbI npI1roTOBJ1eHI15I BOllbI llJl5I I1H1>eKUHH
MeTOA ClliA EBPon3 jJnoHHJI POCCHJI
llHcTHJ1Jl5IUH5I + + + +
06paTHbIH OCMOC +* - + +
YJlbTPaHJ1bTpaUI15I +* - + -
* Tpe6yeToi J10Ka3aTellbCTBO 3KBI10aJICHTHOCTI1 3TI1X MCT0J10B MCTOJ1Y J1I1CTI111-
llHUl111

208
F11060 8
B EBpone .llOnYCKaeTC5I npI1roTOBJ1eHI1e BOilbl .IIJ15I I1H1>eKUI1H 113 BO-
llbI nHTbeBoH 111160 BOllbI O'lI1111eHHoH. CJ1ellOBaTeJ1bHO, He065I3aTeJ1bHO
YCTpaI1BaTb .IIBe neTl1I1 UI1pKYJ1HUI1H, CHa'lalla npI1roToBHB BOllY O'lI1111eH-
HYIO, a 3aTeM 113 Hee BOllY ll1151 I1H1>eKUI1H. MO)J(HO 060HTHCb O.llHOH neT-
11eH, cpa3Y roTOB5I BOllY ll1151 HH1>eKUHH.
E6poneiicKQJI fjJapMaKoneR npH3HaeT T011bKO OllHH MeTOll npHrOTOB-
J1eHH5I BO.llbI llJ15I I1H1>eKUI1H - iJucmU.ll.llRlI,ulO.
USP ClliA 3aHI1MaeT 60J1ee rH6KYIO n03HUHIO H llonYCKaeT Hcn011b-
30BaHI1e llHCTHJ1J15IUHH HJ1H llPYroro 3KBI1BalleHTHoro MeTOlla. npH 3TOM
He YKa3bIBalOTC5I KpHTepHH 3KBI1BalleHTHOCTI1 H MeTOllbl I1X nOllTBep)J(De-
HH5I. 3TO CTpaHHO. BMeCTO 'leTKI1X KpI1TepHeB npellJ1aralOTC5I 06111I1e
pa3bI. B TaKHX CJ1Y'la5IX lleJ10 3aXOllI1T B TPYllHYIO H HeOnpelleJ1eHHYIO
06J1aCTb MHeHI1H, a He 5ICHbIX HH)J(eHepHbIX peweHHH. Ha npaKTHKe, CY-
ll5I no ny6J111 KaUI15IM, HaH60J1ee pacnpOCTpaHeHHbIM MeTOllOM 5IBJ15IeTC5I
llHCTHJ1J15I UH5I.
TaKa5I n03HUH5I nOH5ITHa. MHorI1e I1pMbI CWA nOCTaB115IIOT 11e-
KapCTBeHHbIe cpellCTBa B EBpony. Pa60Ta no llBOHHOH TeXH0J10fHH, KO-
ma npOllYKUH5I ll1151 BHYTpeHHero H BHeWHero pbIHKOB npOH3BOllHTC5I no
pa3HbIM npHHUHnaM, He3eKTI1BHa. TeM He MeHee, CYll5I no BbICKa3bI-
BaHH5IM aMepHKaHCKHX cneUI1allI1CTOB (KOHepeHUH5I PDA B BawHHr-
TOHe, CeHT5I6pb 20 II r.) npI1MeHeHI1e 06paTHoro OCMoca ll1151 npHroToB-
11eHI15I BOllbI ll1151 HH1>eKUHH - He pellKOCTb.
$lnoHHH 1l0nYCKaeT npI1MeHeHHe BCex Tpex MeTO.llOB nOllroToBKI1:
llI1CTHJ1J15IUI1IO. 06paTHbIti OCMOC H YJ1bTpaqmJ1bTpaUHIO.
B POCCHH nOCJ1e.llHHH pa3 apMaKOneHHa5I CTaTb5I Ha BOllY ll11H HH1>-
eKUI1H nepeCMaTpI1BallaCb B 1997 r. HY)J(HO OTllaTb 1l0J1)J(Hoe aBTopaM
3TOH cPapMcTaTbH. B Hee 3allO)J(eHO CMeJ10e H npaBI1J1bHOe peweHHe 0
npHMeHeHI1H 06paTHoro OCMoca. Ho co BpeMeHH npI1H5ITH5I 3TOH apM-
CTaTbH npOWJ10 MHOro BpeMeHI1.
HY)J(HO ClleJ1aTb 11 BTOpOH war - BBeCTH HenpepbIBHbIH KOHTpOJ1b
npOBO.llI1MOCTH H 06111ero OpraHI1'leCKoro yrJ1epOlla B BOlle. Toma 06-
pamnblii OCMOC (J1Y'lwe llBOHHOH) B coltemanuu C KOnmpO.lleM 3THX napa-
MeTpOB 06eCne'lI1T Han.e)J(Hoe BbInOJ1HeHI1e Tpe60BaHI1H K BOlle ll11}1 I1H1>-
eKUI1H. 3TOT war 110 CI1X nop He C.lleJ1aH.
HaCKOJ1bKO onpaBllaHa n03HUI1}1 EBponbI? Ha 3TY TeMY e)J(erollHo
npOB01l5ITC5I KOHlepeHUI1I1 11 COBelllaHI15I. Pe3YJ1bTaT I1X O.llI1H: 06paTHbIii
OCMOC MeHee Halle)J(eH, eCTb TPY.llHOCTI1 C aTIeCTaUHeH 11 llOKa3aTeJ1b-
CTBOM ue110CTHOCTI1 YCTaHOBOK 06pHTHOro OCMoca B HenpepblBHOM npo-
uecce 11 np.
H I1KHKI1e 1l0BO.llbI He npI1HI1MHIOTC5I.

060pyrl060Hue u cucmeMbl
209
ABTOp 3allall Bonpoc 5IpOMY CTOpOHHI1KY .llI1CTI1J1J15IUI1I1, O.llHOMY 113
H3BeCTHbIX HHcneKTopOB GMP BeJ1I1K06pI1TaHI1I1: «Ha 'leM OCHOBbIBaeT-
C5I Bawe y6e)J(DeHI1e?» OTBeT 6bIJ1 y6I1HCTBeHHbIM: <<I think so!» - «fl
mOK iJYMOIO!'), 3TO HenOH5ITHO. MO)J(HO llYMaTb (think), 'lTO yrollHO, HO
npH npHH5ITHH cepbe3Horo TeXHH'leCKoro peWeHH5I HY)J(HbI 1l0Ka3aTeJ1b-
CTBa, a He MHeHI15I.
nOxo)J(e, 'lTO paBHeHHe Ha llHCTHJ1J15IUI1IO He 60J1ee, 'leM llorMa H3
TOro )J(e pa3p5IDa, 'lTO KOHTp011b BO.llbI B KOHue XX-ro BeKa no KpI1TepH-
HM 1840 r. (CM. n. 8.6.3).
HHKaKOH AMepI1KH B nJ1aHe 06paTHoro OCMoca OTKpblBaTb He HY)J(-
HO. HY)J(HO B35ITb TO, 'lTO llaBHO HCn0J1b3yeTC5I B llPyrI1X OTpaCJ15IX. Teo-
pH5I H npaKTI1Ka Halle)J(HOCTH CJ10)J(HbIX CI1CTeM HMeeT B CBoeM apCeHalle
3eKTHBHbIe MeTOllbI 06eCne'leHI15I BbICOKOH 6e30TKa3HOCTI1 CI1CTeM,
.aa)J(e eCJ1I1 OHH nOCTpoeHbI Ha 3J1eMeHTax C OTHOCHTeJ1bHO HeBbICOKOH
HMe)J(HOCTblO.
B llaHHOM CJ1Y'lae BbIXOll H3 n0J10)J(eHI1SI O'leBI1lleH: HHO npHMe-
H5ITb llBOHHOH 06paTHbIH OCMOC C KOHTpOJ1eM 06111ero OpraHI1'leCKoro
ymepolla nOCJ1e Ka)J(DOH cTyneHH. BbICOKa5I Han.e)J(HOCTb TaKOH CHCTeMbI
06eCne'lHBaeTC5I pe3epBHpOBaHHeM (.lly6J1I1pOBaHHeM) H HenpepblBHbIM
KOHTpOJ1eM I1CnpaBHOCTH K3)J(DOro 6J10Ka no 06111eMY OpraHI1'leCKOMY yr-
JIepOllY (npOBOllHMOCTI1).
8.6.3 K3'1eCTBO BO,ll.bI
llp06.1leMa
BOlla - OCHOBa Bcero, B TOM 'lHCJIe J1eKapCTBeHHbIX cpe.aCTB H Tex-
HOJIOrH'leCKHX npoueCCOB HX np0I13BOllCTBa.
B 1980-e rollbI Han.30pHbIe opraHbI CWA 06paTHJ1H BHHMaHI1e Ha
peK.IlllMall,UU U om3blebl npodYKlI,UU, CB5I3aHHbIe C 3alpR3nenueM CI1CTeM
nO.llrOTOBKI1 BOllbI. <DapMaKonetiHa5I KOHBeHUI15I COellI1HeHHbIx WTa-
TOB, KOTOpa5I pa3pa6aTbIBaeT H H3llaeT <DapMaKonelO CoellHHeHHblx
WTaToB (USP), 06paTI1J1aCb no 3TOMY nOBOllY B KOMI1TeT no Ka'leCTBY
BOllbI AccoUI1aUI1I1 apMaUeBTH'leCKI1X npoH3BollCTB (Pharmaceutical
Manufacturing Association).
AHallI13 nOKa3all, 'lTO:
- CYllleCTBOBaBWI1e MeTOllbl He 06eCne'lI1BallH nO.llnomy anll./lU3a BO-
llbI 11 YCTapeJ1I1;
- KOHTpOJ1b OCYllleCTB115IJIC5I T011bKO B J1a60paTOpH5IX, nepUOdUlteCKU.
B TO )J(e BpeM5I B 3J1eKTpOHHOH npOMbIWJ1eHHOCTI1 6bIJ1 .llaBHO OCBO-
eH MeTOll KOHTpOJ15I Ka'leCTBa BO.llbI no 06111eMY OpraHI1'leCKOMY ymepOllY
H npOBOllI1MOCTI1, KOTOpbIH .llaeT B03MO)J(HOCTb KOHTpOJ1I1pOBaTb napa-
MeTpbI Henpepbleno, «Ha J1I1HI1I1'), 11 n03B0J15IeT BbI5IBJIITb ece OTKJIOHeHHH
6 MOMeHm UX 603HUKn06euU1I (pI1c. 8.1).
MeTO.llbI KOHTpOllfl BO.llbI He TOl1bKO YCTdpeJ1I1. 3TOMY aHaXpOHI1JMY
BP5ID 1111 CCTb aHaJIOrI1 0 J1pymx OTpaCJ1}Ix.

2/0
[;1060 8
npHMeH5IBWI1eC5I B CWA B Ha'lalle 90-x ro.llOB MeTOllbI KOHTpOJ15I
6bIJ1H pa3pa60TaHbI B nepBoH nOl1OBHHe XIX-ro BeKa, Koma He 6bIJ10
3J1eKTpI1'leCTBa, a napOB03bI TOJ1bKO n05IBI1J1I1Cb.
Y Hac Ha 3TI1X MeTOllax pa60Ta OCHOBaHa 11 no ceH .lleHb.
OC03HaHHe np06J1eMbI H 03HaKOMJ1eHI1e C OnbITOM pa60TbI .IIPYfHX
OTpaCJ1eH n03B0J1I1J10 B C)J(aTbIe CpOKH pa3pa60TaTb 11 npI1H5ITb HOBbIe
apMaKoneHHbIe CTaTbI1 B CWA H EBpone, OCHOBaHHbIe Ha KOHTpOJ1e
BO.llbI O'lI1111eHHOH 11 BOllbI ll1151 HHDeKUHH no 06eMY opzanUlteCKoMY yz-
Jlepooy H npoeoOUMocmu. DYKBallbHO Ha ma3ax n05IBI1J1I1Cb TeXHI1'leCKI1e
cpellCTBa KOHTpOJ15I 3TI1X napaMeTpoB.
Bce n03B0J1I1J10 pe3Ko ynpocTHTb MeTOllbI KOHTpOJ15I BOllbI 11 nOBbl-
CHTb HX 3eKTHBHoCTb. I1CTopH5I pa3BI1TH5I MeTOllOB KOHTpOJ15I Ka'le-
CTBa BOllbI B CWA nOKa3aHa B Ta6J1HUe 8.5112]:
T06J1UU,0 8.5
CTapble H HOBbIe MeTOllbI KOHTpOJ1H BOllbI O'lI1111eHHOH
H BOllblllJ15I HH1>eKUHH no USP
rOll BBe- CTapbIe nepeXOll
lleH 1151 nOKa3aTeJ1H Ha HOBbIe nOKa3aTeJ1I1
1840 CYJ1bcPaTbl
1840 KallbuHH
1850 LI.BYOKHCb ymepolla
1890 Xnop I1CKJIIO'leHbI
1890 AMMI1aK
1890 OKHCJ15IeMble BellleCTBa
1900 T 5I)J(eJ1bIe MeTallJ1bI
1947 DaKTepHH 3aMeHeHo Ha 'lHCJ10 KOE
(cnpaBO'lHa5I BeJ1H'lI1Ha)
1947 06111ee KOl1H'leCTBO I1CKJIIO'leHO
TBepllblX BellleCTB
1970 pH I1CKJIIO'leH
1983 DaKTepI1allbH bIe npH aHallI13e BOllbl
3HllOTOKCHH bI .11115I HH1>eKUI1H
1996 - 06111I1H OpraHH'leCKHti ymeooll
1996 - n POBOllHMOCTb
fl151J151 Ha 3TO Ta6lll1UY, BCnOMI1HaeTC5I ellle OJ1Ha J1aTa. B Ballll1HITOHe
Ha ymy 7-i1 11 F Yl1l1U eCTb 31IaHI1e C MeMOpl1aJ1bHOH J10CKOt\:
3decb 6 1842 z. C:JMI03Jl Mople (Samuel Morse) 060pyiJ06UJl nep6blu
meJleZpatjJublu ny",cm.
C Tex nop TeXHI1Ka CBHJI1 113MeHI1llaCb HeY3HaBaeMO, a K OCBOeHl11O
coopcMeHHblX MeTOlIOB aHaJlI13a BOJ1bl Mbl TOllbKO npl1cTynaeM.

060pyiJ060Hue u CUCmeMbl
2/1
'lmo OWIO eeeoenue KOnmpO./lR TOC?
I) 4HCJ10 nOKa3aTeJ1eH Ka'leCTBa BOllbI B CiliA COKpaeHO C lleC5ITH
110 TPex 1UI5I BOllbI O'lI1111eHHOH H C lleCHTH 110 'leTbIpex 1UI5I BOllbI 1UI5I
HHDeKUI1H.
2) nOBbIweHa "Y6cm6ume.llbnocmb MeTOllOB 11 npOBOllI1TC5I n011HbIH
KO.llUlteCm6ennblii aHallH3.
3) ClleJ1aH npopblB Bnepell, OT nepI1011H'leCKoro KOHTp0115I B J1a60pa-
TOpHH K nenpepbl6nOMY KOnmpO.ll1O Ha J1HHI1I1.
nOCJ1ellHI1H cpaKTop I1rpaeT npI1HUI1nI1allbHYIO pOJ1b.
Henpepblenblii u nepuooultecKuii KOnmpO.llb
HenpepblBHblH KOHTpOJ1b n03B0J15IeT BbI5IBHTb CKpbITbIe TeHlleHUHH
H npOZH03up06amb BbIXOll napaMeTpOB 3a 1l0nYCTI1MbIe npeLl.eJ1bl.
3eKTI1BHOCTb HenpepbIBHoro KOHTpOJ15I no cpaBHeHHIO C nepHO-
AHQeCKHM nOKa3aHa Ha pHC. 8.1. npH 3nI13011H'leCKOM KOHTpOJ1e B 11a60-
paTopHH MHome nI1KH 3arp5I3HeHHH 06HapY)J(HTb Hel1b35I. HenpepbIBHbIH
KOHTpOJ1b n03B0J15IeT I1CKJIIO'lHTb cpaKTop CJ1Y'laHHOCTH 11 pemCTpI1pOBaTb
3Ha'leHHe 06111ero OpraHH'leCKoro yrJ1epOlla B peallbHOM BpeMeHI1.
IItHI
_.tHI
;..
'= 4tHI

Q.
Q.
- _'tHI
-
...
ItHI
11111
I _I 4 .. 7 H
- KOtiTpOl1b Toe He 1111..,11 .11aOoplITOpHbIiIlOHTpOf1b BpetMI (AHII)
- cn110WHa51 1111HI1H J1aeT 3Ha'JeHI1H TaC B peaJIbHOM MaClllTa6e (Ha 1111HI1I1),
- TO'JKaMI1 nOKa33Hbl 3Ha'JeHI151 TaC npl1 3n1130J1114eCKOM KOHTpOlle
PI1C. 8.1 KOHTpo11b Ha J1I1HI1H 11 KOHTpOJ1b B J1a60paTopHH
8.7 r33bI H CJK3TbIH B03.ayX
I1Cn0J1b3yeMbIe B np0I13BOllCTBe J1eKapCTBeHHbIX Cpe.llCTB 11 I1MelO-
lime KOHTaKT C npollYKUI1eH I1J1I1 MaTepI1allaMI1 ra3bI, B TOM 4HCJ1e c)J(a-
TbIH B0311YX, DOl1)J(HbI 6bITb 'lI1CTbIMI1. 3T0 06ecne l IHBaeTC5I npI1MeHeHI1-
eM 6e3MaCJ15IHbIX KOMnpeccopOB, lJI1CTbIX ceTeH pacnpeLl.eJ1eHI1H ra30B,
I<J1anaHOB I111PYroro 060PYllOBaHI15I.

212
[;1Oeo 8
fa3bI, B TOM 'lI1CJ1e C)J(dTbIH B0311YX. MOfYT KOHTpOJ1l1pOBaTbC5I Ha OT-
CYTCTBHe napOB MaCeJ1, BJ1am, OKCH.lla ymepO.lla, .llI10KCI111a ymepolla,
llHOKCI1lla cepbI, OKCHlla H llI10KCH.lla a30Ta, nepeKI1CI1 BO.llOpO.lla. MeTo-
llbI 06HapY)J(eHHH Jarp5I3HeHHH B ra3ax YCTaHOBJ1eHbI EBponeHCKOH ap-
MaKoneeH - EP [23). lI..n5I C)J(aToro B0311yxa pa3pa60TaH CneUI1allbHbIH
KOMnJ1eKC CTaHllapTOB fOCT P I1CO 8573 (rJ1aBa 22).
EBponeHCKa5I apMaKOne5I YCTaHaBJII1BaeT llBa BHlla MeTOllOB KOH-
TpOJ15I ra30B, B TOM 'lI1CJ1e C)J(aToro B0311yxa:
- aHallHTH'leCKHe MeTOllbI (c I1Cn0J1b30BaHI1eM I1HpaKpacHoro H3J1Y-
'leHH5I, XeMI1J1IOMI1HeCueHTHoro aHallI13a H np.) (n.n. 2.5.24-2.5.29 EP);
- HCn0J1b30BaHHe HHllI1KaTOpHbIX Tpy60K (n. 2.1.6 Ep).
AnQ./lUmUlteCKUe .MemoObi
EBponeHcKaSl apMaKOne5I YCTaHaBJ1HBaeT CJ1ellYlOlllI1e MeTOllbI KOH-
TpOJ1S1 'lHCTOTbI ra30B:
aKCI1J1 ymepOJ1a
MeTOll KOHTpOllH
MeTOJ1 C npl1MeHeHl1eM I1H<j)paKpacHoro
a HaJlI13aTOpa
MeTOJ1 I. XI1MI1'JeCKI1H aHaJlI13 C I1CnOl1b-
30BaHI1eM Tl1ocYl1b<j)aTa HaTpl151
MeTOll 2. npl1MeHeHl1e I1H<j)paKpacHoro
aHaJlI13aTOpa
XeMI111IOMI1HeCueHTHbIH aHaJlI13
KOHTpOllHpyeMoe 3arpH3HeHHe
LlI10KCI1J1 ymepoJ1a
aKCI1J1 11 J1110KCI1J1 a30Ta
KI1CllOpOJ1
BOJ1a B ra3ax
MeTOll 3np (MeTOJ1 311eKTpoHHoro napa-
MarHI1THoro pe30HaHca)
MeTon C npl1MeHeHl1eM 311eKTp0l1I1TI1'Je-
CKOro mrpOMeTpa
XI1MI1'JeCKI1H aHaJlI13
LlI10KCI1J1 cepbl
Bce 3TH MeTOllbI Tpe6YlOT CneUI1allbHoro 060pYllOBaHI15I 11 I1CnbITa-
TeJ1bHbIX CTeHllOB.
DOJ1ee npOCTbIM MeTOllOM 5IBJ15IeTC5I npI1MeHeHHe I1HllI1KaTOpHbIX
Tpy60K.
HnduKamopnbie mpy6Ku
I1HllI1KaTOpHbIe Tpy6KI1 npe.llHa3Ha l IeHbI llJl5I KOHTpOJ15I BbIweYKa3aH-
HbIX 3arp5I3HeH11 H. OHI1 repMeTH'lHbI 11 BbInOJ1HeHbI 113 HHepTHoro npo-
3pa l IHoro MaTepI1alla, HanpI1Mep, CTeKJIa. BHYTPI1 Tpy6KI1 HaXO.llHTCSI
HHepTHbIH MaTepI1all, Ha KOTOpbIH an.COp6I1pOBaH peareHT, n03B0l1HIOlllHH
BI13YallbHO KOHTpOJ1I1pOBaTb HallJ1lII1e 3arp5I3HeHI1H B ra3C npI1 ero npoxo-
lle IIepe3 Tpy6KY. Tpy6KI1 MOfYT 6bITb npellHa3Ha l IeHbI llJ15I KOHTpOJ15I Oll-
HOro I1J1I1 HeCKOl1bKI1X 13I1ll013 3arpSl3HeHI1H (MHoroCl1oHHble Tpy6KI1).
npI1 I1CnbITaHI1S1X 'lCpC3 Tpy6KY npI1HY.llI1TCJ1bHO npOXO.llI1T onpC.lle-
l1eHHbII1 061>eM (np06a) ra3a. 0 H,UIJ1lII111 3arp5I3HCHI1H CYllSlT no H3MC-

060PY0060Hue U CliCmeMbl
2/3
HeHI110 UBeTa I1HllI1KaTopHoro MaTepI1alla. HeKOTOpbIe Tpy6KH 11 Me lOT
rpa.IIYI1pOBKY. B 3aBI1CI1MOCTI1 OT BeJ1I1'lI1Hbl 3arpH3HeHI1H MeH5IeTC5I UBeT
HHllI1KaTOpHoro MaTepI1alla no llJII1He Tpy6KI1, Ha'lI1HaH OT ee Ha'lalla, no
HanpaBJ1eHI11O llBI1)J(eHHH ra3a.
CxeMa KOHTpOJ15I 'lI1CTOTbl C)J(aToro B03Ilyxa 11 llPYrHX ra30B npI1Be-
lleHa Ha pI1C. 8.2.
1
o
2 
3
[><]
4
1  1
5
7
5
I - I1CTO'JHI1K C)I(aToro B0311yxa; 2 - peryl151Top J1aBlleHI1H;
3 - I1rol1b'JaTbIH KJIanaH; 4 - TpoHHI1K; 5 - BbIXOJ1 B aTMoc<j)epy;
6 - YCTpol1CTBO J1Jl51 YCTaHOBKI1 I1HJ1I1KaTOpHbIX Tpy60K (pa3BeTBI1Tel1b);
7 - I1HJ1I1KaTOpHa5I Tpy6Ka
PHC. 8.2. CxeMa nOllKJIIO'leHH5I HH.llHKaTOpHbIX Tpy60K
I1HllHKaTopHbIe Tpy6KH He 5IBJ15I1OTC5I cpellCTBaMH H3MepeHH5I KOJlH-
'leCTBa Jarp5I3HeHHH, a J1HWb YKa3bIBalOT Ha HX HallH'lHe. 3TO He TO'lHbIe
MeTOllbI, HO BnOJ1He AOCTaTO'lHbIe ll1151 npaKTI1KI1. KallH6poBKa Tpy60K
npOH3BOllHTC5I no I1HCTPYKUI1H I13rOTOBI1TeJ15I, 06bI'lHO Ha caMOM npell-
npH5ITHH-H3roTOBI1TeJle. Tpy6KH 5IBJ15I1OTC5I OllHopa30Bb1MH. 0 Ka'leCTBe
OTlleJ1bHbIX Tpy60K CY1l5IT no BbI60pKe 113 cepHH I13roT0BJ1eHHbIX Tpy60K
Ha npellnpI15ITHH-I13roTOBI1TeJ1e.
EBponei1cKOH apMaKoneeH YCTaHOBJ1eHbl CJ1e.llYlOlllI1e Tpe60BaHH5I
K HHllHKaTOpHbIM Tpy6KaM (Ta6J1Hua 8.6).
T0611UU,0 8.6
Tpe60BaHI15I K HHllHKaTopHbIM Tpy6KaM ll1151 KOHTpOJ1S1 'lHCTOTbI ra30B
KOIrrpoJIHpyeMoe 3arpR3He- t.JYBCTBHTe.JIbHOCTb CTaH,lJ,apTHOe OT-
HHe KJIOHeHHe, He 60JIee
napbl Macell 0,1 Mr/M 3 +30%
Bl1ara (BOJ1HHOH nap) 67 ppm :t20%
aKCI1J1 yrnepOJ1a 5ppm +15%
D.110KCI111 yrnepoJ1a 100 ppm :t15%
D.110KCI1J1 cepbl 0,5 ppm +15%
aKCI111 11 J1110KCI1J1 a30Ta 0,5 ppm +15%
CepoBolIoPOlI I ppm +10%

214
[;1060 8
8.8 YTHJlH33UUH OTXOllOB
Pe3YJ1bTaTOM pa60TbI J11060ro npOH3BOllCTBa, HapHllY C roTOBOt! npo-
llYKUHeH, HBJ15IIOTC5I OTXOllbI. OTXOllbI MOfYT 6bITb TBepllbIMI1 (MYCOp),
)J(HllKHMH (CTOKH), ra3006pa3HbIMH (BbI6poCbl B aTMocepy), 6I10J10rI1-
'leCKHMH 11 pallI10aKTHBHbIMI1.
Ha Ka)J(DblH BI1ll OTXOllOB CYllleCTBYIOT npelleJ1bHO .llOnYCTHMbIe HOp-
MbI. OllHOH 113 3alla'l npOeKTa np0I13BOllCTBa 5IBJ15IeTC5I npOBepKa COOT-
BeTCTBH5I paC'leTHbIX OTXOllOB 3THM HOpMaM. C 3TOH uel1blO npOeKT 1l0J1-
)J(eH BKJIIO'laTb pa311eJ1 «OXpaHa OKPY)J(alOllleH CpellbI'), COllep)J(alllI1H pac-
'leTbI KOJ1I1'leCTBa Bcex BI1110B OTXOllOB 11 060CHOBaHI1e MeTOllOB HX YTH-
J1H3aUHI1.
npOeK1 nOll11e)J(HT roCY.llapCTBeHHOH 3KCnepTI13e, npOBep5IIOllleH
nOJ1HOTY H npaBHJ1bHOCTb paC'leTOB, npaBI1J1bHOCTb BbI60pa MeTO.llOB
YTHJ1H3aUI1I1 H peallbHOCTb HX BbInOJ1HeHH5I (HallH'lHe llOroBOpOB Ha npI1-
eM Mycopa, CTOKOB H np.). npH 3KCnJ1yaTaUI1I1 npOBep5IeTC5I COOTBeT-
CTBHe peallbHbIX OTXOllOB npelleJ1bHO 1l0nYCTHMbIM HopMaM.
HaI160J1ee pacnpOCTpaHeHHbIMH MeTOllaMH YTHJ1H3aUHH 51 B115IIOTC5I:
- ll1151 TBepllbIX OTXO.llOB - BbIB03 3a npelleJ1bI npellnpH5ITH5I B YCTa-
HOBJ1eHHbIe MeCTa, C)J(HraHI1e 11 np.;
- ll1151 )J(I1llKHX OTXOllOB - CTaHUI1I1 HeHTpallI13aUI1H H O'lHCTHbIe CO-
opY)J(eHH5I (J10KallbHbIe 11 UeHTpallH30BaHHble), CJ1I1B B np0I13BO.llCTBeH-
HYIO HJ1H CneUHallbHYIO KaHall H3aUH 10, c60p OTXOllOB B CneUI1allbHbIe
eMKOCTH H BbIB03 HX no lloroBOpy C opraHH3aUHeH, 3aHHMalOllleHC5I YTI1-
J1H3aUHeH, H np.;
- ra3006pa3HbIe OTXOAbI - BbI6poc B aTMocepy C npellBapI1TeJ1bHOH
O'lHCTKOH (HanpHMep, UHKJIOHaMH, cKPy66epaMH), npI1 He06xo.llI1MOCTH;
- 6H0J10rI1'leCKHe OTXOllbI - HX c60p H HeHTpallI13aUI15I (lle3HHeK-
UH}J, CTepHJ1I13aUH}J), Yllep)J(HBaHHe MHKpOOpraHI13MOBI13 BbIT5I)J(HOro
B0311yxa HEPA I1J1bTpaMI1 C nOCJ1ellYlOllleH YTHJ1I13aUI1eH, C)J(I1raHI1C
TpynoB )J(I1BOTHbIX 11 np.;
- pan.I10aKTHBHbIe OTXOllbI - HX c60p 11 YTHJ1H3aUH5I B YCTaHOBl1eH-
HOM nOp5IllKe.
Oc06YJO CJ10)J(HOCTb npellCTaBJ15IeT YTI1J1H3aUH5I OTXOllOB, COllep)J(a-
lllHX naToreHHbIe MHKpoopraHH3Mbi 11 pallI10aKTHBHbJe BellleCTBa. 11MI
YHH'lTO)J(eHH5I MI1KpOOpraHI13MOBI1Cn0J1b3YIOTC5I XHMI1'leCKa5I H TenJ10Ba5I
lle3HHeKUH}1 (CTepHJ1I13aUH5I).
llnSl YTHJ1H3aUHI1 pallI10aKTI1BHbIX OTXOllOB CJ1Y)f(I1T CneUI1cUlbHa}I Ka-
HallH3aUI15I C nOCJ1e.llYlOlllI1M C60POM 11 lle3aKTHBaUI1eH OTXOllOB, BbIB03
HX B YCTaHOBJ1eHHble MeCTa 11 np. Bbl6poCbl B aTMOC(I)epy TaK)J(e HC
1l0J1)J(Hbl npeBbIwaTb .llOnYCTHMbIX 3Ha'leHI1H.

060pyiJ060Hue u CUCme.Mbl
215
8.9 TUnU'IHble HeCOOTBeTCTBUJI Tpe60B3HH5IM GMP
HH)J(e npHBOllSlTC5I npI1MepbI HeCOOTBeTCTBHH 060PYlloBaHI15I Tpe60-
BaHH5IM GMP:
TeXnO.ll02UlteCKOe 060pydoeanue:
- He COOTBeTCTByeT G M P 11 He MO)J(eT 6bITb aneCTOBaHO;
- npI106peTeHO 110 Ha'lalla npOeKTI1pOBaHI1S1 11 He COOTBeTCTBYeT
npoeKTY 11 3allaHI11O Ha npOeKTI1pOBaHHe;
- 3J1eMeHTbI e.llI1HbIX KOMnJ1eKCOB npH06peTeHbi Y pa3HbIX nOCTaB-
lllI1KOB, 'lTO YCJ10)J(H5IeT HallallKY H aTTeCTaUHIO;
- 060PYllonaHI1e MOpallbHO YCTapeJ10;
- HHOCTpaHHa5I HpMa no.ll BHllOM 060PYllOBaHI15I no GMP nOCTa-
BHJ1a Hero.llHbIe I1311eJlH5I;
- OTCYTCTByeT npellCTaBHTeJlb H3roToBHTeJ15I, H n0J1b30BaTeJ1b JlHWeH
nOll.llep)J(KH B 3KCnJ1yaTaUHH, B03BpaT Ha 3apy6e)J(HbIH 3aBOll CJ10)J(eH HJ1H
HeB03MO)J(eH H3-3a TaMO)J(eHHOH npouellypbI;
- comaCHO 1l0KYMeHTaM H Ha.llnHCH Ha J1HueBOH naHeJ1H 060PYllO-
BaHHe I13roTOBJ1eHO B H3BeCTHOH CBOHM BbICOKHM Ka'leCTBOM CTpaHe;
npH OTKa3e 060PYllOBaHI15I 11 lleMOHTa)J(e naHeJ1eH Kopnyca 06HapY)J(I1Ba-
eTC5I, 'lTO Bce H3roTOBJleHO nJ10XO H COBceM B llpyroH TO'lKe MHpa.
TeXnO.ll02UR:
- pa30pBaH TeXHOJlOfI1'leCKHH npouecc: MapwpYT llBH)J(eHH5I npoxo-
llHT 'lepe3 30HbI B - D - B, B - K - B H np.;
- nJ1aHHpOBO'lHbIe peWeHH5I He COOTBeTCTBYIOT TeXHOJlOfl1H;
- nepenYTaHbI nOTOKH I1CXOllHbIX MaTepI1allOB, nepCOHalla 11 roTOBOH
npOllYKUHH;
- HenpaBI1J1bHO 3an.aHbI TI1nbI (KJIaCCbI) 'lI1CTbIX 30H;
- He BbInOJlHeH paC'leT 6allaHCa MOlllHocTeH;
- He BbInOJ1HeH paC'leT MaTepI1allbHoro 6allaHCa;
- HenpaBI1J1bHO pa3pa6oTaHbI peWeHH5I no nOllroToBKe BO.llbI, ra30B
H C)J(aToro B0311yxa;
- He BbInOJ1HeHbI Tpe60BaHH5I K 'lHCTOTe H MHoroe .IIpyroe.
06pa60mKa odeJICdbl (npalteltnQJI):
- He npellYCMOTpeHa COBceM;
- BbInOJ1H5IeTC5I B He'lHCTbIX nOMellleHH5IX;
- HeT MeCTa ll1151 BbInOJ1HeHI15I Bcex onepaUI1M (npl1eM, npOBepKa 11
COpTHpOBKa HCn0J1b30BaHHOH Olle)J(Dbl, peMOHT, CTHpKa, CYWKa, ynaKoB-
Ka H T. A.) C BbI.lleJleHHeM ll1151 HHX OTlleJ1bHbiX nOMellleHI1H;
- He I1Cn0J1b3YIOTC5I npOXO.llHbie CTI1pallbHbIe MaWI1HbI 11 3 BTOKJIa BbI
TaM, me OHI1 He06xOllHMbl, 11 T. ll.

216
r JlaBa 9
MCnbITAHIUI H ATTECTAIJ.HD
9.1 BHAbI HCnbIT3UH" (3TTeCT3I\UH)
J11060e 060PY.llOBaHI1e, nOMellleHI1e I1J1I1 npouecc 1l0J1)J(HbI COOTBeT-
CTBOBaTb CBoeMY Ha3Ha'leHHIO. 3TO eCTeCTBeHHO 11 O'leBHllHO. nOKa3aTe-
J1I1 Ha3Ha'leHH5I, Tpe6oBaHH5I K npOllYKUI1I1, 060PYlloBaHHIO H npoueccaM
npOH3BOllCTBa 3allalOTC5I .llOKYMeHTauHeH: cneuHHKaUI15IMI1, TeXHH'le-
CKHMH YCllOBH5IMI1, npOeKTOM, CTaHllapTaMI1 H np.
CooTBeTcTBHe 3THM Tpe60BaHH5IM HY)J(HO npOBep5ITb. npouecc npo-
BepKH Ha3bIBaeTC5I I1CnbITaHH5IMH HJ1H aTTeCTaUI1eH. 3TH llBa TepMI1Ha no
CMbICJ1Y paBH03Ha'lHbI, n03TOMY B llallbHeHWeM llJ15I KpaTKOCTH HCnOJ1b-
3yeTC5I OllHH H3 3THX TepMHHOB. OTJ1H'lHe COCTOHT J1HWb B npellMeTe
npHMeHeHH5I. B npaKTI1'leCKOH pa60Te 11M MO)J(eT npHllaBaTbC5I pa3HbIH
OTTeHOK.
IlcnblmanUJI nOllpa3YMeBalOT npOBelleHHe H3MepeHI1H, C03.llaHHe HllH
MOllellI1pOBaHHe onpe.lleJ1eHHbIX YCJ10BHH .llJI5I nOllTBep)J(DeHI15I COOT BeT-
CTBI15I xapaKTepHCTHK I1311eJ1H5I HJ1H BbIHBJ1eHH5I ero lleeKTOB.
Ammecmal(UJI 60J1bWeH 'laCTblO OTHOCHTC5I K npoueccaM (aTTeCTa-
UH5I npouecca CTepHJ1 H3aUI1 11), MeTOllHKaM (aTTeCTaUI15I aHallHTH'leCKHX
MeTOllOB) H nOMellleHH5IM (aTTeCTaUH5I 'lHCTbIX nOMellleHI1H).
3TH llBa TepMI1Ha llaBHO H WI1pOKO npHMeH5IIOTC5I Ha npaKTHKC 11
5IB115IIOTC5I npH3HaHHbIMI1 PYCCKHMI1 TepMI1HaMH.
npI1 nnaHI1pOBaHI1I1 HCnbITaHHH (aTTeCTauHH) HY)J(HO OTBeTI1Tb Ha
CllellYlOlllHe BonpOCbI:
- 'lTO HcnbITbIBaTb?
- me 11 Koma HCnbITbIBaTb?
- KTO npoBOllHT HcnbITaHI15I?
- no KaKI1M 1l0KYMeHTaM npOBOll5ITC5I HCnbITaHH5I?
l{mo ucnblmbl6amb?
npOBep5ITb HY)J(HO Bce. Bonpoc 3aKJIIO'laeTC5I B 061>eMe npOBepKI1 H
ee BJIH5IHI1I1 Ha Ka'leCTBO np0.llYKUI1I1. MbI He KynI1M HJ1lICro 6e3 BI13Y-
allbHOro OCMOTpa, npOBepKI1 KOMnJ1eKTHOCTI1 11 pa60Tocnoc06HOCTI1 113-
lleJ1I15I. 3TO .lleJ1aeTC5I BceMH H Be311e.
B 'leM )J(e OTJ1I1 I II1e 06bI'lHOH npOBepKI1 OT I1CnbITaHI1H no Tpe60ua-
HHHM G M P? - OTllI1'lI1C B TOM, 'lTO Ha COOTBCTCTBI1e G M P npOBep5IIOTC5I
TOJ1bKO npOUCCCbI 11 060PY.llOBaHI1e, KOTopbIe BJ1I1HIOT Ha 6C30naCHOCTb
J1CKapCTBeHHbIX CpC.llCTB 11 I1X COOTBeTCTBl1e CBoeMY Ha3Ha'lCHI1IO. TaKoc
npoueCCbl 11 060PY.llOnaHI1C Ha3blBcUOTC1 KpI1TI1IICCKI1MI1.

J1cnblmoHUfl U ommecmou,Ufl
217
ComaCHO npaBI1J1aM G MP np0I13BOllI1TeJ1b J1eKapCTBeHHbIX Cpe.llCTB
1l011)J(eH npOBO.llHTb HCnbITaHH5I KpumulleCIWZO 060PYllOBaHI1 11 npouec-
COB, a He Bcero, 'lTO OH I1MeeT. 3T0 Ba)J(Ha5I OTnpaBHa5I TO'lKa.
KpI1TepI1I1 OTHeceHHH 060PYlloBaHH5I H npoueCCOB K KpHTH'leCKHM
paccMoTpeHbI HH)J(e, B n. 9.5.
CneuHHKoH npOH3BOllCTBa J1eKapCTBeHHbIX cpellCTB 5IBJ15IeTC5I TaK-
)J(e TO, 'lTO nOKa3aTeJ1H pa60TbI OllHOro H TOro )J(e 060PYllOBaHI15I MorYT
pa3J1I1'laTbC5I llJ15I pa3HbIX l1eKapCTBeHHbIX cpellCTB. n03TOMY HCnbITaHH5I
npOB01l5ITC5I C Y'leTOM oc06eHHOCTeH KOHKpeTHOH npOllYKUI1I1.
lOe u KOlda ucnblmbl6amb?
I1cnbITaHI15I npOBOll5ITC5I Ha 3aBOlle-I13roTOBI1TeJle 060PY.llOBaHI15I.
Ha MeCTe 3KCnJ1yaTaUI1I1 npOBOll5ITC HCnbITaHI15I KpI1TI1'leCKoro 060PY-
,D.OBaHI15I.
I1cnbITaHH5I 060PYlloBaHI15I MOfYT 6bITb pa3J1I1'lHbIMH (pHC. 9.1):
I. I1cnbITaHH5I npH pa3pa60TKe H311eJ1H5I H nOCTaHOBKe ero Ha npo-
H3BOllCTBO;
2. I1cnbITaHH5I CepI1HHOH npOllYKUHH Ha 3aBolle-H3roToBHTeJ1e;
3. I1cnbITaHH5I Ha MeCTe 3KCnJ1yaTaUI1I1.
nOllXOll K HCnbITaHH5IM 3a Py6e)J(oM aHallOfH'leH.
IIIcnblT3HJtR HcnblT3HHJI npneMO- I;fcnblTaHl1H Ha TCKYllWii
M3KeTHbiX 11 YCTJ.HOBOllHbIX C1l3TOl.JHble MeCTe
onblTllblX 06paJuoB cepit" J1CnbIT3HIUI 3KcnnYaTamU1 KOHTponb
0 \ A A A A ) Jh1HIHI )l(IB  1I
--y---- -y-- -y-' --y--- -----y-- 060PYllOBaHIIJI
MOHTa)l( II
PaJpa60TKa nOCTaHOBKa Ha CepIIHHoe BBOll B '3KCOJlyaTauIIsl
060pY1l0BaHI!JI 0P0l! jBOllCTBU OpOIlJBOllCTI!O 3KCOJlyaTawlIO
PHC. 9.1 I1cnbITaHH5I (aTTeCTaUH5I) 060PYllOBaHI15I Ha pa3HbIX CTMI15IX
Kmo npoeodum ucnblmanUJI?
BclO nOJlHOTY OTBeTCTBeHHOCTI1 3a Ka'leCTBO pa60TbI 060PYllOBaHI15I
HeCeT npOH3BOllI1TeJ1b J1eKapCTBeHHbIX cpen.CTB, HO npOBOllHTb Bce HCnbITa-
HH5I OH He MO)l(eT H He 1l0J1)J(eH. Ero 3Ma'la - opraHH30BaTb npOBelleHHe
I1cnbITaHHH, npoBepHTb, no KaKI1M 1l0KYMeHTaM npOB01l5ITC5I I1CnbITaHH5I H
y6ellI1TbC5I B nOJIHOTe I1CnbITaHHti H 0OpMJ1eHH5I npOTOK0J10B (OT'leTOB).
P5Ill HCnbITaHHH nOJIb30BaTeJ1b MO)J(eT npOBOllI1Tb caM (Ta6J1HUa 9.1).
llo KaKUM dOKYMenmllM np060dumb ucnblmanUJI?
I1cnbITaHI15I npOBOll5ITC5I no MemoduKe I1CnbITaHI1H, npe.llOCTaBJl5IeMOH
npoH3BOllHTeJ1eM 060PY.lloBaHI15I, HJ1I1 cO.llep)J(allleHC5I B HOpMaTI1BHOM .llOKY-
MeHTe. 060PY.lloBaHI1e pa60TaeT B OnpC.llel1CHHOM npouecce. TeXH0J10rI1IIe-
CKl1e npoueCCbl pa3JII1'laIOTC5I B 3aBI1CI1MOCTI1 OT I1CXO.llHblX 11 ynaKOBO'lHbIX
MaTepHlliIoB, I3LmycKacMoH np0.llYKUI1I1, nOCl1C.llOOaTeJ1bHOCTH 11 CO.llCp)l(aHI1I

218
lJ1060 9
onepaUI1H, 'lI1CTOTbI oKPY)I(alOWeH Cpe.llbI, RflI15IHI15I nepCOHalla 11 np. B O.ll-
HOM npouecce MOryr Y'laCTBOBaTb HeCKOJ1bKO e.llHHHU 06oPYlloBaHH5I.
Bce 3TO OnpelleJ15IeT undu6udYQ./lbHbie oco6ennocmu npouecca, RflI15I1O-
lllHe Ha Ka'leCTBO npOllYKUI1I1. He.llOCTaTO'lHO y6e.llHTbC5I TOJ1bKO B npaBI1J1b-
HOCTH pa60TbI OTlleJ1bHbIX ellI1HI1U 06oPY.llOBaHI1H (CTepI1J1H3aTOpa, Ta6J1e-
TO'lHOro npecca) HJ1I1 CI1CTeM (nonroToBKH BOllbI. 'lI1CTbIX nOMellleHHI1).
HHO npoBepHTb, COOTBeTCTByeT 1IH 3an.aHHbIM Tpe60BaHHHM npo-
uecc B ueJ10M, cnoc06eH J1H OH YCTOti'lI1BO BbmycKaTb npollYKUI11O Tpe6ye-
MOro Ka'leCTBa.
nOllTBep)J(DeHI1e 3TOro COOTBeTCTBI15I, T. e. COOTBeTCTBHH npouecca
3allaHHbIM Tpe60BaHHSlM, Ha3bIBaeTC5I ammecmau,ueii npou,ecca.
CooTBeTCTBI1e PYCCKHX H aHfllI1HCKHX TepMHHoB no HcnbITaHI15IM
(aTTecTauHH) nOKa3aHO B Ta6J1Hue 9.1.
T0611UU,0 9.1
TepMI1HbI no I1CnbITaHI15IM (aTTecTauHH)
06"beKT , MCnOJlHHTeJlb BH.lI. HCnblTaHHH (aTIeCTaLUtH)
CTa.LUUI PyCCKHH Jl3blK Aur.JIHHCKHH Jl3bIK
060PY.lI.OBaHHe
- Ha 3aBOlle- M3roTOBI1Tel1b npl1eMO-CJ1aTO'JHble I1C- FAT - Factory
113rOTOBI1Tel1e* nblTaHI151 Acceptance Test
- Ha MeCTe MOHT8)I(Ha51 nYCKOHaJlaJIO'JHble SAT - Site
3Kcnl1yaTaUl111 OpraHl13aUI151, I1CnbITaHI151 Acceptance Test
nOli b30BaTel1 b (MOryr 6bITb COBMellleHbl
C aTTeCTaUl1eH, CM. HI1)1(e)
nOl1b30BaTellb I1cnblTaHI151 (aTTeCTaUI151):
- YCTaHOBlleHHoro - IQ (Installation
060PYJ10BaHI1H, Qualification),
- B OCHallleHHOM - aQ (Operational
COCTOH HI1 11 , Qualification),
- B 3Kcnl1yaTaUI111 - PQ (Performance
Qualification)
npouecc nOli b30BaTel1 b ATTeCTaUI1H (I1CnbITaHI1H) PV - Process
npouecca Validation
*) paCCMaTpI1UaeTC5I TOllbKO CCpl1HHO BbInYCKaeMoe o60pynoBaHl1e; CTaJ11111 paJ-
pa60TKH 11 nOCTaHOBKI1 Ha npoI13BOJ1CTBO CM. B n. 9.2.
Pa3J1H'laIOTC5I TaK)J(e C1IellYIOlllHe 6uabl ammecmau,uu:
- nepCneKTHBHa5I, npOBOllI1TC5I nepell BBOllOM 061>eKTa B 3KCnJ1yaTa-
UHIO;
- TeKYlllaSl, npOBO.llI1TC5I C YCTaHOBJ1eHHOH nepI1011I1IIHOCTblO B npo-
uecce 3KCnJ1yaTaUI1H;
- peTpocneKTHBHaSl, npOBOllI1TC5I ll11H .lleHcTBYlOlllI1X 061>eKTOU Ha
OCHOBe npCllweCTUYIOWI1X llaHHblX, perI1CTpaUI1I1 napaMcTpoo, aHallH3C
OTKJIOHeHHH OT cnCUI1q)I1KaUI1H 11 np.

J1cnblmoHuR u ommecmol(UR
219
I1cnbITaHI15I npOBOll5ITC5I no nporpaMMe I1CnbITaHI1H (n. 9.6) 11 Me-
TOllHKaM I1CnbITaHI1H.
MeTO.llI1Ka I1CnblTaHI1H 060PYlloBaHH5I .llOJ1)J(Ha BXOllI1Tb B KOMnJ1eKT
nOCTaBKH 060PYlloBaHHH, J1I160 cOllep)J(aTbC5I B HOpMaTI1BHOM .llOKYMeH-
Te, HanpI1Mep, aTTeCTaUI15I aCenTH'leCKHX npoueCCOB npOBOllHTC5I no
fOCT P 52249-2009 11 fOCT P I1CO 13408-1-2000.
nOll'lepKHeM, 'lTO Ka'leCTBO 060PY.llOBaHI15I 11 npouecca 3aKJIan.bIBa-
eTC5I ero KoncmpYKII,Ueii H mexno.ll02ueii H3roT0BJ1eHI15I. npOH3BOllI1TeJlb
060PYllOBaHH5I .aOJ1)J(eH npOHTH Bce CTan.HH pa3pa60TKI1 11 nOCTaHOBKH
060PYllOBaHH5I Ha npOH3BOllCTBO, 'lT06bI OHO COOTBeTCTBOBallO CBoeMY
Ha3Ha'leHHIO. B 3TOM KopeHb Bonpoca, KOTOpbIH 'laCTO ynYCKaeTC5I, H
Bce CBOllHTC5I K ynpa)J(HeHH5IM no «BallHllaUHH» Ha MeCTe 3KCnJ1yaTaUHH.
B CB5I3H C 3THM B n. 9.2 paCCMOTpeH nOp5I.llOK pa3pa60TKH H nOCTaHOBKH
H311eJ1HH Ha np0I13BOllCTBO.
Ka'leCTBO npouecca OnpelleJ15IeTC5I Ka'leCTBOM npoeKTa, KOTOpblH
npellYCMaTpI1BaeT He06xollHMoe 06oPYlloBaHHe, ero KOMnOHOBKY H np.
)J,J15I nOllTBep)J(DeHH5I COOTBeTCTBH5I npoeKTa npaBHJ1aM G M P H llpyrHM
Tpe60BaHH5IM BbInOJ1H5IeTC5I aTTeCTaUH5I npoeKTa - DQ (Design Qualifica-
tion), fJlaBa 6.
Ha MeCTe 3KcnJlyaTaUHH npOBOll5ITC5I TPH 3Tana aTTeCTaUI1H:
- YCTaHOBJ1eHHOrO 060pYlloBaHH5I - IQ (Installation Qualification);
- B OCHallleHHOM COCT05IHHH, 6e3 MaTepHallOB H npOllYKUHH - OQ
(Operational Qualification);
- B 3KCnJ1yaTaUHH, npOBep5IeTC5I npollYKT - PQ (Performance Quali-
fication).
MO)J(eT BbInOJ1H5ITbC5I aTTeCTaUI15I Bcero npouecca - PY (Process
Validation).
CYTb HcnbITaHHH Ha 3Tanax IQ, OQ, PQ, PY OllHa H Ta )J(e, pa3J1H-
'lHe - B 3Tanax C03llaHH5I 11 3KCnJ1yaTaUI1I1 np0I13BOllCTB H B MeTOllHKax
HcnbITaHI1H. He Bcerlla eCTb CMbICJ1 pa311eJ15ITb IQ 11 OQ. Bo MHOfI1X
cJ1Y'la5Ix (HcnbITaHI15I 'lHCTbIX nOMellleHHH, CHCTeM C)J(aToro B0311yxa) HX
ueJ1eC006pa3Ho 06bellHH5ITb.
B llaHHoH fJlaBe paCCMOTpeH nOp5IllOK npOBelleHI15I I1CnbITaHI1H (aT-
TecTauHH) 11 npI1BelleHbI HeCKOJ1bKO npHMepOB HCnbITaHI1H: CI1CTeM nOll-
rOTOBKI1 BOllbI, Ta6J1eTnpeccoB. npOH3BOllCTB 6I10J10fI1'leCKH aKTHBHbIX
cy6cTaHUHH, a TaK)J(e paCCMOTpeH 06111HH CJ1Y'laH. CJ10)J(HOH 11 O'leHb
Ba)J(HOH np06J1eMe aTTeCTaUHH npoueCCOB O'lHCTKH nOCB5IllleHa fJlaBa 10.
ATTecTaUI15I aHallHTH'leCKHX MeTOllOB paCCMOTpeHa B fJlaBe II.
J1cnbITaHI15I KpHTH'leCKoro 060pYlloBaHI15I 11 npoueCCOB (napoBbIe H
cyxo)J(apoBbIe CTepHJ1H3aTOpbI, CTepHJ1H3YlOllla5I HJ1bTpaUH5I )J(I1llKOCTeH
H ra30B, JlI10I1J1I13aUI15I, 'lHCTbIe nOMellleHI15I, aCenTI1'leCKI1e npoueccbI)
paccMoTpeHbI B KHI1re [10].
B CWA HaMe'leHbI HOBbie nOllXOllbI K aTTeCTaUI1I1 B CBSl3I1 C npI1H5I-
THeM CTaHllapTa ASTM E2500 (CM. HI1)J(e n. 9.11). CYlllccTBeHHbIH C.llBI1r
B CTOPOHY 311panoro CMblCJla Cllel1aH B HOBOM PYKOBO.llCTBe FDA (9.12).

220
r11060 9
Ee pa3 0 mepMunax
B apMaueBTH'leCKOH npOMbIWJ1eHHOCTI1 n05IBHJ1aCb CB05I «cneUH-
HKa», Bep05ITHO, OT He3HaHHH 3TOH 06111eH CXeMbi.
C Cepe.llI1HbI 90-x HaM HaC3)J(DaIOT HeHY)J(HbIe HCKYCCTBeHHbIe Tep-
MHHbI «BepI1I1KaUI15I», «KBallI1HKaUH5I», I1.lleHTI1'lHbIe no CMbICJ1Y Tep-
MHHaM «I1CnbITaHI15I» 11 «aTTeCTaUH5I». 3TO CHJ1bHO 3anYTbIBaeT Bcex H
YBO.llHT B CTOPOHY OT CYTI1 pa60TbI no GMP.
B pa3HbIX 3apy6e)J(HbIX 1l0KYMeHTax TepMI1HY «BallI1llaUH5I» (Valida-
tion) llalOTC5I pa3Hbie OnpelleJ1eHH5I, nopoH npoTHBOpe'lHBbIe. LI.onOJ1HH-
Tel1bHO BBe.lleHbl TepMI1Hbl «Qualification,) - «Verification,), TO)J(e nYTaHbIe
11 nepeCeKalOlllI1eC5I C TepMHHoM «Ball HllaUI15I'). I1x CMbICJ1 OllHH 11 TOT )J(e
- nOllTBep)J(DeHHe COOTBeTCTBH5I, HO B pa3HbIe nepHOllbI BpeMeHI1 H B
pa3HbIX YCJ10BI15IX. 3TO TBOp'leCTBO B TepMHH0J10fI1H COBepweHHO 6ec-
CMbICJ1eHHO. CHTyauHH MO)J(eT 6bITb MHOro. He HHO D.JI5I Ka)J(DOH 113
HHX H306peTaTb CBOH TepMHH. HY)J(HO K KJIIO'leBOMY TepMHHY llaBaTb
YT0'lH5IIOlllee OnpelleJ1eHHe. 3TO llaBHO npHH5ITO B PYCCKOH H 3apy6e)J(-
HOH TeXHI1'leCKOe TepMHHOJIOrHH.
CYllleCTBYIOT TepMHHbI «nYCKOHallallO'lHbIe I1CnbITaHI15I'), «HcnbITa-
HH5I THna», «npI1eMO-CllaTO'lHbIe HCnbITaHI15I» H np. KnIO'leBbIM CJ10BOM
HBJ15IeTC5I «I1CnbITaHH5I», 11 B Ka)J(.llOM CJ1Y'lae K HeMY 1l06aBJ15IeTC5I CJ10BO,
YT0'lH5IIOlllee HX CMbICJ1 D.JI5I AaHHoro CJ1Y'la5I. To )J(e caMoe eCTb H B aH-
rJ1HHCKOH TepMHH0J10fI1H. ECTb KJIIO'leBOe CJ10BO «test» I1J1H «testing» H K
HeMY ll06aBJI5IIOTC5I CJ10Ba <<joctory» «<H3roToBHTeJ1b»), «site» «<MecTo 3KC-
nJ1yaTaUHH») H T. ll. HeT Hy)J(DbI H306peTaTb Ka)J(DbIH pa3 CBOH TepMHH,
HHO n0J1b30BaTbC5I llBYM5I CJ10BaMH: KJIIO'leBbIM H YTO'lH5IIOlllHM.
OTXOll OT 3TOro npaBI1J1a npOH30WeJ1 nepBOHa'lallbHO no He3HaHHIO,
a nOTOM 3Ta HCKpa 6bIJ1a nOllXBa'leHa MOlllHbIM BeTpoM OT J1HU, llBI1)J(I1-
MbIX KOMMep'leCKHM HHTepecoM.
LI.a, cTaHllapTH3aUI15I, B TOM 'lHCJ1e TepMI1HbI, 5IBJ15I1OTC5I BI1.ll0M 6H3-
Heca. Ho He B CMblCJIe 3apa6aTbIBaHH5I lleHer 3a XOPOWYIO pa60TY, a B
CMbICJ1e HaMepeHHoro C03.llaHH5I HeHY)J(HbIX cTaHllapToB 11 TepMI1HOB, I1C-
X01l5I H3 c06CTBeHHbIx MepKaHTI1J1bHbIX I1HTepecoB.
K.nunUlteCKUe ucnblmanUR
LI.0 2003 r. GMP EC He Tpe60BallH aTTeCTaUHH npoueCCOB npI1ro-
TOBJ1eHH5I (npOH3BOllCTBa) npenapaTOB D.JI5I KJII1HH'leCKHX HCCJ1ellOBaHI1ti.
TpallI1UI10HHO C'lI1TallOCb, 'lTO BO BpeMH HCnbITaHI1H npouecc MO)J(eT H3-
MeH5ITbC5I, a cepI1I1 npO.llYKUI1H MallbI. B 3TI1X YCJ10BH5IX BbInOJ1HHTb aTTe-
CTaUHIO, T. e. nOllTBepllHTb HeH3MeHHOCTb npouecca 11 COOTBeTCTBI1e ero
3a.llaHHbiM Tpe60BaHI15IM, TPYllHO 11 6bIJ10 He O'leHb aKTYallbHO. nOCJ1C
2003 r. n0J10)f(eHI1e I13MeHI1JIOCb. npI1J1o)J(eHI1e 13 K npaBI1J1aM GMt>
(fOCT P 52249) Tpe6yeT npOBO.llHTb aneCTaUI110 np0I13BOllCTB J1eKap-
CTBeHHblX Cpe.llCTB, npe.llHa3Ha l leHHbIX D.JI51 KJII1HI1'leCKI1X I1CCJ1e.llOBaHHi1.
FDA TaK)I(e Tpe6ycT KOHTp0J11 KpI1TJ1lleCKI1X napHMeTpoB 11 npocJ1C-
)J(I1BdCMOCTI1 np0l13BO.llCTBa cepHi1 D.JI51 KJII1HI1IICCKI1X I1CCl1C.llOBHHI1H.

HcnblmOHUR U ommecmou,UR
221
9.2 HcnbIT3HuH npH p33p360TKe H nOCT3HOBKe H3AeJlUH H3 npOH3-
BOACTBO
B POCCHI1 BI111bI HCnbITaHI1H onpe.lleJ1eHbI E.llI1HOH CI1CTeMOH KOH-
CTPYKTOpCKOH .llOKYMeHTaUHH - ECKll (fOCT P 15.201-2000 «CI1CTeMa
pa3pa60TKH 11 nOCTaHOBKI1 npOllYKUHI1 Ha npOH3BOllCTBO. npOllYKUH5I
npoH3BollcTBeHHO-TeXHI1'leCKoro Ha3Ha'leHH5I. nOp5IllOK pa3pa60TKH H
nOCTaHOBKH npOllYKUI1H Ha np0I13BOllCTBO,».
C03llaHI1e I13lleJ1HH Ha'lI1HaeTC5I C TexHJ1llecKoro 3an.aHI1H Ha OnbIT-
HO-KOHCTPYKTOpCKYIO pa3pa60TKY, B KOTOpOM YKa3bIBalOTC5I Tpe6yeMbIe
xapaKTepHCTHKH H3lleJ1I15I.
B XOlle pa3pa60TKI1 MorYT I13roTaBJ1I1BaTbC5I MaKeTHbIe 11 J1a60paTop-
HbIe 06pa3ubI, Ha KOTOpbIX npOBep5IeTC5I npaBHJ1bHOCTb 3aMbICJ1a KOH-
CTpYKTOpa 11 npI1H5ITb1X peWeHI1H. I1ToroM .llaHHoro 3Tana 5IBJ15IeTC5I KOH-
CTpYKTOpCKa5I nOKYMeHTaUH5I Ha onblmnblii 06pa3eu, H npoeKT TeXHI1'le-
CKHX YCJ10BHH Ha H3lleJ1He, B KOTOpbIX YKa3bIBalOTC5I ero xapaKTepHCTHKH
H MeTOllbI HcnbITaHI1H.
113roToBJ1eHHe OnbITHoro 06pa3ua MO)J(eT 6bITb nepellaHO npOMbIW-
J1eHHOMY npellnpH5ITHIO, Ha KOTOpOM nJ1aHI1pyeTC5I cepHHHblH BbInYCK
H3lleJ1I15I. 3T0 npe.llnpH5ITHe, I13roTOBHB OnbITHbIH 06pa3eu, npOBOllHT
ero nped6apUme.llbnble, a 3aTeM npUe.MOltnble ucnblmanUR no nporpaMMaM
H MeTOllHKaM HcnbITaHHH. no pe3YJ1bTaTaM npHeMO'lHbIX I1CnbITaHI1ti
MOfYT 6bITb BHeceHbI H3MeHeHI15I B KOHCTPYKTOPCKYIO .llOKYMeHTaUI1IO,
3aTeM H3roTOBJ1eH H I1CnbITaH HOBbIH 06pa3eu. 3TOT npouecc MO)J(eT no-
BTOp5ITbC5I HeCKOJ1bKO pa3. B HTore 6YlleT nOJ1Y'leH OnbITHbIH 06pa3eu,
ycnewHo npOWellWI1H npI1eMO'lHbIe HCnbITaHH5I, J1H60, B cJ1Y'lae HeYlla-
'lH, 1l0KYMeHTaUH5I 6YlleT B03BpallleHa pa3pa60T'lHKY HJ1H npI1H5ITO pe-
weHHe 0 npeKpallleHHH pa3pa60TKH.
ECJ1I1 OnblTHbIH 06pa3eu ycnewHo npoweJ1 npI1eMO'lHbIe I1CnbITa-
HH5I, TO YTBep)J(DaIOTC5I TeXHI1'leCKHe YCJ10BH5I H npI1HI1MaeTC5I peweHHe
06 I13roTOBJ1eHI1I1 ycman060llnoii cepuu. Ha 3TOM :nane BelleTC5I mexno.llo-
lUlteCKWI noOlom06Ka npou3600cmea TaK, 'lT06bI 6blJ1 Halla)J(eH BbmYCK
H3lleJ1HH B 3an.aHHOM 061>eMe B COOTBeTCTBHH C TeXHI1'leCKI1MI1 YCJ10BH5I-
MH H npI1 npHeMJ1eMbIX 3KOHOMH'leCKHX nOKa3aTeJ15IX. no pe3YJ1bTaTaM
113roToBl1eHH5I YCTaHOBO'lHOH CepI1H TeXH0J10fH'leCKHH npouecc 1l0pa6a-
TbIBaeTC5I 11 npHHHMaeTC5I peWeHI1e 0 roTOBHOCTI1 npOH3BOllCTBa K ce-
PHHHOMY BbInYCKY npOllYKUI1I1. npOBepKa roTOBHOCTI1 np0I13BOllCTBa K
BbInYCKY CepI1HHOH npOllYKUI1I1 npOBOllHTC5I nYTeM K6Q.flU,puKau,uonnblX
Ucnblmanuii.
nallee, B XO.lle CepI1HHoro np0I13BO.llCTBa npOBO.ll5ITC5I nepuOOUlteCKUe
ucnbimanuR, I1CnbITaHI15I muna 11 np., ueJ1b KOTOpbIX - nOllTBepAI1Tb no-
CT05IHHOe COOTBeTCTBI1e 060PY.llOBaHI15I 3an.aHHbIM Tpe60BaHI1HM.
TaKI1M 06pa30M, Ha Bcex 3Tanax pa3pa60TKI1, nOCTaHOBKI1 Ha npo-
I13BO.llCTBO 11 CepI1HHoro np0I13BO.llCTBa npOBO.llSITC5I I1CnbITaHI1H (MaKeT-
HblX, J1a60paTopHbIX 11 OnblTHbIX 06pa3UOB, YCTaHOBOIIHOH cepI1I1 11 np.).

222
[;1060 9
3anOMHHM Ba)J(HbIH aKT: I1CnbITaHlliI npOROll5ITCH no MemOOUKe
pa3pa60mltUKa UJlU U3l0m06Ume.llR H311eJ1I15I.
He HYJK:HO nymomb npUeMO'lHble ucnblmOHUR onblmH020 06p03U,0. KO-
mopble omHOCRmCR K npueMKe KOHcmpYKmopcKou iJoKYMeHmou,uu 30eoOoM-
U320m06umeJ1eM om p03p060m'lUKO u3iJeJ1UR. u npueMo-ciJomO'lHble ucnblmo-
HUR cepuu npoiJYKu,UU 6 cepuUHOM npou360iJcm6e.
4eTKoe BbInOJ1HeHI1e :,HOH cxeMbI rapaHTI1pyeT BbInYCK npOllYKUHH
BbICOKOro Ka'leCTBa.
MHorHe J1H npOH3BODI1TeJ1I1 TeXH0J10rI1'leCKOrO 060PYllOBaHI15I llJ15I
apMaueBTl1'leCKOH npOMbIWJ1eHHOCTH pa60TalOT no HeH? Bonpoc OTHO-
CI1TC5I 11 K 3apy6e)J(HbIM I1pMaM. De3 3TOH cxeMbI rOBOpI1Tb 0 Ka'leCTBe
6eCn0J1e3HO 11 HHKaKHe «BallI111aUI1I1') He nOMOfYT.
ECJ1H B.llYMaTbC5I B J10rI1KY pa3pa60TKH H nOCTaHOBKH Ha np0I13BOll-
CTBO TeXHI1'leCKI1X cpellCTB, TO BI1n.Ha aHallOrI1H C pa3pa60TKOH J1eKap-
CTBeHHbIX cpellCTB. B TOM H llPyroM CJ1Y'lae nOCJ1e OnpelleJ1eHHbIX 3TanOB
pa3pa6OTKH npOB01l5ITC5I HCnbITaHI15I (1lJ15I J1eKapCTBeHHbIX cpellCTB - J1a-
60paTopHbIe 11 KJIHHH'leCKHe).
9.3 I1cnb1T3HHj! cepHHHoH npo.nyKQHH H3 33BOAe-U3fOTOBHTeJle
OOCJ1e ycnewHbIX HcnbITaHI1H YCTaHOBO'lHOH cepI1I1 npHHI1MaeTC5I
peweHHC 0 CepI1HHOM npOH3BOllCTBe. OCHallleHI1e np0I13BOllCTBa MO)J(eT
BbInOJ1H5ITbC5I n03TanHO, MOfYT H3roTaBJlHBaTbC5I H HCnbITbIBaTbC5I He-
CKOJ1bKO YCTaHOBO'lHbIX cepHH.
B cepHHHoM np0I13BOllCTBe npOBOD5ITC5I npueMo-COamOltnble ucnbl-
manUR Ka)J(DoH cepI1I1 npOllYKUHH HHllHBHllYallbHO llJl5I Ka)J(Doro 06pa3ua
HJlI1 BbI60pO'lHO, C oT60pOM 06pa3uoB H3 cepI1I1 npO.llYKUI1I1.
3TI1 I1CnbITaHH5I npOBOll5ITC5I Ha 3aBOlle-I13roToBHTeJ1e Ha CTeHllax C
npI1MeHeHI1eM, eCJ1H HHO, 1l0POroro cneUI1allI13I1pOBaHHoro 060py.llo-
BaHI15I, KOTopoe n03B0J15IeT npOBeCTH HcnbITaHI15I B nOJ1HOM 061>eMe no
nporpaMMe 11 MeTO.llI1Ke npI1eMO-C.llaTO'lHbIX I1CnbITaHI1H, cOllep)J(allleHC}(
B TeXHI1'leCKI1X YCJ10BI15IX. Pe3YJlbTaTbI HCnbITaHHH 0OpMJ15IIOTC5I B YCTa-
HOBJ1eHHOM nOp5IllKe. 113lleJ1I1e HJ1H CepH5I npOllYKUHH MorYT 6bITb BbI-
nYllleHbI B peallI13aUHIO TOJ1bKO npI1 nOJ1O)J(HTeJ1bHbIX pe3YJ1bTaTaX npI1e-
MO-CllaTO'lHbIX I1CnbITaHHH.
B aHfJ1I1HCKOM 5I3blKe aHalloroM TCpMI1HY «npI1eMO-CllaTO'lHbIe I1C-
nbITaHHH') 5IBJ15IeTC5I TepMHH FAT - Factory Acceptance Test.
3aBO.ll- I13roTOBI1TeJ1b nCpI1011I1'leCKI1 npOBO.llI1T I1CnbITaHI1}( TI1na
no CneUI1allbHOH, paCWI1peHHOH nporpaMMe, 'lT06bl nOKa3aTb HCI13-
MeHHOCTb COOTBCTCTBI11 BbInycKaeMoH npOllYKUI1I1 TeXHJ1lleCKI1M
YCJ10BI15IM. npI1 BHeCeHHI1 I13MeHCHI1H B KOHCTPYKTOPCKYIO 1l0KYMeH-
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I1x ueJ1b:
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- npOBepHTb COOTBeTCTBHe nJTOlllallKH (noMellleHI15I 11 np.) Tpe60Ba-
HH5IM K YCTaHOBKe 060PYlloBaHH5I (HallI1'lHe 1l0CTaTO'lHoro MeCTa 11 BbI-
nOJ1HeHI1e llPYfI1X YCJ10BHH, HanpHMep, OTCYTCTBHe nonallaHH5I np5IMbIX
COJ1He'lHbIX J1Y'leH, Tpe6yeMoe paCCT05IHHe llO HarpeBaTeJ1bHbIX npI160-
pOB, YKJIOHbl, Halll1'II1e 3HeproHocHTeJ1eH, BOllbI, KaHallI13aUI1H H np.);
- npOBepI1Tb, He nOJ1Y'leH J1I1 6paK OT nOCTaBlllHKa, He BbI5IBl1eHHbIti
npH npI1eMO-CllaTO'lHbIX HcnbITaHI15IX, npI1 BbI60pO'lHOM KOHTpOJ1e HJ1H
HaMepeHHO CKpbITbIH 6paK;
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BHeceHHbIX npH MOHT3)J(e;
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3TO OCHOBHbIe 3an.a'lI1 nYCKOHalla.IIO'lHbIX HcnbITaHHH. OHH MOfYT
BapbHpOBaTbCH, HO I1X CMbICJ1 Be3lle OllI1HaKOB - npOBepKa COOTBeTCTBH5I
060pYllOBaHI1S1 3allaHHbIM Tpe60BaHI15IM Ha MeCTe 3KCnJ1yaTaUI1H.
B aHrJ1I1HCKOM 5I3bIKe aHalloroM TepMI1HY <<nYCKOHallallO'lHbIe I1CnbI-
TaHH5I') 5IBJT5IeTC5I TepMI1H «SAT - Site Acceptance Test».
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)J(lleHHoH I13roToBHTeJ1eM 060PYlloBaHH5I, J1I160 no CTaHllapTY I1J1H llPYro-
MY 1l0KYMeHTY. Ho rJ1aBHOe - MeTOllI1Ka nYCKOHallallO'lHbIX HCnblTaHHH
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)J(lleHa I13roTOBI1TeJ1eM, J1H60 B 1l0KYMeHTaUHH 1l0J1)J(Ha 6bITb CCbIJ1Ka Ha
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3Ta MeTOllI1Ka llOJ1)J(Ha COOTBeTCTBOBaTb Tpe60BaHH5IM G M P.
B npOTI1BHOM CJ1Y'lae HI1KaKI1X npeTeH3I1H K I13roTOBI1TeJ11O npell1>-
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3aUI1eH. nYCKOHallan.O'lHble pa60TbI, HanpI1Mep, III1CTbIX nOMellleHHH,
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225
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226
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aTTeCTaUHH. 3TO oc06eHHo Ba)J(HO ll1151 CI1CTeM nO.llroToBKH BOllbI, TaK
KaK npI1 aTTeCTaUHH MorYT nOTpe60BaTbC5I MaTepI1allbI OT llPymx I1cnOJ1-
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CTBH5I H CHCTeMa He 6YlleT aTTeCTOBaHa.
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ATTeCTaUH5I YCTaHOBJ1eHHOrO 060PYlloBaHH5I BbInOJ1HHeTCH nOCJ1e 3a-
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ct>aKTH'leCKH YCTaHOBJ1eHHoro 060PYlloBaHI15I H ceTeH) npoeKTY CHCTeMbI
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npOBepKa Ha COOTBeTCTBHe 3an.aHI11O H HopMaTHBHOHllOKYMeHTaUHH;
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H HCnOJ1HHTeJ1bHOHllOKYMeHTaUHH;
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OllHOro pa3a B HelleJ1lO.
BbInOJ1H5IIOTC5I TaK)J(e TeCTbI Ha CTpeCCOBbIe HarpY3KH, HcnbITaHI15I
6J10KHpOBOK H npelloxpaHHTeJ1bHbIX 3J1eMeHTOB, npOBep5IeTCH 3cf>cf>eK-
THBHOCTb O'lHCTKI1 CHCTeMbI.
npelleJ1bHO .llonycTHMbIe 3Ha'leHHH napaMeTpOB .llaHbI B maBe 8. n. 8.6.
,il.n5I paHHero npellynpe)J(DeHH5I 0 B03MO)J(HOCTH BbIXO.lla napaMeTpa
3a 1l0nYCTHMbIe npelleJ1bI peKOMeH.llyeTC5I 3an.aBaTb yp06nu npedynpeJICde-
nUR (alert level). 3Ha'leHH5I 3THX ypoBHeH peKoMeHllyeTC5I npHHHMaTb
paBHbIMH OT 10 llO 50% OT npelleJ1bHO 1l0nYCTHMoro 3Ha'leHH5I.
10% COOTBeTCTBYIOT xopoweH npaKTHKe, 'lTO nOllTBep)J(DaeTC5I onbI-
TOM 3KCnJ1yaTaUHH COBpeMeHHbIX CHCTeM nO.llroToBKI1 BOllbI (KOHueH-
TpaUH5I 06111ero OpraHH'leCKOrO ymepolla COCTaBJ15IeT 20-30 ppb npI1
npelleJ1bHOM 3Ha'leHHH 500 ppb). npI1 HOpMallbHOH 3KCnJ1yaTaUHI1 ma-
'leHI15I napaMeTpOB He .llOJI)J(HbI BbIXOllHTb 3a 3TI1 npelleJ1bI.
B 3apy6e)J(HOH J1HTepaType HCnOJIb3yeTC5I TaK)J(e TepMHH «ypOBeHb
lleHCTBH5I') «<action level»), T. e. 3Ha'leHHe napaMeTpa, npI1 KOTOpOM
He06xollHMO BbInOJ1HHTb pa60TbI no TeXHH'leCKoMY 06CJ1Y)J(I1BaHHIO I1J1I1
peMoHTY. I1Homa «ypoBeHb lleHCTBH5I') npHHHMalOT paBHbIM npelleJ1bHO
1l0nycTHMoMY 3Ha'leHHIO. C HaweH TO'lKI1 3peHH5I J1Y'lwe npI1HI1MaTb 3TO
3Ha'leHI1e C 3anaCOM, HanpHMep, Ha 20-30% MeHbwe npe.lleJ1bHO .llony-
CTI1MOro.
Ammecmau.UR e 3Kcn.llyamau.uu - PQ
3TOT BI1.ll aTTeCTaUI1I1 npOBOAI1TC5I B Te'leHI1e O.llHOro rolla llJI5I no.ll-
TBep)J(DeHI15I cTa6I1J1bHOCTI1 nOKa3aTeJ1el1 nO.llroTOBJIeHHoti BOllbI npI1 ce-
30HHbIX I13MeHeHI15IX HCXO.llHOH BO.llbI.
B Ha'lallbHbIH nepHOll 3KcnnyaTaUI1I1 CJ1e.llyeT oT6I1paTb np06bI BO.llbI
H npOBOllI1Tb I1X aHallH3 TPI1 pa3a B HelleJ1lO:

J1cnblmoHUR U ommeCmOll,UR
229
- YTPOM B nOHe.lleJ1bHI1K, Y'lHTbIBaeTC5I BJ1HHHI1e Hepa60'lero nepI1o-
JIa, KOma HeT nOTpe6J1eHI15I BO.llbI (cB06011Ha5I UHPKYJ15IUH5I B neT lie 6e3
paCXO.lla);
- B cpellY;
- B n5ITHHUY B KOHue llH5I.
ECJlI1 B Te'leHHe BOCbMH HelleJlb CI1CTeMa pa60TaeT HOpMallbHO, TO
MO)J(HO nepeHTI1 K oT60PY np06 OllI1H pa3 B He.lleJ1IO, HanpI1Mep, no no-
HelleJlbHI1KaM.
CHcTeMa C'lI1TaeTCSI npowellweH aTTeCTaUI110 B 3KCnJ1yaTaUI1I1, eCJ1I1
npI1 ee pa60Te B Te'leHI1e rolla napaMeTpbl BOllbI He BbIXOllHJlH 3a 3a.llaH-
HbIe npelleJlbI npH YC110BHH BbInOJ1HeHI15I npellYCMOTpeHHbIX UI1KJIOB
O'lHCTKH.
9.8 ATIeCT3u,uSl T36J1eTOQHbIX npeCCOB
06111I1e Tpe60BaHI1H K 060PYlloBaHI11O llJl5I npOH3BOllCTBa TBep.llbIX
OpM paCCMOTpeHbI B n. 8.4. P5Ill ellHHHU 3TOro 060PY.llOBaHI15I, B TOM
'lHCJle Ta6J1eTnpeCC, OTHOC5ITC5I K KpI1TI1'leCKOMY (n. 9.5).
ATTeCTaUH5I npOBO.llI1TC5I B TPI1 3Tana: YCTaHOBl1eHHoro 060PYlloBa-
HHSI, B OCHallleHHOM H 3KcruIyaTHpyeMoM COCTOHHI1HX [19].
Ammecmau,UR ycman06.1lennOlO ma6.1lemnpecca
UeJ1b aTTeCTaUI1I1 - y6eJII1TbC5I, 'lTO Ta6J1eTnpeCc YCTaHOBJ1eH B co-
OTBeTCTBI1I1 C 1l0KYMeHTaUI1eH H3roToBHTeJ15I. CJ1ellyeT npOBepHTb:
- COOTBeTCTBI1e H KOMnJ1eKTHOCTb Ta6J1eTnpeCca 3aKa3Y;
- HallH'lHe BceHlloKYMeHTaUI1I1, B TOM 'lI1CJ1e MeTOllHKI1 aTTeCTaUI1I1;
- nOllBOll 3HeproHocHTeJ1eti;
- npHMeH5IeMbIe CMa30'lHbIe MaTepI1allbI H YKa3aTb, KaKI1e 113 HHX H
me MOfYT HMeTb KOHTaKT C npOllYKTOM;
- npaBI1J1bHOCTb YCTaHOBKH Ta6JleTnpeCca Ha nJ1aHe;
- BbInOJlHeHHe Tpe60BaHI1H TeXHHKH 6e30naCHOCTH.
Ammecmau,UR 6 ocnaennOM cocmORHUU
UeJ1b aTTeCTaUHI1 - y6e.llHTbC5I, 'lTO Ta6J1eTnpeCC pa60TaeT B COOT-
BeTCTBHI1 C llOKYMeHTaUI1eH B 3an.aHHbIX npe.lleJ1ax. Ha 3TOM 3Tane npo-
Bep5IeTC5I pa60Ta caMoro Ta6J1eTnpeCca KaK ellI1HI1Ubl 060pYllOBaHI15I npI1
OTCYTCTBI1I1 MaTepI1alla. Pe3YJ1bTaT pa60TbI - Ta6J1eTKa, npOBep5IeTCSI Hd
CJ1eJIYlOllleM 3Tane.
npOBepKe nO.llJ1e)l(aT:
- BbInOJ1HeHI1e Bcex YHKUHH;
- npaBI1J1bHOCTb peampOBaHI15I Ha lleHCTBH5I onepaTopa (Ha Ha)J(aTHe
KHonOK, KaCaHI1e ceHcopOB, OTKpbIBaHI1e llBepel1 11 np.);
- pa60Ta KOHTpOl1bHbIX npH60pOB 11 I1X KallI16pOBKa;

230
"-1060 9
- llBH)J(eHI1e BepxHero H HH)J(Hero nyaHcoHoB no HanpaB115IIOlllI1M 11
Me)J(Dy npeCCYlOlllI1MI1 pOJ1I1KaMI1 no 1l0KYMeHTaUI1H H3roToBHTeJT5I;
- onYCKaHHe HI1)J(Hero nyaHcoHa B Tpe6yeMoe n0J10)J(eHI1e 11 OllHO-
BpeMeHHoe HaXO)J(DeHI1e nyaHcoHa B caMOM BepXHeM n0J10)J(eHHH;
- HanpaBJ1eHHe BpallleHH5I pOTopa;
- 'lI1C110 UI1KJIOB pa60Tbi B MI1HYTY (npOH3BOllI1TeJ1bHOCTb);
- llpyme onepaUI1I1 B 3aBI1CHMOCTH OT KOHCTPYKUI1I1 Ta6J1eTnpecca.
Ammecmau.uJI 6 :JKCnJlyamau.uu
UeJ1b aTTeCTaUI1I1 - y6ellI1TbC5I, 'lTO Ta6J1eTnpCCC nOCT05IHHO np0I13-
BO.llHT Ta611eTKI1 C 3anaHHbiM BeCOM 11 TBepllOCTblO B COOTBeTCTBI1H co
CneUHI1KaUHeH Ha HI1X. B OTJ1H'lI1e OT npellbIllYlllero 3Tana npOBep5IeT-
C5I He pa60Ta caMoro Ta6J1eTnpeCca, a ee pe3YJ1bTaT - Ta6J1eTKa.
npOBepKa BbInOJ1H5IeTC5I C nOMOlllblO nJ1aue60, T.e. npI1 OTCYTCTBHI1
aKTHBHoro HHrpellI1eHTa. OT6I1paIOTC5I no 5 Ta6J1eTOK B Ha'lalle pa60Tbl,
3aTeM 'lepe3 10, 20 H 30 MHH. Bec 11 TBePllOCTb Ta6J1eTOK 3anHCbIBalOTC5I
B Ta6J1HUY. 3aTeM BbI'lHCJ15IIOTC5I cpellHHe 3Ha'leHI15I ll1151 Ka)J(Doro BpeMe-
HH. OTKJIOHeHH5I Cpe.llHHX 3Ha'leHI1H OT 3allaHHoti BeJ1I1'lI1HbI He 1l0J1)J(Hbl
npeBbIwaTb YCTaHOBJ1eHHoro 3Ha'leHH5I.
I1cnbITaHH5I npOB01l5ITC5I ll1151 pa3HbiX 3Ha'leHHI1 npOH3BOllI1TeJ1bHO-
CTH Ta6J1eTnpeCca (MHHHMallbHOH, Cpe.llHeH H MaKCHMallbHOH) H MI1HH-
MallbHOH H MaKCHMallbHOH Macc Ta6J1eTOK.
nOCJ1e :noro BbInOJ1H5IeTC5I npOBepKa nOCT05IHCTBa CKOpOCTH pa60-
Tbl.
LI.n5I npOBepKH npaBHJ1bHOCTI1 K3)J(DOro nyaHcoHa H nOHCKa npH'lI1-
HbI OTKJIOHeHHH pa60Ta BelleTC5I TOJ1bKO npI1 OllHOM YCTaHOBJ1eHHOM ny-
aHCOHe - npOBep5IeMOM.
nOCJ1e npOBelleHI15I Ka)J(Doro 3Tana aTTeCTaUI1I1 OcPopMJ15IeTC5I npo-
TOKOJ1 C BKJIIO'leHI1eM B Hero Bcex nOJ1Y'leHHbIX llaHHbIX, cpaBHeHI1eM I1X
C YCTaHOBJ1eHHbIMH 3Ha'leHHHMI1 H 3aKJIIO'leHHeM 0 COOTBeTCTBHI1 Ta6-
J1eTnpeCca Tpe60BaHI1HM.
9.9 ATTecT311IDI npOU3BOACTB 6UOJlOlWleCKH 3KTHBHbiX Cy6CT3HlluH
npOH3BOllCTBO 6I10J10m'leCKI1 aKTI1BHbIX cy6cTaHUI1H HMceT CBOII
'leTKO Bblpa)J(eHHblC oc06eHHOCTI1:
- B npoueccax Y'laCTBYIOT MaTepI1allbl )l(I1BOH npI1pOllbl - MI1KpOOP-
raHI13MbI, xapaKTepI13YlOlllI1CC5I I13MeH'lI1BOCTblO, B OTJ1I1'lI1e OT XI1MJ1lIC-
CKI1X COellI1HeHI1H;
- CKOpOCTb pa3MHO)J(eHI15I 11 nOBelleHI1e MI1KpOOpraHI13MOB OIICHh
3aBI1CHT OT BHeWHI1X YCJ1oBI1ii, KOTopbIe MorYT MCH5ITbC5I OT cepI1I1 K cc-
pI1I1; :no MO)l(eT Bl1l1ITb Ha COCTaB Cpe.llLI 11 npouccc OIII1CTKI1; MO)l(Cr

ffcnblmOHUR U ommecmou,UR
231
nOTpe60BaTbC5I 60J1ee )J(eCTKI1H KOHTpOJ1b 060PYllOBa H 1151 , MaTepI1allOB 11
OKPY)J(alOllleH Cpellbl ll1151 CBe.lleHI15I K MI1HI1MYMY pI1CKa 3arp5I3HeHHH;
- Ha npOueCCbl BJII15IeT p5I.ll napaMeTpOB, K H3MeHeHHIO KOTOpbIX
MI1KpOOpraHH3MbI I1MeIOT BbICOKYIO 'lYBCTBI1TeJ1bHOCTb; npO.llYKT H npo-
uecc He MOfYT 6bITb oxapaKTepI130BaHbI TO'lHO;
- He3Ha'lI1TeJ1bHOe I13MeHeHI1e YCJ10BI1H MO)J(eT npHBeCTI1 K He)J(el1a-
TeJ1bHbIM H HeO)J(HllaHHbIM H3MeHeHI15IM cy6cTaHUI1I1 11 roTOBOro npO.llYKTa.
TaKHM 06pa30M, maBHbIM OTl1H'lI1eM 6HOTeXH0J10rHH OT XHMI1IIe-
CKOro CHHTe3a 5IBJ15IeTC5I 6apua6e.llbnOCmb (H3MeH'lI1BOCTb) npouecca.
npouecc O'leHb CI1J1bHO 3aBHCHT OT KOJ1H'leCTBa MHKpoopraHH3MOB, Me-
TOllOB O'lHCTKH H llPYrHX aKTopOB.
CJ1ellyeT HMeTb B BHllY, 'lTO Bce 3TO OTHOCHTC5I H K roTOBOMY npo-
llYKTY, nOJ1Y'laeMOMY MeTOllaMH 6HOTeXH0J10rHH.
Ammecmau,UR npou,ecca
UeJ1eBOH 3alla'leH 5IBJ15IeTC5I nOJ1Y'leHHe npOllYKTa C 3anaHHbIMH
CBOHCTBaMH. 3TI1 llaHHbIe 11 llonYCTHMbIe npelleJ1bI HX H3MeHeHH5I CO-
llep)J(aTC5I B CneUI1HKaUI1H Ha roTOBYIO npOllYKUHIO. B Ha'lalle npouecca
npOH3BO.llCTBa Haxon.5ITC5I HCXOllHbIe MaTepHallbl. Tpe60BaHI15I K HI1M CO-
llep)J(aTC5I B cneUHHKaUHH Ha HCXOllHbIe MaTepHallbI. Me)J(DY HCXOllHbI-
MH MaTepHallaMH H roTOBOH npOllYKuHeH HaX01l5ITC5I TeXH0J10rH'leCKHH
npouecc H onepaUHH no KOHTpOJ1IO.
KaK H B J11060M npOH3BOllCTBe, BHa'lalle CJ1ellyeT nOCTpOI1Tb llI1a-
rpaMMY npouecca (6J10K-cxeMY), maBa 7.
,il.n5I Ka)J(Doro 3Tana 1l0J1)J(HbI 6bITb YKa3aHbi 060pYlloBaHI1e, HCXOll-
HbIe H TeXH0J10rH'leCKHe MaTepI1allbI, He06xollHMOCTb npOBelleHI15I BHYT-
pI1npOH3BO.llCTBeHHoro KOHTpOJ15I H ero co.nep)J(aHHe, npHMeH5IeMbIe aHa-
J1I1TH'leCKHe MeTOllbI H KOHTp0J1bHO-H3MepHTeJ1bHbIe npH60pbI.
J]allee npOBOllI1TC5I oueHKa BJ1H5IHI15I Ka)J(Doro 3Tana H ellHHI1UbI
060PYlloBaHI15I Ha KOHe'lHbIH pe3YJ1bTaT H BbI6HpalOTC5I KpHTH'leCKI1e
3TanbI, KOTopbIe OKa3bIBalOT CYllleCTBeHHoe BJ1H5IHHe Ha COCTaB H CBOH-
CTBa npOllYKUHI1, HanpHMep, cPHJ1bTpaUH5I, npoueCCbl O'lHCTKH.
1ln5I 6I10TeXH0J10rI1I1 npI1MepaMI1 KpHTH'leCKI1X aKTOpOB 5IBJI5I1OTC5I:
- HeCOOTBeTCTBI1e KOHueHTpaUI1I1 I1HOKYJ1I1pOBaHHbIX KJIeTOK HopMe;
- 3arp5I3HeHI15I MaTepHalla;
- nepella'la MaTepHalla B 6HopeaKTop;
- npouecc O'lI1CTKH 6I10peaKTopa.
OnpelleJ1HB KpI1TH'leCKI1e 3TanbI H aKTopbI, CJ1ellyeT npI1H5ITb MepbI
no npelloTBpallleHI1IO 3THX C06bITHH H 06eCne'lI1Tb KOHTpOJ1b. HanpI1-
Mep, BbIXOll 3a npelleJ1bI CneUHI1KaUI1I1 KOHueHTpaUHH I1HOKYJ1I1pOBaH-
HbIX KJIeTOK MO)J(eT npI1BeCTI1 K He)J(eJ1aTeJ1bHOMY H3MeHeHHIO KHHeTHKH
pa3MHO)J(eHI15I. Bo I136e)J(aHI1e 3TOro CJ1ellyeT OpraHI130BaTb BHYTpI1npO-
113BOllCTBeHHbIH KOHTpOJ1b ncpell nOMellleHI1eM MaTepI1alla B 6I10peaKTop.

232
f11060 9
KpHTH'leCKHMH napaMeTpaMI1 H onepaUI15IMI1 B 6I10TeXH0J10rI1H HB-
J15I IOTC5I [211:
- 'lI1CTOTa 060PY.llOBaHHH;
- CBOHcTBa I1CXOllHbIX MaTepI1allOB, B T.'l. KJIeTOK;
- B3BeWHBaHHe;
- paCTBopeHHe;
- npHroTOBJ1eHI1e cpe.ll;
- KYJ1bTHBHpOBaHI1e;
- napaMeTpbI B 6I1opeaKTope (pH, pacTBopeHHbIH KI1CJ10pOll, nepe-
MeWI1BaHHe);
- c60p MaTepI1alla;
- O'lHCTKa;
- HanOJ1HeHHe;
- J1HOHJ1H3aUH5I;
- ynaKoBKa;
- MapKHpOBKa.
HaI160J1ee BapI1a6eJ1bHbIM npoueCCOM 5IBJ15IeTC5I KYJ1bTI1BI1pOBaHHe
KJIeTOK. )l(HBbIe MI1KpOOpraHH3MbI MOfYT BbIlleJ15ITb 6eJ1KH, nOCJ1e HI1X
OCTaeTC5I KJIeTO'lHbIH De6pHc. 113MeHeHI15I B HX BbIlleJ1eHHI1 BJ1H5IIOT Ha
KPHBYIO pa3MHO)J(eHH5I. HHO npOBepHTb CTa6I1J1bHOCTb KJIeTOK 11 I1X
'lHCTOTY H CneUHallH3HpOBaTb 6HOpeaKTOpbI no BH.llaM 6aKTepHH,
.D.p0)J()J(eH HJ1I1 KJIeTOK MJ1eKOnHTaIOUlHX ll1151 HCKJIIO'leHH5I nepeKpecTHoro
3arp5I3Hemrn, eCJ1H He 060CHOBaHO HHoe.
9.10 0611J,Hu CJI}"I3U
HeCMOTp5I Ha Bce MHoroCJ10BI1e BOKpyr aTTeCTaUHH (BallH.llaUI1I1),
KOJ1H'leCTBeHHbIX KpI1TepI1eB OueHKI1 nO'lTH HeT. I1CKJIIO'leHI1eM 5IBJ15IIOT-
C5I npoueCCbI O'lI1CTKI1 (maBa 10), CTepHJ1H3aUI1I1 H aCenTH'leCKHe npo-
ueCCbI [10]. FDA CWA H EBponeHCKa5I KOMHCCH5I H36eralOT llaBaTb 'leT-
KHe KpHTepI1I1, orpaHI1'lHBa5ICb YKa3aHI1eM Ha COOTBeTCTBI1e «cBoeMY
Ha3Ha'leHHIO» HJ1H CneUI1HKaUH5IM.
1ln5I 060pYlloBaHI1S1 BbIXOll H3 n0J10)l(eHI15I eCTb - HcnblTaHI15I no MC-
TOllHKe 3aBolla-H3roTOBI1TeJ15I HJ1H cTaHllapTY, eCJ1I1 TaKoH eCTb.
A KaK 6bITb C npoueccaMH, B KOTopbIe BXO.ll5IT HeCKOJ1bKO HJ1I1 MHO-
ro ellI1HI1U 060PYlloBaHI15I H KOTopbIe He OTHOC5ITC5I K aCenTI1'leCKHM?
Ha 3TOT C'leT eCTb peKOMeH.llaUH5I PYKOBO.llCTBa ICH Q7 [36] 0 npo-
Be.lleHI1I1 Tpex nOCJ1ellOBaTeJ1bHbIX npoueCCOB ll1151 nepcneKTHBHoH H Te-
KYllleH aTTeCTaUHH, npI1'leM llOJ1)J(HbI 6bITb I1Cn0J1b30BaHbl TPH pa3Hbic
cepI1I1 MaTepI1allOB. 1ln5I peTpOCneKTI1BHOH aTTeCTaUI1I1 Tpe6yeTC5I npoBe-
CTI1 OT 10 .llO 30 nOCJ1e.llOBaTeJ1bHbIX npoueCCOB. 1ln5I CJ10)J(HbIX npouec-
COB MO)J(eT nOTpe60BaTbC5I 60J1bWee 'lHCJ10 nOBTOpeHI1H.

J1cnb/moHuR u ommeCmOll,UR
233
9.11 CT3HAapT ASTM E2500
lfTO HOBOro npOHCXO.llHT B cepe «BallHllaUHH» 3a Py6e)J(oM?
KaK npaBHJ10, Bce HOBoe H nepe.llOBOe CHa'lalla n05IBJ15IeTC5I B CiliA,
3aTeM npI1XOllHT B EBpony. Pa3pbIB MO)J(eT HC'lHCJ15ITbC5I HeCKOJ1bKHMI1
rollaMH, a MO)J(eT H lleC5ITHJleTHHMH. 3a py6e)J(oM TepMI1H «BallH.llaUH5I')
nOllBepraeTC5I pe3KoH KpHTHKe llaBHO. Ho peaKUI15I npoMblwl1eHHocTH H
06111eCTBa OTCTaeT H3-3a HCKJIIO'lI1TeJ1bHO arpeCCI1BHOH aKTI1BHOCTH «Ba-
J1HllaUHOHHbIX» HpM. nOcTeneHHo J1IO.llI1 pa306pallI1Cb B CYTH lleJ1a 11
nOH5IJ1I1, 'lTO «BallHllaUH5I') - 3TO TO )J(e, 'lTO 11 HeBI1llI1MOe nJ1aTbe H3
.n:eTCKOH CKa3KI1 0 roJlOM KOpOJ1e, TOJ1bKO O'leHb .lloporoe.
B CiliA HaWJ1HCb YBa)J(alOlllHe ce65I CneUI1allHCTbI, KOTopbIe npa-
BHJ1bHO paCueHHJlH «BallI1llaUHIO» KaK mYMJ1eHHe Han. npoeCCHOHallH3-
MOM. BepmITHO, B cpellY npellnpHHHMaTeJleH TO)J(e npHWJ10 nOHHMaHHe,
'lTO OHH TpaT5IT MHJ1J1I10HbI H MHJ1J1HapllbI BnycTYIO. B pe3YJ1bTaTe B 2007 r.
B CiliA n05IBHl1C5I cTaHllapT ASTM E2500 [IS].
ASTM (American Society for Testing and Materials) - AMepHKaH-
CKoe 06111ecTBo no HCnbITaHH5IM 11 MaTepI1allaM, 6bIJ10 C0311aHO 6oJ1ee 100
J1eT Ha3an., KaK He3aBHCHMa5I OpraHI13aUH5I npocPeCCI10HallOB. KOTOpa5I
pa3pa6aTbIBaeT cTaHllapTbI no KJIIO'leBbIM HanpaBJ1eHH5IM TeXHHKH H Tex-
H0J10rHH.
3TH CTaHllapTbI n0J1b3YIOTC5I aBTopHTeTOM H npI13Ha1OTC5I OHUH-
allbHbIMH opraHaMI1 B Ka'leCTBe KpHTepHeB oueHKH COOTBeTCTBH5I, B TOM
':lHCJ1e H B npOH3BOllCTBe J1eKapCTBeHHbIX cpellCTB.
B 2007 r. HM 6bIJ1 npI1H5IT CTaHllapT «Standard Guide for
Specification, Design and Verification of Pharmaceutical and Biophormoceu-
tical Manufacturing Systems and Equipment') - «PYKOBOllCTBO no 3a.llaHI11O
Tpe60BaHHH. npOeKTHpOBaHHIO 11 nO.llTBep)J(DeHI11O COOTBeTCTBI15I np0I13-
BOllCTBeHHbIX CI1CTeM 11 060pYlloBaHI15I apMaueBTI1'leCKHX H 6I10apMa-
LleBTH'leCKHX npellnpH5ITHH».
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234
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AmmeCmOll,UR npOll,eCC06 OLfUCmKU 060pyiJ060HUR
239
B 'IeM pa3llH'IHe Me)l(,!Q' .ae3HHclleKIIHeH H crepHJlH3aQHeH?
B 060I1X Cl1Y'JaHX npOBOJ1I1TC5I I1HaKTI1BaUI1H MI1KpOOpraHI13MOB, HO B
pa3JII1'JHOH CTeneHI1.
Uel1blO oe3uHfjJeKu,UU HBJI5leTC5I CHI1)1(eHl1e 'JI1Cl1a naTOreHHblX OpraHl13-
MOB J10 MI1HI1MYMa. 4TO nOHI1MaTb nOJ1 MI1HI1MYMOM? PyKOBOJ1CTBO Ba3 no
06pa60TKe BOJ1bl 11 KOHTpOl1lO naToreHHblX OpraHI13MOB J1aeT Kpl1Tepl111 10- 2 ,
T. e. 113 100 OpraHI13MOB nOCl1e npoBeJ1eHI151 J1e3I1H<j)eKUI1I1 He J1011)1(HO Bbl-
)l(I1Tb 60llee O.aHOro [59J. B J1pyrl1x I1CTO'JHI1KaX npI1BOJ1I1TC5I Kpl1Tepl1H 10- 5
J1Jl51 cneUI1<j)I1'JeCKI1X MI1KpoopraHI13MOB.
K cmepUllu3au,uu npeJ1'b5lB1l5lIOTC5I 6011ee )l(eCTKl1e Tpe60BaHI151. B HeKO-
TOpblX PYKOBOJ1CTBaX nOJ1 CTepl1Jl113aUI1eH nOHI1MaeTCH «nOl1Hoe,) YHI1 I ITO)l(e-
Hl1e MI1KpOOpraHI13MOB.
EBponeHcKa51 <j)apMaKOne51 [23J nOJIXOJ1I1T K 3TOMY BOnpocy 6011ee
OCTOpo)l(HO, nOCKOl1bKY npoueCCbl rn6el111 11 pa3MHO)l(eHI1H MI1KpOOpraHI13-
MOB HOCHT CTaTI1CTI1'JeCKI1I1 xapaKTep C Bblp8)l(eHHbIM <j)aKTOpOM CllY'JaHHO-
CTI1 11 onepl1pYIOT C I1CKJIIO'JI1Tel1bHO MaJlblMI1 Bep05lTHOCT5IMI1, KOTopble
nOJ1TBepJ1I1Tb Kpal1He C110)l(HO 113-3a He06xoJ1I1MOCTI1 npoBepKI1 MI1J1J1110HOB
e.aI1HI1U npOJ1YKUI1I1. 3TI1 npoueCCbl nOJ1'JI1H5IIOTC5I 3KcnOHeHUI1aJ1bHOMY 3a-
KOHY, comaCHO KOTOpoMY Bcema CYlllecTByeT HeKOTOpa51 BepOHTHOCTb BbI-
)KI1BaHI151 MI1KpOOpraHI13MOB.
n03TOMY EBponeHcKa5I <j)apMaKOne51 YCTaHaBJII1BaeT zapaHmup06aHHbiU
yp06eHb cmepUAbHocmu (Sterility Assurance Level - SAL), KOTOpblH npeJ1-
CTaBJI5IeT co60H Bepo5lTHOCTb BbJ)l(I1BaHI151 MI1KpoopraHI13MOB nOCl1e 3aBep-
rneHI151 npouecca CTepl111113aUI1I1. Hanpl1Mep, J1Jl51 CTepl111113aUI1I1 napoM 3TOT
ypoBeHb YCTaHoBlleH paBHblM 10- 6 .
O'lI1CTKa nOBepXHOCTeH MO)J(eT BKJIIO'laTb B ce65I:
- lle3HHeKUI11O 11 MbITbe, BbInOJ1H5IeMbIe nOCJ1ellOBaTeJ1bHO;
- I1Cn0J1b30BaHHe KOM6HHHpoBaHHoro MOlOlllero-lle3I1HI1UI1PYlOlllero
paCTBopa;
- TOJIbKO MbITbe 6e3 lle3I1HeKUI1I1.
nOCJIe 06pa60TKI1 nOBepXHOCTeH HX CJ1ellyeT OnOJIOCHYTb BOllOH 3a-
llaHHoro Ka'leCTBa B 1l0CTaTO'lHOM 06DeMe, 4T06bI YllallI1Tb OCTaTKI1 MO-
I0111HX H lle3I1HHUHPYlOlllHX cpellCTB.
flpu nocJ20m06Ke K ommecmoll,UU npOll,eCC06 O'1UCmKU Hy.JlCHO om6e-
mumb HO c11eiJYJOUJ,ue 60npOCb/:
. '1mo OLfUUJ,omb,
. K02cJO OLfUUJ,omb,
. KOK O'1UUJ,omb (MemoiJb/ OLfucmKU),
. 6 KOKUX CJ1YLfORX np060iJumcR ommeCmOll,UR npOll,eCCO O'1UCmKU,
. KOK np060cJumCR (KOKoeo MemocJUKO ommecmoll,Uu),
. KOK06b/ Kpumepuu ommecmoll,UU npOt(eCC06 OLfucmKU,
. KOK ocjJopMJ1Rmb pe3Y11bmamb/ ommecmoll,Uu.
3TanbI aTTeCTaUHI1 npoueCCOB OIII1CTKI111aHbI B n. 10.7.1.

240
r11060 10
10.2 HOpM3THBHble Tpe60B3HIDI K O'lUCTKe 06oPYAoBaHHSI
06111I1e Tpe60BaHI15I K npoueccaM O'lI1CTKH 060PYlloBaHI15I YCTaHOB-
JIeHbI npaBHJIaMH GMP.
fOCT P 52249-2009 (GMP EC)
3.36 KOHCTPYKUI1H np0I13B0J1CTBeHHOro 060PYJ10BaHI151 1l011)1(Ha 06ec-
ne'JI1BaTb YJ106CTBO 11 B03MO)l(HOCTb ero O'JI1CTKI1. anepaUl111 no O'JI1CTKe
060PYJ10BaHI151 J10ll)l(Hbl BbInOllH5ITbC5I B COOTBeTCTBl111 C n0J1p06Hb1MI1
nl1CbMeHHblMI1 11 HCTPYKUI1HMI1. a60py.aOBaHl1e ClleJ1yeT COJ1ep)l(aTb B CYXOM
11 'JI1CTOM COCTOHHI1I1.
3.37 MHBeHTapb 11 MaTepl1aJ1bI DJIH MbITb51 11 O'JI1CTKI1 He J1011)1(Hbl 6blTb
I1CTO'JHI1KaMI1 3arpH3HeHI1H.
npnnO}KeHHe 15 K fOCT P 52249-2009
I C uel1blO .aOKa3aTellbCTBa COOTBeTCTBI151 napaMeTpOB KpI1TI1'JeCKI1X
npoueCCOB (060pY.llOBaHI151) 3anaHHbIM Tpe60BaHI1HM np0113B0J1I1Telll1 l1eKap-
CTBeHHblX CpeJ1CTB .aOll)l(Hbl npOBOJ1I1Tb aTTeCTaUl110 (I1CnbITaHI151) npoueCCOB
11 060pYJ10BaHHH, I1cnol1b3yeMbIX npl1 np0I13B0J1CTBe l1eKapCTBeHHbIX CpeJ1CTB.
ATTeCTaIIHH npOlleCCOB O'lHCTKH
36 ATTeCTaUI151 npoueCCOB O'JI1CTKI1 BbInOl1H5IeTC5I C uel1blO nOJ1TBep-
)I(JleHI151 3<j)<j)eKTI1BHOCTI1 MeTo.aOB O'JI1CTKI1. npl1 3TOM J1011)1(HbI 6blTb 3aJ1a-
HbI J10nYCTI1Mble npeJ1el1bHble 3Ha'JeHI1R Ha OCTaTKI1 npOJ1)'KUI1I1, MOIOIl{I1X
cpeJ1CTB 11 MI1Kp06HOe 3arp3HeHl1e. 3m npeJ1ellbHble 3Ha'JeHI1H J10ll)/(HbI
6bITb peaJIbHO J10CTI1)1(I1MbIMI1 11 npOBepHeMbIMI1.
37 Lln51 Onpe.llelleHI151 YCTaHOBJIeHHbIX npeJ1e110B OCTaTKOB BellleCTB I1JII1
3arp5l3HeHI1l1 Cl1eJ1yeT I1Cn0l1b30BaTb aTTeCTOBaHHble aHaJlI1TI1'JeCKl1e MeTOJ1bl
C .aocTaTo'JHOI1 'lYBCTBI1Tel1bHOCTblO.
38 KaK npaBI1110, aTTeCTaUl110 npoueCCOB O'JI1CTKI1 Cl1e.ayeT npOBo.aI1Tb
TOl1bKO DJI51 nOBepXHOCTel1, KOHTaKTl1pYlOllll1X C npOJ1YKTOM. ClleJ1yeT TaK)I(e
npl1HI1MaTb BO BHI1MaHl1e J1eTaJll1 060pYJ10BaHI151, He BCTynalOllll1e B KOHTaKT
C npOJ1YKTOM. Cl1eJ1yeT npOBOJ1I1Tb aTTeCTaUl110 DJII1TeJ1bHOCTI1 I1HTepBaJlOB
BpeMeHI1 Me)l(J1y OKOH'JaHl1eM npouecca 11 O'JI1CTKOH, a TaK)l(e O'JI1CTKOH 11
Ha'laJIOM Cl1eJ1YlOlllero npouecca. CJ1e.ayeT OnpeJ1el1l1Tb MeTOJ1bI O'JI1CTKI1 11
HHTepBaJlbI BpeMeHI1 Me)l(Jly npOBeJ1eHl1eM O'JI1CTKI1.
39 Lln51 MeT0J10B O'JI1CTKI1 CXOJ1HbIX BI1J10B npoJ1YKUI1I1 11 npoueCCOB
J10nYCKaeTC5I BbI6paTb npeJ1CTaBI1TeJ1bHbIH pHJ1 aHaJlOfl1'JHblX MaTepl1aJ10B 11
npoueCCOB. B TaKI1X CllY'Ja5IX MO)l(HO npOBOJ1I1Tb OJ1HO aTTeCTaUl10HHOe I1C-
ClleJ10BaHl1e }lJlH «HaI1XYJ1Wero CllY'Ja5l'), npl1 KOTOpOM Y'JI1TblBaIOTC5I Bce
KpI1TI1'JeCKl1e <j)aKTOpbI.
40 LlnH aTTeCTaUl111 MeTOJ1a O'JI1CTKI1 J10CTaTO'JHO ycnewHoro npoBeJ1e-
HI1H Tpex nOCl1eJ10BaTel1bHblX UI1KJIOB O'JI1CTKI1.
41 MeTOJ1 «npOBepRTb, nOKa He 6YJ1eT 'JI1CTO') He 3aMeHSIeT aTTeCTaUl110
npouecca O'JI1CTKI1.
42 B Ka'JeCTBe I1CKJIIO'JeHI151 npl1 aTTeCTaUl111 npoueCCOB O'JI1CTKI1 J10-
nYCKaeTC5I I1Cn0l1b30BaHI1e MaTepl1aJ10B, KOTopble I1MI1TI1PYIOT <j)113I1KO-
XI1MI1'JeCKl1e CBOHCTBa YJ1aJ1HeMbIX BellleCTB, eClll1 nOClleJ1Hl1e HBllHIOTC5I TOK-
CI1'JHbIMI1 111111 onaCHbIMI1.

Ammecmou,ufI npou,eCC06 O'1UCmKU 060pyiJ060HUfi
241
cGMP CiliA
KOlleKC <j)eJ1epaJIbHbIX npaBI111 CWA 21 CFR Parts 210 and 211 [16]
YCTaHaBJII1BaeT ClleJ1YlOllll1e Tpe6oBaHI151 K npoueccaM O'JI1CTKI1:
 211.67 ()qUCTKa H TeXHHlJeCKOe 06CJIYlKHBalIHe o60PY,lJ,OBaHHH
(a) a60PYllOBaHI1e 11 npI1Ha.LIJ1e)l(HOCTH nODJIe)l(aT nepI10J1I1'JecKoH
O'JI1CTKe, TeXHI1'JeCKOMY 06CllI1BaHI1IO 11 06pa60TKe C uel1blO npeJ10TBpa-
llleHI151 HenpaBI111bHoro <j)YHKUI10Hl1pOBaHI151 11 3arpH3HeHI151, KOTopble MO-
fYT 113MeHI1Tb 6e30nacHocTb, COCTaB, 3<j)cPeKTI1BHOCTb, Ka'JeCTBO I1JII1 'JI1CTO-
TY l1eKapCTBeHHoro CpeJ1CTBa no cpaBHeHl110 C O<j)I1Ul1aJ1bHbIMI1 111111 llPYrH-
MI1 YCTaHOBJIeHHblMI1 Tpe6oBaHI151MI1.
(b) a'JI1CTKa 11 TeXHI1'JeCKoe 06cllY)l(I1BaHI1e 06opYJ10BaHI151, B TOM 'JI1C-
lie npI1Ha.LIJ1e)l(HOCTeH, I1cnol1b3yeMblx npl1 np0I13B0J1CTBe, ynaKoBKe 111111
06paweHI111 C l1eKapCTBeHHbIMI1 CpeJ1CTBaMI1. 1l011)1(Hbl BbInOl1H5ITbC5I B COOT-
BeTCTBl111 C nl1CbMeHHbIMI1 I1HCTPYKUI151MI1. 3T11 I1HCTPYKUI1I1 J1011)1(HbI
BKJIIO'JaTb, KaK MI1HI1MYM, ClleJ1YlOlllee:
. anpe.lleJ1eHl1e OTBeTCTBeHHOCTI1 3a npOBe,lJ,eHl1e O'JI1CTKI1 11 TeXHI1-
'JeCKoro 06CllI1BaHI1H 060pYJ10BaHI1H;
. fpa<j)I1KI1 O'JI1CTKI1 11 TeXHI1'JeCKoro 06Cl1I1BaHI1H, BKJIIO'JaH, npl1
He06xoJ1I1MOCTH, rpa<j)I1KI1 06pa60TKI1;
. LlOCTaTO'JHO n0J1p06HOe Onl1CaHl1e MeT0J10B, 060pYJ10BaHI151 11 Ma-
Tepl1aJ10B. I1CnOl1b3yeMblx npl1 O'JI1CTKe 11 TeXHI1'JeCKOM 06CllY)l(I1BaHI111, no-
pH,lJ,Ka pa36opKl1 11 c60pKl1 060pY,lJ,OBaHI151, He06xoJ1I1MbIX DJIR npOBe,lJ,eHI151
O'JI1CTKI1 11 TeXHI1'JeCKoro 06Cl1I1BaHI151;
. Y,lJ,aJleHl1e 3TI1KeTKI1 111111 J1PYroro J10KYMeHTa, OTHocHlllerocR K
npeJ1blJ1YllleH cepl1l1;
. npeJ10XpaHeHl1e (3alllI1TY) 'JI1CTOro 060pY1l0Bamm OT 3arpH3HeHHH
J10 ero I1Cn0l1b30BaHI151;
. nOp5lJ10K npOBepKI1 'lI1CTOTbI 060pYJ10BaHI151 HenocpenCTBeHHO ne-
peJ1 ero I1Cn0l1b30BaHl1eM.
KaK BI1llI1M, npaBI1J1a G MP cOllep)J(aT 06111I1e YKa3aHH5I no npOBe-
lleHHIO O'lHCTKH 060PYllOBaHI15I H He OTllalOT npellnO'lTeHI15I PY'lHbIM HJ1H
aBTOMaTI1'leCKHM cpellCTBaM O'lI1CTKH, He roBOpHT 0 B03MO)J(HOCTH (HJ1H
HeB03MO)J(HOCTH) aTTeCTaUI1I1 MeTOllOB O'lHCTKH B 3aBI1CI1MOCTH OT CTe-
neHH aBTOMaTH3aUHH H np.
npaBHJ1a cGMP CiliA YKa3bIBalOT TaK)J(e Ha He06xOllI1MOCTb Yllalle-
HH5I npe)J(HeH 3THKeTKH ( 211.67, n. 4), T. e. Ha :,meMeHTapHbIe BelllH,
KOTopbIe 3aBI1C5IT OT nepCOHalla.
fOCT P 52249 (GMP EC) YCTaHaBJ1HBaeT Tpe60BaHH5I K aTTeCTa-
UHH KpHTI1'leCKHX npoueCCOB, K KOTOpbIM B p5Ille CJ1Y'laeB OTHOC5ITC5I
npoueCCbI O'lHCTKH. npI1J1o)J(eHI1e 15 .llaeT 'leTKI1e YKa3aHI15I, 'lTO HY)J(HO
llenaTb npI1 aTTeCTaUHH npoueCCOB O'lI1CTKI1.
Bce 3TI1 Tpe60BaHI15I HOCHT 06111I1H xapaKTep. KOHKpeTHbIe MeTO.llbl
O'lI1CTKI1 H I1X aTTeCTaUI15I 3aBI1C5IT OT KOHKpeTHoro np0I13BOllCTBa.

242
[;1060 10
10.3 CneUU3JIH3aUHSI 060PY1J.OBaHHSI
np06J1eMa CneUHallI13aUI1I1 060PY.llOBaHI15I 5IBJ15IeTCH OllHOH 113 ueH-
TpallbHbIX npI1 npOH3BOllCTBe J1eKapCTBeHHbIX Cpe.llCTB. HeOnpaB.llaHHa5I
CneUI1allI13aUH5I 03Ha l JaeT HeHHbIe KanHTallbHbIe 11 3KCnJ1yaTaUI10HHbIe
paCXOllbI, B03MO)J(HbIe npOCTOH 060PYllOBaHI15I H np. BbInycK HeCOBMe-
CTHMOH npOllYKUHH 11 HenpHCnOc06J1eHHOCTb 060PYllOBaHI15I K O'lHCTKe
aTTecTyeMbIMH MeTO.llaMI1 OnaCHbI llJ15I nOTpe6HTeJ15I.
Bcema J1H 1l0nYCTI1M BbInYCK pa311I1'lHOH npO.llYKUI1I1 Ha O.llHOM 060-
PYllOBaH11 H?
- HeT, He Bcema.
COBpeMeHHbIe aHallHTH'leCKI1e MeTOllbI He llalOT rapaHTHH 06Hapy-
)J(eHH5I HeKoTopbIX allJ1epreHOB (HanpI1Mep, neHI1UI1J1J1I1HOB 11 ueallOC-
nopHHOB) H CHJ1bHOlleHCTBYlOlllHX BellleCTB (OT.lleJ1bHbIX CTepOI1ll0B, UI1-
TOTOKCI1HOB H np.). B TaKI1X clIY'la5Ix HeJ1b35I 060cHoBbIBaTb B03MO)J(-
HOCTb BbInYCKa pa3HbIx BI1ll0B npollYKUHH Ha OllHOM 060PYllOBaHHH
npHMeHeHHeM OC06bIX MeTOllOB O'lHCTKH H HX aTTecTaUHeH. npOH3BOLl-
CTBO CJ1ellyeT opraHH30BbIBaTb Ha CneUI1allH3HpOBaHHoM 060PYllOBaH 11 11,
npellHa3Ha'leHHOM TOllbKO D.J15I llaHHoro npollYKTa.
CYllleCTByeT MHeHHe, 'lTO MO)J(eT 6bITb YCTaHOBJ1eHa HeKa5I npelleJ1b-
Ha5I CTeneHb 3arp5I3HeHH5I TaKHMH BelllecTBaMH, KOTOpa5I 6bIJ1a 6bI HH)I(e
npelleJ1a 'lYBcTBHTeJ1bHOCTI1 caMoro 'lYBCTBHTellbHoro H3 I13BeCTHbIX aHa-
J1HTH'leCKHX MeTOLlOB, T. e. npe.lleJ1 .llOJ1)J(eH 6bITb TaKI1M, 'lT06bI ero
Hellb3H 6bIJ10 06HapHTb.
C HaweH TO'lKH 3peHH5I TaKOH nOllXOll HellonYCTHM. J11060H MeTO.ll
onepI1pyeT J1HllIb C OrpaHH'leHHOH BbI60pKOHllaHHbIX B npelln01l0)J(eHHH,
'lTO CBOHCTBa BbI60pKI1 MO)J(HO pacnpOCTpaHHTb Ha BeCb 061>eKT B ue-
110M. 3T0 Bcero J1I1Wb llonYllleHHe, KOTopoe HOCHT Bep05ITHOCTHbIH xa-
paKTep. OHO MO)J(eT 6bITb ClleJ1aHO llJl5I HeonaCHbIX cHTyaUI1H. B CJ1Y'lae C
onaCHbIMI1 BellleCTBaMI1 CJ1ellyeT onepI1pOBaTb He nOH5ITI1eM «6epORm-
nocmb», a nOH5ITHeM «603MOJICnOcmb» , Koma UCK.IlIO'IaemCR caMa 603-
MOJICnOCmb nacmYn.IlenUR onacnozo co6blmUR.
I1MeHHo 3TOMY YClIOBHIO 11 OTBe'laeT Tpe60BaHHe GMP 06 HCnOJ1b-
30BaHI1H 060PYlloBaHH5I I1HllHBHllYallbHO D.J15I KOHKpeTHoro BI1lla onacHoH
npollYKUI1H:
rOCT P 52249-2009 (GMP EC)
3.6 Lln51 MI1HI1MI13aUI111 pl1CKa DJIn 3J10poBb51 111OJ1ei1 113-33 nepeKpeCT-
HblX 3arpH3HeHI1H npl1 np0I13B0J1CTBe HeKOTopblX l1eKapCTBeHHblX cpeJ1CTB,
TaKI1X KaK ceHcI1611lll1311PYlO1lll1e BellleCTBa (Hanpl1Mep, neHI1UI11111I1Hbl) I1JlI1
6110110rl1'JeCKl1e l1eKapCTBeHHble CpeJ1CTOa (Hanpl1Mep, 113 )l(I1BbIX MI1KpOOp-
raHI13MOB), ClleJ1yeT npeJ1YCMaTpl1BaTb CneUl1aJ1bHble 111111 113011l1poBaHHble
TeXHI1'JeCKl1e cpeJ1CTBa (nOMeUleHI151, 060PYJ10BaHl1e, CpeJ1CTBa 06Cl1Y)l(I1Ba-
HI1H 11 J1p.)...

Ammecmou,UR npou,eCC06 O'lUCmKU 060PY0060HUR
243
B TaKI1X CJ1Y'la5IX 1l0JDKHO 6bITb OpraHH30BaHO cneu,UQ./lU3Up06annOe
npOH3BOllCTBO Ha cneu,UQ./lU3Up06annOM 060PYllOBaHHI1. ATTeCTaUI15I Me-
TO.n.OB O'lHCTKI1 He 5IBJ15IeTC5I naHaueeH 11 He .llaeT OCHOBaHH5I llJ15I APYroro
peWeHH5I.
I1TaK, cneUI1allI13I1pOBaHHoe 060PYllOBaHHe CJ1ellyeT I1Cn0J1b30BaTb:
. npH pa60Te C TPYllHO Yllall5IeMbIMI1 BellleCTBaMH llJ15I llaHHoro BI1-
lla nOBepXHOCTeH (BBI1llY CHJ1bHOH a.n.re3I1I1);
. eCJ1I1 060PYllOBaHI1e TPYllHO nOllilaeTC5I O'lI1CTKe (H3-3a HallI1'lI15I
CKpbITbIX n0J10CTeH H np.);
. npH np0I13BOllCTBe np0.llYKUI1I1, npellCTaBJ15IlOllleH BbICOKI1H pI1CK
(TOKCI1'lHbIe, ceHCH6HJ1H3I1PYlOlllI1e 11 np. BellleCTBa);
. npI1 np0I13BOllCTBe CI1J1bHOlleHCTBYlOlllHX J1eKapCTBeHHbIX
cpellCTB. CJ1ellbI KOTOpbIX TPYllHO 06HapY)J(HTb npH ypOBH5IX,
MeHbWI1X npe.lleJ1bHO-.llOnYCTI1MbIX KOHueHTpaUI1H (nllK).
PacnpOCTpaHeHHOH OWH6KOH 5IBJ15IeTCH peWeHI1e 0 BbInYCKe Ha Oll-
HOM 060PYllOBaHHH llBYX HJ1H HeCKOJ1bKHX BI1ll0B HeCOBMeCTHMOH npo-
llYKUHI1. npI1Mep npHBe.n.eH B maBe 6 (n. 6.8, npHMep 9).
10.4 eToAbI OHCTKH 060PYAOB3H
npHMeH5IIOTC5I PY'lHbIe, nOJ1yaBToMaTH'leCKI1e 11 aBTOMaTH'leCKHe
MeTOllbI O'lHCTKH «<O'lHCTKa Ha MecTe»). Ka)J(DbIH H3 HHX HMeeT npaBO
Ha )J(H3Hb. BbI60p MeTOlla 3aBHCHT OT cf>aKTopa ueJ1eC006pa3HocTH, OT-
BeTCTBeHHOCTH npOH3BOllCTBa, TeXHH'leCKOH peallI13yeMocTH aBTOMaTH'le-
CKHX MeTOllOB O'lI1CTKH H np.
10.4.1 P)"IHble MeTOAbl
3TI1 MeTOllbl WHpOKO pacnpOCTpaHeHbI. OHI1 npOCTbl 11 He Tpe6YIOT
60J1bWI1X 3aTpaT.
Ho OHH I1MeIOT CYllleCTBeHHbIH HellOCTaTOK: pe3YJ1bTaT CHJ1bHO 3aBH-
CI1T OT J1H'lHbIX Ka'leCTB J1Hua, npOB01l5Illlero 06pa60TKY. npI1 aTTeCTaUHH
PY'lHbIX MeTOllOB npI1HI1MaeTC5I AonYllleHI1e, 'lTO nepCOHall Bcer.aa pa60-
TaeT TO'lHO no HHCTPYKUHH. K CO)J(alleHHIO, npaKTI1Ka llaeT npI1MepbI OT-
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.IJ.bI 3aMeH5IIOTC5I, r.ae B03MO)J(HO, aBTOMaTI1'leCKI1MI1.
B TO )J(e BpeM5I PYIIHbIe MeTO.IJ.bI O'lI1CTKI1 ycnewHo npHMeH5IIOTC5I B
caMbIX pa3HbIX CJ1Y'la5IX, oc06eHHO .n.J15I 060PYllOBaHI15I 60JlbWHX pa3Me-
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H HeCTepI1J1bHbIX J1eKapCTBeHHbIX cpellCTB. Bo MHOrI1X CJ1Y'la5IX PYIIHOH
MeTOll MO)J(eT OKa3aTbC1 ellI1HCTBeHHblM peaJlbHbIM MeTO.llOM O'lI1CTKI1.

244
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npHMep H3 npaKTHKH
B CTaTbe (45) paCCMaTpI1BaeTC5I onblT aTTeCTaUl111 npouecca O'II1CTKI1
6JlUCmepHoii MaWUHbi. LlnH npOBeJ1eHI151 aTTeCTaUl111 3aKa3'JI1KOM 6bll1a npl1-
rl1aweHa He3aBI1CI1Ma51 <j)l1pMa (I1CnOl1HI1Tel1b).
PaHee 3aKa3'JI1K npOB0J1I111 O'JI1CTKY no cllenYlOllleH cxeMe:
I) D.o Ha'JaJla O'JI1CTKI1 BOJ10H 11 J1eTepreHTOM npoB0J1I111aCb TwaTel1bHa51
06pa60TKa Bcex Y3JlOB nbll1eCOCOM, KOTOpblH 6bl11 npl106peTeH CneUl1aJ1bHO
J1Jl51 3TOH uel1l1. KpoMe TOro, npeJ1YCMaTpl1BaJlaCb 06pa60TKa nbIJIeCOCOM
Bcex Y3JlOB 060PYJ10BaHI151 B KOHue pa60'Jero J1H5I, eCl1l1 Ha ClleJ1YIOWI1H
J1eHb HaMe'JaJlaCb pa60Ta C TOH )l(e Cepl1eH;
2) BbInOllH5I110Cb MbITbe 060PYJ10BaHI1H BPY4HYIO Mbll1bHOH B0J1011;
3) npOB0J1I1110Cb ero npOMbIBKa npoTO'JHoH B0J10H 11 PY4HbIM nYllleM.
3TOT MeTOJ1 COJ1ep)l(aJI HeKOHTpol1l1pyeMble 311eMeHTbI:
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CTaHnapT113aUI151 3TI1X onepaUI1H. 3aKa3'JI1K 11 I1CnOl1HI1Tel1b npl1Wl1l1 K CO-
maweHMIO, 'JTO MeTOJ1 O'JI1CTKI1 HOBOro 060PY.llOBaHI151 J10ll)l(eH 6bITb noxo-
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npe)l(Jle Bcero, 6bIJIa peweHa 3aJIa'Ja CTaHJ1aPTI133UI1I1 MbITbR. PaCTBOp
J1eTepreHTa J1011)1(eH I1MeTb OnpeJ1el1eHHYIO KOHueHTpaUI1IO. Lln51 OTMepI1Ba-
HI151 J1eTepreHTa 6bl110 npeDJIO)l(eHO I1CnOllb30BaTb MepHYIO 'JalllKY, DJI51 BO.llbl
- 60llbWYIO BaHHY C OTMeTKOI1 ypOBH5I BOJ1bI. nOCKOl1bKY 06a npouecca
(OTMepI1BaHI151 J1eTepreHTa 11 BOJ1bl) I1Mel1l1 HeKOTOpylO HeonpeJ1elleHHOCTb
(pa36poc), TO npl1 aTTeCTaUl111 6bl110 nOKa33HO, 'JTO 060PYJ10BaHl1e MO)l(eT
6bITb O'JI1111eHO, J18)1(e eClll1 OTMepeHO MaJlO J1eTepreHTa 11 OCTaTKI1 J1eTepreH-
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CKaH Bona 113-n0J1 KpaHa C TeMnepaTypoH OK0110 40°C. nOCl1eJ1H5I5I npoMbIB-
Ka OCYllleCTB1l5l11aCb BOJ10M nOCl1e 06paTHoro OCMoca C TeMneparypoH TaK)l(e
OK0110 40°C. KOHTpOllb TeMnepaTypbl BOJ1bl OCYllleCTBllHl1CH CI1CTeMOH MO-
HI1TOpl1Hra (J1aT'JI1KaMI1), KOTOpa51 J1aBaJla Cl1rHaJI npeJ1ynpe)l(JleHI151 npl1 Bbl-
XOJ1e TeMnepaTypbl 3a HI1)1(HI1H 11 BepXHI1H npeJ1el1bI.
CTaHJ1aPTI133UI151 npouecca nocl1elIHeH npOMblBKI1 6bllla peaJIl130BaHa
3a C'JeT HanOllHeHI151 BaHHbl OnpeJ1el1eHHblM KOlll1'JeCTBOM BOJ1bl 11 nOCl1eJ1Y-
10111I1M onOl1aCKI1BaHl1eM.

Ammecmou,UR npou,eccoe O<fUCmKU o6npyooeoHuR
245
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TeJ1bHOCTb 11 nOCJ1ellOBaTeJ1bHOCTb. 06pa60TKa TPY.llHO.llOcTynHbIx MeCT H
T. ll.) .llOJ1)J(HbI 6bITb pemaMeHTI1pOBaHbI HHCTPYKuHeH no O'lI1CTKe.
CaMOH TPY.llHOI1 np06J1eMoti PY'lHbIX MeTOllOB O'lHCTKH 5IBJ1HeTC5I
'leTKOe BbInOJ1HeHI1e nepCOHallOM Tpc60BaHHH I1HCTPYKUI1H. HY)J(HO Y'lH-
TblBaTb Bl1H5IHHe 'leJ10Be'leCKoro aKTopa Ha npouecc O'lHCTKH npH aTTe-
CTaUHI1 npouecca. CYllleCTBYIOT pa3HbIe cnoc06bI CBelleHH5I 3TOro aK-
Topa K MHHHMYMY, HO I1CKJIIO'lHTb ero nOJ1HOCTblO npI1 PY'lHbIX MeTOllax
HeJ1b35I. n03TOMY Bce 6oJ1ee WHpOKoe npHMeHeHHe HaX01l5IT COBpeMeH-
HbIe Cpe.llCTBa KOHTpOJ15I 'lHCTOTbI BOllbI nOCJ1e nOCJ1e.llHeH npOMbIBKI1, B
'laCTHOCTI1, aHallI13 06111ero OpraHI1'leCKoro ymepolla B BOlle.
npI1 pa3pa60TKe MeTOlla O'lI1CTKI1 CJ1ellyeT HMeTb B BHllY. 'lTO OH
llOJ1)J(eH 6bITb aTTeCTOBaH. n03TOMY Bce onepaUI1H llOJ1)J(Hbl 6bITb MaK-
CHMallbHO nOBTOp5IeMbIMH, paCXOll .lleTepreHTOB H BOllbI ll1151 O'lHCTKI1
1l0J1)J(eH 6bITb O.llHHaKOBbIM. 3TO llOJ1)J(HO 6bITb o6ecne'leHO opraHH3aUH-
OHHbIMH H TeXHH'leCKHMH MepaMH, HHa'le aTTeCTaUH5I He HMeeT CMbICJ1a.
npH nOllroToBKe K pa60Te no GMP MO)J(eT nOTpe6oBaTbC5I I13MeHe-
HHe MeTOlla O'lHCTKH, MOllepHH3aUH5I 060PYllOBaHH5I HJ1H KoppeKTHpOBKa
npouecca ll1151 06eCne'leHHH COOTBeTCTBH5I Tpe60BaHH5IM G M P.
llo.llya6mO.MamUlteCKue .MemOdbi
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lllHX aBTOMaTH'leCKI1H KOHTPOJ1b npouecca H ero napaMeTpoB (TeMnepa-
Typa, KOHueHTpaUI15I paCTBopa H np.).
K PY'lHbIM onepaUI15IM OTHOC5ITC5I: 'laCTH'lHaH pa360pKa 060PYllOBa-
HH5I, TpaHcnopTHpOBaHI1e C1>eMHbIX 'laCTeH K MeCTY MOHKI1, 3arpY3Ka H
BbIrpY3Ka H3 MOe'lHOH MaWI1HbI, ynaKoBKa 'lHCTOro 060PYllOBaHHH (c
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BaHH5I K MeCTY YCTaHOBKH 11 xpaHeHH5I), MOHTa)J( C1>eMHbIX 'laCTeH.
npI1 PY'lHOM 11 nOJ1yaBTOMaTI1'leCKOM MeTOllax KJIIO'leBOe 3Ha'leHI1e
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JIa, TlllaTeJ1bHa5I aTTeCTaUI15I npoueCCOB O'lI1CTKI1 C pa3pa60TKOH HHllHBI1-
llyanbHblx MeTOllI1K aTTeCTaUI1I1 11 KOHTpOJ1b npouecca.
10.4.2 MeTOAbI O'lUCTKU Ha MeCTe
O'lHCTKa 060PYlloBaHH5I MO)J(eT BbInOJ1H5ITbC5I llBYM5I cnOC06aMI1:
- c pa360pKoH 060PYlloBaHH5I H O'lI1CTKOH (MOHKOH, lle3HHeKUI1eH)
C1>eMHbIX 'laCTeH 3a npe.lleJ1aMH 060PYlloBaHI15I;
- O'lHCTKOH 060PY.llOBaHH5I 6e3 ero pa360pKI1.
B nepBOM Cl1Y'lae Tpe6yeTC5I C0311aHI1e .,ucmbLX YC.Il06uii B .Mecme 06-
pa60mKu Cbe.MnbLX .,acmeii, npI1MeHeHI1e CneUI1allbHbIX npI1eMOB ynaK06-
#cu C1>eMHbIX 'laCTeH 11 I1X mpaHcnopmup06allUR OT MeCTa 06pa60TKI1 K
060PYlloBaHHIO, C03.llaHI1C .,ucmbiX YCJl06uii 6 .Mecmax C60PKU, YCTaHOBKI1

246
111060 10
CDeMHbIX 'laCTeH B 060PY.llOBaHI1e 11 nodcoenUnenUR KOMMYHUKau,uii. 3TI1
OnepaUI1H 'lYBCTBI1TeJ1bHbI K BJ1I15IHI11O OKpY)J(alOllleH Cpe.llbI 11 nepCOHa-
J1a, B TOM 'lHCJ1e OWI16KaM nepCOHalla H OTKJIOHeHI11O OT BbInOJ1HeHI15I
Tpe60BaHHH HHCTPYKUHH. ATTeCTaUI15I TaKI1X MeTOllOB 3aTpY.llHI1TeJ1bHa 11
np06J1eMaTH'lHa Bo06we BBI1n.y Bl1H5IHHH He Bcema KOHTpOJ1I1pyeMbIx
BHeWHHX aKTopOB.
Bo BTOpOM CJI}"lae pa360pKa 060PYllOBaHHH He Tpe6yeTCH. MOlOlllHe
cpellCTBa nOllalOTC5I HenocpellCTBeHHO B 060PYllOBaHI1e, 11 O'lI1CTKa BHYT-
peHHHX nOBepXHOCTeH BbInOJ1H5IeTC5I 6e3 HapyweHH5I ueJ10CTHOCTH 060-
PYlloBaHH5I. OnepauI15I MOHKH BbInOJ1H5IeTC5I nOJ1yaBToMaTH'leCKH HJ1H
aBTOMaTH'leCKI1, 6J1arollapSl 'leMY BJ1H5IHI1e 'leJ10BeKa 11 oKPY)J(alOllleH
cpellbI CBOllHTC5I K MI1HHMYMY I1J1H HCKJIIO'laeTC5I COBceM. B 3TOM H co-
CTOHT CYTb MeTOlla O'lI1CTKI1 Ha MeCTe - CIP.
O'lHCTKa Ha MeCTe (Ciean-in-pJace - CI P): MeTO.ll O'JI1CTKI1 BHYTpeHHI1X
nOBepxHocTeH 060PYJ10BaHI1H 111111 TeXH0110rl1'leCKOH CI1CTeMbl B uel10M 6e3
pa360pKH 111111 C MI1HI1MaJlbHOH pa360pKoH.
flpUMeliaHue: MemoiJ CIP npedYCMampu6aem maKJlCe ydaJ/eHue ocmamK06
MOIOU(elO cpeiJcm6a iJo yp06HR, onpeiJeJ/ReMolo mpe606aHuRMu K npoiJYKl(UU U
npOl(eccy.
MHoma npI1MeH5IeTC5I repMI1H WIP - Wash-in-pJace. CYTb ero aHaJlO-
rl1'JHa TepMI1HY CIP. B HeKOTopbIX CllY'Ja5lX MeTOJ1Y WIP npl1nl1CblBaeTC5I
MeHbllla51 )l(eCTKOCTb C n0311Ul1H GMP, 'lTO I1MeeT CKopee 3MOUl10HaJlbHYlO
npl1poJ1Y, 'JeM TeXHI1'JeCKYIO.
O'lHCTKa Ha MeCTe npHMeH5IeTC5I B cPapMaUeBTH'leCKOH, nHllleBoH,
KOCMeTH'leCKOH npOMbIWJ1eHHOCTI1, 6I10TeXH0J10rHH H llpymx OTpaCJ15IX.
Ha'lallOM ee WHpOKOro npHMeHeHH5I MO)J(HO C'lHTaTb CepellI1HY XX-ro
BeKa. Oc06ylO pOJ1b OHa I1rpaeT B 3aKpbITbIX npoueccax 11 aCenTI1'leCKOM
np0I13BOllCTBe.
OHa Hcnollb3yeTC5I ll1151 O'lHCTKH peaKTopOB H llpymx COCYllOB, TPy-
60npOBO.llOB, MeCT nOllcoellHHeHH5I KOMMYHI1KaUI1H K JII10HJ1bHbIM
YCTaHOBKaM H np.
Tpe60BaHH5I K MeTOllaM O'lHCTKH Ha MeCTe B aCenTH'leCKOM npOH3-
BOACTBe MellI1UHHCKOH npOllYKUHH llaHbI B fOCT P I1CO 13408-4-2010
«AcenTH'leCKOe np0I13BOllCTBO MellI1UI1HCKOH npOllYKUI1I1. 4acTb 4.
O'lI1CTKa Ha MeCTe,).
npl1 npol13BOllCTBe CTepl111bHbIX l1eKapCTBeHHblX CpeJ1CTB BO MHomx
Cl1Y'Ja5lX nOCl1e O'JI1CTKI1 Ha MeCTe BbInOl1H5IeTCH CTep11Jl113aUI151 Ha MCCTe.
CMblCll KOTOPOH 6111130K K O'JI1CTKe Ha MeCTe: npouecc 06pa60TKI1 BbInOl1HH-
eTC5I 6e3 p<\360pKI1 060PYJ100aHI1H BHYTpl1 Hero.
Tpe6oBaHI1H K npoueccaM CTepl1lll13aUl111 Ha MeCTe J1aHbl 0 faCT P
MCO 13408-5-2010 «Aceml1'JecKoe npoI13BOJ1CTOO Melll1UI1HCKOH npoJ1YKul1ll.
'-IaCTb 5. CTepl111I1JaUml Ha MeCTe,).

Ammecmou,UR npou,eCC06 OlfucmKU 060pyd060HUR
247
KnIO'leBbIMI1 3J1eMeHTaMI1 MeTOlla O'lI1CTKI1 Ha MeCTe 5IBl1HIOTC5I cno-
C06bI nO.lla'lH MOlOlllero areHTa B 060PY.llOBaHHe 11 paCnpelleJleHH5I ero
BHyTPH 060PYlloBaHI1H. PacnpOCTpaHeHHbIM npI1eMOM 5IBJ15IeTC5I npHMe-
HeHI1e paCnbIJ1I1TeJ1eti MOlOlllero Cpe.llCTBa (spraybolf). KOHcTPYKUI15I pac-
nbIJ1I1TeJ1eH. HX 'lHCJ10 H MeCTa pacn0J10)J(eHH5I BHYTpH 060PY.llOBaHI15I
1l0Jl)J(HbI 6bITb TaKHMI1, 'lT06bI 06eCne'lHTb Han.e)J(HYIO O'lHCTKY nOBepx-
HOCTeH 060PYllOBaHH5I, conpHKacalOlllHXC5I C MaTepHallaMH H npOllYKTOM.
ComacHo faCT P I1ca 13408-4-2010 (n. 5.1.1) npl1 pa3pa60TKe Me-
TOJ1a O'JI1CTKI1 HHO Y'JeCTb Cl1e.llYlOllll1e OCHOBHble <j)aKTopbl:
a) <j)11311'JeCKl1e 11 XI1MI1'JeCKl1e CBOHCTBa MaTepl1aJ1a, OT KOTOporo
J1011)1(Ha 6blTb O'JI1111eHa nOBepXHOCTb C Y'JeTOM CI111bI aJIre31111 MaTepl1aJ1a K
J1aHHOM nOBepXHOCTI1;
b) <j)11311'JeCKl1e 11 XI1MI1'JeCKl1e CBOHCTBa 11 npl1HUl1n n.eHCTBI151 MOIO-
lllero cpeJ1CTBa;
c) B3al1MHYIO COBMeCTI1MOCTb 060PYJ10BaHI151, MOlOlllero CpeJ1CTBa C
YC110BI1HMI1 pa60Tbl;
d) DJII1Tel1bHOCTb nepl10J1a BpeMeHI1 n.o npooen.eHI1H O'JI1CTKI1 11 YCJIO-
BH5I, KOTopble J1011)1(Hbl 6bITb BbInOl1HeHbI B 3TOT nepI10J1;
e) 'JI1C110 UI1KJ10B O'lI1CTKI1;
f) DJII1Tel1bHOCTb nepl1on.a Han0l1HeHI151 MOlOllll1M CpeJ1CTBOM 11 06pa-
60TKI1;
g) MeTOn. nepeMeWI1BaHI1SI 111111 pacnbll1eHH5I MOlOwero cpeJ1CTBa;
h) nOpHJ10K YJ1aJ1eHI151 MOlOlllero CpeJ1CTBa;
i) nOp5lJ10K BbICYWI1BaHI151 060PYJ10BaHI151 nOCl1e O'JI1CTKI1;
j) Mepbl no nOJ1llep)l(aHI1IO 060PYJ10BaHI1H B 'JI1CTOTe nOClle 3aBepwe-
HI1H O'JI1CTKI1;
k) MaKCI1MaJlbHO J10nYCTI1MYIO DJII1Tel1bHOCTb nepl10J1a Me)l(JlY 3aBepwe-
Hl1eM O'JI1CTKI1 11 Ha'JaJlOM I1Cn0l1b30BaHI151 060Pyn.oBaHI151. a TaK)l(e YC110BI151,
B KOTOpbIX J1011)1(HO HaXOJ1I1TbC5I 060Pyn.oBaHl1e B Te'JeHl1e 3TOro nepl10J1a
BpeMeHI1.
Ammecmau,uR MemoOoe O'lUCmKU Ha Mecme
nOp5IllOK aTTeCTaUHH llaH B fOCT P I1CO 13408-4-2010.
npH aTTeCTaUHH CJ1ellyeT 06paTI1Tb oc060e BHI1MaHI1e Ha TPY.llHO.llO-
cTynHbIe MeCTa (deodlegs) 11 HaI1XYllWI1e YCJ10BH5I .llJ15I O'lI1CTKI1 (worst-to-
clean).
KoncmpYKu,UR 060PY.llOBaHI15I I1rpaeT KJIIO'leBYIO pOJ1b B nJ1aHe ero
npHrollHOCTH K O'lHCTKe. He .llJ15I BC5IKOro 060PYlloBaHI15I BOJMO)J(HbI
npoueccbl O'lHCTKH, KOTopbIe MOfYT 6bITb aTIeCTOBaHbI. npI1cnOC06J1CH-
HOCTb 060PYlloBaHI15I K O'lI1CTKe C rapaHTI1eH ero aTIeCTaUHH 1l0Jl)J(Ha
6bITb 3allO)J(eHa B ero KOHCTPYKUHIO. 3To O.llHO 113 OCHOBHbIX YCJ10BHH
COOTBeTCTBH5I 060PYllOBaHH5I Tpe60BaHI15IM GMP.
B H.llealle 3aBOll-I13roTOBI1TeJ1b 060PYllOBaHI1H .llOJ1)J(eH BKJIIO'lI1Tb B
COCTaB 1l0KYMeHTaUI1H Ha 060PYllOBaHI1e I1HCTPYKUI11O no O'lI1CTKe 11 MC-
TOllI1KY aTTeCTaUI1I1 npouecca O'lI1CTKI1. HaI1J1Y I IWI1M 06paJOM 3TOMY
YCJ10BHIO COOTBeTCTBycT 060PYllOBaHI1C C CI1CTCMal\H1 OIII1CTKI1 (CI P).

248
[;1060 JO
06pa60mKa (CmepUJlU3au,UJl) napOM UJlU ZQ30M
B p5Ille Cl1Y'laeB 3eKTHBHbIM MeTO.llOM o6pa60TKI1 (CTepI1J1H3aUI1I1)
nOBepXHOCTeH HBJl5IeTC5I 06pa60TKa XI1MI1'leCKI1MI1 Cpe.llCTBaMI1 B opMe
napa HJ1H ra3a. 3TI1 MeTOllbl WI1pOKO npI1MeH5IIOTC5I B aCenTH'leCKOM
npOH3BO.llCTBe H H30J1I1PYlOllleH TeXH0J10rI1I1 (fOCT P I1CO 13408-6-
2009 «AcenTI1'leCKOe npOH3BO.llCTBO MellI1UI1HCKOH npOllYKUI1H. l.JacTb 6.
1130J1HPYlOlllI1e CI1CTeMbI'), fOCT P I1CO 14644-7-2007 l.JI1CTbIe nOMe-
llleHH5I H CB5I3aHHbIe C HI1MI1 KOHTpOJ1HPyeMbIe. Cpe.llbI. l.JacTb 7. 1130J1H-
PYlOlllHe YCTpoHcTBa (YKpbITI15I C 'lHCTbIM B0311YXOM, 60KCbI nep'laTO'l-
HbIe, H30J15ITOpbI 11 MI1HH-oKPY)J(eHH5I).
)],n5I 06pa60TKI1 nOBepxHocTeH HCn0J1b3YIOTC5I napbl nepeKHcH BOllO-
pOlla, Han.YKCYCHOH KHCJ10TbI, 3THJ1eHOKCHlla H np. nOp5IllOK aTTeCTaUI1I1
npoueccoB CTepHJ1H3aUI1I1 3TI1J1eHOKCI1ll0M llaH B fOCT P I1CO 11135-
2000 <,Me.llHuI1HcKI1e H3lleJ1H5I. BallHllaUH5I H TeKYlllI1H KOHTpOJ1b CTepI1J1I1-
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10.4.3 3alll,HTa OT MUKp06HbiX 3arpS13HeHUH
060Py.noBaHHe nOCJ1e OKOH'laHI15I TeXH0J10fH'leCKoro npouecca H
nOCJ1e npOBelleHH5I O'lI1CTKH 1l0J1)J(HO 6bITb CYXHM. He llonYCKaeTC5I
HallI1'lHe OCTaTKOB BJ1arI1 H 3aCTOHHbIX 30H C BOllOH. HY)J(Ho nOMHHTb,
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. BJ1ara,
· nHTaTeJ1bHa5I cpella,
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06pa60TKa nOBepXHOCTeH He rapaHTI1pyeT nOJ1Horo, a6C0J1IOTHOro
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HOro 3arp5I3HeHH5I OTHOCHTeJ1bHO Ha'lallbHoro ypOBH5I. l.JeM MeHbwe 'la-
CTHU 6YlleT Ha nOBepXHOCTH llO Ha'lalla 06pa60TKH, TeM MeHbwe 6YlleT ee
MI1Kp06HaH 3arp5I3HeHHOCTb nOCJ1e ee 3aBepWeHI15I.
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BaHH5I 11 ero Y3JlOB nOCJ1e xpaHeHH5I H B nepI10.ll Me)J(DY I1Cn0J1b30BaHHeM.
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. OKOH'laHI1eM TeXH0J10rI1'leCKoro npouecca 11 Ha'lallOM O'lI1CTKI1,
. OKOH'laHI1eM O'lHCTKI1 11 Ha'lallOM CJ1ellYlOwero TeXH0J10rI1'leCKOrO
npouecca.
npOBepKa llJ1HTeJ1bHOCTI1 3TI1X I1HTepBallOB BpeMeHH 1l0mKHa, npu
He06xo.llI1MOCTI1, npe.llYCMaTpl1n,nbCH MeTO.llI1KOH aTTeCTaUI1H npoueccon
OIII1CTKI1.

Ammecmou,UR npou,eCC06 O'1UCmKU 060PY0060HlIR
249
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. HaI1MeHOBaHI1e 06oPYlloBaHI15I C YKa3aHI1eM nOBepxHocTeH, nOll-
J1e)J(alllHX O'lHCTKe;
. YKa3aHHe, B KaKHX CJ1Y'la5IX npOBO.llI1TC5I O'lI1CTKa;
. npHMeH5IeMbIe MaTep11 allbI 11 Cpe.llCTBa;
. npe.lleJ1bHO 1l0nYCTI1MbIe KOHueHTpaUI1I1 3arp5I3HeHHH;
. nOCJ1e.llOBaTeJ1bHOCTb npOBe.lleHI1}1 O'lI1CTKH;
. 3aTpaTbI BpeMeHI1 Ha O'lI1CTKY;
. 1l0nycTHMbIH HHTepBall BpeMeHH Me)J(DY 3aBepweHHeM BbInYCKa
npellbIllYllleH CepI1H npOllYKUI1H 11 npOBelleHI1eM O'lHCTKH;
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Ha'lallOM BbInYCKa CJ1ellYlOllleH cepHH npOllYKUI1I1;
. nOp5I.llOK KOHTpOJ15I 3eKTHBHOCTH O'lI1CTKH;
. nOp5I.llOK 0OpMJ1eHH5I 1l0KYMeHTaUHH 0 npoBelleHHH O'lHCTKH C
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. Tpe60BaHI15I K nepCOHallY.
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Tpe606anUJl K nepcona.llY
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nOllroToBKa 060PYllOBaHH5I K pa60Te, ero O'lHCTKa. Ho OHH CaMI1 MO-
rYT OCTaBJI5ITb nOCJ1e ce65I OCTaTKI1, T. e. SIBJ15IIOTC5I 3arp5I3HeHH5IMI1.
n03TOMY 065I3aTeJ1bHb1M Tpe60BaHI1eM K lleTepreHTY 5IBJ15IeTC5I
lIerKOCTb ero YllaJ1eHI1SI C 06pa6aTbIBaeMOH nOBepXHOCTI1. lleTepreHTbI,
He YllOBJ1eTBOp5IIOlllHe 3TOMY YCJ10BI1IO, He npI1rollHbI llJI5I I1Cn0J1b30-
BaHH5I B QJapMaUeBTI1IIeCKOH npOMbIWJ1eHHOCTI1.
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nocJ1e 3aBepWeHI15I O'lI1CTKI1. npI1 aTTeCTaUI1I1 npouecca O'lI1CTKI1 Cl1e.llY-
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250
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CTeHbI H llPyme nOBepXHOCTH nOMellleHHH H np.
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J],allee paCCMaTpHBalOTC5I TOJ1bKO KpI1TI1'leCKHe nOBepXHOCTH.
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- 060PY.llOBaHI15I, Ha KOTOpOM MO)J(HO BbInYCKaTb pa3J1H'lHYIO npo-
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IlYCKa TOJ1bKO OllHOro BHlla npOllYKUI1I1) HCn0J1b3yeTC5I B CJ1Y'la5IX, Koma
TPYllHO YD.allI1Tb OCTaTKI1 npOllYKTa, npOBe.lleHHe O'lI1CTKH KpHTI1'leCKHX
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llleCTB nOCl1C npOBelleHI1H OIII1CTKI1 HC 1l0J1)J(HbI npeBbIwaTb 3apaHce
YCTaHOI3J1CHHbIX npeiJeJlbnblX 3l1altellUU.

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ro I1HrpellHeHTa, eCJ1I1 npellYCMOTpeH BbInYCK npOllYKUHI1 OllHOro BI1lla,
HO C pa3HoH 3eKTI1BHOCTblO;
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252
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- 'lHCJ10 ellHHHU np0.llYKUHH B Ka)J(DOH CepI1I1 (MaKC/MI1H.),
- 'lHCJ10 CepI1H (MaKC/MHH).
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npOBOllHTC5I aTTeCTaUH5I I1X BeJ1H'lHH.
llp06edenue ammecmau.uu O.llJl neCKO.llbKUX euooe cxodnoii npOdYKu.UU
ECJ1H Ha OllHOM H TOM )J(e 060PYllOBaHHH BbInYCKalOTC5I pa3J1I1'lHbIe
npOllYKTbI, CXOllHbIe no COCTaBY 11 CBOHCTBaM, TO MO)J(HO npOBO.llHTb aT-
TeCTaUHIO MeTOllOB O'lHCTKH llJ15I O.llHOro npOllYKTa. ECJ1H pa3HbIe npo-
llYKTbI C03llalOT pa3J1H'lHbIe TpYllHOCTH llJ15I O'lHCTKH, TO aTTeCTaUI15I
llOJ1)J(Ha npOBOllHTbC5I ll1151 HaHXYllwero CJ1Y'la5I. T. e. ll1151 npOllYKTa,
npellCTaBJ15IlOlllero HaH60J1bWHH pHCK.
npouecc O'lHCTKH, BKJIIO'la5I MOlOlllHe BellleCTBa H MeTOllbI O'lHCTKH,
,D,OJDKeH 6blTb OllHHaKOB llJ151 Bcex BI1ll0B npOllYKUHH.
flp06edenue ammecmau.uu O.llJl neCKO.llbKUX CXOJICUX 6Ud06 060pyd06aHUH
ECJ1H B npOH3BOllCTBe HCn0J1b3yeTC5I HeCKOJ1bKO ellHHHU OllI1HaKOBO-
ro 060PYllOBaHH5I, TO aTTeCTaUH5I MeTOllOB O'lHCTKH MO)J(eT BbInOJ1H5ITbC5I
TOJ1bKO llJ15I OllHOH ellI1HHUbI 060PYlloBaHI15I. To )Ke OTHOCI1TC5I H K cxo-
)J(eMY 060PYlloBaHI1IO, pa3J1I1'lalOllleMYC5I TOJ1bKO pa3MepaMI1, HanpI1Mep,
pe3epByapaM BMeCTI1MOCTblO 300, 500 H 1000 J1. B 3TOM CJ1Y'lae aTTeCTa-
UH5I MO)J(eT BbInOJ1H5ITbC5I .IIJ15I pe3epByapoB C HaH60J1bWHMH 11
HaHMeHbWHMH pa3MepaMH.
HnmepeQ./lbl epeMenu, nOd.lleJICaue ammecmau.uu
npH aTTeCTaUHH npoueCCOB O'lHCTKH CJ1ellyeT nOllTBep.llHTb .llony-
CTHMOCTb BeJ1I1'lI1HbI CJ1ellYlOlllHX I1HTepBallOB BpeMeHH:
- Me)J(DY OKOH'laHI1eM npouecca H O'lI1CTKOH;
- Me)J(DY O'lI1CTKOH 11 Ha'lallOM CJ1ellYlOlllero npouecca;
- Me)J(DY nOCJ1ellOBaTeJ1bHbIMI1 O'lI1CTKaMI1.
npI1 onpe.lleJ1eHI1I1 aKTopoB pI1CKa, pa3pa60TKe 11 aTTeCTaUI1I1 Me-
TOllOB O'lI1CTKI1 n0l1e3HO nOCTpOI1Tb BpeMeHHYIO llI1arpaMMY np0I13BOll-
CTBeHHOro npouecca C HaHeCeHI1eM Ha .lll1arpaMMY BpeMeHI1 O'lI1CTKI1
060PY.llOBaHI15I (npl1Mepbl nOKa3aHbl Ha pI1C. 10.1 11 10.2).

254
FlO60 10
BblnYCK
npoAYKTa A
BblnYCK
npoAYKTa B
04."cTKa OT 
npoAYKTa A
wzz.2j
BblnYCK
npoAYKTa A

04."CTKa OT
npoAYKTa B
IWZL:I
I I
o
t. BpeM
PHC. 10.1. BbInycK npon.YKUI1I1 A 11 B 11 npOBelleHHe O'lI1CTKI1
BblnYCK cep."i4 OAHOi4 npOAYKU."H
I  \
04."CTKa
AeTepreHTOM
npOMblBKa
Wffn01
o
1 < t
I. BpeM
PI1C. 10.2. BbInycK O.llHOH npOllYKUHI1 OllHHaKOBbIMI1 CepmIMI1
PaCCMOTpHM mnH'IHble CJIy'laH
BbmycK iJ6YX PU3JlUIIHblX 6U006 npooYKu.UU HQ OiJHOM 060pyiJo6aHuu
Ha OJ1HOM 11 TOM )l(e 060PYJ10BaHI1I1 npelIYCMOTpeH BbInYCK npOJ1YKTOII
A 11 B (pl1c. 10.1). BHa4aJ1e BbInYCKaeTCH Cepl1H (HecKol1bKO cepl1i1) npo-
J1YKUI1I1 A.
3aTeM 'lepe3 BpeM5I t. npoBOlII1TC5I O'JI1CTKa 060PYlloBaHI1H. 3TO UpCMH
He J10n)l(HO 6blTb 60nbllll1M, 'JT06bl He J10nYCTI1Tb pacnaJIa npOJ1YKUI1I1 A H
He npe1!.YCMaTpl1BaTb cnem1anbHbiX Mep no YJ1aJ1eHI1IO 3TI1X npOJ1YKTOB pac-
naJIa, a 3aTeM npOBOlIl1Tb aTTeCTaUl110 npouecca O'II1CTKII.

Ammecmou,ufI npou,eCC06 O'1UCmKU 060PY0060HUfi
255
BbInYCK npOJ1YKUI1I1 B Ha'JI1HaeTCH 'Jepe3 BpeM5I tZ' 3TO BpeM5I TaK)l(e
He J1011)1(HO 6bITb 6ollbWI1M, 'JT06bl He J10nYCTI1Tb HaKOnl1eHI1H 3arp5l3HeHI1M
113 OKPY)I(alOllleH CpeJ1bI.
llaJIee npouecc nOBTOp5leTCH, HO BpeM5I t3 (BpeMH nOCl1e 3aBepWeHI1H
BbInYCKa npollYKU1111 B) MO)l(eT OTlll1'JaTbCH OT BpeMeHI1 tl.
nOClle 3TOro 'Jepe3 BpeM5I t 4 CHOBa Ha'lI1HaeTCH BbInYCK npOllYKUl111 A.
3TI1 I1HTepBaJlbl BpeMeHI1 nODJIe)l(aT aTTeCTaUI1I1.
BbtnYCK oiJHoil U moil 3ICe npoiJYKlI,UU
Ha OJ1HOM 060PYJ10BaHI1I1 npeJ1YCMOTpeH BbInYCK OllHOH npOJ1YKUI1I1
OJ1I1HaKOBbIMI1 Cepl151MI1 (pI1C. 10.2), HO npOJ1YKUI1H xapaKTepl13yeTcH 6bICT-
pOH paCnaJIaeMOCTblO. Ha'JI1HaH C BbInYCKa nepBoH cepl1l1 npOJ1YKUI1I1 (TO'J-
Ka 0) npoI1CXOJ1I1T HaKOnl1eHl1e OCTaTKOB npOJ1YKTa 11 npOJ1YKTOB ero pacna-
J1a. B8)I(HO OnpeJ1el1I1Tb:
- 3Ha'JeHl1e tHI. B Te'JeHl1e KOTOporo KOHueHTpaUI151 ocmamK06 npo-
iJYKma npeBblCI1T J10nYCTI1Mble 3Ha'JeHI1H 11
- 3Ha'JeHI151 tl 11 tz.
a6WaH DJII1Tel1bHOCTb pa60<lI1x UI1KJIOB to J10ll)l(Ha 6bITb MeHbwe tHI.
10.6 MeTOAbI OlJ,eHKH 'IHCTOTbl nOBepxnoCTeH
.lI.n5I oueHKH 'lHCTOTbI nOBepxHoCTeH npHMeH5IIOTC5I CJ1e.uYlOlllHe MeTOllbI:
- BH3YallbHbIH OCMOTP,
- oT60p np06 C nOCJ1e.uYlOlllHM aHallH30M,
- MeTOll nnaue60.
10.6.1 BH3YaJIbHblH OCMOTp
B CTapbIe 1l06pbIe BpeMeHa BH3YallbHbIH OCMOTp HeBoopY)J(eHHbiM
ma30M 6bIJ1 OCHOBHbIM MeTOllOM oueHKH 'lI1CTOTbI nOBepxHocTeH. 3aTeM
n05IBI1J1HCb pa3J1H'lHble MeTOllbI oT60pa 11 aHallI13a np06. Ho 3Ha'lI1MOCTb
BH3YallbHOro MeTO.lla He YMeHbWHJ1aCb. HanpOTI1B, nOCT05IHHOe YCJ10)J(-
HeHI1e 11 y.uopO)J(aHI1e MeTOilOB aHallI13a 'lI1CTOTbI nOBepXHOCTeH 3aCTaB-
J15I1OT I1Cn0J1b30BaTb caMbIe npOCTbIe H lleweBbIe MeTOllbl.
BI13YallbHbIH MeTOll, KaK npaBI1J10, 1l0CTaTO'leH ll1151 HeKpHTI1'leCKHX
nOBepXHOCTeH. .lI.n5I KpHTH'leCKHX nOBepXHOCTeH aTTeCTaUH5I MeTOllOB
O'lI1CTKI1 llOJ1)J(Ha npOBOllI1TbC5I C nOMOlllblO oT60pa 11 aHallI13a np06 C
nOBepXHOCTeH 060pYllOBaHH5I. Ho 11 B 3TOM CJ1Y'lae, He3aBI1CI1MO OT BbI-
60pa aHallI1TH'leCKoro MeTOlla, BI13YallbHbIH OCMOTp 065I3aTeJ1eH, 3a I1C-
KJIIO'leHI1eM nOBepXHOCTeH, HellocTynHblx llJ15I OCMOTpa.
nOH5ITI1e «BI13YallbHO 'lI1CTbIH» COOTBeTcTByeT npI1MepHO ypOBHIO
3arp5I3HeHI1H 4 MKrjcM 2 . 3TOT KpI1TepI1i1 He npI1MeHI1M llJ15I CI1J1bHollei1-
CTBYlOlllI1X npenapaTOB I1J1I1 npenapaTOB C MallOH .u030H aKTI1BHOH cy6-
CTaH UI1 11.

256
[;1060 JO
BI13YallbHbIH MeTO.ll n03B0115IeT 06HapY)J(HBaTb BHilHMbIe ma30M He-
60J1bWHe no nJ10111a.llI1 CKOnJ1eHI15I 3arp5I3HeHHH, KOTopbIe MorYT OKa-
3aTbC5I BHe npelleJ10B oT60pa np06. ECTb on bIT 06HaPY)J(eHH5I 3arp5I3He-
HI1HllO ypOBH5I 1,0 MKr/CM 2 c nOMOlllblO HCTO'lHHKa CBeTa [271.
MeToll Ma3KOB npe.llYCMaTpI1BaeT OT60p np06 He co BceH nOBepXHO-
CTH, a l1I1Wb C ee 'laCTI1, npe.llnOJ1ara5I, 'lTO 3arp5I3HeHI15I pacnpe.lleJ1eHbI
no nOBepXHOCTI1 paBHOMepHO. 3T0 O'leHb YCJ10BHOe npe.lln0J10)J(eHI1e,
KOTopoe HOCHT BbIHY)J(DeHHbIH xapaKTep. nOHI1Ma5I 3TO, npaBI1J1a GMP
CWA Tpe6YIOT BI13YallbHOro oCMoTpa nOBepxHocTeH He3aBI1CI1MO OT Me-
TOlla aHallH3a.
npaBI1J1a cGMP CWA (21 CFR 211.67.b.6) [16] Tpe6YIOT npOBeLle-
HI15I OCMOTpa nOBepxHocTeH 00 nalltua pa60mbl. 3TOT OCMOTp .llOJ1)J(HbI
npOBOllHTb Bce onepaTopbI, He3aBI1CI1MO OT npHMeHHeMbIX MeTOllOB OT-
60pa 11 aHallH3a np06.
OCMOTp TaK)J(e cJlellyeT npOBOllHTb nepe.ll Ha'lallOM oT60pa np06.
BI13YallbHbIH OCMOTp MO)J(eT 6bITb 1l0n0J1HeH TaKI1MI1 MeTOllaMH KaK
BbICoK03eKTHBHa5I )J(l1llKOCTHa5I xpoMaTOrpaH5I (High Peiformonce
Liquid Chromatography - HPLC) H aHallI13 06111ero OpraHH'leCKoro yrJle-
pOlla (Total Organic Corbon- TOC). MO)J(HO cpaBHHBaTb llaHHbIe, nOJ1Y-
'laeMbIe BH3YallbHbIM OCMOTpOM H 3THMH MeTOllaMH, BbIHBJl5ITb 3aBHCH-
MOCTb Me)J(Dy HHMH H HCn0J1b30BaTb ee Ha npaKTHKe.
HellocTaTKoM BH3YallbHOro oCMoTpa 5IBJl5IeTC5I ero cy61>eKTHBHOCTb,
I13-3a 'lero MHome C'lHTaIOT ero «HeBallI1llI1pyeMbIM», T. e. Hero.llHbIM.
Ho )J(I13Hb CJ1O)J(Hee I1CKYCCTBeHHbIX nOCTpoeHHH. nmIBJ15IIOTC5I npI1eMbl,
YMeHbWalOlllI1e BJ1H5IHI1e cy61>eKTI1BHoro aKTopa.
KpoMe TOro, 'leJ10BeK MO)J(eT OueHI1Tb 'lHCTOTY oceH BHllI1MOH no-
BepxHocTH, a He TOJ1bKO OT.lleJ1bHbIX MeCT oT60pa np06, KaK B MeTOlle
Ma3KOB. npH npaBHJ1bHOM nopHllKe 3eKTHBHOCTb BI13YallbHOro
OCMOTpa He YCTynaeT HHCTpYMeHTallbHbIM MeTOllaM 127].
10.6.2 OT60p np06 C nOCJ1e.ayIOUJ.HM aH3JlH30M
113BecTHbi llBa MeTO.lla oT60pa np06 C nOBepxHocTeH:
. MeTOll Ma3KOB (swab samples);
· MeTOLl CMbIBOB (rinse samples).
MeTOA Ma3KOB
OT60p np06bI npOBOllI1TC5I C nOMOlllblO nallOII, KI1 Ha OllHOM KOHUC
KOTOpOti HaXOllI1TC5I TaMnOH 113 WepCTI1, XJ10nKa I1J1H llPYroro HeHTpallb-
HOro MaTepI1alla, He BHOC5Illlero I1CKa)J(eHI1H B pe3YJ1bTaT KOHTpOJ15I. B
onpe.lleJ1eHHOM nOpH.llKe npOBOmlT TaMnOHOM no nOBepXHOCTI1. 3aTC!\1
TaMnOH nOMeruaeTC5I B paCTBOpI1TeJ1b, KOTOpbIH I13I3J1eKaeT OCTaTKI1 3a-
rp5I3HeHHH, oT06paHHbIe C nonepXHOCTI1. 3TO - np5IMOH MeTOll oT60pa
np06.

Ammecmou,Ufl npou,eCC06 O<fUCmKU 060pyd060HUfl
257
CYllleCTBYIOT pa311I1'lHbIe peKOMeHllaUI1I1 B OTHOWeHHH 061>eMa np06
C nOMOlllblO Ma3KOB: nJ10111Mb nOBepXHOCTI1, C KOTOpOH COnpI1KOCHYJ1C5I
TaMnOH, llOJ1)J(Ha 6bITb He MeHee 100 CM 2 , CJ1e.llyeT B35ITb He MeHee n5ITH
np06 H T. ll. He CJ1ellyeT npeYBeJ1I1'lHBaTb 3Ha'lHMOCTb 3THX peKoMeHlla-
UI1H. Bce OHH cy61>eKTHBHbI H He Y'lI1TblBaIOT oc06eHHOCTeH KOHKpeTHO-
ro 060pYllOBaHH5I. I1x pOJlb - llaTb ellI1Hble, cpaBHHMbIe KpHTepHI1
oueHKH.
nOpSIllOK oT60pa np06, BKJIIO'la5I nJ10111Mb nOBepXHOCTH, 'lHCJ10
Ma3KOB H Bbl60p MeCT ll11H B35ITH5I np06 YCTaHaBJ1HBaIOTC5I MeTOllHKOH
aTTeCTaUHH C Y'leTOM oc06eHHOCTeH 060pYllOBaHH5I H npouecca. rJlaBHOe
YCJ10BHe - OT60p np06 1l0J1)J(eH 6bITb npellCTaBHTeJ1bHbIM.
CJlellyeT nOMHHTb, 'lTO no oT06paHHbIM np06aM C 'laCTH nOBepXHO-
CTH 060pYllOBaHH5I 6YlleT ClleJ1aH BbIBOll 0 'lHCTOTe BceH nOBepXHOCTi1.
BbI6paHHbIe MeCTa oT60pa np06 AOJ1)J(HbI 6bITb npellCTaBHTeJ1bHbIMH ll1151
BceH nOBepXHOCTI1 H llaBaTb HaHXYllWHe YCJ10BH5I ll1151 OueHKI1.
npH pa60Te no 3TOMY MeTOllY HHO Y'lHTblBaTb CJ1eJlYlOlllI1e cpaKTOpbI:
. llaHHbIe 0 nOCTaBlllHKe TaMnOHOB;
. nOBepXHOCTb, C KOTOpOH oT6HpalOT np06bI;
. 'lHCJ10 HCn0J1b3yeMbIx TaMnOHOB;
. xapaKTepHCTHKa TaMnOHOB (BJlIDKHbIe HJ1H CYXHe);
. nopSIllOK xpaHeHHH H 06paIl.leHMH C TaMnOHaMH;
. nopSIllOK BbInOJ1HeHHH Ma3KOB.
Ba)J(HYIO pOJ1b HrpaeT xapaKTep nOBepXHOCTH, C KOTOpOH oT6HpalOT
np06bI (HallH'lHe BbIcTynoB, YTJ1y6J1eHHH, KpenJ1eHHH), H ee MaTepI1all
(CTeKJIO, CTallb H np.). npH OnpelleJ1eHHH nopSIllKa BbInOJ1HeHH5I Ma3KOB
CJ1e.ayeT Y'leCTb HaH60Jlee He6J1aronpH5ITHbIe aKTOpbI. nOpSIllOK BbInOJl-
HeHH5I Ma3KOB H llaHHbIe 06 3THX cpaKTopax llOJ1.>KHbl 6bITb npHBelleHbI B
HHCTPYKUHH no O'lHCTKe 060pYlloBaHH5I.
MeToll Ma3KOB ycnewHo HCn0J1b3yeTcH ll1151 JlerKollocTynHbIx no-
BepxHocTeH, Koma MO)J(HO YCTaHoBHTb npelleJ1bHO llonycTHMble KOHueH-
TpaUHI1 3arp5I3HeHHH, a TaK)J(e npI1 HallI1'lI1H HepaCTBOpI1MbIX 1arp5I3He-
HHH H CYXHX OCTaTKOB.
K HellOCTaTKaM MeTOlla OTHOC5ITC5I:
. orpaHH4eHIDI Ha HCn0J1b30BaHHe ll115I TPYllHollocTynHbIx MeCT;
. 1l0nyw:eHHe 0 paBHoMepHOCTI1 paCnpelleJ1eHH5I 3arp5I3HeHHH no
BceH nOBepXHOCTI1;
. 3KCTPan0J1HpOBaHI1e (pacnpocTpaHeHHe) pe3YJ1bTaTOB KOHTpOJ15I
OT.llel1bHbIX Y'lacTKoB nOBepxHocTH Ha BCIO nOBepxHocTb;
. BJ1H5IHHe onepaTopa, BbInOJ1HHlOlllero Ma3KH;
. 3aBHCHMOCTb OT 3eKTHBHOCTH :JKcTpampoBaHIDI 3arpH3HeHHH
H3 TaMnOHa.

258
rJ1060 10
TOltKU om60pa np06
Ma3KH CJ1e.llyeT oT6HpaTb B KpHTH'leCKHX TO'lKaX, T.e. TO'lKaX,
HaH60J1ee nOllBep)J(eHHbIX HaKOnJ1eHHIO 3arp5I3HeHI1H. K HI1M OTHOC5ITC5I:
MeCTa CBapKH, J1aHUeBbIe COellHHeHI15I, ymbI, KJIanaHbI, Kpene)J(HbIe lle-
TallH, MeCTa CTOKOB - BCe, 'lTO BCTynaeT B KOHTaKT C npO.lI.YKTOM H me
BbInOJ1HeHI1e O'lI1CTKH 3aTpYllHeHO (pHC. 10.3). HaKOnJ1eHHe 3arp5I3He-
HHH MO)J(eT npOHCXOllHTb B pe3epByape Ha OTMeTKe 06bI'lHOro ypOBH5I
)J(HllKOCTH.
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cblpbe
CMOTPOBOe
OKHO
BOlla lIJ1H
HHbeKUHM
* - TO'lKa oT60pa np06bI
U OT60p np06bl 1IJ151 npOBepKH
Ka4eCTBa O'JHCTKH
PHC. 10.3 npI1Mep pacn0J10)J(eHI15I TO'leK oT60pa np06 MeTOllOM Ma3KOB
npH aTTeCTaUI1H npouecca O'lI1CTKI1 pe3epByapa
MeTOA CMbIBOB
npI1 oT60pe np06 no 3TOMY MeTOllY BbInOJ1H5IeTC5I OnOJ1aCKI1BaHI1C
nOBepXHOCTH 060pYlloBaHH5I 11 nOCJ1e.llYlOlllI1H aHallH3 c06paHHoH (CTeK-
weH) C nOBepXHOCTH )J(I1llKOCTI1. B 3aBHCHMOCTI1 OT pa3MepOB 060py.llO-
BaHH5I HJ1H ero C1>eMHbIX 'laCTeH MO)J(eT I1Cn0J1b30BaTbC5I I1X OKYHaHl1e B
eMKOCTb C )J(\1llKOCTblO C aKTI1BHbIM OnOJ1aCKI1BaHI1eM.
MeToll n03B0J15IeT OueHI1BaTb 'lI1CTOTY nOBepxHocTeH CJ1o)f(Hoii
OpMbI 11 60J1bWHX pa3MepOB, TPYllHOllocTynHbIx MeCT, He nOllJ1e)f(,lllllI,\
pa360pKe lJaCTeH 060pYAOBaHH5I, H B llPYfI1X CJ1Y'lMX, Koma npHMeHeHIlC

Ammecmou,Uf/ npou,eCC06 O<fUCmKU 060PY0060HUf/
259
MeTona Ma3KOB 3aTpYllHeHO I111H HeB03MO)J(HO. OH llaeT 06111YIO KapTHHY
3arp5I3HeHHH Bcex nOBepxHocTeti, OXBaTbIBaeMbIX OllHHM UHKJIOM CMbIBa.
MeTOll ycnewHo I1Cn0J1b3yeTC5I AJlH oueHKH OCTaTKOB MOlOlllI1X
cpellCTB. K HellOCTaTKaM MeTO.lla OTHOCI1TC5I HeB03MO)J(HOCTb 06Hape-
HH5I HepaCTBopHMbIX 3arp5I3HeHI1H, B TOM 'lI1CJ1e a6cop6I1pOBaHHbIx 060-
pYlloBaHI1eM HJ1H 3aCTp5IBWI1X B HeM.
npH I1Cn0J1b30BaHI1I1 MeTOlla CMbIBOB CJ1ellyeT oueHHTb 3eKTHB-
HOCTb CMbIBa OCTaTKOB BellleCTBa C nOBepXHOCTH B npoueHTax.
KaK npaBHJ10, MeTOll CMbIBOB HCnOJ1b3yeTC5I B CO'leTaHHH C MeTOllOM
Ma3KOB. MeTOllbl Ma3KOB H CMbIBOB WI1pOKO pacnpOCTpaHeHbI H no-
llp06HO onHcaHbI B HopMaTHBHOH J1HTepaType.
'i)tlJtlJeKTHBHOCTb oT6opa np06
JI.n5I TOro, 'lT06bI oueHHTb npHCYTCTBHe (I1J1I1 OTCYTCTBHe) KaKoro-
111160 BellleCTBa Ha nOBepxHocTH, HHO B35ITb np06y C nosepxHoCTH.
ECJ1H llaHHoe BellleCTBO npHcYTcTByeT B npelleJ1aX, npeBbIwalOlllHx .n.ony-
CTHMble, TO O'lHCTKa npOBeAeHa HeYllOBJ1eTBOpmeJ1bHO.
A eCJ1H MeTOll oT60pa np06 He rapaHTHpYeT, 'lTO HaX01l5IllleeC5I Ha
nOBepXHOCTH BellleCTBO 6y.n.eT B35ITO npH oT60pe np06bl?
ECJ1H Bo06111e llaHHbIH MeTOll OT60pa np06 cnoco6eH TOJ1bKO B He-
KOTOpblX CJ1Y'laSlX OT06paTb np06y npI1CYTCTBYlOlllero Ha nOBepXHOCTI1
BelllecTBa? - Tor.n.a pe3YJ1bTaT aTTeCTaUHH 6YlleT J10)J(HbIM. 3arp5I3HeHHa5I
nOBepXHOCTb 6YlleT oueHeHa KaK 'lHCTa5I H3-3a HenpaBHJ1bHoro oT60pa
np06.
n03TOMY nepBblM H O'leHb Ba)J(HbIM 3TanOM aTTeCTaUI1H npoLlecca
O'lHCTKH 5IBJ15IeTC5I np06epKa 3fjJfjJeKmu6nocmu MeTO.n.a oT60pa np06.
JI.n5I KOJ1H'leCTBeHHOH oueHKH 3efJefJeKTHBHoCTH MeTOlla OT60pa np06
CJ1HT K03fjJfjJuu.uenm 3fjJfjJeKmu6nocmu R.
OnpedeJlenUe Ko3ljJfjJuu.uenma 3ljJfjJeKmu6nocmu MemoiJa om60pa np06 R
OueHKa 3eKTI1BHOCTH MeTo.n.a oT60pa np06 (recovery test) BbInOJ1-
HHeTC5I AJl5I K3)J(DOro MaTepI1alla. H3 KOTOpOro H3roTOBJ1eHO 060pYlloBa-
HHe, H onpe.lleJ15IeTC5I K03HuHeHT R.
3TOT K03HUHeHT OnpelleJ15IeTC5I 3KcnepHMeHTallbHbiM nYTeM:
- Ha Y'laCTOK nosepxHoCTH K3)J(DOro MaTepI1alla HaHOCHTC5I onpelle-
JIeHHoe KOJII1'leCTBO aKTHBHoro I1HrpellHeHTa M / C OnpelleJ1eHHOH KOH-
LleHTpaUHeH;
- 3aTeM oT6HpaeTC5I np06a C 3TOro Y'laCTKa nOBepXHOCTI1 H onpelle-
JI5IeTC5I KOJ1I1'leCTBO 3arp5I3HeHI1H M 2 B np06e;
- 3eKTI1BHOCTb MeTOlla oT60pa np06 AJl5I .n.aHHoro MaTepHalla 6y-
lleT paBHa:
R = M2IM/.

260
fJ1060 10
HaHMeHbwee 3Ha'leHHe 3eKTHBHOCTH OKpYfJ15IeTC5I B MeHbWYIO
CTOPOHY (npHHUHn HaHXY.llWero Cl1y<Ia5I), KOTOpOe H CJ1Y)J(HT )J)I5I onpe-
lleJ1eHH5I llOnYCTHMbIX OCTaTKOB B np06e.
.D.aHHbIH MeTOll HMI1THpyeT OT60p np06 C nOBepXHOCTI1 060PYllOBa-
HI15I OT60pOM np06 C KOHTpOJ1bHOH nJ1aCTHHbI. 1lrI5I TOro, 'lT06bI OH llall
KoppeKTHbIe pe3YJ1bTaTbI, nJ1aCTI1Ha 1l0J1)J(Ha 6bITb H3roT0BJ1eHa H3 TOro
)J(e MaTepI1alla, 'lTO H nOBepXHOCTb 060PYllOBaHH5I, H Bo06111e YC110BH5I
aLlre3HI1 MaTepHalla K nJ1aCTHHe H B03MO)J(HOCTH oT60pa np06bI C nJ1a-
CTHHbI J10J1)J(HbI 6bITb MaKCHMallbHO npI16J1H)J(eHbI K CBOHCTBaM nOBepX-
HOCTH 060pYJ10BaHH5I.
KpI1TepHI1 3KTI1BHOCTH (OueHKH) MeTOllOB OT60pa np06.llaHbI B Py-
KOBOllCTBe B03 [56] B 3aBHCHMOCTI1 OT npouema BbI5IBJUIeMoro BellleCTBa:
n po I(eHT BblHBJleHHH BelI(eCTBa K03cMJH_eHT R OLleHKa
f- > 80 % > 0,8 Xop ow o
> 50 % > 0,5 YJ10BneTBOpI1TellbHO
< 50 % < 0,5 ----
COMHI1TellbHO
npI1eMJ1eMbIM C'llffileTCH 3Ha'leHHe K03Q>cPHUHeHTa R> 0,7.
OT06paHHbIe npo6bI nOllJIe)J(aT aHallH3Y (CM. HH)J(e).
10.6.3 MeTO,ll. nJlaue60
CYTb 3TOro MeTOlla COCTOHT B TOM, 'lTO nOCJ1e O'lHCTKH 060PYllOBa-
HH5I OCYllleCTBJ15IeTCH BbInYCK CepHH nJ1aue60 - BellleCTBa, He CO.llep)J(a-
lllero aKTHBHbIX HHrpellHeHTOB, a 3aTeM 3Ta cepIDI aHallH3HpyeTC5I Ha
HallH'lHe nOCTopOHHI1X BellleCTB (OCTaTKOB npellbILlymero npOllYKTa HJ1H
lleTepreHTOB).
3TOT MeTOll HMHTHpyeT npouecc npOH3BOllCTBa H HafJ15IllHO nOKa3bI-
BdeT xapaKTep CJ1ellOB npellbILlYllleH cepHH B nOCJ1ellYlOllleH CepI1H npo-
llYKUHH. ECJ1H opraHH30BaTb OT60p np06 B pa3HbIX TO'lKaX TeXH0J10rH'le-
CKOH uenH, TO MO)J(HO 06HapY)J(HTb HCTO'lHHKH 3arp5I3HeHHH, T. e. MeCTa
CKOnJ1eHH5I npellbIllYlllero npOllYKTa.
HeJ10CTaTKaMH MeTO.lla 5IBJ15I1OTC5I ero CJ10)J(HOCTb H TpYlloeMKOCTb.
KpoMe TOro, paCnpelleJ1eHHe c06paHHbIX 3arp5I3HeHHH pa3J1I1'lHbIMI1
ellHHHuaMH npOllYKUHH B cepHH nJ1aue60 HepaBHOMepHO, oc06eHHO npI1
CYllleCTBeHHbIX pa3Mepax 3arpH3HemiH.
BbtnYCK cepuu fl./l0lJ,e60 HO o60PY0060HUU. npoweOUIeM OllucmKY. npll
mex :JKe nopoMempax npOlJ,eCCO, limo u npu peOJ1bHOM npou3600cm6e, n0360-
J1f/em npo6ecmu om60p np06 U3 cepuu fl./l0lJ,e60 u OlJ,eHumb 6 Heit HOJ1UIIUe 30-
2pf/3HeHuu. 3mom Memoo cJ1eoyem ucnOJlb3060mb mOJ1bKO 6 COllemOHull C
MemOOOM M03K06 U/UJ1U CMb/606, 66udy Hep06HOMepHocmu pocnpeoeJ1eHlIR
302pf/3HeHuit 6 cepuu fl./l0u,e60.

Ammecmou,UR npnu,eccoe OIJUCmKU 060PY0060HUR
261
no 3TOti npH'lHHe FDA CiliA He paCCMaTpI1BaeT MeTO.ll nJ1aue60 B
Ka'leCTBe ellHHCTBeHHO B03MO)J(Horo MeTO.lla, a llonYCKaeT ero npHMeHe-
HHe J1I1Wb B CO'leTaHHH C llPYfHMH MeTO.llaMH oueHKH 'lHCTOTbI.
l1Tom:
- BH3YallbHbIH MeTOll 3eKTHBeH, HO He SIBJUIeTC5I KOJ1H'leCTBeH-
HbIM H n03TOMY npI1MeH5IeTC5I B CO'leTaHHH C llPYfHMH MeTOllaMH;
- MeTOll CMbIBOB I1Cn0J1b3yeTC5I B CO'leTaHI1I1 C MeTOllOM Ma3KOB;
- MeTOll Ma3KOB 5IBJ15IeTC5I OCHOBHbIM MeTOllOM ll1151 1l0cTynHbIx no-
BepXHOCTeH H npHMeH5IeTCSI Be3lle, file 3TO B03MO)J(HO;
- MeTOll nJ1aue60 HaXO.llHT J1I1Wb orpaHI1'leHHOe npHMeHeHI1e H MO-
)J(eT npHMeH5ITbC5I TOJ1bKO B CO'leTaHI1H C llPYfHMH MeTOllaMH.
H H)J(e paCCMaTpHBalOTC5I TOJ1bKO KOJlH'leCTBeHHbIe MeTon.bI oueHKH
':IHCTOTbI nOBepXHOCTeH, OCHOBaHHbIe Ha oT60pe H aHaJ1H3e np06.
10.7 ATIeCT3I\IDI npoll,eccoB O'lHCTKH C nOMOUl,b1O oroopa np06
10.7.1 3Tanbl aTTeCTall,lfH
ATTeCTaUH5I npOBO.llHTC5I B HeCKOJ1bKO 3TanOB:
- paC'leT npelleJ1bHO 1l0nYCTHMbIX OCTaTKOB npellbIllYlllero npOllYKTa
(lleTepreHTa, npOllYKTOB pacnMa), T. e. 3MaHHe KpumepUR ItUCmOmbl;
- oT60p np06;
- aHallH3 np06;
- npOBepKa COOTBeTCTBHSI KpHTepHIO llonYCTHMOCTH;
- OOpMJ1eHHe npOTOKOJ1a aTTeCTaUHH.
10.7.2 KpHTepHH'IHCTOTbI (ocTaTKH npeAbl.nyUJ.ero npo.nyKTa)
3Ma'la OnpelleJ1eHI15I npelleJ1bHO 1l0nYCTI1MbIX OCTaTKOB HeOllH03Ha'lHa.
npe)J(De Bcero, B03HI1KaeT Bonpoc: KaKHX OCTaTKOB H me?
- Ha nOBepXHOCTH 060PYlloBaHH5I'?
- nOna.llalOWI1X B CJ1en.YlOwHH npollYKT?
- 06HapY)J(eHHbIx B np06e?
rJ1aBHOe - 3TO oueHHTb KOJ1H'leCTBO OCTaTKOB npellbIllYlllero npo-
llYKTa, KOTopbIe MOfYT nonaCTb B c.lleiJYIOuii npodYKm. OCTallbHbIe nOKa-
3aTeJ1H HOC5IT BcnOMOraTeJ1bHbIH xapaKTep H CB5I3aHbi C MeTOllOM oT60pa
np06.
3Ta 3Ma'la pa3.lle115IeTC5I Ha llBe:
- 3allaTb 3Ha'leHI1e npelleJ1bHO 1l0nYCTI1MbIX OCTaTKOB, KOTopoe CJ1Y-
)J(HT KpI1TepI1eM OUeHKI1;
- npOBepI1Tb aKTI1IIeCKOe COOTBeTCTHI1e OCTaTKOB 3aLlaHHOMY KpI1Tepl1lO.

262
FJ1060 JO
Kpumepuu ItUCmOmbl
npHH5ITbI CJIeJJ,YJOlllHe KpHTepHH oueHKH:
a) He 60JIee 0, I % MUnUMQ./lbnoii TepaneBTH'leCKOH ll03bl JII060ro
npOllYKTa B MaKCI1MallbHOHllHeBHOM A03e nOCJ1e.llYlOlllero npOllyKTa;
b) He 60J1ee 10 ppm 111060ro npO.llYKTa, 06HapHBaeMoro B llPyroM
npOllYKTe;
c) OTCYTCTBHe BI1llI1MbIX OCTaTKOB Ha 060PYllOBaHHI1 nOCJIe npOBe-
JJ,eHH5I O'lHCTKH;
d) AJ15I HeKOTopbIX allJ1epreHOB, neHI1UHJ1JIHHOB, ueallOCnOpI1HOB
HJ1H CHJ1bHOlleHCTBYlOlllHX CTepOI1ll0B H UHTOTOKCHHOB OCTaTKH llOJI)J(HbI
6bITb HH)J(e npeJJ,eJIa 06HapeHH5I JI}"-IWHMH HMelOlllHMHC5I B pacnop5I-
)J(eHHH aHallHTH'leCKHMH MeTOAaMH; Ha npaKTHKe 3TO MO)J(eT 03Ha'laTb
opraHH3aUHIO npOH3BOACTBa Ha CneUHallH3HpOBaHHbIX npellnpIDITH5IX.
,lJ,JUI aTTeCTaUHH MeTOllOB O'lHCTKH JJ,OCTaTO'lHO ycnelllHoro npOBe-
lleHH5I Tpex nOCJ1eAOBaTeJIbHbIX UHKJIOB O'lHCTKH.
PaClJeT no TepaneBTH'IeCKOH A03e
HaH60J1ee pacnpOCTpaHeHHbIM KpHTepHeM oueHKH 'lHCTOTbl 5IBJ15IeT-
C5I npHHUHn:
O, 1 % mepane6mUlteCKOii d03bl»
3TO 03Ha'laeT, 'lTO OTHoweHHe MUnUMQ./lbnoii llHeBHoHllo3bI npellbI-
llYlllero npOllYKTa K MaKCUMQ./lbnoii llHeBHoH ll03e nOCJ1ellYlOlllero npo-
JJ,yKTa JJ,Ol1)J(HO 6bITb He 60JIee 0, I %;
0, I % I111H 1/1000 5IRlI5IeTC5I K03cPHUHeHTOM 6e30nacHocTH, T. e.
npellnOJ1araeTC5I, 'lTO eCllH B nOCJ1eJJ,YlOlllHH npOllYKT nonMer He 60JIee
1/1000 1l0JIH npellbJ.aYlllero npoJJYKTa, TO 3TO JJ,OCTaTOlJHO ll1151 6e30naCHOCTI1
nalI.HeHTa.
3TOT K03HlI.HeHT HCn0J1b3yeTC5I JJ,JUI npOH3BOllCTBa TBepllblX
OpM. B03MO)J(HbI llpyme K03HUHeHTbI. B KHHre [28] H TexHH'lecKoM
OT'leTe PDA NQ 29, 1998 r., AalOTC5I CJIellYlOlllHe peKOMeHllaUI1H:
* YCTaHOBI1Bllla5lC5I npaKTI1Ka B npoMblUIJleHHOCTI1
LI.allee B03HHKalOT BonpOCbI:
- 'lTO TaKoe «npellbIllYlllHH npOllYKT»
- 'lTO TaKoe «nocl1ellYlOlllI1 npollYKT»?
B03MO)l(HbI pa311I1'lHbIC pa3Mepbl CepI1H 11 pa311I1'lHbIe D03I1pOBKI1 a....-
TI1BHOrO HHrpCllHCHTa.

AmmecmOt(UR npOt(eCC06 O/.fUCmKU 060py(J060HUR
263
3TO Y'lHTbIBaeTCH nOH5ITI15IMI1 «MUnUMQ./lbnaJI llHeBHa5I .ll03a npellbI-
.nYlllerO npOn.YKTa,) H «MaKCUMQ./lbnaJIllHeBHa5I ll03a nOCJ1e.nYlOlllero npo-
AyKTa,), KOTOpbIe B35ITbI no npHHUHny HaHXYllwero CJ1Y'la5I.
DOJIbHOH npHHHMaeT B CYTKH onpe.neJIeHHOe KOl1H'leCTBO JIeKap-
CTBeHHoro cpellCTBa, npH'leM pa3HbIe 60J1bHbIe MOfYT npHHHMaTb pa3Hoe
KOJ1H'leCTBO. HaHXYllWHM CJ1Y'laeM 5IBJ15IeTC5I npHeM MaKCHMallbHOro KO-
JIH'leCTBa JIeKapCTBeHHoro cpellCTBa, nOCKOJIbKY BMeCTe C HI1M OH npH-
MeT MaKCHMallbHOe KOJ1H'leCTBO OCTaTKOB npellbI,IXYlllero npOllYKTa.
3TOT npellbIllYlllI1H npOllYKT TaK)J(e MO)J(eT 6bITb npellHa3Ha'leH ll1151
npHeMa pa3HbIMH CYT0'lHbIMI1 1l03aMI1. HaI1XYllWHM CJIY'laeM 5IB115IeTC5I
MHHHMallbHa5I A03a npellbIllYlllero npOllYKTa. nOCKOJIbKY MeHbwee KOJIH-
'leCTBO 06HapY)J(I1Tb npI1 oT60pe np06 TpY.llHee, 'leM 6011bwee.
B PYKOBOJ1CTBe Ba3 [56] 11 HeKOTOpbIX J1pymx I1CTO'JHI1KaX rOBOpI1TC5I
o cpeJ1HeH TepaneBTI1'JecKOI1 111111 «HOpMaJIbHOH» J103e npeJ1bm)'lllero npo-
JIYKTa, a He 0 MI1Hl1MaJlbHOH J103e; PYKOBOJ1CTBY5lCb npl1HUl1nOM HaI1XYJ1We-
ro CllY'la51 Cl1eJ1yeT 6paTb I1MeHHO MI1Hl1MaJlbHyIO J103Y, 'lTO 11 J1ellaeTCH BO
MHornx CllY'Ja5IX Ha npaKTI1Ke.
BBelleM 0603Ha'leHlf5I:
LDD - MHHHMallbHa51 llHeBHa51 A03a (Lowest Daily Dose) npellbUXY-
lllero npOllYKTa, Mr;
D - npeAeJIbHO 1l0nYCTHMa5I Macca npellbIllYlllero npOllYKTa B MaK-
CHMallbHOH .nHeBHOHl103e nOCJIellYlOlllero npOllYKTa, Mr,
N J - HaI1MeHbWHH pa3Mep cepHH nOCJIellYlOlllero npOllYKTa
(HanpHMep, Ta6J1eToK), lllT.;
N 2 - MaKCI1MallbHOe 'lI1CJIO ll03HpOBaHHbIX cPOpM (HanpHMep. Ta6J1e-
TOK) B .IIHeBHOH .n03e, WT.;
E - Macca npellbIllYlllero npOllYKTa BO BceH cepHH nOCJIellyJOlllero
npOllyJ<Ta, Mr;
F - npelleJIbHO 1l0nYCTHMM Macca OCTaTKOB B np06e, Mr;
FrjJaKm - aKTH'leCKa5I Macca OCTaTKOB B np06e, Mr.
R - K03HuHeHT 3cPcPeKTHBHOCTH MeTOlla oT60pa np06 (n. 10.6).
ATTeCTaUI15I MeTOlla O'lHCTKH CBOllHTC5I K OnpelleJ1eHHIO npelleJ1bHO
llonycTHMoro KOJ1H'leCTBa (MaccbI) OCTaTKOB B np06e F paC'leTHbIM ny-
TeM, OnpeAeJIeHHIO aKTH'leCKoro KOJ1H'leCTBa OCTaTKOB BO B35ITOH npo6e
FrjJaKm H cpaBHeHI1H llBYX 3THX BeJ1H'lHH.
ECJ1H FrjJaKm<F, TO MeTO.n O'lHCTKH MO)J(eT 6bITb aTTeCTOBaH.
BeJIJ1lIHHa FrjJaKm OnpelleJ15IeTC5I nYTeM oT60pa H aHallH3a np06.
BeJ1I1'lI1Ha F 51BJ15IeTC5I paC'leTHOH.

264
fJ1060 JO
llOC.IleiJ06ameJlbnOCmb pacltema 6e.llUltUnbl F
1. OnpelleJ15IeTC5I MHHI1MallbHaH llHeBHM 1l03a npe.llbIllymero npo-
.llYKTa LDD, Mr, KaK npoH3BelleHHe MHHHMallbHOHll03bI B ll03HpoBaHHoH
opMe (HaHMeHbwM 3eKTHBHocTb) Ha MHHHMallbHOe 'lHCJ10 ll03,
npHHHMaeMbIx B CYTKH.
2. Onpelle115IeTC5I npe.llel1bHO 1l0nYCTHMa5I Macca npellbIllymero npo-
llYKTa B MaKCHMallbHOHllHeBHoH .ll03e nOCJ1ellYlOlllero npOllYKTa, Mr,
D = 0,001 x LDD
3. OnpelleJ15IeTC5I 'lHCJ10 llHeBHbIX 1103 B cepHH nOCJ1ellYlOllleH npo-
.nYKUHH llJI5I HaI1XYllwero CJly<Ia5I:
N= N 1 /N 2
3TO 6YlleT HaHxYllwHH CJly<IaH no llBYM npH'lHHaM:
- npH HaHMeHbweM pa3Mepe cepHH nOCJ1ellYlOllleH npOllYKUHH B OT-
lleJlbHYIO A03HpoBaHHYIO OPMY nonMeT HaH60JlbWee KOJlH'leCTBO
OCTaTKOB (3arp5I3HeHHH);
- npH npHeMe MaKCHMallbHOro KOJlH'leCTBa ll03HpoBaHHbIX OpM
naUHeHT npHMeT B lleHb MaKCHMallbHOe KOJlH'leCTBO 3arp5I3HeHHH.
B Ka)J(DOH H3 3THX ll03 1l0JDKHO 6bITb He 60J1ee D Mr npellbIllymero
npOllYKTa.
4. PaCC'lHTbIBaeTC5I BeJ1H'lHHa E.
Bo BceH cepHH nOCJ1ellYlOlllero npOllYKTa MO)J(eT COllep)J(aTbC5I He 60J1ee
E = D x N Mr npellbI11Ylllero npOllYKTa.
3Ta BeJ1H'lHHa E H 5IBJl5IeTC5I npelleJlbHO 1l0nYCTI1MbIM 3Ha'leHHeM
Bcex OCTaTKOB npellbI.nYlllero npOllYKTa Ha BceM 060PYllOBaHHH nOCJle
npOBelleHH5I O'lHCTKH.
ATTeCTaUH5I npouecca O'lHCTKH 3aKJ1IO'laeTC5I B nOllTBep)J(DeHHH TO-
ro, 'lTO CYMMapHble OCTaTKH npellbIllYlllero npo.nYKTa Ha Bcex nosepxHo-
CT5IX 060PYllOBaHH5I, KOHTaKTHpYlOlllHX C npOllYKTOM, llJ15I llaHHoro MeTO-
lla H llaHHoro npOllYKTa He npeBbIwalOT BeJ1H'lHHbl E. npI1HHMaeTC5I 1l0-
nYllleHHe, 'lTO 3TI1 OCTaTKH nOJ1HOCTblO nepeHOC5ITC5I Ha CJ1e.llYlOlllYIO ce-
pHIO H paCnpelleJ15IlOTC5I B HeH paBHOMepHO.
E- 3TO TeOpeTH'leCKa5I BeJlH'lHHa, npellnOJ1aralOllla5I, 'lTO MeTOll OT-
60pa np06 I1MeeT 3eKTI1BHOCTb 100 %, T. e. llaHHbIM MeTOllOM B llaH-
HOM MeCTe c06HpalOTC5I Bce 3arp5I3HeHI15I nOJ1HOCTblO. B lleHCTBHTeJ1bHO-
CTH 3TO He TaK. MeTOll oT60pa np06 HMeeT OrpaHH'leHHYIO 3eKTI1B-
HOCTb, T. e. n03B0J15IeT c06paTb B onpe.neJ1eHHOM MeCTe He Bce 3arp5I3He-
HH5I, a TOJlbKO HX 'laCTb.
TaKI1M 06pa30M, HellOCTaTO'lHO OnpelleJlHTb npelleJ1bHO .llOnYCTHMoe
3Ha'leHHe OCTaTKOB 3arp5I3HeHHH na 060pyd06anuu. 3TO a6CTpaKTHa5I Be-
JlH'lI1Ha, «6eUl,b 6 ce6e» , BbIpa)J(a5ICb I1110COCKI1M 5I3bIKOM. PeallbHml
Bel1H'lHHa, «6eUl,b OJ1R HOC» - :no npellel1bHO 1l0nYCTI1MOe 3Ha'leHI1C

Ammecmou,Ufl npou,eCC06 O'lUCmKU 060pyiJ060HUfl
265
OCTaTKOB 6 np06e F. Ee MO)J(HO npOBepHTb B 3KCnepI1MeHTe. OHa Bcerna
MeHbllle BeJ1H'lI1HbI E.
5. PaCC'lI1TbIBaeTC5I BeJ1H'lHHa F.
Pa3J1H'lHe Me)J(DY BeJlH'lHHaMH E H F Y'..JHTbIBaeTC5I K03HUI1eHTOM
3eKTHBHOCTH MeTOlla oT60pa np06 R:
F= Ex R.
Oc06enHocmu pac'Iema 6eJlUltUnbl F npu om60pe np06 MemoOOM Ma3K06
npH 3TOM MeTOlle oT60p np06 OCYllleCTB115IeTC5I He co BceH nOBepx-
HOCTH, a C ee 'laCTH. npH 3TOM npellnOJ1araeTC5I, 'lTO 3arp5I3HeHH5I pac-
npelleJ1eHbl no BceH nOBepXHOCTH paBHOMepHO H Ma30K llaeT npellCTaBH-
TeJ1bHbIe llaHHbIe. B lleHCTBHTeJ1bHOCTH 3TO He TaK, HO MaJOK 6epeTC5I H3
HaHxYlllllHX MecT, n03ToMY TaKoe 1l0nYllleHHe B03MO)J(HO.
0603Ha'lHM IUIOlllMb nOBepxHocTH, C KOTOpOH 6epYTc5I Ma3KH KaK
Sf, a 06111YIO IUIOlllMb nOBepXHOCTH 060PYllOBaHHH, conpHKacalOlllYIOC5I
c npOllYKTOM - KaK S2.
Torna BeJlH'll1Ha npelleJIbHO 1l0nYCTHMbIX OCTaTKOB B npo6e 6YlleT paBHa
F= Ex R x Sf/S2
KaK YKa3bIBallOCb BbIwe, peJYJ1bTaTbI cPaKTH'leCKoro oT6opa np06
FtjJaKm npH aTTeCTaUI1H MeTOlla O'lHCTKH llOJ1)J(HbI 6bITb MeHbwe 3TOro
3Ha'leHI1H: FtjJaKm < F.
npHMep paC'IeTa (Ta6lleTKH)
nOKa3aTeJIb 3Ha'leHHe
IDD - MI1HI1MaJlbHa5I llHeBHa5I J103a npeJ1blJ1Ylllero npoJ1YKTa 10 Mr
D - npeJ1el1bHO J10nYCTI1Ma5I Macca npeJ1blJ1Ylllero npOJ1YKTa B 10- 2 Mr
MaKCI1MaJlbHOI1 J1HeBHOI1 J103e nOCl1eJ1YlOlllero npollYKTa
N / - Hal1MeHbWI1H pa3Mep cepl1l1 nOCl1eJ1YlOlllero npoJ1YKTa 10 6
N) - MaKCI1MaJlbHOe 'JI1C110 J1031100BaHHb1X Q:>OPM B llHeBHoH J103e 4
N IIN] - 'JI1C110 J1HeBHbIX J103 B cepl1l1 nOClleJ1YlOlllero npoJ1YKTa 2,5x10 5
SI - nJlOlllallb nOBepXHOCTI1, C KOTOpOH 6epYTc5I Ma3KI1 4x 10 2 CM 2
S) - 06111aH n110lll3llb nOBepXHOCTI1, COnpl1KaCalOllleHC5I C npoJ1YKTOM 10 4 CM 2
E - Macca npeJ1blJ1Ylllero npOJ1YKTa BO BceH Cepl1l1 nOCl1e}1ylOlllero 2,5x 10 3
F - npeJ1el1bHO J10nYCTI1Ma1 Macca OCTaTKOB B np06e 80
F",____ - <j)aKTI1'JecKa51 Macca OCTaTKOB B npo6e 20
R - K03<p<pI1Ul1eHT 3<j)<j)eKTI1BHOCTI1 oT60oa npo6 0,8
<DaKTI1'leCKa5I Macca OCTaTKOB npellbIll.Ylllero npollYKTa B np06e
MeHbllle npe.lleJ1bHO DonycTHMoH no paC'leTY. ECJ1H TaKoH pe3YJ1bTaT
n01J.TBep)J(DeH ll1151 Tpex nOCJ1ellOBaTeJ1bHbIX UHKJIOB O'lHCTKH, TO MeTOll
alTeCTOBaH.

266
TJ1060 10
10.7.3 ATTeCrnll.IDI MeTOAOB O'lHCTKH OT APYrux 3arpH3HeHuii
I1Horn.a I1Cn0J1b3yeTC5I npHHUHn <<10 ppm nOCTopoHHero BellleCTBa B
npollYKTe (I1J1H 10 MKr 3arp5I3HeHH5I Ha I r npollYKTa),).
3TOT npl1HUl1n MO)l(eT Cl1I1Tb Kpl1Tepl1eM HaJll1'Jl151 T5I)I(el1blX MeTaJI-
110B B I1CXOJ1HbIX MaTepl1aJIax.
He.llOCTaTO'lHO YCTaHOBHTb 3Ha'leHH5I npelleJ1bHO llonYCTI1MbIX
OCTaTKOB, MeTOllbI oT60pa H aHallI13a np06 TOJ1bKO llJ15I OCTaTKOB npo-
iJYKma, conymcm6YIOUX MamepUQ./l06 H B03MO)J(HbIX npodYKm06 pacnaiJa.
HY)J(HO BbInOJ1H5ITb npOBepKY HallH'lH5I c.lleiJoe MOIOUX U iJe3uHlJJUII,UPY-
IOUX cpeiJcm6.
,il.n5I oT60pa H aHallH3a np06 TPe6yeTC5I pa3pa60TaTb HOBbIe MeTOllH-
KH HJ1H HCn0J1b30BaTb CYllleCTBYIOIUHe, nOKa3aB HX pa60Tocnoc06HOCTb.
MUKp06nbie 3aZpJl3nenUR
B npOH3Bon.CTBe CTepHJ1bHbIX cPOpM nOBepXHOCTH, conpHKacalOlllHe-
C5I C npOllYKTOM H CTepHJ1bHbIMH MaTepHallaMH 1l0J1)J(HbI, 6bITb CTepHJ1b-
HbIMH.
J],n5I HeCTepHJ1bHbIX OpM npOMbIlliJ1eHHOCTb B HaCT05Illlee BpeM5I
HCn0J1b3yeT KpHTepHH «MeHee 25 KOE Ha 25 CM 2 » HJ1H «MeHee I KOE
Ha I CM 2 », 'ITO TO )J(e caMoe.
10.7.4 KorAa cJ]e.uyeT npOBO,ll.HTh aTTeCTalUtlo?
ATTeCTaUI15I npoueCCOB O'lHCTKH 060PYlloBaHH5I BbInOJ1H5IeTC5I npH:
- BBOlle B 3KCnJIyaTaUHIO HOBOro 060PYlloBaHH5I HJ1H npoueCCOB;
- H3MeHeHH5IX B HOMeHKJIaType npOllYKUHH, B TOM 'lHCJ1e B ll03H-
pOBKe J1eKapCTBeHHoro cpellCTBa;
- H3MeHeHH5IX B 060PYllOBaHI1H HJ1H TeXH0J10fH'leCKOM npouecce,
KOTopbIe MOryr OKa3aTb BJ1H5IHHe Ha 3eKTHBHOCTb O'lI1CTKH;
- H3MeHeHI15IX B MeTOllax O'lHCTKH.
J],n5I aTTeCTaUHH MeTOllOB O'lHCTKH llOCTaTO'lHO ycnewHoro npOBe-
lleHH5I Tpex nOCJ1ellOBaTeJ1bHbIX UHKJIOB O'lI1CTKH (fOCT P 52249, npI1-
J1O)J(eHHe 15, n. 40, [I]).
3Ta HopMa Tpe6yeT paCWI1<j)poBKI1 DJI51 PY'JHbIX npoueCCOB.
EClll1 O'JI1CTKY BbInOl1H5IIOT HeCKOl1bKO 'le110BeK 11 ee pe3Yl1bTaT 3aBI1CI1T
OT 1111'JHb1X Ka'JeCTB. TO MO)l(eT nOTpe60BaTbC5I aTTeCTaUI151 DJI51 K3)I(Jl0ro I1C-
n0l1HI1Tel151 (He 06513aTellbHO no Tpl1 pa33, B03MO)l(HO, no J1Ba pa33). ll.aH-
Hbll1 nOJ1XOJ1 He pemaMeHTl1pyeTc5I HOpMaMI1, a C<j)OPMYl1l1pOBaH 113 06we-
HI151 aBTopa C 3apy6e)l(HbIMI1 KOJlJleraMI1.
MeTOll «np06epflmb, nOKO He 6yoem 'lUcmo» He.llOnycTHM. HY)l(HO
pa3pa60TaTb MeTOll OIII1CTKI1 11 aTTeCTonaTb ero.

Ammecmou,UR npou,eCC06 O'tUCmKU 060pyd060HUR
267
10.8 Au3JIU3 npo6
npH aHallH3e np06 oueHHBalOTC5I HallI1'lHe 3arp5I3HeHHH B np06e H
HX KOJ1I1'leCTBO. MeTO.llbI aHallH3a np06 MOfYT 6bITb:
- cneu,ufjJullecKUMu, OnpelleJ15IlOlllI1MH HaHMeHOBaHHe 3arp5I3HeHI15I,
- 06UMU, YKa3bIBalOlllHMI1 Ha HallH'lHe 3arp5I3HeHI1H C KOJlH'le-
CTBeHHOH oueHKOH.
npHMepoM CneUI1H'leCKoro MeTOlla 5IBJ15IeTC5I xpoMaTorpaH5I, KO-
TOpa5I YCTaHaBJ1HBaeT XHMH'leCKHH COCTaB BellleCTBa, 06111ero MeTOlla -
aHallH3 06111ero OpraHH'leCKoro ymepolla B BOlle.
D.n5I aHallH3a np06 HCnOJ1b3YIOTC5I CJ1ellYlOlllHe MeTO.llbI:
- oueHKa pH 06J1MaeT BbICOKOH 'lYBCTBI1TeJ1bHOCTblO K HOHaM BOllO-
pOlla, HCn0J1b3yeTC5I ll1151 06HapY)J(eHH5I CJ1ellOB KHCJ10T H llleJ10'leH, npI1-
MeH5IeMbIX npH O'lHCTKe 060pYlloBaHI15I;
- oueHKa npOBOAHMOCTH 'lYBCTBHTeJ1bHa K HallI1'lI11O HOHOB J11060H
npHpOAbI;
- aHallH3 o6lQero OpraHH'leCKOrO YfJlepoA3 (Total Organic Carbon -
TOC) B BOlle n03BOJUleT 06HapHBaTb OpraHH'leCKHe 3arp5I3HeHH5I B HC-
KJ11O'lHTeJ1bHO MallbIX KOHueHTpauIDIX, 110 ypOBHeH ppt- OllHa 'laCTb (MO-
JleKYJ1a) 3arp5I3HeHHH Ha TpHJ1J1HOH 'laCTeH (MOJ1eKYJ1) BOllbI, HO llaeT 06-
mylO KapTHHY 3arp5I3HeHHH 6e3 lleTallH3aUHH llO KOHKpeTHoro BellleCTBa;
- xpoMarorpa«IJH'IeCKHe MeTOllbI HMelOT BbICOKYIO 'lYBcTBHTeJ1bHOCTb
11 cneUHH'lHbI, HanpHMep, MeTOll BbICoK03cPeKTHBHOH )J(I1llKOCTHOH
xpoMaTOrpaHI1;
- YJIbTpa«IJHOJIeTOBaB cneKTpOCKOnH5I 06JlMaeT cneUHH'lHOCTblO B
OnpelleJ1eHHOH cTeneHH, HO He llaeT KOJ1H1.JeCTBeHHOH oueHKH;
- ELISA (En(yme-Iinked immunosorbent assay - Memod 06HopYJK:eHUH
cneu,urjJu'tecKux OHmumeA UJ1U OHmUi!eH06 C nOMOUl,blO UMM06UJ1U3060HHOi!0
HO OHmUi!eHe UJ1U OHmUmeJ1e rjJepMeHmo) HCn0J1b3yeTC5I B npOH3BOllCTBe
JleKapCTBeHHbIX cpellCTB 6I10J10fH'leCKOH npHpOllbI, 06J1MaeT BbICOKOH
'lYBCTBI1TeJlbHOCTblO H cneUHH'lHOCTblO, HO llopor H TpYlloeMOK.
XopowHe pe3YJ1bTaTbI llaeT KOM6HHaUH5I Tpex MeTOllOB: pH, npOBO-
llHMOCTH H aHaJ1H3a TOe. n05IBHJ1I1Cb aHallH3aTOpbI, nOKa3bIBalOlllI1e
npOBO.llHMOCTb BOllbI H ypOBeHb TOC OllHOBpeMeHHO. OHH 5IBJ15I1OTC5I
YHHBepCallbHbIM 11 061>eKTHBHbIM cpellCTBOM OLl,eHKH ypOBH5I 3arp5I3He-
HHH.
XapaKTepHCTHKH aHallI1TH'leCKHX MeTOllOB paCCMOTpeHbI B maBe II.
MeToll 1l0Jl)J(eH HMeTb 1l0CTaTO'lHYIO 'lYBCTBHTeJ1bHOCTb, 'lT06bI nOllTBep-
llHTb YCTaHOBl1eHHbIe A11H llaHHoro CJ1y<1a5I npelleJ1bHO 1l0nYCTHMble KO-
J1H'leCTBa 3arp5I3HeHHH.

268
rJ1060 JO
10.9 npOTOKOJI aTTeCTaQUH npOQecca O'lUCTKH
npOTOKOJ1 aTTeCTaUI1I1 npouecca O'lI1CTKH JIOJ1)J(eH COllep)J(aTb
CJ1ellYlOlllee:
1 06ue danHbie
1.1 HaHMeHOBaHH5I npellnpH5ITH5I H np0I13BOllCTBeHHoro Y'laCTKa H
HOMep nOMellleHI15I;
1.2 LI.ary H BpeM5I npOBelleHH5I aTTeCTaUHH;
1.3 HaHMeHOBaHI1e ellHHHUbI 060PYJIOBaHH5I C YKa3aHHeM MOJIeJ1 11 ,
cepHHHoro HOMepa HJ1H llPYroro 0603Ha'leHH5I;
1.4 XapaKTepHCTHKY 060PYlloBaHI15I B nnaHe ero npHcnoc06J1eHHO-
CTH K O'lHCTKe (HallH'lHe TPYllHOlloCTynHbIX MeCT, C1>eMHbIX Y3J10B 11 np.);
1.5 HaHMeHOBaHHe BbInYCKaeMoro npOllYKTa H llaHHbIe 0 ero pac-
TBOpHMOCTI1;
1.6 LI.aHHbIe npe.llbIllYlllero onbITa, KacalOlllHeC5I O'lHCTKH.
2 Memod OllucmKU
2.1 XapaKTepHCTHKY MeTOlla O'lHCTKH (pY'lHa5I, aBTOMaTI1'leCKa5I -
WIP, Clp); npH npHMeHeHHH aBTOMaTI1'leCKOH CHCTeMbl O'lHCTH - YKa-
3aHHe Ha ee THn, H3roToBHTeJ15I, cepHHHbIH HOMep, JIaTY BBOlla B 3KC-
lliIyaTaUHIO, npOTOKOJ1 HCnblTaHHH npH BBOAe B 3KCnJ1yaTaUHIO;
2.2 CCblJ1KY Ha HHCTPYKUHIO no O'lHCTKe (HoMep HHCTPYKUHH, ee
HaHMeHOBaHHe, llaTa YTBep)J(DeHH5I H llaTa nOCJ1ellHero nepeCMOTpa, eCJ1H
OH I1MeJ1 MecTo);
2.3 cDaKTH'lecKHH HHTepBall BpeMeHH Me)J(DY 3aBepweHHeM BbInYCKa
npOllYKUHH 11 Ha'lallOM O'lHCTKI1 (BeJ1H'lHHa 3TOro I1HTepBalla MO)J(eT
CTaTb npellMeTOM H3Y'leHH5I, nOCKOJ1bKY OHa MO)J(eT BJ1H5ITb Ha 3cPeK-
THBHOCTb O'lHCTKI1);
2.4 LI.aHHbIe 0 MOlOllleM cpellCTBe, ero 6e30nacHocTH H J1erKOCTI1
YllalleHH5I OCTaTKOB;
2.5 YKa3aHH5I no npHMeHeHHIO MOlOlllero cpellCTBa OT np0I13BOllH-
TeJ15I, BKJIIO'la5I TeMnepaTYPY, paCXOll, Tpe60BaHH5I K OnOJ1aCKHBaHHIO.
3 MemoiJuKa ammecmau,uu npou,ecca OllucmKU
3.1 CCbIJ1KY Ha MeTOllHKY aTTeCTaUI1I1 (HaI1MeHOBaHHe, HOMep, .llaTa
YTBep)J(DeHI15I 11 DaTa nOCJ1ellHero nepeCMOTpa, eCJ1I1 OH I1MeJ1 MecTo);
3.2 MeTOll oT60pa np06 H MeTOll aHallI13a np06;
3.3 LI.aHHbIe 0 MaTepI1allaX, npI160pax 11 06oPYlloBaHI1H C YKa3aHI1er.\
.llaT HX nOCJ1ellHeH KallI16pOBKI1 (noBepKe, npOBepKe pa60Tocnoc06HOCTI1);
3.4 3Ha'leHI15I npe.lleJ1bHO .llOnYCTI1MbIX OCTaTKOB npODYKTa, MOIOUlHX
cpellCTB 11 np., C 060CHOOaHI1eM 11 .llOnYCKaMH Ha OWI16KY;
3.5 LI.aHHbIe 0 BOCnp0I13BOllI1MOCTI1 11 3eKTI1BHOCTI1 oT6opa np06.

AmmeCmOI{Ufl np0l{eCC06 OIJUCmKU 060PY0060HUfl
269
4 JtaHHble 0 np06edenuu ammecmau,uu npou,ecca OllucmKU
4.1 MHKp06HYIO 3arp5I3HeHHOCTb nOBepXHOCTH 110 Ha'lalla O'lHCTKI1
(eCJ1H Tpe6yeTC5I);
4.2 Pe3YJ1bTaTbI aHallH3a 3eKTI1BHOCTI1 MeTOlla O'lHCTKH:
4.2.1 HaHMeHoBaHHe 06oPYlloBaHH5I, Y3J1a, nOBepXHOCTH: peaKTOp llJIH
npI1rOTOBJ1eHH5I Ta6J1eTO'lHOH MaCCbI, BHYTPeHH5I5I nOBepXHOCTb, KJIanaHbi.
BeJ1H'IHHa OTKJ10HeHHe COOTBeT -
NQ MeTOlI MeTOlI _ 3arnSl3He HHSI _ _cpaK_9TllK _ CTBHe
omopa np06bI aHaJlI13a nllK <PaKT MHHH- <PaKTH- HopMe
MaJlb- '1eCKOe (lIa/HeT)
Hoe
I Ma3KH, nOBepXHOCTb pH
(cxeMa)
d- aJKIh.. KJ1anH oH
3 CMbIB. nOBepXHOCTb TOC 500 porn 370 oorn 20% 26 % lIa
4 CMbIB. nOBepxHocTb npOBO-
1II1MOCTb
4.3 PeKoMeHllauHH no npOBelleHHIO CJ1ellYlOllleH aTTeCTaUI1H (eCJ1H
OHH eCTb)
5 3aK.lllOltenue 0 coomeemcm6UU npou,ecca OltUCmKU npedMl6.1lJle.MbLM
mpe606anU1LM
llOAUUCH
J1HUO, YTBep.lI.HBwee npOTOKOJ1 aTTeCTallHH:
i<PaMI1JII151 11 I1HI1Ul1aJ1bI I
J1Hua, BbInOJ1HI1BWI1e aTTeCTaUHIO:
J],Ol1)1(HOCTb
nO.nnl1Cb
1'JQ - .il.Ol1)1(HOCTb
nO.llnl1Cb CDaMl1JIl1H 11 11 HI1 Ul1aJ1 bl
I
-- -------------------------- ------------------------- -------------------------
KaK npaBHJ10, aTTeCTaUHIO AOJDKHbI npOBOllHTb He MeHee llBYX cne-
llHallHCTOB.
LI.n5I llaHHoro 060PYllOBaHH5I, npouecca HJ1I1 npOAYKTa CJ1ellyeT YCTa-
HOBHTb MaKCHMallbHO 1l0nYCTHMoe BpeM5I Me)J(DY 3aBepWeHI1eM BbInYCKa
CepHI1 np0.llYKUHH H Ha'lallOM npOBelleHH5I O'lI1CTKH.
BbICbIxaHHe 3arp5I3HeHHOH nOBepXHOCTI1 060PYllOBaHHH nOCJ1e 3a-
BepWeHI15I TeXH0J10fH'leCKoro npouecca \10)J(eT npI1BeCTI1 K TPY.llHOCT5IM
npI1 O'lI1CTKe H CHH)J(eHHIO 3eKTI1BHOCTI1 O'lI1CTKI1, HanpI1Mep, nOCJ1e
BbInYCKa cycneH3I111 11 llPYfHX npenapaTOB.
l.facTb II npaBI1J1 GMP EC (fOCT P 52249-2009), pa3.neJ1 12.7,
YCTaHaBJ1I1BaeT Tpe60BaHI15I K aTTeCTaUHI1 MeTOllOB O'lI1CTKI1 060PYlloBa-
HI15I npI1 np0I13BOllCTBe cy6cTaHUI1H.

270
r J1aBa 11
AHAJII1TI1QECKI1E METO,ll;bI
1l.1 06J]3CTh npHMeHeHHJI
KOHTpOl1b MaTepHallOB H npOllYKUHH OTHOCHTC5I K HCKJIIO'lHTeJ1bHO
OTBeTCTBeHHbIM OnepaUI15IM. MeTOllbl KOHTpOJ15I nOCT05IHHO pa3BHBaIOT-
C5I, n05IBJ15IeTC5I 60J1ee COBepWeHHOe 060PYllOBaHHe C npI1HUHnHallbHO
HOBbIMH B03MO)J(HOCT5IMH.
B TO )J(e BpeM5I KOHTpOJ1bHbIe J1a60paTOpHH 6bIJ1H H OCTalOTC5I Y3KHM
MeCTOM B pa60Te npellnpmlTHH. B 2010 r. Ha HHX npHXOllHJ10Cb 26, 1%
Bcex nHceM-npellynpe)J(DeHHH FDA CiliA H Ha aHallHTH'leCKHe MeTOllbl
OTlleJ1bHO - 5,2 % (maBa 20).
,lJ,JUI OnpelleJ1eHH5I COCTaBa MaTepHallOB H npOllYKUI1I1 H HallH'lH5I B
HHX nOCTopOHHHX BellleCTB (3arp5I3HeHI1H) CJ1y)J(aT aHallHTH'leCKHe MeTO-
llbl KOHTPOJ15I. 3TI1 MeTOllbI HCnOJ1b3YIOTC5I TaK)J(e npH aTTeCTaUHH npo-
ueCCOB O'lHCTKH 060PY.llOBaHH5I (oueHKH OCTaTKOB npellbmYlllero npo-
.lI.YKTa, MOlOlllHX Cpe.llCTB, npOllYKTOB pacnMa) H B llPYTHX CJ1Y'la5Ix.
TaKHM 06pa30M, 06J1aCTblO npHMeHeHH5I aHallHTH'leCKHX MeTOllOB
HBJUleTC5I KOHTpOJ1b:
- HCXOllHblX MaTepHallOB;
- npoMe)J(YTO'lHOH npOllYKUHH;
- roTOBOH npOllYKUHH;
- npoueCCOB O'lHCTKH 060PYlloBaHH5I H np.
AnQ./lUmUlteCKuii Memoi) 1l0J1)J(eH llaBaTb OllHHaKOBbIe pe3YJ1bTaTbI npI1
pa60Te Ha OllHHaKOBOM 060pYlloBaHI1I1 B pa3JlJ1lIHbIX J1a60paTOpI15IX 11
pa3HbIMI1 onepaTopaMH.
.lln5I 3TOro He06xollHMO, 'lT06bI:
- caM MeTO.ll. COOTBeTCTBOBall 3allaHHbiM Tpe60BaHI15IM;
- MeTOll 6bIJI 060cHoBaH H YTBep)J(DeH;
- npH60pbl 11 060PYlloBaHHe YHKUHOHHPOBallH TaK, KaK npe.llY-
cMoTPeHO;
- nepCOHall pa60Tall rpaMOTHO 11 .ll06pOCOBecTHo.
PaCCMaTpI1Ba5I aTTeCTaUI110 aHallI1TI1'leCKI1X MeTO.llOB, CJ1ellyeT BbI-
lleJl I1Tb:
- aTTeCTaUI110 c06cTBeHHo anQ./lUmUlleCKUX Memoo06 (llallee aHaJlI1-
TJ1lIeCKI1e MeTO.llbI 11 aTTeCTaUI15I aHallI1TI1'leCKI1X MeTolloB);
- aTTeCTaUI110 npu60p06 U 060pyooeanuR (llallee npI160pbl) B ueJ1eCO-
06pa3HoM 06'beMe;

AHGJlUmUlfeCKue MemOObl
271
- npOBepKY pa60TOCnoc06HOCTH MeTO.lla Ha MeCTe nOJIb30BaHI15I, KO-
TOpa5I BKJIIO'laeT B ce65I KaK npOBepKY caMoro MeTOlla, TaK 11 npH60pOB.
nOp5I.llOK aTTeCTaUHH MeTOllOB H npH60pOB pa3J1H'laeTC5I npI1HUI1nI1-
allbHO. KnIO'leBbIMH BOnpOCaMI1 5IBJ15I1OTC5I pa311eJ1eHHe YHKUHH 11 OT-
BeTCTBeHHOCTH Me)J(lly pa3pa60T'lHKOM MeTOlla (npH60pOB) H n0J1b30Ba-
TeJ1eM 3TI1M MeTOllOM (npH60pOM).
ATTecTaUH5I MeTOllOB paCCMOTpeHa B n.n. 11.2-11.5, aTTeCTaUH5I
npH60poB - B n. 11.7.
11.2 npHHLI.Hnbl aTTeCTaLI.HU H npoBepKa pa6oTOcnoco6Hocm MeTO,ll.OB
OCHOBHbIMI1 BonpocaMH npH pa60Te C aHallHTH'leCKHMH MeTO.llaMI1
5IBJI5IIOTC5I:
- KTO pa3pa6aTbIBaeT MeToll?
- KTO YTBep)J(DaeT MeTO,lI.?
- KTO pa3pa6aTbIBaeT MeTOllI1KY aTTeCTaUHH MeTolla?
- KTO BbInOJ1H5IeT aTTeCTaUHIO MeTOlla H Korlla?
- 'lTO 1l0J1)J(Ha ClleJ1aTb J1a60paTOpI15I DJI5I pa60TbI no llaHHOMY MeTOllY?
PaCCMOTpHM 3TH BonpOCbI nOllp06Hee.
AHallHTH'leCKHe MeTOllbI pa311eJ15IIOTC5I Ha llBe rpynnbI:
- apMaKoneHHbIe MeTOllbI,
- HeapMaKoneHHbIe MeTO.ll:bI.
11.2.1 <l>apMaKoneuHbIe MeTO,ll.bI
<DapMaKoneHHbIe MeTOllbI YCTaHaBJIHBalOTC5I apMaKoneeH. B MI1pe
lleHCTByeT MHO)J(eCTBO apMaKoneH, H «rapMOHH3aUI15I» B 3TOM Bonpoce
llalleKa 110 3aBepWeHH5I.
Ho )J(H3Hb, T. e. peallbHO lleHCTBYlOlllI1ti MI1pOBOH pbIHOK JIeKapCTB,
Tpe6yeT ellHHbIX nOllXOllOB. TaKHe nOllXOllbI 3MaHbi BellYlllHMH llOKYMeH-
TaMH: <DapMaKoneeH COellI1HeHHbIx WTaToB (USP) H EBponeHcKoH ap-
MaKoneeH, a TaK)J(e MaTepHallaMH ICH 11 B03 [35; 561. D.allbHeHWHH Ma-
TepHall OCHOBaH Ha 3THX llOKYMeHTax. POCCI1HCKa5I apMaKOne5I HBJ15IeTC5I
HCKeHHOH KOMnHJ15IUHeti EBponeHcKoH apMaKoneH C BHeceHHeM He-
H}0KHbIX H3MeHeHHH H YCJ1o)J(HeHHH H He paCCMaTpI1BaeTC5I.
B CWA ollHHaKoBYIO CI1J1Y C apMaKoneHHbIMH MeTOllaMI1 11 Me lOT
MCTOllbI, COllep)J(alllI1eC5I B llPyrHx 1l0KYMeHTax. KOlleKC ellepallbHbIX
npaBI1J1 CWA 21 CFR Part 211,  211.194(a)(2) [16J npI13HaeT YllOBlle-
TBOpHTeJ1bHbIMI1 MeTOllbI, npI1Be.lleHHbIe B <DapMaKonee CoellHHeHHbIx
WTaToB, HauI1oHallbHOM OpMYJ1Hpe, C60pH11 Kax MeTOllOB AOAC
INTERNATIONAL, Book of Methods I1J1I1 llPyrHx npI13HaHHbIX CTaH.llapTax
\1J1H OnI1CaHHbIe B YTBCp)J(DeHHbIX 3a5IBKaX Ha HOBbIe J1eKapCTBeHHbIC cpell-
CTBa, eCJ1I1 3TaJ10HHbIH MCTO.ll He I13MCHeH.

272
rJ1060 II
LLrrH 0603Ha'leHH5I BCeX 3THX MeTOllOB npHMeH5IeTC5I TepMHH
«compendiol method». <DapMaKOne5I COe.llHHeHHbIX WTaTOB (USP) 11 HauI1o-
HallbHbIH OPMYJ15Ip (NF) paCCMOTpeHbI B maBe 21. B llallbHeHWeM ll115I
KpaTKocTH 6YlleM n0J1b30BaTbC5I TepMI1HOM «apMaKoneHHbIti MeTOll'),
HMe5I B BHllY, 'lTO B Hero MO)J(eT BKJI3llbIBaTbC5I 60J1ee WI1pOKHH CMbICJ1.
npH3HaHo, 'lTO apMaKoneHHbIe MeTOllbI (<DapMaKOne5I CoellHHeH-
HbIX WTaTOB - USP, EBponeHCKa5I 11 llpyme apMaKoneH) 11 MeTO.llbI,
cOllep)J(alllHecH B llpymx HOpMaTI1BHbIX llOKYMeHTax, a TaK)J(e npH3HaH-
HbIe npaKTHKoM, 060CHOBaHbi 11 e aTTeCTOBaHbI. HI1KaKoHllPyroH aT-
TeCTaUHH Ha MeCTe npHMeHeHH5I He Tpe6yeTC5I no on pelleJ1e H 11 10, HHa'le
OHH He MOrJ1H 6bITb YTBep)J(DeHbI H BKJIIO'leHbl B cf>apMaKonelO I1J1H llPY-
roM HopMaTHBHbIHllOKYMeHT.
Ha 3TO np5IMO YKa3bIBaeT EBpOneHCKa5I cf>apMaKoneH [23], pa311eJ1 I
«General notices», 1.1 «General statements,), p. 3:
ATTeCTaQIUI apMaKoneHHbIx MeTOOB (Validation of pharmacopoeial me-
thods). npl1BelleHHbIe B MOHorpa<j)I1HX 11 06111HX rl1aBax MeTOJ1bl aTTeCTOBa-
HbI B COOTBeTCTBHI1 C npl1HHTOI1 HaY'JHOI1 npaKTI1KOI1 11 J1eI1CTByIOIlU1MI1 pe-
KOMeHJ1aUI151MI1 no aTTeCTaUl111 aHaJlI1TI1'JeCKI1X MeT0J10B. ATTeCTaUH5I MeTO-
J10B KOHTpoJIH I1CnOl1HI1Tel1eM He Tpe6YeTCH, eCl1l1 B MOHorpa<j)1111 111111 06-
lllel1 maBe He YKa3aHO I1Hoe.
AHallOm'lHOe YKa3aHHe .llaHO B <DapMaKonee CoellHHeHHblX WTaToB -
USP (1125):
n0l1b30BaTel1l1 aHaJll1m'JeCKI1MH MeTOllaMI1, npl1BelleHHbIMI1 B USP-
NF, He J10J])l(Hbl BbInOl1H5ITb aTTeCTaUl110 TO'lHOCTI1 11 Hane)l(HOCTI1 3TI1X Me-
T0J10B, HO Ol1)I(HbI npOBepHTb I1X pa60Tocnoc06HoCTb (suitability) B peaJIb-
HbIX YC110BH5IX npl1MeHeHI1H.
EBponeHCKa5I <DapMaKOne5I H <DapMaKOne5I CoellHHeHHbIx WTaToB
HCHO YKa3blBalOT, KeM npoBollHTCH aTTeCTaUH5I aHallI1TI1'leCKHX MeTO.llOS:
OHa npOBOJJHTC5I pa3pa60mlluKOM MeTOlla llO ero YTBep)J(DeHI15I, a ne nO.llb-
306ame.lleM.
3TO YKa3aHI1e llaeT KOHKpeTH3aUHIO 06111ero n0J10)J(eHI15I npaBI111
GMP (fOCT P 52249), l.JacTb I. n. 6.15:
«AHaJlI1TI1'JecKl1e MeTOJ1I1KI1 1l011)1(Hbi 6blTb aTTeCTOBaHbI').
l.JaCTb 11 npaBI1J1 GMP, OTHOC5Illla5IC5I K aKTI1BHbIM apMaueBTI1'le-
CKHM cy6cTaHUH5IM, AaeT 60J1ee KOHKpeTHYIO OPMYJ1I1pOBKY (n. 12.80):
«Cl1eJ1yeT npeJ1YCMaTpHBaTb aTTeCTaUl110 aHaJlI1TI1'JeCKI1X MeT0J10B, 3a
I1CKJIIO'JeHl1eM <j)apMaKoneHHblx I1JII1 J1pyrl1x YTBep)l(JleHHblX MeT0J10B').
TaKI1M 06pa30M, aTTeCTaUI110 aHallI1TI1'leCKoro MeTOlla Ha MeCTe npH-
MeHeHI15I npOBO.llI1Tb He Tpe6yeTC5I, HO CJ1e.llyeT nposepI1Tb ero pa60Tocno-
C06HOCTb B KOHKpeTHbIX YCJ10BI15IX. KaK 3TO .lleJ1aeTCH, nOKa3aHO HI1)J(e.

AH011UmU'IeCKUe MemOObl
273
nOp5IllOK aTTeCTaUHH (npOBepKI1 pa60TOcnoc06HOCTH) MOfYT pa3J1H-
'laTbC5I ll1151 apMaKonei1HbIx H HeapMaKoneHHbIX MeTOllOB:
AuaJIHTH'IeCKHH MeTO.n.
<1>apMaKondiHblH:
- aTTeCTaUI151
- npOBepKa (J1eMOHCTpaUI151)
pa60Tocnoc06HOCTI1
He<j)apMaKoneHHblH:
- aTTeCTaUI151
- npOBepKa (J1eMOHCTpaUI151)
pa60Tocnoc06HOCTI1
Pa3pa6oT'lHKH
n O.JIb30BaTeJlH
BKJIIO'JeHa B pa3pa60TKY
D.a*
HeT
D.a
BKJIIO'JeHa B pa3pa60TKY
D.a*
(pa3pa60T411K HBJIHeTCH n0l1b30BaTel1eM)
* npl1 aTTeCTaUl111 npoBep5leTC5I MeTOJ1I1Ka npOBepKI1 pa60Tocnoc06HOCTI1
MeTOll, BKJ1IO'leHHbIH B apMaKonelO, e aTTeCTOBaH no onpelle-
J1eHHIO, H ero aTTeCTaUH5I npH3HaHa YLlOBJ1eTBOpHTeJ1bHOH npH YTBep-
)J(DeHI1I1 MeTOlla H B llallbHeHWeM He paCCMaTpHBaeTC5I.
3aoallu pa3pa6omltUKa Memoda
COrJ1aCHO USP (1225) pa3pa60T'lHK HOBOro MeTO.lla 1l0J1)J(eH npe.ll-
CTaBHTb He06xoLlHMbIe llaHHbIe, 'lT06bI MO)J(HO 6bIJ10 oueHHTb 1l0CTOHH-
CTBa MeTOlla. K TaKHM llaHHbIM OTHOC5ITC5I:
- 060cHoBaHHe He06xollHMOCTH BBelleHH5I llaHHoro MeTOlla (R06o-
nole), onHcaHHe ero B03MO)J(HOCTeH (Capability) H 061>5ICHeHI1e npeHMY-
llleCTB 3TOro MeTOlla no cpaBHeHHIO C llPYfHMH. npH nepeCMOTpe MeTOlla
CJ1ellyeT llaTb cpaBHeHHe C CYllleCTBYlOlllHM MeTOllOM, BKJIIO'la5I orpaHH-
'leHI15I Ha ero npHMeHeHHe, H npeHMYllleCTBa HOBOro MeTOlla (3mo O'leHb
YMHO - '1m06bl 3PR He 30COpflJ/U MUP HeHYJlCHblMU H06blMU MemoooMU -
npUM. oemopo KHUZU);
- nOJ1HOe onHcaHHe MeTOlla (Proposed Analytical Procedure) C .lleTallI13a-
UI1ei1 llO TaKOH CTeneHH, '!T06bI nOllroTOBJ1eHHbIH onepaTop Mor ero nOBTO-
pI1Tb. OHO llOJ1)J(HO BKJIIO'laTb Bee B3)J(HbIe napaMeTpbI H CneUHallbHbIe YKa-
3aHI15I, HanpHMep, no npHroTOBJ1eHHIO peareHTOB, npOBepKe pa60Tocno-
C06HOCTH (System suitability tests), Mepbl npellOCTopo)J(HOCTH, 5ICHbIe cfx>PMY-
J1bI ll1151 BbI'lI1CJ1eHI15I pe3YJ1bTaTOB TeCTa H np.;
- TlllaTeJ1bHO 11 B nOJ1HOM o6'heMe COCTaBJ1eHHa5I llOKYMeHTaUH5I no
aTTeCTaUI1I1 MeTO.lla (Data Elements), KOTOpa5I llOJ1)J(Ha BKJIIO'laTb CBOll
3KCnepI1MeHTallbHbIX llaHHbIX H paC'leTbI. 060CHOBbiBalOlllHe Ka)J(DYIO H3
XapaKTepHCTHK MeTO.lla.
3TI1 xapaKTepHCTHKI1 paCCMOTpeHbI B n. 11.5.
113 CKa3aHHoro eCTb HCKJIIO'leHHe. CTaTbI1 (1227) USP 11 n. 5.1.3 EBPO-
nei1cKoH apMaKoneH npellYCMaTpI1BalOT aTTeCTaUI110 MeTOllOB HeHTpallI1-
3aUI1I1 aHTHMHKp06Horo lleHCTBH5I npenapaTOB C aHTI1MI1Kp06HbIMI1 CBOH-
CTBaMI1 npI1 npOBe.lleHHH TeeroB Ha MI1Kp06I10J1ofI1'lecKYIO 'lHCTOry H CTe-
PHJ1bHOCTb B J1a60paTopI15Ix. HeHTpallI13aUI15I 1l0CTI1raeTC5I pa36aBJleHI1eM,
npOMbIBaHHeM H np., 3KTHBHOCTb KOTOpbIX 1l0Jl)J(Ha 6bITb .llOKa33Ha.

274
r11oeo II
3adallu nOJlb306ame./lR
np0I13BOllCTBO 1l0J1.>KH0 BbInYCKaTb J1eKapCTBeHHbIe cpellCTBa, a He
pa3pa6aTbIBaTb MeTOllbI KOHTpOJ1$1. (])apMaKOne5I H llPYfHe HopMaTHBHbIe
D.OKYMeHTbI ll1151 TOro H CYllleCTBYIOT, 'lT06bI n0J1b30BaTeJ1I1 MOfJ1H no
HHM pa60TaTb, a He 3aHI1MaTbC5I HCCJ1ellOBaHI15IMI1.
I1cnoJ1b3Y5I H3BeCTHbIH MeTOll, npe.llnpH5ITHe .llOJ1.>KHO nOKa3aTb, 'lTO
OHO pa60TaeT no HeMY npaB\1J1bHO, T. e. Y Hero eCTb 060PYllOBaHHe, nOMe-
llleHH5I H pa60'lHe MeCTa, 'lTO OKpalOlllaH cpella OTBe'laeT He06xOllHMbIM
YCJIOBH5IM, nepCOHall 06Y'leH H llOKYMeHTaUH5I BelleTC5I TaK, KaK nOJIO)J(eHO.
BC5I 3Ta npOBepKa llOJl)J(Ha 6bITb OOpMJ1eHa 1l0KYMeHTallbHO. Ha aH-
fJIHHCKOM 5I3bIKe OHa Ha3bIBaeTC5I «verification». nepeBollHTb 3TOT TepMHH
KaK «BepHHKaUH$I» He HHO. OH H Ha aHfJ1HHCKOM 5I3bIKe He 0D.H03Ha-
'leH H 'laCTO CMeWHBaeTC$I C TepMHHoM «validation», KOTOpbIH BbI3Ball ny-
TaHHUY B OTe'leCTBeHHoH npaKTHKe (fJ1aBa 2).
Ha PYCCKOM 5I3bIKe 3TO D.eHCTBHe JIY'lwe Ha3BaTb «npo6epKa npUMene-
nUH anQ./lUmUlteCKOlO .MemoiJa» ,lI)I$I onpe.lleJ1eHHbIX KOHTpOJ1bHbIX onepa-
llHll. CaM MeTOll e YTBep)J(DeH H ero HeJIb3$1 «BallHllHpOBaTb» \1J1H «Be-
P\1(PHUHpoBaTb,>. MO)J(HO TOJIbKO npOBepl1Tb npaB\1J1bHOCTb era npHMeHe-
HH5I B KOHKpeTHOM cJIY'Iae.
npellnpH5ITHe He pa3pa6aTbIBaeT aHallHTH'leCKHH MeTOll, OHO CJIe.llY-
eT TOMY, 'lTO HanHcaHO B TeXH0J10fH'leCKOM perJIaMeHTe \1J1H pefHCTpa-
UHOHHOH llOKYMeHTaUHH, 6epem HY.>KHbIH MeTOD., roTOBHTC$I K He MY 11
nOKa3bIBaeT, 'lTO pa60TaeT no HeMY npaBHJ1bHO, pHC. 11.1.
1-------------
1 Pa3pa6oT'IHK 1
1 MeTona 1
1 1
1 ATTeCTOBaHHbIH 1
1 1
I MeTO.D:
I 1
1- _ _ _ _ _ _ _ _ _ _ _ 
n0J1b30BaTeJ1b
(KOHl'pOflbHaH J1a60paTOpHH)
n pl160pbI
npOBepKa
(nO.D:TBep)l(,lleHl1e
pa60Tocnoc06HOCTI1
MeTO.lla 11 npl160pOB,
KpaTKO - MeTO.D:a)
1
1
1
L______________
PHC. 11.1. ATTeCTaUH5I H npOBepKa pa60Tocnoc06HOCTH
aHallI1TH'leCKoro MeTOlla
nO'leMY YTBep)J(DeHHbIH apMaKoneei1 MeTOll MO)J(eT He pa6OTaTl2
nOTOMY 'lTO I1cnOJ1b3yeTC5I nJ10Xoe 060PY.llOBaHI1e, He 06Y'leH nepCOHcUl.
HeT Tpe6yeMbIx MaTepI1allOB. ECJII1 3TO TaK, TO npellnpH5ITHe He roTOBO K
BbInYCKY J1eKapCTBeHHbIX CpeD.CTB 11 He COOTBeTcTByeT Tpe6oBaHH5I1\1
GMP. HY)J(HO BbInOJIHI1Tb BCIO nOllroTOBI1TeJIbHYIO pa60TY 11 3aTeM no-
Ka3aTb, 'lTO JIa60paTOpI1$1 OCBOI1lIa 3TOT MeTO.ll.

AH011umu<teCKue MemOObt
275
11.2.2 Hecl»3pM3KoneHHbie MeTO,ll.b1
HeapMaKonei1Hble MeTOllbI - 3TO MeTOllbI, He BX01l5IlllHe B BbIwe
nepe'lI1CJIeHHble 1l0KYMeHTbi.
B KaKHX CJIY'la5IX OHI1 pa3pa6aTbIBalOTCH?
npe)J(lle Bcero, HY)J(HO 060CHOBaTb, nO'leMY CYllleCTBYlOlllHe apMa-
KoneHHble MeTOAbl He 1l0CTaTO'lHbl H TPe6yeTC5I pa3pa60TKa HOBOro Me-
TOAa. KaK npaBHJ10, 3TO AeJ1aeTC5I npH pa3pa60TKe HOBOro J1eKapCTBeH-
HOro cpeACTBa, npH'leM aHallHTH'leCKHH MeTOllllOJ1)J(eH 6bITb pa3pa60TaH
H aTTeCTOBaH Ha CTMHH KJIHHH'leCKI1X I1CnbITaHHH.
ECJ1H opraHH3yeTC5I BbInYCK HOBOH npOAYKUHH, ll1151 KOTOpOH OTCYT-
CTBYIOT cf>apMaKoneHHbIe aHallHTI1'leCKI1e MeTOAbI, TO npOH3BOllHTeJ1b JIe-
KapCTBeHHbIX cpeACTB 065I3aH npOBeCTI1 I1CCJ1ellOBaHHe H 1l0Ka3aTb 003-
MO)J(HOCTb npI1MeHeHI15I 3TOro MeTOAa.
HeapMaKoneHHble MeTOAbI MorYT pa3pa6aTbIBaTbC5I caMHMH
npOH3BOAHTeJ1HMH JIeKapCTBeHHbIX cpeJJ.CTB HJIH llPyrHMH opraHH3a-
UHHMH. HeapMaKoneHHblH MeTOll JJ.OJ1)J(eH 6bITb YTBep)J(lleH Ha}J30p-
HbIM opraHOM 110 ero npHMeHeHHH H JJ.OJI)J(eH BOHTH B COCTaB perHCT-
paUHoHHoro 1l0Cbe.
lI.n5I HeKOTopbIX HeapMaKoneHHbIX MeTOAOB nopRiJoK aTTeCTaUHH
YCTaHaBJ1HBaeTC5I apMaKoneeH. HanpHMep, cDapMaKoneH CoellHHeHHbIX
lllTaTOB (1223) H EBponeHCKa5I apMaKOne5I (n. 5.1.6) YCTaHaRJIHBalOT
nopMOK aTTeCTaUHH MHKp06HOJIOfH'leCKHX MeTO.llOB.
EBponeHCKa5I apMaKOne5I (n. 5.1.10.13) npeJJ.YCMaTpHBaeT B03-
MO)J(HOCTb aTTeCTaUHH MeTOllOB npOBepKH Ha HallH'lHe 3HllOTOKCHHOB H
He06xoJJ.HMbIe ll1151 3TOro YCJ10BH5I. ECTb ynoMHHaHHe 0 B03MO)J(HOCTH
npHMeHeHH5I HeapMaKoneHHblx MeTOllOB ll11H KOHTpOJ1H CTepHJ1bHOCTH
npH YCJIOBHH llOKa3aTeJIbCTBa HX 3KBHBalleHTHOCTH cf>apMaKoneHHbIM
MeTOllaM.
MbmepnamU6Hble Memodbl ou.enKU iHUKp06uOAOlUlteCKOii ItUCmOmbi
USP AonYCKaeT B03MO.>KHOCTb npHMeHeHH5I allbTepHaTHBHblX (He-
<papMaKoneHHblx) MeTOAOB ll1151 H.lleHTI1HKaUHH MHKpoopraHH3MOB H
ou.eHKH HX Bbl)J(HBaeMOCTH. TaKHe MeTOllbI HCn0J1b3YIOTC5I MI1Kp06I1oJIo-
fH'leCKI1MH J1a60paTopHHMH B CHJ1Y CTOHMOCTHbIX aI<TOpOB, npOH3BOllH-
TeJIbHOCTH (3aTPaT BpeMeHH) H YJJ.06cTBa.
OHH JJ.OJ1)J(HbI 6bITb aTTeCTOBaHbI ll1151 nOllTBep)J(DeHH5I HX 3KBHBa-
JIeHTHOCTH apMaKoneHHbIM MeTOJJ.aM I1J1I1 HX 60J1ee BbICOKOro ypOBH5I.
nOp5IllOK aTTeCTaUI1I1 npHBelleH B CTaTbe (1223) USP. B CJ1Y'lae COMHe-
HHH CJ1ellyeT n0J1b30BaTbC5I apMaKoneHHbIM MeTOllOM. HY)J(HO nOKa3aTb,
nO'leMY apMaKoneHHbIH MeTOll He nOAXOJJ.I1T 11 1l0Ka3aTb, 'lTO llPyroH
MeTOll npHrolleH H pa60TaeT J1Y'lwe.

276
F11060 II
t 1.3 npoBepK3 p36oTOcnoco6HoCTU 3H3JlHTH'IeCKHX MeTOAOB
nOp5IllOK npOBepKH pa6oTocnoc06HOCTI1 apMaKoneHHoro MeTOlla
(verification procedure) llaH B USP (1226) [54]. BbInOJ1H5I5I 3TO npOBepKY.
CJIeAyeT nOATBepllHTb, 'lTO:
- JIa60paTOpI15I HMeeT HHoe 060PYlloBaHHe, KOTopoe YCTaHOBJ1eHO
.nOJDKHbIM 06pa30M, npOWJIO nYCKO-HallMO'lHbIe HcnbITaHH5I (npH He06-
XOllHMOCTH), KallH6pOBaHo I1JIH nOBepeHO;
- nOMellleHI15I HJ1H 30HbI He npHBHOCHT HCKa)J(eHHH B pe3YJ1bTaTbI
KOHTpOJ15I (HMeIOT Tpe6yeMYIO 'lHCTOTY, B HI1X HeT nJ1eCeHH 11 np.);
- HCnOJIb3YIOTC5I YKa3aHHbIe B cf:>apMaKonee MaTepHallbI;
- B J1a60paTOpI1I1 H Ha pa60'lHX MeCTax eCTb 1l0KYMeHTaUI15I (MeTO-
llHKH) llJ15I pa60TbI no .llaHHOMY MeTOllY;
- nepCOHall 06Y'leH H pa60TaeT TO'lHO B COOTBeTCTBHH C MeTOllHKOH;
- Halla)J(eH KOHTpOJ1b pa60TbI H Y.llOCTOBepeHI1e pe3YJIbTaTOB aHallI1-
3a BTOpOH nOllnHCblO (BTOpa5I nOllnI1Cb CTaBHTC5I TOJ1bKO nOCJ1e TOro,
KaK KOHTpOJIep JIH'lHO y6ellHJ1C5I B npaBHJ1bHOCTH nOJ1Y'leHHbIX pe3YJ1b-
TaTOB, I1MeHHO J1H'lHO, a He Ha OCHOBe llOBepH5I K CJ10BaM);
- pa6OTocnoco6HOCTb MeTOlla npOBep5IeTC5I no 3TaJ10HHbIM MaTepHallaM;
- pe3YJ1bTaTbI KOHTpOJ15I 0cf:>OPMJ15IIOTC5I llOJI)J(HbIM 06pa30M.
3TO nOllTBep)J(DeHHe 0OpMJ15IeTC5I npOTOK0J10M npOBepKI1 pa6OTO-
cnoc06HOCTH aHallI1TH'leCKoro MeTo.na.
HeCMOTp5I Ha TO, 'lTO npH npOBepKe pa60Tocnoc06HOCTI1 He BbI-
nOJ1H5IeTC5I BeCb KOMnJ1eKC pa60T llJ15I aTTeCTaUHH, MO)J(eT npellYCMaTpI1-
BaTbC5I npOBepKa HeKOTopbIX xapaKTepHCTHK (Ta6J1HUbI 11.1 HJ1H 11.2).
HO TOJIbKO B onpaBllaHHbIX CJ1Y'la5Ix. MeTollHKa npOBepKH pa60Tocno-
C06HOCTH 1l0J1)J(Ha 6bITb 3allO)J(eHa B caMOM aHallHTH'leCKOM MeTOlle. Ha
npaKTHKe MOfYT BbInOJ1H5ITbC5I 1l0n0J1HHTeJ1bHbIe npOBepKH, o6'heM KOTO-
pbIX 3aBHCHT OT nOllroTOBJIeHHOCTH H onbITa nepCOHalla, CJ10)J(HOCTI1 Me-
To.na H npH60poB.
HanpI1Mep, peallbHa5I 3arp5I3HeHHOCTb cy6cTaHUI1H, ll06aBoK, aHTI1-
OKCHllaHTOB 11 np. MO)J(eT MeH5ITbC5I OT nOCTaBlllHKa K nOCTaBlllI1KY B
WI1pOKHX npe.lleJ1ax. B 3TI1X CJ1Y'la5IX MO>KeT OKa3aTbC5I n0J1e3HOH npo-
BepKa CneUHI1'lHOCTH MeTO.lla, TO'lHOCTH 11 npelleJ10B 06HapeHH5I 11
KOJ1H'leCTBeHHOH oueHKH.
11.4 ATTeCT3u.HSI 3H3JlHTH'IeCKHX MeTOAOB
KaK nOKa3all0 BbIwe, aTTeCTaUI15I aHallI1TH'leCKHX MeTOllOB npoBO-
llHTC5I npH I1X pa3pa60TKe. MaTepI1all llaHHoro p.l311eJ1a OTHOCI1TCSI K
3TOMY CJ1Y'lalO 11 He npe.llHa3Ha l ieH llJ15I KOHTpOJ1bHbIX J1a60paTOpI1H.
npI1MeHSIIOWI1X aHallI1TI1'leCKI1e MeTO.llbI. Ha MeCTe I1Cn0J1b30BaHI15I npo-
Bep5IeTCH pa60Tocnoc06HOCTb MeTO.lla (n. 11.3 KHl1rI1).

AH011UmUl1eCKUe MemOObl
277
ATTeCTaUH5I - 3TO nOllTBep)J(DeHHe COOTBeTCTBHH MeTOlla YCTaHOB-
J1eHHbIM Tpe60BaHI15IM. 06111He Tpe60BaHI15I YCTaHOBl1eHbI B PYKOBO-
,llCTBaX ICH H B03 [35; 56]. CneUI1allbHbIe Tpe60BaHH5I K KaKoMY-J1H60
MeTOllY npHBelleHbI B COOTBeTCTBYlOllleH apMcTaTbe (MoHorpaHH).
nOBTOpHa5I aTTeCTaUH5I MeTOD,a npOBOllHTC5I npH BHeceHHH H3Me-
HeHHH B:
- npouecc CHHTe3a J1eKapCTBeHHoro cpellCTBa;
- COCTaB roTOBOro J1eKapCTBeHHoro cpellCTBa;
- caM aHallHTH'leCKHH MeTOll.
3TH xapaKTepHCTHKH (HO He Bce llJl5I Bcex CJ1Y'laeB) 1l0J1)J(HbI npOBe-
p5ITbC5I npH aTTeCTaUHH.
B Ta6J1HUe 11.1 YKa3aHbI CJ1Y'laH, Koma npOB01I.I1TC5I aTTeCTaUHH Me-
TOD,a no OnpelleJ1eHHbIM xapaKTepHCTHKaM comaCHO PYKOBOllCTBaM ICH
H B03. B Ta6J1Hue He npHBe.lleH nOKa3aTeJ1b «YCTOH'lHBOCTb», HO OH
D,OJl)J(eH npOBep5ITbC5I Ha 3Tane pa3pa6oTKH MeTOlla.
T0611UU,0 11.1
XapaKTepHCTHKH, no KOTOpbIM npOBO.lI.HTC5I aTTeCTaUHH
comaCHO PYKOBOllCTBaM ICH H B03
XapaKTepHCTHKa
aHanHTHeCKoro Me-
To.aa
npOBepKa
Ha lI)J.eH-
THHOCTb
npOBepKa Ha
nOCTopOHHHe BKJ1JOeHHH
OQeHKa KOHTpOJlb
KOJlHeCTBa no npe.aeJlY
TO'JHOCTb
CXOlII1MOCTb:
- nOBTOp5IeMOCTb
- BHYTpHJla60pa-
TOpHa51 CXOlIHMOCTb
CneUl1c1JH'JHOCTb (2)
npelIeJl
06HapY)I(eHI151
npellell KOlll1'JeCT-
BeHHOH Ol\eHKI1
JIHHeHHocTb
.LI.I1ana30H
+
AnanH3 (assay):
- paCTBopHMOCTb
(TOJlbKO H3MepeHHH)
- COCTaB
/3$$eKTHBHoCTb
+
+
+ (I)
+
+ (I)
+
+ +
- (3) +
+
+
+
+
+
+
YC110BHbIe 0603Ha'JeHH5I:
- He nODJIe)l(l1T oueHKe, KaK npaBI1110
+ nODJIe)l(l1T oueHKe, KaK npaBI1JIO
(l) BHYTPl1Jla60paTOpHa51 TO'JHOCTb He npOBepHeTC5I, eCJlI1 npOBep5leTC5I BOC-
np0I13B0J1I1MOCTb
(2) HeJ10CTaTO'JHaH cneUI1<j)I1'JHOCTb OJ1HOro aHaJll1TI1'JeCKoro MeTOJ1a J1011)1(-
Ha KOMneHCl1poBaTbC5I J1pymM BcnOMoraTel1bHblM MeT0J10M
(3) MO)l(eT nOTpe60BaTbC5I B HeKOTopblX Cl1Y'JaHX
B USP Ta6J1HUa TOro )l(e CMbICJ1a npellCTaBJ1eHa 60J1ee nOllp06HO
(Ta6J1HUa 11.2), npI1'leM Bce MeTOllbI pa3.llel1eHbI Ha 'leTbIpe KaTeropI1l1.

278
F110eo II
T0611UU,0 11.2
XapaKTepHCTHKI1, no KOTOpbIM npOBOllHTC5I aTTeCTaUH5I comaCHO USP
KaTeropHH II
XapaKTepHCTHKa KaTeropHH OueHKa KOHTPOJIb KaTeropHH KaTeropHH
I KOJIH'IeCTBa no npe.aeJIY III IV
TO'JHOCTb .LJ.a .LJ.a * * HeT
CX01Il1 MOCTb .LJ.a .LJ.a HeT .LJ.a HeT
CneUl1c1JI14HOCTb .LJ.a .LJ.a .LJ.a * .LJ.a
npellen HeT HeT .lla * HeT
o6HapeHI151
n pelIeJ1 KOnl1'Jec- HeT .LJ.a HeT * HeT
TBeHHoH OueHKI1
JII1HeMHOCTb .LJ.a .LJ.a HeT * HeT
.LJ.l1anaJoH .LJ.a ,lI,a * * HeT
* BbInOl1HeHl1e MO)l(eT nOTpe60BaTbcR }1JlH KOHKpeTHOro TeCTa.
KaTeropHH I - AHaJlHTI1'JecKl1e MeTOJ1bl DJI51 KOl1l1'JeCTBeHHOH OueHKI1 OC-
HOBHbIX KOMnOHeHTOB cy6CTaHul1H B 6aJ1K-<j)opMe 111111 aKTI1BHbIX I1HrpeJ1l1eHTOB
(BKJIIO'JaH KOHcepBaHTbI) B roTOBOM l1eKapCTBeHHOM cpeJ1CTBe.
KaTeropHH II - AHaJlI1TI1'JecKI1e MeTOJ1bI DJIR OnpeJ1el1eHI151 nOCTOpOHHI1X
BKJIIO'JeHI1I1 B cy6CTaHUHHX B 6aJ1K-<j)opMe 111111 npoJ1YKTOB pacnana B roTOBOM
l1eKapCTBeHHOM cpeJ1CTBe.
KaTeropHH III - AHaJll1Tl1'lecKl1e MeTOJ1bl DJIH OnpeJ1elleHI151 xapaKTepl1CTI1K,
CB5I33HHbIX C Ha3Ha'JeHl1eM npoJ1YKUI1I1 (HanpI1Mep, paCTBOpI1MOCTb, BbICB06o)l(-
.neHl1e aKTI1BHoro I1HrpeJ1l1eHTa 11 np.).
KaTeropHH IV - TecTbI Ha l1J1eHTI1<j)I1KaUI1IO.
B KHHre [53J H llpymx ny6J1HKaUH5IX llalOTC5I nOllp06HbIe peKoMeH-
.n:aUHH no KOHTpOl1lO A<DC H roTOBbIX OpM (Ta6J1HUbI 11.3 H 11.4).
11.5 X3p3KTepUCTHKH 3HUTUeCKHX MeTOAOB
XapaKTepHCTHKH aHallHTH'leCKHX MeTOllOB H nOp5IAOK I1X onpe.lleJ1e-
HH5I llaHbI B [23; 54J H llpyrHx PYKOBOllCTBax. K HHM OTHOC5ITC5I:
- TO'lHOCTb;
- CXOllHMOCTb, nOBTOp5IeMOCTb (pa3llemreTcSI Ha nOBTOp5IeMOCTb,
BHYTPHJ1a60paTopHYIO nOBTOp5IeMOCTb 11 BOcnpoH3BollHMOCTb);
- YCTOH'lHBOCTb;
- J1I1HeHHOCTb;
- llI1ana30H;
- cneUHH'lHOCTb (I136I1paTeJ1bHOcTb);
- npeAeJ1 06HapY)J(eHI15I;
- npeAeJ1 KOJ1I1'leCTBeHHOH oueHKH.

AHGJlUmU'leCKUe MemOObl
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T0611UU,0 11.3
KpI1TepHH aTTeCTaUMH aHallMTWleCKMX MeTO.llOB .llJIH XHMI1'IeCKHX cy6cTaHuHH B 6aJ1K-OpMe
::t:...
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S!:
To'l- JIHHeH IIoBTo- Bocnpo- CneL\H- IIpeeJl IIpeeJl KO- CTa6HJlb- YCTOH-
MeTO HeH- H3BOAl\- c1JH'IHOCTb o6Hapy- JlH'IeCTBeH- HOCTb aHa.rJH-
HOCTb pBeMOCTb 'IHBOCTb
HOCTb MOCTb :!KeHHB HOH OL\eHKH Ta H CHCTeMbl
llrIeHTHcbHKaL\HH - - - - + - - - -
cI>H3HKO-XHMH'IeCKHH aHa.rJH3:
- nomOllleHHe CBeTa - - + - - - - - -
- pa3Mep 'IaCTHU - - + - - - - - -
- npYrHe - - +/- - - - - - -
HaJllI'IHe npHMeceH:
- CYJ1b<paTH!UJ JOJla, nDKeJlble MeTaJlJ1bl - - - - - - - - -
KaTHOHHo-aHHOHHblH COCTaB:
- TeCT Ha paCTBopHMOCTb + - + - + + + - -
- HOHOCeJ1eKTHBHbIH 3J1eKTPOlI + + + - + + + - -
- aTOMH!UJ cneKTpOCKonHH + + + - + + + - -
COCTaB:
- TOHKOCJ10HH!UJ xpOMaTorpacIJMH + - + + + + - + +
(TCX)
- BbIcoK03cIJl}JeKTHBH!UJ )J(MJIKOCrnaH + + + + + + + + +
xpOMaTorpal}JHH (B3)!(X)
- raJOBaH XPOMaTorpa<pMH (rx) + + + + + + + + +
Coep)J(aHHe BOb1
- nOTepH B Macce npM BblCYlllMBaHHM + - + - - - - - -
- THTPOBaHHe no KapJlY cI>Mlllepy + - + - - - - - -
XnMll'leCKHH aHaJlH3:
- THTPOBaHMe + - + + - - - + -
- CBeTOnOmOweHMe + + + + - - - + -
- xpOMaTorpal}JHH + + + + + - - + +
OnpeneJ1eHHe OCTaTKOB paCTBOpHTeJ1eH:
- ra30B3H xpOMaTorpaI}JMH + + + + + + + + +



T0611UU,0 11.4

gg
KpHTCpI1I1 aTTeCTaUI1H aHallI1TI1IIeCKHX MeTO.llOB ll1151 roTOBOH npO.llYKUI1H
To'l- JlHlleA nOBTO- Bocnpo- CneI\HcIIH'I- npeeJI npeeJl KO- CTa6HJlb-
MeTOlI HeA- H3BOH- o6Hapy- JlH'IeCTBeH- HOCTb aHIIJIH-
HOCTb pHeMOCTb HOCTb HOH Ol\eHKH
HOCTb MOCTb 1KeHHH Ta H CHCTeMbi
l1eHTHcIIHKaI\HH - - - - + - - -
PacTBOpHMOCTb:
- 6e3 H3MeHeHHSI COCTaBa + + + + + - - +
- C H3MeHeHHeM COCTaBa + + + + + - - +
COCTIUI:
- lUHKOCJ10Hliml xpOMaTO- + - + + + + - +
rpaqJl1S1 (TCX)
- BbICOK03<)J</JeKTHI!HaSi + + + + + + + +
)l(111IKOCTHaSi xpOMaTorpa-
</JHSI (B3)1(X)
- ra30BaSi xpOMaTorpa<)JHSI + + + + + + + +
(rx)
MeTObl aHIIJIH33 KOHcep-
B3HTOB:
- nOrJJOllleHHC CBeTa + + + + - - - +
- xpoMaTorpaqlHH + + + + + - - +
AIIaJlH3 aKTHBHblX HHrpeH-
eHTOB:
- CBeTOnOrJJOUlCHHe + + + + - - - +
- xpoMaTorpacIJlH1 + + + + + - - +
::-,
is
a;,

....
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280
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AH011UmU'leCKUe MemoiJbl
281
11.5.1 TO'lHOCTb
TO'lHOCTb (accuracy) - CTeneHb COOTBeTCTBH5I pe3YJIbTaTa HcnbITa-
HHH HCTHHHOMY 3Ha'leHHIO OnpelleJI5IeMOH BeJ1H'lHHbI HJ1H pa3HHua Me)J(-
llY pe3YJIbTaTOM HCnbITaHHH H HCTHHHbIM 3Ha'leHHeM BeJIH'lHHbI.
OnpelleJ15IeTC5I cpaBHeHHeM C 3TallOHHbIM MeTOllOM (apMaKonefufbIM).
A. TO'IHOCTh npu KOJlll'leCTBeHHOM 3H3JIJl3e (Assay)
Cy6cmanu.uu
CYllleCTByeT HeCKOJIbKO BapHaHToB oueHKH TO'lHOCTH MeTOllOB aHa-
JIH3a cy6cTaHUHH:
a) oueHKa 3TallOHHOro BellleCTBa C H3BeCTHOH CTeneHblO 'lHCTOTbI H
cpaBHeHHe nOJ1Y'leHHoro pe3YJ1bTaTa C H3BeCTHbIM 3Ha'leHHeM;
b) cpaBHeHHe pe3YJ1bTaTOB aHallH3a no paCCMaTpHBaeMOMY MeTO.llY H
no .n.PyroMY MeTOllY C H3BeCTHOH TO'lHOCTblO;
c) 3aKJIIO'leHHe 0 TO'lHOCTH MO)J(eT 6bITb BbInOJ1HeHO, eCJ1H H3BeCTHbI
nOBTOp5IeMOCTb, JIHHeHHOCTb H cneUHH'lHOCTb MeTOlla.
Tomoeoe .IleKapCm6ellnoe cpedcmeo
CYlllecTByeT HeCKOJIbKO BapHaHTOB oueHKH TO'lHOCTH:
a) oueHKa JIeKapCTBeHHoro cpellCTBa, COllep)J(alllero H3BeCTHoe KO-
JIH'leCTBO cy6cTaHuHH (cy6cTaHuHH);
b) npH HeB03MO)J(HOCTH nOJIY'lHTb 06pa3UbI Bcex KOMnOHeHTOB,
BXOll5IlllHX B COCTaB JIeKapCTBeHHoro cpellCTBa, MO)J(eT HCn0J1b30BaTbC5I
JIH60 ll06aBJ1eHHe H3BeCTHbIX KOJ1H'leCTB aHallH3HpyeMoro BellleCTBa B
JIeKapCTBeHHoe cpellCTBO, J1H60 cpaBHeHHe C pe3YJ1bTaTaMH, nOJ1Y'leHHbI-
MH ll115I llPYroro, XOPOWO oxapaKTepH30BaHHoro MeTOlla, TO'lHOCTb KOTO-
poro YKa3aHa H/HJ1H OnpelleJIeHa;
c) 3aKJIIO'leHHe 0 TO'lHOCTH MO)J(eT 6bITb BbInOJ1HeHO, eCJIH H3BeCTHbI
nOBTopHeMOCTb, J1HHeMHOCTb H cneumpH'lHOCTb MeTOlla.
B. Ol\eHK3 TO'lHOCTU no 33rpS13HeHIDIM (Impurities)
TO'lHOCTb MO)J(eT 6bITb oueHeHa no 06pa3uaM cy6cTaHUHH HJ1H J1e-
KapcTBeHHoro cpellcTBa, B KOTopoe BBelleHO 3arp5I3HeHHe B H3BeCTHOM
KOJ1H'leCTBe, pe3Ko OTJ1H'lalOllleMC5I OT 06bI'lHOro.
ECJ1H 3TO HeB03MO)J(HO, TO 1l0nYCKaeTC5I npOBeCTH cpaBHeHI1e C pe-
3YJ1bTaTaMH llpyroro H3BecTHoro MeTOlla.
C. PeKOMeH.lIYeMble KpUTepUH Ol\eHKH TO'lHOCTU
TO'lHOCTb MO)J(eT 6bITb oueHeHa KaK MHHHMYM no .n.eB5ITI1 np06aM
llJ15I He MeHee 'leM Tpex KOHueHTpaUHH, nOKpbIBalOlllHX 3a.llaHHbIH .IIHa-
na30H, HanpI1Mep, TPI1 np06bI .n.J15I Tpex KOHueHTpaUI1H.
TO'lHOCTb Onpe.lle115IeTC5I KaK npoueHTHoe COOTHOllleHHe KOl1H'leCTBa
BellleCTBa, 06HapY)J(eHHoro no llaHHOMY MeTOllY, K I13BeCTHOMY KOl1l1'leCTBY

282
F11060 II
BBelleHHoro BellleCTBa, l1H60 KaK pa3HOCTb Me)l(llY CpellHI1M 3Ha'leHI1eM 11
npHH5ITbIM HCTHHHbIM 3Ha'leHHeM C Y'leTOM .llOBepI1TeJ1bHbIX HHTepBaJIOB.
11.5.2 CXOAHMOCTb (Precision)
XapaKTepI13yeT CTeneHb pa36poca pe3YJ1bTaTOB pa3HbIx H3MepeHI1H
OllHOH H TOH )J(e BeJ1H'lHHbI. Onpe.lleJ15IeTC5I no pe3YJ1bTaTaM oT60pa np06
O.llHOrO H TOro )J(e OllHOpOJJHOro MaTepHalla. OueHI1BaeTC5I cTaHllapTHbIM
OTKJIOHeHHeM.
Pa311eJ15IeTC5I Ha TPH ypOBH5I (Ta6J1HUa 11.5):
- nOBTOp5IeMOCTb;
- BHYTPHJ1a60paTOpHa5I nOBTOp5IeMOCTb;
- BocnpOH3BOllHMOCTb Me)J(DY J1a60paTOpIDIMH
T0611UI{O 11.5
XapaKTepHCTMKH CXOllMMOCTH
XapaKTepHCTHKa Y'IeT BJIHJlIIUJI Ha YCJIOBHSI
pe3YJIbTaT
nOBTOp5leMOCTb CaMoro MeTOJ1a aJ1HHaKOBble: a.llHa l1a60paTOpl151,
OJ1I1H onepaTOp, OJ1HO 11 TO )l(e
BpeMR 11 o60py.aoBaHl1e
BHYTPl1Jla60paTopHa5I Pa3Hblx YC110BI1l1 aJIHa J1a60paTOpl151, HO pa3Hble
nOBTopReMOCTb B OJ1HOI1 onepaTOpbI, pa3HbIe JIHI1, pa3Hoe
l1a60paTOpl1l1 o60PYJ1oBaHl1e
BocnpoI13BOJ1I1MOCTb YCJ10BI1H pa3HblX Pa3Hble l1a60paTOpl1l1
(nOBTOp5leMOCTb DJI51 l1a60paTOpl1H
pa3HbIX l1a60paTOpI1H)
nOBTOpSeMOCTh (repeatability): CTeneHb pa36poca 3Ha'leHHH npI1
OllHHaKOBbIX YCJ10BH5IX. OueHHBaeTC5I O.llHHM H3 llBYX cnoc060B:
- KaK MHHHMYM no .lleB5ITI1 np06aM, HanpI1Mep, ll1151 Tpex KOHueH-
TpaUMH (HanpHMep, 85%; 100%; 105% no TPH np06bI ll1151 Ka)J(}JOi1) HJ1H
- KaK MHHHMYM no weCTH np06aM 100%-H KOHueHTPaUHH.
np06bI oT6HpalOTC5I no B03MO)J(HOCTH 6bICTpO OllHHM 'leJ10BeKOM
npH O.llHHaKOBbIX YCJ10BH5IX.
CYTb - oueHHTb OTKJIOHeHI15I, 3allO)J(eHHbIe B caMOM MeTOlle.
P33J1H'lH5I Me)l(llY TO'lHOCTblO H nOI3TOp5IeMOCTblO nOKa3aHbI Ha pHC. 11.2.
BHYfPHJJ36op3TOPH3JI nOBTOpSeMOCTh (intermediate precision): CTe-
neHb pa36poca pe3YJ1bTaTOB KOHTpOJ15I I13-3a BJ1H5IIOlllI1X aKTOpOB B O.ll-
HOH J1a60paTopHI1. npOBep5IeTC5I npI1 BbInOJ1HeHI1I1 aHallH3a pa3HbIMI1
l1I1uaMI1, B pa3HbIe AHI1, Ha pa3HoM 060PYlloBaHI1I1 (H3 I1MelOllleroC5I 11
npellHa3Ha'leHHoro .IIJ15I npOBelleHI15I llaHHoro aH<UlI13a). npH OUCHKC
BocnpOH3BOllI1MOCTI1 npOBO.llHTb He Tpe6yeTC5I.

AHGJlUmU'leCKUe MemOObl
283
BocnpoU3BOAHMOCTb (reproducibility): CTeneHb pa36poca pe3YJ1bTaTOB
KOHTpOJ15I. TO'lHOCTb MeTOAa npH ero npHMeHeHHH B pa3J1H'lHbIX YCJlO-
BH5IX (HanpHMep, npH pa60Te B pa3HbIX J1a60paToplliIx, pa3J1H'lHbIMH HC-
nOJlHHTemIMH, Ha pa3HOM 060PYlloBaHHH HJlH B pa3Hoe BpeM5I).
a) BblCOKa5I CXOJ1l1MOCTb
npM HI13KOH TO'JHOCTI1
(6beM TO'JHO MI1MO uel1l1)
b) B cpe.lIHeM nOna}1aHI151
rpynnl1pYIOTc5I BOKpyr
uel1l1, HO CXOJ1I1MOCTb
(noBTOp5leMOcTb) nnoxa5I
PHC. 11.2. Pa3J1H'llliI Me)J(DY TO'lHOCTblO H CXOllHMOCTblO Ha npHMepe
CTpeJlb6bI no MHweHH
11.5.3 YCTOH'lHBOCTb
c) BbICOKa51 TO'JHOCTb 11
BbICOKa51 nOBTOp5leMOCTb
YCTOH'lHBOCTb (robustness or ruggedness) - :no CBOHCTBO MeTOlla lla-
BaTb pe3YJlbTaTbI C npHeMJ1eMOH TO'IHOCTblO H OTKJIOHeHH5IMH npH pa60-
Te B pa3J1H'lHbIX YCJlOBHHX.
np0611eMa YCTOI1'JI1BOCTI1 - 06111a51 npo611eMa DJI51 MHornx 06llaCTel1
npI1MeHeHI151. TaHKI1 B roJ1bl BOHHbI MOfJIl1 npl1uel1bHO CTpel151Tb TOl1bKO 113
HenOJ1BIDKHoro n0110)l(eHI151. npl1 J1BI1)1(eHI1I1 no HepoBHOCTHM CTBOl1 0PYJ1I151
peampoBaJI Ha MaJleHWl1e OTKJIOHeHI151. 3aTeM CTBOl1 cHa6J1111111 mpOCKonOM
- YCTPOHCTBOM, o6ecne'JI1BalOIW1M cTa611J1bHOCTb opMeHTaU1111 CTBOlla He3a-
BI1CI1MO OT J1BIDKeHI151 TaHKa. AHaJlOrn'JHbIH cnoc06 6bIJI npl1MeHeH DJI51 KO-
pa6el1bHblX 0PYJ1l1H 11 T.J1.
MeTOJ1bI KOHTpol151 TO)l(e J1011)1(Hbl 6bITb YCTOH'JI1BbIMI1.
OueHKa YCTOH'lI1BOCTI1 npOBODHTC5I pa3pa60T'lI1KOM MeTOlla Ha
CTMHH ero pa3pa60TKI1. Oc06eHHOCTI1 3TOH oueHKH 3aBHC5IT OT KOH-
KpeTHoro MeTODa. HanpI1Mep, MOfYT CpaBHI1BaTbC5I pe3Yl1bTaTbI aHallH3a
OllHHaKOBbIX np06 npI1 pa3J1H'lHbIX YCJ10BH5IX. npI1 oueHKe CJ1ellyeT HC-
KyCCTBeHHO H3MeH5ITb napaMeTpbI H nOKa3aTb Halle)J(HOCTb MeTOlla, T. e.
YCTOH'lI1BOCTb pe3YJ1bTaTOB K H3MeHeHI11O 3TI1X napaMeTpOB.
ECJlI1 MeTO.ll 'lYBCTBHTeJ1eH K H3MeHeHH5IM KaKI1X-J1I160 napaMeTpOB,
TO 3TO 1l0J1)J(HO 6bITb YK33aHO B onHcaHHH MeTOlla. B l1a60paTopHH, I1C-
n0J1b3YlOllleH 3TOT MeTOll, 1l0J1)J(HbI 6bITb C0311aHbl He06xOllHMbIe YCJ10BH5I
H Halla)J(eH HX KOHTpOl1b.

284
F11060 II
Ha YCTOH'lHBOCTb MOfYT BJ1ID1Tb pa3JIH'lH5I B:
- OnbITe I1CnOJ1HHTeJ1eH;
- TeMnepaType H BJ1a)J(HOCTI1 B0311yxa;
- cTa6HJ1bHOCTH KOHTpOJ1bHbIX H CTaHllapTHbIX 06pa3UOB;
- peareHTaX (HanpI1Mep, nOl1Y'laeMbIX OT pa3J1H'lHbIX nOCTaBlllHKOB);
- 3Ha'leHI15IX pH;
- CepH5IX npOllYKUHH H np.
B 135] npHB01l5ITC5I npHMepbI THnH'lHbIX napaMeTpOB, BJII15IIOlllHX Ha
YCTOH'lHBOCTb:
a) ,lI)l5I >KI1llKOCTHOH xpoMaTorpaHH:
. H3MeHeHH5I pH B nOllB\1)J(HOH a3e;
. H3MeHeHH5I B COCTaBe nOllBH)J(HOH a3bI;
. npoI1CXO)J(DeHHe MaTepHallOB (pa3HbIe CepHI1 HJ1I1 nocTaBlllHKH);
. TeMnepaTYpa;
. CKOpOCTb nOTOKa;
b) ,lI)l5I ra30BOH xpoMaTOrpaHH:
. npOHCXO)J(DeHHe MaTepHallOB (pa3HbIe cepHH HJ1H nocTaBlllHKH);
. TeMnepaTYpa;
. CKOpOCTh nOTOKa.
KOHKpeTHbIe Tpe6oBaHH5I YKa3bIBalOTC5I B apMaKonee HJ1H OIIHca-
HH5IX MeTOlla (eCJ1H MeTOll HecPapMaKoneHHbIH). ECJIH TaKHX YKa3aHHH
HeT, TO npI1MeH5IIOTC5I 06111He Tpe60BaHH5I. HanpHMep, eCJ1H aHallHTH'le-
CKHH MeTOll He COllep)J(HT Tpe60BaHHH K TeMnepaTYpe, TO CJIellyeT PYKO-
BOllCTBOBaTbC5I CJIellYlOlllHMH 3Ha'leHH5IMH (EBponeHCKa5I apMaKOne5I):
- B JIHOHJ1bHOH CYWHJ1Ke: HH)J(e -1ST;
- B X0J1011HJ1bHHKe: OT 2 llO 8°C;
- B XOJIOllHbIX HJ1H OXJ13)J(DeHHbIX YCJ10BH5IX: OT 8 llO 15°C;
- npH KOMHaTHOH TeMnepaType: OT 15 110 25T.
npoBepKa YCTOH'lHBOCTH Tpe6yeT 6oJ1bworo 061>eMa pa60TbI, HO 3TH
3aTpaTbI onpaBllaHbI, nOCKOJIbKY OnpelleJI5IIOTC5I B03MO)J(HbIe TPYllHOCTH 11
BJ1H5I1OlllHe aKTOpbI. ECJ1H MeTOll HeYCTOH'lI1B, TO CJ1ellyeT O)J(\1DaTb
JIO)J(HbIX pe3YJ1bTaTOB KOHTp0J151, He06'b5ICHHMbIX BbIXOllOB 3a npelleJ1bl
cneUHHKaUI1H H nOCT05IHHbIX pa36I1paTeJIbCTB.
11.5.4 JIHueHUOCTh (linearity)
3TO CBOHCTBO MeTOlla nOJ1Y'laTb pe3YJ1bTaTbI, np5IMO nponopuHo-
HallbHbIe KOHueHTpaUHH HCCJIellyeMoro BellleCTBa B np06e.
,l],n5I npoBepKH JIHHeHHOcTH 6epYTc5I He MeHee n5ITH np06 BerneCTBa
C pa3J1H'lHbIMH KOHueHTpaUH5IMH B llHana30He H3MeHeHHH 3Ha'leHUli
aHallH3HpyeMoH BeJ1H'lHHbI. npH J1HHeHHOCTH MeTOlla 06eCne'lI1BaeTOI
ero ODHHaKOBa5I 'lYBCTBHTeJIbHOCTb K H3MeHeHI11O napaMeTpa BO BCel\1
DI1ana30He ero 3Ha'leHHH. JlI1HeHHOCTb xapaKTepI13yeTC5I K03HUHeH-
TOM JIHHel1HOCTH (ymoM HaKJIOHa np5IMOH) 11 lleMOHcTpHpyeTC5I rpmlm-
KOM.

AHGJ1UmUlfeCKue MemoiJbl
285
11.5.5 ,l],u3n33oH (range)
LI.Hana30H 03Ha'laeT 06J1aCTb Me)J(DY HaHMeHbWI1M H HaH60J1bWHM
3Ha'leHH5IMH aHallH3HPyeMoH BeJ1H'lI1HbI, KOTopbIe llOJ1)J(HbI onpe.lleJ15ITb-
C5I ll115I llaHHoro npOllYKTa.
YCTaHaBJ1HBaeTC5I npH aHallH3e J1HHeHHOCTI1 MeTOlla.
11.5.6 CneH(I>HIJHOCTb, H36Hp3TeJlbHOCTh (specificity, selectivity)
3TO CBOHCTBO MeTOlla pearHpOBaTb Ha xapaKTepI1CTHKH TOJ1bKO on-
pelleJ1eHHoro BellleCTBa B npHCYTCTBHH .IIPymx BellleCTB, HanpI1Mep, llO-
6aBoK I1J1H 3arp5I3HeHHti. OnpelleJ15IeTC5I npH aTTeCTaUHI1 MeTo.aOB Ha
HlleHTI1'lHOCTb, OnpelleJ1eHHe npHMeceH (3arp5I3HeHHH) H npH XI1MI1'le-
CKOM aHallH3e.
11.5.7 qYUCTBUTeJIbHOCTh (sensitivity)
nOll 'lYBcTBHTeJ1bHOCTblO nOHHMaeTC5I CBOHCTBO MeTOlla 06HapY)J(H-
BaTb MallbIe H3MeHeHI15I B KOHueHTpaUHH BellleCTBa. XapaKTepH3yeTC5I
npelleJ10M 06HapeHH5I H npelleJ10M KOJ1H'leCTBeHHoH oueHKH [35].
A. npeAeJi 06H3pyJKeHIDI (Detection Limit - DL): HaI1MeHbWee KOJ1H-
'leCTBO BellleCTBa, KOTopoe MO)J(eT 6bITb 06HapY)J(eHO (He 065I3aTeJ1bHO C
oueHKoti ero KOJ1I1'leCTBa).
MofYT HCn0J1b30BaTbC5I HHCTpYMeHTallbHbIe H HeHHCTpYMeHTallbHbIe
MeTOllbI:
- BH3YallbHaH oueHKa;
- OTHoweHHe CHfHalljWYM;
- CTaHllapTHoe OTKJIOHeHI1e pe3YJ1bTaTa 11 ymoBoH K03cPq)J1UHeHT;
- CTaHllapTHoe OTKJIOHeHHe npI1 nYCTOH np06e;
- KallH6pOBO'lHa5I KpHBa5I.
BU3Ya.llbnaR ou,eHKa
UeJ1b aTTeCTaUI1H - OnpelleJ1I1Tb MHHI1MallbHOe KOJ1I1'leCTBO BellleCT-
Ba, KOTopoe MO)J(eT 6bITb 06HapY)J(eHO HeBoopY)J(eHHbIM ma30M. HanpI1-
Mep, npI1 aTTeCTaUI1I1 MeTO.llOB O'lHCTKI1 nOBepXHOCTeH 060pYllOBaHI1S1
npen.eJ1bI 06HapeHHH 3arp5I3HeHI1H COCTaBJ15IIOT 4 MKrjcM 2 11 .aa)J(e I
MKrjcM 2 .
npH aTTeCTaUI1I1 MeTOlla BH3YallbHOH oueHKH npOBep5IIOTC5I He-
CKOJ1bKO np06 C pa3J1H'lHOH (I13BeCTHoH) KOHueHTpaUHeH BellleCTBa 11
YCTaHaBJ1I1BaeTC5I MI1HI1MallbHaH KOHueHTpaUH5I, npH KOTOpOH BellleCTBO
MO)J(eT 6bITb 06HapY)J(eHo BI13YallbHO.
CUma.ll/WYM
OueHKa 3TOro COOTHOWeHI15I Tpe6yeTC5I .llJ15I npI160pOB, I1MelOlllI1X
C06CTBeHHbIH OH (HanpI1MCp, 3J1eKTpOHHbIe WYMbl), KOTopble MorYT

286
f11060 II
BHeCTH HCK3)J(eHH5I B pe3YJIbTaTbi KOHTpOJI5L B 3TOM CJIY'lae B Te'leHHe
HeKoToporo BpeMeHI1 aHallH3HpYIOTC5I np06bI C H3BeCTHbIMH HH3KHMH
KOHueHTpaUH5IMH BellleCTBa H nYCTble np06bl, 11 Onpe.lleJ15IeTC5I 3Ha'leHI1e
WYMa. 06bI'lHO OTHOWeHHe CHfHalljWYM, paBHOe = 3: I I1J1I1 2: I. C'lHTa-
eTC5I npHeMJ1eMbIM.
Cmanoapmnoe om1<Jlonenue pe3Y.Ilbmama u YlO.ll Ha1<JlOHa
npelleJ1 06HapY)J(eHI151 MO)J(eT 6bITb OnpelleJ1eH KaK
DL = 3,3ajS,
file a - CTaHllapTHoe OTKJIOHeHHe pe3YJIbTaTOB,
S - yroJ1 HaKJIOHa KallH6pOBO'lHOH KpHBOH.
YroJI HaKJIOHa S MO)J(eT 6bITb oueHeH no KallH6pOBO'lHOH KpHBOH
aHallH3HpyeMoro BellleCTBa.
OueHKa a MO)J(eT 6bITb BbInOJ1HeHa pa3J1H'lHbIMH MeTOllaMH, HanpHMep:
- no CTaHllaPTHOMY OTKJIOHeHHIO, nOJ1Y'laeMOMY npH aHallI13e 1l0CTa-
TO'lHOro KOJIH'leCTBa nYCTblX np06;
- no KallH6pOBO'lHOH KpHBOH; npH 3TOM aHallH3I1pYIOTC5I np06bI,
CO.IIep)J(alllHe BellleCTBO B npe.IIeJIax 3Ha'leHHH DL; OCTaTO'lHOe CTaHllapT-
Hoe OTKJIOHeHI1e (Residual standard deviation) JIHHHH perpeCCHH HJ1H
CTaHllapTHoe OTKJIOHeHHe 3Ha'leHH5I Ha OCH Y B TO'lKe nepeCeQeHH5I C
HeH JIHHHH perpeCCHH, T.e. x = 0, (y-intercepts) MOryr HCn0J1b30BaTbC5I B
KaQeCTBe CTaHllapTHoro OTKJIOHeHH5I.
PeKOMeHdYeMbie 3HalteHUR
CJ1ellyeT YKa3aTb npelleJ1 06HapY)J(eHH5I H MeTOll, no KOTOPOMY OH
OnpelleJ1eH. ECJ1H npelleJ1 06HapeHI15I OnpelleJ15IeTC5I BH3YallbHbIM Me-
TOllOM HJ1H Ha OCHOBe OTHOWeHH5I CI1fHalljWYM, TO .IIOCTaTO'lHO npI1J10-
)J(HTb llaHHbIe xpOMaTorpacf>H'leCKoro aHallH3a.
B CJIY'lae, eCJ1H npelleJI 06HapY)J(eHH5I onpeAeJ1eH paC'leTOM I1J1I1 3KC-
TpanOJI5IUHeH, TO ero JHa'leHHe MO)J(eT 6bITb nOllTBep)J(DeHO He3aBHCI1-
MbIM aH3J1H30M OnpelleJ1eHHoro KOJ1H'leCTBa np06, ll1151 KOTOpbIX H3BeCT-
HO, 'lTO HX napaMeTp HaXOllHTC5I B6J1H3H npelleJIa 06HapeHH5I HJ1H OHI1
npHroTOBJ1eHbI TaK, 'lT06bl napaMeTp 6bIJ1 B6J1H3H 3TOro npelleJ1a.
B. npeAeJI KOJIWleCTBeHHOH ou.eHKU (Quantification Limit): HaI1-
MeHbwee KOJ1I1'leCTBO BellleCTBa B np06e, KOTopoe MO)J(eT 6bITb 06Hapy-
)J(eHO C npI1eMJ1eMOH TO'lHOCTblO H CXOllHMOCTblO (noBTOp5IeMOCTblO,
pa36pocoM). I1Cn0J1b3YIOTC5I Te )J(e MeTO.llbI, 'lTO H ll1151 npelleJ1a 06Hapy-
)J(eHHH. npI1 oueHKe no KpI1TepI11O CHfHalljWYM npelleJ1 06HapY)J(eHI151
paBeH 3Ha'leHI11O WYMa, YMHO)J(eHHOMY Ha 10, T. e. OTHOWeHI1e CHr-
HalljWYM = 10:1 [351.

AH011UmU'leCKUe MemOObl
287
BU3YUJlbnQJl ou,enKa
npOBep5IIOTC5I HeCKOJ1bKO np06 C pa3J1I1'lHOH (H3BecTHoi1) KOHueH-
TpaUHeH BellleCTBa H YCTaHaBJ1HBaeTC5I MI1HHMallbHaH KOHueHTpaUI15I, npI1
KOTOpOH MO)J(eT 6bITb llaHa ero KOJ1H'leCTBeHHM oueHKa C 3MaHHOH TO'l-
HOCTblO H CXOllHMOCTblO.
CmaHdapmHoe OmK.llOneHUe pe3Y.Ilbmama U YlO.ll naK.llona
npelleJ1 KOJ1I1IIeCTBeHHOH oueHKH MO)J(eT 6bITb OnpelleJ1eH KaK
QL = lOa/S,
rile a - CTaHllapTHoe OTKJlOHeHHe pe3YJ1bTaTOB,
S - yroJ1 HaKJIOHa KallH6pOBO'lHOH KpHBOH.
YroJ1 HaKJIOHa S MO)J(eT 6bITb oueHeH no KallH6pOBO'lH0i1 KpHBOH
aHallH3HpyeMoro Belll.eCTBa no aHallOfHH C npeAeJ10M 06HapY)J(eHH5I (CM.
BbIllIe).
Tpe606aHUR
OpelleJ1 KOJ1H'leCTBeHHOH oueHKH 1l0J1)J(eH 6bITb 060CHOBaH (aTTe-
CTOBaH) nYTeM aHallH3a LlOCTaTO'lHoro 'lHCJ1a np06 co 3Ha'leHH5IMH na-
paMeTPa B6J1H3I1 Hero HJ1H 1l01l)J(eH 6bITb npHroTOBJ1eH TaK, 'lT06bI 3TO
YCllOBHe BbIn0J1H5IJ10Cb.
11.5.8 llpoBepK3 p36oTOcnoco6HOCTH
npoBepKa pa60TOcnoc06Hocm (System suitability testing) BXOlllIT B co-
CTaB MHOfHX aHallHTH'leCKHX MeTOllOB. nOp5I.D.OK npoBepKH pa60Tocno-
C06HOCTH 3aBHCI1T OT oc06eHHocTeH MeTOlla H npHBelleH B cPapMaKOne5Ix.
11.6 Tpe6oB3HIDI K 3H3JlHTHlJeCKHM MeTOA3M
B OnHCaHI1e MeTOlla 1l0J1)J(HbI BXOllHTb:
- nOp5I.D.OK oT60pa np06 (o6'heM H 'lHCJ10 np06, MeTOll oT60pa np06,
KOHTeMHepbI, B KOTopbIe oT6HpalOTC5I np06bI, YKa3aHH5I no npellBapH-
TellbHOH 06pa60TKe np06bI, npH He06xollHMOCTH, H T. ll.);
- oc06bIe YCJ10BH5I xpaHeHHH np06, npH He06xOllI1MOCTH;
- Tpe6oBaHH5I K peareHTaM;
- OnI1CaHHe 060pYlloBaHH5I;
- MeTOllHKa npOBepKH pa60TOcnoc06HoCTH 060pYlloBaHH5I;
- MeTOLlHKa npOBepKH pa60Tocnoc06HocTI1 aH3J1I1TI1'leCKOrO MeTOLla
(HanpI1Mep, pa311eJ15IIOllleH cnoc06HOCTH xpoMaTOrpaH'leCKHX K0J10HOK);
- Tpe60BaHI15I K YCJ10BI15IM npOBe.lleHI1S1 KOHTp01l5I, BKJIIO'laSl YCJ10BI1S1
npOBe.lleHI15I peaKUI1H H HCn0J1b30BaHHe peareHTOB ll1151 npI1roToBl1eHH5I
np0I13BO.llHbIX;

288
f11060 II
- MepbI npe.llOCTOpO)J(HOCTH;
- nOp5IllOK 06pa60TKI1 pe3YJ1bTaTOB C YKa3aHI1eM MeTOlla CTaTI1CTI1'le-
CKOrO aHallH3a, eCJ1H 3TO Tpe6yeTC5I.
CJ1e.llyeT YKa3aTb KOHTpOJ1bHbIe (3TaJ10HHbIe) 06pa3UbI HJ1I1 MaTepHallbI.
11. 7 ATTeCT31\ID1 npu6opoB
fla60paTopHoe 060pYlloBaHHe pa3Ho06pa3Ho: OT npOCTblX BeCOB 11
HcnapHTeJ1eH a30Ta 110 CJ10)J(HOro MHOroYHKUHOHallbHOro 060PYlloBa-
HH5I C KOMnblOTepHbIM ynpaBJ1eHI1eM 11 KOHTpOJ1eM.
Tpe60BaHH5I K aTTeCTaUHI1 aHallHTH'leCKI1X MeTO.llOB llaHbI B PYKO-
BOllCTBax ICH H B03. ,il.n5I aTTeCTaUI1H KOHTpOJ1bHbIX npI160pOB H 060-
PYlloBaHI15I Me)J(DYHapollHbIX PYKOBOllCTB B HaCT05Illlee BpeM5I HeT, HO
eCTb 5ICHbIe YKa3aHHH no llaHHOMY Bonpocy B C1>apMaKonee CoellHHeH-
HbIX WTaToB (Analytical Instrument Qualification - AIQ) (1058) [54].
npH60p llOJ1)J(eH pa60TaTb npaBHJ1bHo. LI..mI npOCTbIX npH6opoB (Tep-
MOMeTp, fHrpOMeTp, MaHOMeTp, BeCbI H np.) )10CTaTO'lHO BbInOJ1HHTb I1X
KallH6pOBKY (noBepKY), 11 Ha 3TOM aTTeCTaUH5I npH60pa 3aKaH'lHBaeTC5I.
LI.n5I CJ10)J(HbIX npH60poB npOBepKa pa60TOcnoc06HoCTH HeO'leBI1llHa
H Tpe6yeT npI1MeHeHH5I CneUHallbHOH MeTOllI1KH. npH 3TOM B03HHKaIOT
06bI'lHbIe B 3TOH cHTyaUHH BonpocbI:
- KTO pa3pa6aTbIBaeT MeTO.llHKY H YTBep)J()1aeT ee?
- KTO BbInOJ1HHeT aTTeCTaUHIO H OTBe'laeT 3a ee npHMeHeHHe?
ATTeCTaUH5I npH60pa - 3TO nOllTBep)J(DeHHe TOro, 'lTO npH60p COOT-
BeTcTByeT CBOeMY Ha3Ha'leHHIO, OOpMJ1eHHOe lloKYMeHTallbHo. 3Tanbl
aTTeCTaUHH aHallOfH'lHbI paCCMOTpeHHbIM B rJ1aBe 9:
- aTTeCTaUH5I npoeKTa (KOHCTPYKUHH) - DQ;
- aTTeCTaUH5I YCTaHOBJ1eHHoro 060PYlloBaHH5I - IQ;
- aTTeCTaUHH B OCHallleHHOM COCT05IHHH - OQ;
- aTTeCTaUI1H B 3KCnJ1yaTaUI1I1 - PQ
HY)J(HO I1MeTb B BHllY, 'lTO BeCb Ha60p 3TanOB )1J15I Bcex BI1110B npI1-
60POB He HY)J(eH. He06xOllHMOCTb 3Tana OnpelleJ15IeTC5I xapaKTepHCTHKa-
MI1 npI160pa 11 peallbHOH He06xOllHMOCTbIO BbInOJ1HHTb KaKI1e-J1I160 pa-
60TbI. C1>OPMallH3M H J1HWHHe onepaUHI1 llOJ1)J(HbI 6bITb HCKJIIO'leHbI.
PeKOMeHllaUHH no 3TanaM llaHbI B Ta6J1I1ue 11.5.
11.7.1 npoBepK3 X3p3KTepHCTHK npH6op3
Design Qualification (DQ) - TaK Ha3BaHa B USP nepBa5I CTMI15I pa-
60TbI C npH60poM. 1l0CJ1oBHO OHa nepeBOllI1TC5I KaK «aTTeCTaUHH KOH-
CTpYKUI1I1'). CMbICJ10BOH nepeBO.ll B .llaHHOM CJ1Y l Jae 3BY'lI1T KaK «npOBep-
Ka xapaKTepI1CTI1K npI160pa 3a.llaHHbiM Tpe6oBaHI15IM'),
3TO OTBeTCTBeHHbIH 3Tan. OH BKJIIO'laCT B ce65I:
- Bbl60p nOCTaBlliI1Ka;

AHOJ1UmU'1eCKUe MemOObl
289
- Bbl60p HY)J(HOro npI160pa;
- BbI60p .llOnOJ1HI1TeJ1bHbIX npHHallJ1e)J(HOCTeH (OnUI1H).
Bce 3TO lleJ1aeTC5I .llO npI1H5ITI15I peWeHI15I 0 nOKynKe.
Bbl60p nOCma6UKa
npH BbI60pe nOCTaBlllHKa HY)J(HO I1CXOllI1Tb 113 CJ1ellYlOlllI1X KPH-
TepHeB:
- HallI1'lI1e B HOMeHKJIarype npOH3BO.llCTBa HJ1H nOCTaBKH npH60pOB
HY)J(HOro TI1na;
- TeXHI1'leCKI1H ypOBeHb H311eJII1H H penYTaUH5I nOCTaBlllI1Ka Ha pbIHKe;
- HallH'lHe npellCTaBHTeJ15I B POCCHH H nOp5IllOK nOllllep)J(KI1 npH60-
pa B 3KCnJ1yaTaUHH.
PbIHOK np0I13BOllI1TeJ1eH npI160pOB K HaCT05IllleMY BpeMeHH Ccf>oPMI1-
pOBallC5I. HOBbIe, ll3)J(e npHHUHnHallbHO HOBbie npH60pbI 06bI'lHO pa3pa6a-
TbIBalOTC5I CYllleCTBYlOlllHMI1 HpMaMI1. Ha nYCTOM MeCTe BbICOKOTeXH0J10-
fI1'lHOe KOHCTPYKTOpCKOe 61Opo H npOH3BOllCTBO 6blCTpO He nOCTpOI1Tb.
KOHe'lHo, MO)J(HO KynHTb npl160p Y COBceM HOBOH HpMbI. Bce KO-
ma-TO npOI1CXO.llHT B nepBbIH pa3. Ho 3TO HMeeT CMbICJ1 neJ1aTb TOllbKO B
TOM CJ1}"-Iae, Koma npH60p no CBOHM nOKa3aTe115IM lleHCTBHTellbHO HO-
BbIH, a HOBa5I qmpMa lleHCTBHTellbHO 1l0CTOHHa TOro, 'lT06bI C HeH pa60-
TaTb. B a6COllIOTHOM 60J1bWHHCTBe CJ1Y'laeB MbI npH06peTaeM CepI1HHO
BbInYCKaeMbIe npI160pbI H 060PYllOBaHI1e, I1HOpMaUH5I 0 pa60Te KOTO-
poro eCTb. HHO TOJ1bKO ee nOHCKaTb, He HMe5ICb «Ha aBOCb», 'lT06bI
He CTaTb nOllOnbITHbIM KpOJ1HKOM.
llocmaeKa u nOddepJICKa 6 :JKCn./lyamau,uu
npOH3BO.llHTeJ1b npH60pOB 11 ero npellCTaBHTeJ1b (nOCTaBlllHK)
1l0J1)J(HbI I1MeTb XOPOWYIO penYTaUHIO. MbI )J(HBeM B Y3KOM npoeCCI10-
HallbHOM MI1pe, rile Bce llPyr llpyra 3HaIOT, H cxeMa pa60TbI llaBHO CJ10-
)J(I1J1aCb. 3apy6e)J(HbIH 3aBoll-H3roToBHTellb OTKpbIBaeT npenCTaBI1TeJ1bCT-
BO B .IIpyroH CTpaHe I1J1H 3aKJIIO'laeT lloroBOp C lleHCTBYlOllleH HpMOH 0
COTpYllHH'leCTBe. 3TO COTpYllHI1'leCTBO HMeeT TPI1 CTOpOHbI:
- npOllBH)J(eHI1e TOBapa, ero npO.lla)J(a H nOCTaBKa;
- nYCKO-HallMO'lHbIe pa60Tbl, 06Y'leHI1e nepCOHalla 11 aTTeCTaUH5I
060pYllOBaHH5I, eCJ1I1 Tpe6yeTC5I;
- TeXHI1'leCKOe 06CJ1Y)J(I1BaHI1e, KallI16pOBKa, peMOHT H Bo06we no.ll-
llep)J(Ka B 3KCnJ1yaTaUI1H.
lI.n5I n0J1b30BaTemI KynI1Tb npH60p - TOJ1bKO Ha'lallO nYTH. HHO,
'lT06bI 3TO 6bIJ10 Ha'lallOM nYTI1 H llJI5I HpMbI, KOTOpa5I npO.llalla npI160p
H 6YlleT BawHM nOMOlllHI1KOM B Te'leHHe Bcero nepHOlla 3KCnJ1yaTaUHI1.
ECTb noroBopKa: «Bce, '1mo MOJICem J10MOmbCR, J1OMoemCR, a '1mo He
MOJICem - 30copRemCR». MaWI1HbI, KaK 11 11IO.llI1, 60J1eIOT. Ho B OTJ1H'lHe
OT J11011eH napK MaWHH HCKJIIO'lI1TeJ1bHO pa3Ho06pa3eH 11 60J1e3HI1 O'leHb
cneUI1I1'lHbl. C HI1MI1 MorYT CnpaBI1TbC5I TOl1bKO CneUI1allbHO nO.llroToB-
J1eHHbIe J11011H, npHIIeM nOllroTOBJ1eHHble 3aB0J10M-I13rOTOBHTel1eM.

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AHOJ1umU'IeCKUe MemOObl
291
OCHallleHI1e npellnpI15ITI1ti COBpeMeHHbIM 060PYllOBaHI1eM HlleT
nOJ1HbIM XO.llOM. 11 nOJ1HbIM XOllOM paCTYT 06pallleHHH n0J1b30BaTeJ1el1 K
OHUHallbHbIM npe.llCTaBHTeJ15IM 3aBO.llOB-I13roTOBI1TeJ1eH 3a nOMOlllblO. B
CJ1Y'lae «CepOH» nOCTaBKH npellCTaBHTeJ1b MO)J(eT OTKa3aTb B nOMOlllI1.
liTO lleJ1aTb nOJlb30BaTeJ1lO? 06 3TOM HY)J(HO 6bIJ10 llYMaTb paHbwe.
OI1UI1allbHbIe npeD.CTaBHTeJ1H B CJ1Y'lae nOCTaBKH B 06XOll HHX OTBeTCT-
BeHHOCTI1 He HecYT HH 3a 'lTO. 06pallleHH5I K CJ1Y'laHHbIM npOllaBuaM
OTe'leCTBeHHoro I1J1H 3apy6e)J(Horo npOI1CXO)J(DeHI15I, KaK npaBI1J10, HH'le-
fO He llalOT, eCllI'I 3THX npOllaBUOB YllaeTC5I OTbICKaTb Bo06111e.
Mopallb: Bbl6Hpa5I nOCTaBlllHKa, HY)J(HO llYMaTb 0 6Y.llYllleM, KTO 11
KaK 6Y.lleT nOMoraTb B CJ1Y'lae He06xOllI1MOCTI1.
Bce, 'lTO CKa3aHO 3D.eCb, HaCTOJ1bKO aKTYallbHO, 'lTO HaWJlO OTpa)J(e-
HHe B <l>apMaKonee CoellHHeHHbIX WTaTOB - USP, me B CTaTbe (1058)
YKa3aHo, 'lTO npH npHH5ITHH peWeHH5I 0 npH06peTeHHH npH60pa HY)J(HO
y6ellI1TbC5I B TOM, 'lTO npOH3BOllHTeJlb 06eCne'lHT adeK6amnyIO noooepJICKY
6 3KCn./lyamau,uu.
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KOTOpbIH BaM HeH H He COllep)J(HT J1HWHero.
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npHMepbI HenpaBHJ1bHoro BbI60pa npH60pOB H 060PYllOBaHl15I npHBO-
MTC5I B llPymx pa311eJ1ax.
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HaweH npaKTHKe eCTb CJ1Y'laI1, Koma 3aKa3'lI1K 3anpaWHBaeT C'leT'lHK
'laCTHU B B0311yxe C HH)J(HHM noporoM 'lYBCTBI1TeJ1bHOCTH 0, I MKM, B TO
BpeM5I KaK npaBI1J1a G MP Tpe6YIOT C'lI1TaTb 'laCTI1UbI C pa3MepaMH 0,5
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rOM 0, I MKM CTOHT BllBoe 60J1bWe, 'leM C'leT'lHK C noporoM 0,5 MKM.
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ll06pocoBecTHbIe OTHOWeHH5I - npI15ITHb1H ClOpnpH3. Ha npaKTI1Ke MbI
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rpaMMbl H MeTOllHKH aTTeCTaUI1H .llOJ1)J(HbI BXOllHTb B KOMnJ1eKT nOCTaBKH.
Te, KTO XO'leT pa60TaTb Ha pOCCHHCKOM pbIHKe, .llOJ1)J(HbI YBa)J(aTb
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ro 06CJ1Y)J(HBaHH5I, BbInOJ1H5IeMoro n0J1b30BaTeJ1eM, llOJ1)J(Ha BXOllHTb B
OCHOBHOH KOMnJ1eKT nOCTaBKI1.
nporpaMMbI H MeTOllI1KI1 I1CnbITaHHH (aTTeCTaUI1H), BXOll5IlllHe B KOM-
nneKT KOHCTPYKTOpCKOH 1l0KYMeHTaUI1I1 Ha H311eJ1He H no I1CnbITaHI15IM,
npOBOllI1MbIM Ha MeCTe n0J1b30BaHH5I, llOJ1)J(HbI nepellaBaTbC5I 3aKa3'l 11 KY.
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HanpI1Mep, I13roToBHTeJ1H C'leT'lHKOB 'laCTHU B B03llyxe BKJIIO'laIOT B on-
UHH llaT'lHK TeMnepaTypbI 11 BJ13)J(HOCTH. Bpolle 6bI Bce xopowo: OllHHM
C'leT'lHKOM Onpelle1l5IeTC5I KOHueHTpaUH5I 'laCTHU B B03llyxe H TYT )J(e Ha
3KpaHe, paCne'laTKe H B llaHHbIX, nepellaBaeMbIx B KOMnbIOTep, eCTb Bce
TPH nOKa3aTeJ15I: KOHueHTpaUH5I 'laCTHU, TeMnepaTypa 11 BJ1a)J(HOCTb B03-
llyxa.
Ho C'leT'lI1K 'laCTHU He 5IBJ15IeTC5I Cpe.llCTBOM H3MepeHH5I. OH nOll11e-
)J(I1T KallH6pOBKe, J1Y'lwe 3aBOlloM-H3roToBHTeJ1eM I1J1I1 ero npe.llCTaBI1Te-
J1eM. A llaT'lHKH TeMnepaTypbI H BJ1a)J(HOCTI1 - 3TO Cpe.llCTBa I13MepeHI15I.
KOTopbIe HHO nepellaBaTb Ha nOBepKY MeTp0J10raM.
ECJ1H llaT'lHK pa60TaeT TOJ1bKO co C'leT'lHKOM, TO HHO nepellaBaTb
BeCb C'leT'lHK, C KOTOpbIM He Bce nOBepHTeJ1H YMelOT pa60TaTb. DbIBalOT
CJ1Y'laH nOBpe)J(DeHI15I C'leT'lHKa npI1 «nOBepKe,). n03TOMY J1Y'lwe He
CMeWHBaTb npI1HUHnI1allbHO pa3HbIe YHKUHH B OllHOM npI160pe.
11.7.2 ATTeCTau.HR YCT3HOBJIeHHOrO 060PYAOB3HHSI
AneCTaUH5I YCTaHOBJ1eHHoro 060pYlloBaHI15I (IQ) npoBOllHTC5I BO
Bcex CJ1Y'la5Ix: npI1 npH06peTeHI1I1 HOBoro HJ1H 6bIBwero B ynoTpe6J1eHI1H
npI160pa, nepeMellleHI1I1 npI160pa C O.llHOro MeCTa Ha .IIpyroe B npelleJ1a'\
npellnpI15ITI15I. OHa BbInOJ1H}leTC5I, Koma npI160p 1l0CTaBJ1eH K MeCT}
3KCnJ1yaTaUI1I1.

AHOJ1UmU'IeCKUe .MemO()bl
293
ATTeCTaUI15I YCTaHOBJIeHHOrO 060PYlloBaHI15I npOBO.llI1TC5I no HHCT-
PYKUHH I13roTOBI1TeJ15I I1J1I1 CTaHllapry. npI1 3TOM:
- npOBep5IeTC5I COOTBeTCTBI1e nOCTaBJ1eHHoro 060PYllOBaHI15I 3aKa3Y
H KOMnJ1eKTHOCTb nOCTaBKI1, BKJIIO'la5I 1l0KYMeHTaUI1IO;
- roTOBI1TC5I MeCTO llJ15I YCTaHOBKH 060PYllOBaHH5I (TO, 'lTO 060PYllO-
BaHI1e MO)J(eT 6bITb pa3MellleHO Ha Bbl.lleJ1eHHOM ll11H Hero MeCTe, llOJ1)J(HO
6bITb npOBepeHO npI1 ero 3aKa3e);
- npOBep5IeTC5I nO.llBO.ll He06xo.llI1MbIX KOMMYHI1KaUHH (3J1eKTpO-
3HepmH, BOllbI, C>KaToro B03llyxa 11 np.);
- 060PYllOBaHI1e pacnaKOBbIBaeTC5I, c06HpaeTC5I 11 YCTaHaBJ1HBaeTC5I
Ha npellHa3Ha'leHHOe ll11H Hero MeCTO B COOTBeTCTBHH C Tpe60BaHI15IMH
H3roToBHTeJ15I; 3aBOllCKYIO ynaKOBKY CJ1ellyeT COXpaH5ITb Ha CJ1Y'laH B03-
MO)J(HOro B03BpaTa. C60pKa H YCTaHOBKa BbInOJ1H5IIOTC5I npellCTaBI1TeJ15I-
MH 3aBOlla-H3roTOBI1TeJ15I, CneUHallH3I1pOBaHHoH opraHH3auHeH I1J1I1
n0J1b30BaTeJ1eM npI1 HallI1'lI1I1 He06xollHMOH nOllroToBKI1;
- opraHH3yeTC5I KOMnbIOTepHa5I ceTb HJ1I1 nOllKJIIO'leHI1e K KOMnbIOTe-
Py. DbIBalOT Hellopa3YMeHH5I. O.llI1H H3 3aKa3'l11 KOB, B35IBWI1Cb caM YCTa-
HOBHTb C'leT'lHK 'laCTHU B napeHTepallbHbIX paCTBopax, 06paTHJ1C5I C BO-
npOCOM, nOCKOJ1bKY nepCOHallbHbIH KOMnblOTep He BocnpHHHMall llaHHbIe
OT C'leT'lHKa. OKa3allOCb, 'lTO Ha KOMnblOTepe 6bIJIa HeJ1HueH3HOHHa5I
nporpaMMa. YCTaHOBKa J1HueH3HOHHOH nporpaMMbI CH5IJ1a np06J1eMY;
- npOBep5IeTC5I pa60TOcnoco6HOCTb 060PYllOBaHI15I Ha llaHHOH CTMHH
no HHCTpYKUI1I1 3aBOlla-H3roTOBHTeJ15I; llallbHei1wee .IIBH)J(eHHe B03MO)J(HO
TOJ1bKO B Cl1Y'lae, Koma npOBepKa no seeM nYHKTaM npOWJ1a ycneWHO.
npOTOKOJ1 aTTeCTaUI1I1 BKJIIO'laeT B ce65I:
- HaI1MeHOBaHHe opraHH3aUHH-n0J1b30BaTeJ15I. uexa, J1a60paTopHH;
- AaHHbIe 0 npI160pe (HaHMeHoBaHHe npH60pa. TI1n. HaI1MeHOBaHH5I
npe.llnpH5ITH5I-H3rOTOBHTeJ15I 11 nOCTaBlllHKa, cepHHHbIH HOMep, .llaTY BbI-
nYCKa, BepCHIO nporpaMMHoro 06eCne'leHI15I);
- aKT HJ1I1 llaHHbIe npOBepKH KOMnJ1eKTHOCTH npH60pa, BKJIIO'la5I
lloKyMeHTaUI1IO, onUHH, 3anaCHbIe 'laCTH 11 np. comaCHO cneUHHKaUI1I1
Ha nOCTaBKY 11 llaHHbIM 0 KOMnJ1eKTHOCTI1 no TeXHH'leCKOH 1l0KYMeHTa-
UHH H3roToBHTeJ15I;
- aKT I1J1H llaHHbIe 0 COOTBeTCTBHI1 MeCTa YCTaHOBKI1 Tpe60BaH1151 M,
o HallH'lI1I1 KOMMYHI1KaUI1H H np.;
- llaHHble 0 KallI16pOBKe (nOBepKe) npI160pa;
- .llary npOBelleHI15I aTTeCTaUHH, nO.llnI1CI1 I1CnOJ1HHTeJ1eH 11 PYKOBO-
llHTeJ15I, npOBepHBwero pa60TY.
11.7.3 ATTeCT31UUl 8 OCH3UJ,eHHOM COCTOJlHHH
ATTeCTaUI1H B OCHallleHHOM COCT05IHI1H (OQ) npOBO.llI1TC5I npH YCJ10-
BI1I1 ycnewHoro 3aBepWeHI1H aTTeCTaUI1I1 YCTaHOBJIeHHoro 060PYllOBaHI1H
(IQ). OHa MO>KeT nOJ1HOCTblO I1J1I1 'laCTI1'lHO COBMelllaTbCH C IQ I1CXOilH
113 KOHKpeTHOM 06CTaHOBKI1. B nepe'leHb pa60T MOfYT OXOllHTb npOBepKa

294
r11060 II
I1KCI1pOBaHHbIX (HeH3MeH5IeMbIX) napaMeTpOB npH60pa, npOrpaMMHoro
06eCne'leHI15I 11 YHKUI10HallbHble npOBepKI1. npOBOllI1TC5I no I1HCTPYK-
UI1H I13roTOBI1TeJ15I I1J1I1 CTaH.llapTY.
11.7.4 ATTeCT3u,HH B 3KcnJ]Y3T3u,HH
ATTeCTaUI15I B 3KCnJ1yaTaUI1I1 (PQ) npOBOllHTC5I npH YCJ10BHI1
ycnewHoro 3aBepWeHI15I IQ H OQ. OHa npellHa3Ha'leHa ll1151 nOllTBep-
)J(DeHI15I npaBHJ1bHOH pa60Tbi npI160pa B YCJ10BI15IX 3KCnJ1yaTaUI1I1. B CO-
CTaB pa60T MOrYT BXO.llHTb TeCTbI no nposepKe pa60Tocnoc06HOCTI1 C
I1Cn0J1b30BaHI1eM KOHTpOJ1bHbIX 06pa3uoB (System suitability tests), TeCTbI
no OQ, HO B paCWI1peHHOM llHana30He 11 np.
B llallbHeHWeM, npH 3KCnJ1yaTaUHH, npoBepKa pa60Tocnoc06HOCTI1
BbInOJ1H5IeTC5I no I1HCTpYKUHH H3rOTOBHTeJ1H C OnpeLleJ1eHHOH nepHOllH'l-
HOCTblO. B03MO)J(HbI pa3HbIe BapHaHTbI, HanpHMep, npoBepKa nepcll
Ka)J(DbIM HCn0J1b30BaHI1eM, eCJlH 3TO He06xOllHMO. n0J1b30BaTeJ1b 1l0Jl)J(eH
BeCTH apxHB llaHHbIX 0 npoBepKax pa60TOcnoc06HOCTH npH60pa 11 ero
pa60Te, KOTopbIe MOfYT CJ1Y)J(HTb OCHOBaHI1eM ll1151 nOllTBep)J(DeHH5I npa-
BHJ1bHOCTH OnpelleJ1eHI15I nepHOllH'lHOCTI1 npoBepoK.
Pe3YJ1bTaTbI aTTeCTaUI1I1 0OpMJ15IIOTC5I B BHlle npOTOKOJ1a.
11. 7.5 ATTeCT3u,IDI nporp3MMHOro o6eCne'leHUH {Software validation}
COrJ1aCHO USP ( 1058) cpellCTBa ynpaBJleHH5I aHallHTH'leCKHM npH60-
pOM pa3lleJ15IlOTCH Ha TPH rpynnbI:
- 6J10K ynpaBJ1eHI15I 11 KOHTpOJ15I (MI1KpOcxeMY) B COCTaBe npH60pa;
ee OTlleJ1bHaH aTTeCTaUI15I He Tpe6yeTC5I; aTTeCTaUI15I BbInOJ1H5IeTC5I npl1
npOBelleHHH aTTeCTaUI1I1 npI160pa;
- nporpaMMHoe 06eCne'leHHe no ynpaBJ1eHHIO pa60TOH npI160pa,
c60py H 06pa60TKe llaHHbIX; pa3pa6aTbIBaeTC5I CneUI1allbHO ll11H .llaHHoro
npI160pa 11 3arpY)J(aeTC5I B KOMnbIOTep, nOllKJIIO'laeMbIH K npI160py; OC-
HOBHbIe YHKUHH no ynpaBJ1eHHIO H KOHTpOJ11O cocpeAOTO'leHbI B 3TOl\I
nporpaMMHOM 06eCne'leHI1I1, OCTaBJ15I5I 3a npH60pOM nepBI1'lHbIH c60p II
06pa60TKY llaHHbIX; TaKI1M 06pa30M, npI160p 11 nporpaMMHoe 06ecne'lc-
HHe, YCTaHOBJ1eHHOe B aBTOHOMHOM KOMnblOTepe, B3aI1MOCB3aHbl, 11 I1X
COBMeCTHa5I pa60Ta nOll11e)J(I1T aTTeCTaUI1I1.
npI160p COBMeCTHO C nporpaMMHblM 06eCne'leHI1eM 1l0J1)J(CH 6bITh
HCnbITaH I13roTOBI1TeJ1eM (DQ). nOLlTBep)J(DeHI1e ycnewHoro npOXO)KJlC-
HI15I 3TI1X I1CnbIH\HI1H .llOJ1)1(HO BXO.llI1Tb B KOMnJ1eKT nOCTaBKI1 npI16opa.
.D.allee nOCJ1e YCT<\HOBKI1 npI160pa Ha MeCTe 3KCnJ1yaTaUI1I1 BbIn0J1H5ICTC1
aTTeCTaUI15I nporpaMMHoro 06CCne'lCHI15I B COCTaBe nYCKO-HIJ1an.O'lHbl'
pa6OT.
Hc063aTeJ1bHO OpMIJ1bHO npOXO.llI1Tb Bce 3Tanbl IQ-OQ-PQ. Ar-
TCCTaUI15I MO)l(CT 6bITb RbInOJ1HCHa B OllHH :nan. npOrpaMMa aTTcCTaUJIJI
npC.llOCTaBJlSICTOI 113roT00I1TCl1CM.

AHoJ1umU'1eCKUe MemoObl
295
OmOeJlbHOe npOi'paMMnOe 06eCllellenue
npHHUI1nbI aTTeCTaUI1I1 nporpaMMHoro 06eCne'leHI15I .llaHbI B PYKO-
BO.llCTBe FDA «General Principles of Software Validation: Final Guidance for
IndustlY and FDA Stoffi) [29]. OHO pacnpOCTpaH5IIOTC5I Ha OTlleJ1bHO pa6o-
TalOlllee nporpaMMHoe 06eCne'leHI1e, HanpI1Mep, LIMS (rJ1aBa 14, n.
14.10).
ArreCTaUI15I BbInOJ1H5IeTC5I pa3pa60T'lI1KoM nporpaMMHoro o6ecne'leHH5I.
11. 7.6 KOHTpOJlb H3MeHeHH"
npH 3KCnJ1yaTaUHH npH60poB B03MO)J(HO BHeceHHe H3MeHeHI1H I1J1H
BbInOJ1HeHHe peMOHTa (KoppeKTI1pOBOK), nOCJ1e 'lero npOBO.llI1TC5I npo-
BepKa pa60Tocnoc06HoCTH npH60pa C llOKYMeHTallbHbIM OOpMJ1eHHeM.
npI1 He06xOllI1MOCTH MO)J(eT nOTpe60BaTbC5I BbInOJ1HeHHe Bcero KOM-
nneKca pa60T no IQ-OQ-PQ.
11.7.7 ,lI,OKYMeHT31\1IJI
.lloKYMeHTaUH5I Ha npI160pbI, BKJIIO'la5I npOTOKOJIbI arreCTaUHH H
)J(ypHallbI TeXHH'leCKoro 06CJ1Y)J(HBaHH5I, 1l0JI)J(Ha xpaHHTbC5I B OllHOM
MeCTe C 06eCne'leHHeM coxpaHHOCTH H 3alllHTbI OT HeCaHKUI10HHpOBaH-
HOro BHeCeHI15I H3MeHeHHH.
.lloKYMeHTaUH5I llOJ1)J(Ha 6bITb ynOp5IllO'leHa, HCKJIIO'leHO nepenYTbI-
BaHI1e H YTep5I 1l0KYMeHTOB.
B llOKYMeHTaUHH Ha npH60pbI OllHOro TI1na MorYT 6bITb 06111I1e llO-
KYMeHTbI (HHCTPYKUI15I no 3KCnJ1yaTaUHI1) H HH.llI1BI1llYallbHbIe llOKYMeH-
TbI (npoTOKOJ1bI aTTeCTaUHH, CepTI1I1KaTbI KallH6pOBKH). 06111I1e H HH-
llHBHllYallbHbIe llOKYMeHTbI MOfYT 6bITb pa3lleJ1eHbI. Bo Bcex Cl1Y'la5IX
llOJ1)J(eH 6bITb 06eCne'leH 6bICTpbIH H 6e30WI160'lHbIti 1l0cTyn K 1l0KYMeH-
TaM J1I1U, I1MelOlllHX Ha TO npaBO.
11. 7.8 TeXHH'IeCKOe 06CJ1Y*HB3HHe
npOBOllHTC5I no I1HCTpYKUI1I1 H3roTOBI1TeJ15I H MO)J(eT BKJIIO'laTb B ce65I:
- nepHOllH'leCKYIO npOBepKY napaMeTpOB H HX peryJII1pOBKY, npH
He06xOllI1MOCTI1;
- npOBepKY pa60TOcnoc06HOCTI1;
- O'lHCTKY;
- KallH6pOBKY;
- nJ1aHOBYIO 3aMeHY C1>eMHbIX 'laCTeH H np.
OTBeTcTBeHHocTb 3a npaBI1J1bHOCTb pa60Tbi aHallHTH'leCKHX npH60-
POB HeceT n0J1b30BaTeJ1b.
Ha npellnpI15ITI1H llOJ1)J(HbI 6bITb rpaI1KI1 TeXHI1'leCKoro 06CJ1Y)J(I1-
BaHH5I 11 nepHOllI1'leCKOH 3aMeHbi C1>eMHbIX lJaCTeH, .llOroBOpbI Ha TeXHH-
'IeCKoe 06CJ1Y)J(I1BaHI1e H nOCTaBKY He06xOllI1MbIX MaTepHaJIOB 11 KOM-
nJ1e KTYlOlllHX.

296
FJ1060 II
11.8 K3TeropHu npH6opoB
nOllXOll K aTTeCTaUHH npH60poB I1HllI1BI1n.YalleH H 3aBI1CI1T OT I1X
CJ10)J(HOCTI1. 111151 npoCTeHwHx e.llI1HHU 06oPYlloBaHH5I MO)J(eT OKa3aTbC5I
1l0CTaTO'lHbIM orpaHI1'lI1TbC5I BI13YallbHbIM OCMOTpOM 11 OOpMJ1eHHeM He-
06XOllHMbIX 3anI1CeH (HaI1MeHOBaHHe npH60pa, CepI1HHbIH HOMep, llaTa
BBO.lla B 3KCnJ1yaTaUI11O 11 np.) 1l11H CJ10)J(HbIX npI160pOB MO)J(eT nOTpe6o-
BaTbC5I npOBe.lleHI1e Bcero KOMnJ1eKCa pa60T no BceM 3TanaM aTTeCTaUI1H.
USP BbIllell5IeT CJ1ellYlOlllI1e KaTeropI1H npH60poB no KpHTepHIO He-
06XOllI1MOCTH aTTeCTaUI1I1:
Fpynna A
BKJIIO'laeT CTaHllapTHoe 060PYlloBaHI1e 6e3 cPYHKUHH I13MepeHI15I
HJ1H KallH6pOBKH (HcnapHTeJ1I1 a30Ta, MarHHTHbIe MeWallKI1, ueHTpHY-
rI1). nposepKa pa60TbI TaKHX npI160pOB BbInOJ1HHeTC5I BH3YallbHO. Tex-
HH'leCKHe xapaKTepHCTI1KH npI160pa )J(eCTKO OnpelleJ1eHbI ero KOHCTPYK-
UHeH, aHallOfI1'lHbI Tpe60BaHH5IM n0J1b30BaTeJ15I 11 He llonYCKalOT llB05IKO-
ro TOJ1KOBaHH5I.
Fpynna B
B Hee BXOllHT CTaHllapTHoe KOHTp0J1bHO-I13MepHTeJ1bHOe 060PYllO-
BaHHe, KOTopoe Tpe6yeT nepHOllH'leCKOH KallH6pOBKH (nOBepKH). Tex-
HH'leCKI1e xapaKTepHCTHKH 3TI1X YCTPOHCTB OnpelleJ1eHbI KOHCTPYKUHeH.
K TaKHM npH60paM OTHOC5ITC5I BeCbI, OnTH'leCKHe MHKpOCKonbI, 06oPY-
llOBaHHe llJI5I OnpelleJ1eHH5I TO'lKH nJ1aBJ1eH, H5I pepaKTOMeTpbI, TepMO-
MeTpbl, BHCK03I1, MeTpbl a K 060PYllOBaHHIO - MyeJ1bHbIe ne'lH, X0J10-
llI1J1bHHKI1 11 MOp03HJ1bHHKH, BOll5IHbIe 6aHH, HaCOCbI, pa36aBHTeJ1I1 H np.
KallI16poBKa H aTTeCTaUH5I (npI1 He06xOllHMOCTH) npOBO.llI1TC5I no
HHCTPYKUHI1 H3roTOBI1TeJ15I.
Fpynna C
BKJIIO'laeT B ce65I aHallI1TI1'leCKHe npI160pbI 11 CHCTeMbI C KOMnblO-
TepHbIM ynpaBJ1eHHeM, npI1'leM Tpe60BaHH5I n0J1b30BaTeJ15I 5IBJl5IIOTC1
cneUHH'lHbIMH, HeCTaHllapTHbIMI1 11 BbInOJ1HeHHe I1X 1l0J1)J(HO nOllTBep-
)J(DaTbC5I aTTeCTaUI1eH llJIH Ka)J(DOro CJ1Y'la5I npI1MeHeHH5I. MeTOllI1Ka aT-
TeCTaUI1H 3TI1X npI160pOB pa3pa6aTbiBaeTC5I H3roToBHTeJ1eM 11 BXOllI1T B
KOMnJ1eKT nOCTaBKH npI160pa.
npI1MepbI:
- aTOMHbIe a6cop6UI10HHbIe cneKTpOMeTpbI;
- llHepeHUI1allbHbIe CKaHI1pYlOlllI1e KallOpI1MeTpbI;
- 3J1eKTpOHHbIe MHKpOCKonbl;
- Macc-cneKTpOMCTpbI;
- )J(I1llKOCTHble xpOMaTorpabl, pa60TalOlllI1e nOll BbICOKI1M .llaBJ1eHI1er.t;
- ra30Bbie xpOMaTorpabl 11 np.
nOl1blH nepelleHb npI1MepOB 113H B USP (1058).

297
fJlaBa 12
nEPCOHAJI
12.1 061l1.He nOJlO}KeHHH
npaBHJ1a GMP CO.llep)J(aT 'leTKI1e Tpe60BaHH5I K nepCOHallY, 3aH5I-
TOMY B np0I13BO.llCTBe, KOHTpOJ1e 11 06pallleHI1I1 J1eKapCTBeHHbIX cpellCTB.
3TI1 Tpe60BaHI15I KOHKpeTHbI H 5ICHbI, HO 'lT06bI 1l06HTbC5I HX BbI-
nOJ1HeHI15I Ha npaKTI1Ke, HY)J(HO npOBeCTI1 60JlbWYIO pa60TY no nOllro-
TOBKe, Bocn I1TaH 11 10, nOll60PY H paCCTaHOBKe KMpOB, HX nOCT05lHHOMY
KOHTpOJ11O 11 nOBbIweHHIO KBallHcf>HKauHH.
Ha npellnpH5ITHH pa60TalOT O'leHb pa3HbIe J11011H no cBoeH KYJ1bTY-
pe, OTHoweHHIO K .lleJ1Y, I1CnOJ1HI1TeJ1bHOCTI1, COCT05IHI11O 3110pOBb5I, KBa-
J1I1cf>I1KaUHI1, ypOBHIO 'lI1CTOnJ10THOCTH H MOTHBaUI1I1 K TPYllY. CJ10)J(HB-
WI1eC5I npI1BbI'lKI1, 06pa3 MbICJ1eH H cTepeoTHn nOBelleHI15I MOfYT npOTH-
BOpe'lI1Tb Tpe60BaHI15IM GMP.
3TI1 J11011H, HeCMOTp5I Ha Bce pa3J1H'l 1151 , llOJ1)J(HbI Ha npe.llnpH5ITI1I1
pa60TaTb CTPoro no HHCTPYKUH5IM, TO'lHO 11 aKKypaTHo, HeYKOCHHTeJ1bHO
BbInOJ1H5I5I CBOH 065I3aHHocTH.
Ll06I1TbC5I 3TOro TpYllHee, 'leM nOCTpOHTb HOBbIH 3aBOll. A ll06HTbC5I
HY)J(HO 065I3aTeJ1bHo. I1Ha'le J1106a5I HOBa5I TeXHHKa, 'lHCTbIe nOMellleHH5I
H J1Y'lWHe MaTep 11 all bI nponMYT 3p5l.
Ha J11060M npellnpI15ITI1I1 5IllpOM KOJ1J1eKTHBa 1l0J1)J(eH 6bITb 30J10TOH
cf>OHll COTPYllHI1KOB. 3TO cnOKOHHbIe 11 YBepeHHbIe npoeCCHOHallbI. no-
HHMalOlllI1e CBOIO J1H'lHYIO OTBeTCTBeHHOCTb 3a 6e30nacHocTb H Ka'leCTBO
npollYKUI1I1 11 BbICOKO UeH5IlllHe CBOIO 3Ha'lI1MOCTb B 06111eM lleJ1e.
BOKPyr 3TI1X J11011eH cf>opMHPyeTC5I KOJ1J1eKTHB, H paCTYT M0J10llbIe
KMPbI.
npoeCCHOHallbHa51 roPllOCTb H 'leCTb - 3TO He BbIllYMKI1 C afHT-
nJ1aKaTOB. 3TO nOTpe6HOCTb HOpMallbHOro 'leJ10BeKa 6bITb BOCTpe60BaH-
HbIM B 06111eCTBe, nOTpe6HOCTb B OC03HaHHOM, n0J1e3HOM KBallHI1UI1-
pOBaHHOM TpYlle.
Ho 3TOT ypOBeHb nOCTI1raeTC5I He cpa3Y 11 He BCeMI1. <DopMl1pOBaHI1e
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TeXH0J10fHI1 np0I13BOllCTBa. Tpe60BaHH5I K nepCOHallY pemaMeHTHpYlOTC5I
npaBHJ1aMH G M P H lleTallH3HpYlOTC5I B CTaHllapTax Ha 'lHCTbIe nOMellle-
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299
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J10 16.30.
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y60PlllI1U, a 113MeHeHI1eM <j)OpMbI rpa<j)I1Ka, B KOTOpoM DJI51 K3)I(J10ro J1HH
HHO 6bl110 npeJ1YCMOTpeTb llBe CTpoKI1: DJIH YTpeHHeH 11 Be'JepHeH y60poK.
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6blTb y6paHbI nOJ1 BOpoTHI1K KOCTIOMa. Clle.llyeT HOCI1Tb MacKY, 'JT06bl
npeJ10TBpaTI1Tb pacnpoCTpaHeHl1e Kanel1b, CTepl111, bHble HeonYJ1peHHbIe pe-
311HOBbie I1JII1 nOl1l1MepHble nep'JaTKI1 11 CTepl1JlbHble (11JI11 J1e3I1H<j)I1Ul1pO-
BaHHble) 6aXI111bI. HI1)1(HHH 'JaCTb WTaHI1H .llOl1)1(Ha 6blTb 3anpaBlleHa BHYTPb
6axl1JI, a pYKaBa O.D.e)l(1Ibl - B nep'JaTKI1. 3allll1THa51 OJ1e)l(1Ia He .D.Ol1)1(Ha Bbl-
J1el151Tb B0110KOH 111111 'JaCTI1U 11 J10ll)l(Ha YJ1ep)l(I1BaTb 'JaCTI1UbI, OT.llel151I0111l1e-
CH OT Tel1a.
n. 44 HapHa51 OJ1e)l(Jla He J1011)1(Ha nonanaTb B KOMHaTbl DJIR nepeo-
J1eBaHI1H, BeJ1Yllll1e B 30Hbl B 11 C. K3)I(J1blH pa60THI1K B 30Hax A 11 B J1011-
)l(eH 6blTb 06ecne'JeH 'JI1CTOH CTepl111bHoi1 oJ1e)l(Jlol1 (cTepl1111130BaHH0I1 111111
npoweJ1wel1 He06xoJ1I1MYIO 06pa60TKY) Ha K3)I(J1YlO CMeHY. Bo BpeMH pa60-
Tbl nep'JaTKI1 ClleJ1yeT peryl151pHo J1e3I1H<j)I1Ul1poBaTb. MacKI1 11 nep'JaTKI1
Cl1eJ1yeT MeH5ITb, no KpaHHeH Mepe. K3)I(J1YlO CMeHY.
llodzom06Ka odeJICObi
CJ1ellyeT npellycMOTpeTb nOp5IllOK 06pa60TKH Olle)J(DbI (CTHpKH, lle3-
HHQ:>eKUHH, CTepHJ1H3aUHI1). 3TO MO)J(eT 6bITb ClleJ1aHO llBYMH nYT5IMI1:
- opraHH3aUI1eH c06CTBeHHoH npa'le'lHOH (Y'laCTKa nOllroTOBKI1
Olle)J(DbI) I1J1 11
- 3aKJIIO'leHHeM 1l0roBopa co CTopoHHeH OpraHI13aUHeH Ha npello-
CTaBJ1eHI1e 3TOro BI111a YCJ1Yr.
B 060I1x CJlY'laHX npa'le'lHa5I llOJ1)J(Ha COOTBeTCTBOBaTb cBoeMY Ha3Ha-
'leHI1IO. ECJ1I1 npe.llycMoTpeHa 06pa6oTKa Olle)J(DbI llJl5I 'lI1CTbIX nOMellleHI1H,
TO B npa'le'lHOHllOJ1)J(Hbl 6bITb nOMellleHI15I 11 30HbI Tpe6yeMoro KJIaCCa 'lH-
CTOTbI, a TeXH0J10fI15I pa60T, COCTaB 060PYllOBaHI15I 11 nJ1aHI1pOBO'lHbIe pe-
WeHH5I .llOJ1)J(HbI 06eCne'lI1BaTb BbInOJ1HeHHe Bcex YCJ10BI1H.
C0311aHI1e npa'le'lHOHllOJ1)J(HO npellYCMaTpI1BaTbC5I npoeKTOM pa3BH-
TH5I npellnpI15ITH5I, J1I160 CJIellyeT pa3pa6aTbIBaTb OTlleJ1bHbIH He60JIbWOH
npoeKT. TI1nI1'lHbIMI1 HellOCTaTKaMI1 TaKI1X npoeKToB 5IBJ15IeTC5I HeHY)J(Hoe
YCJ1o)J(HeHHe H Yllopo)J(aHI1e, JII160 OTCYTcTBI1e B HI1X OTlleJlbHbIX B3)J(HbIX
3JIeMeHTOB.

318
[;WtlO 12
ECJ1I1 06pa60TKa O.lle)J(DbI OpraHI13yeTC5I no 1l0roBOpy. TO HY)J(HO
y6e.llHTbC5I, lITO I1CnOJ1HHTeJ1b 06J1allaeT Tpe6yeMoH npa'leIIHOH, KaK no ee
YPOBHIO, TaK H MOlllHOCTH.
3TO .llOJ1)J(eH npOBepHTb I1HCneKTOp (aYllI1TOp), OueHI1BalOlllHH pa60-
TY npen.npH5ITI1H.
DbIBaeT, lITO 1l0rOBOp Ha CTHPKY H lle3I1HeKUHIO (CTepHJ1H3aUHIO)
3aKJIIO'laeTC5I HKTI1BHO. !lOroBOP eCTb, HO llBI1)J(eHI1H O.lle)J(DbI ll1151 06-
pa60TKI1 HeT, J1I160 OHO npOI1CXOllHT B 3Ha I II1TeJ1bHO MeHbweM 061>eMe,
'leM HY)J(HO. 3TO J1erKO YBH.lleTb, npoBepHB aKTI1'lecKYIO onJ1aTY YCJ1yr
CTopoHHeH OpraHI13aUI1I1 11 llBI1)J(eHI1e Olle)J(LlbI B COOTBeTCTBI1I1 C He06-
XO.llHMbIM 061>eMOM pa60T.
B HaCT05Illlee BpeM5I Ha npellnpI15ITH5IX POCCI1I1, KaK npaBI1J10, co-
3.llalOTC5I CBOI1 npalIe'lHbIe HJ1I1 MI1HHnpa'le'lHbIe, 3aHI1MalOlllI1e ll1151 Ma-
J1bIX npoH3BollCTB 6YKBallbHO lleC5ITOK-.llPyroH KBMpaTHbIx MeTpOB nJ1O-
lllallH.
Ha 3anMe npellnpHHTH5I npI16eralOT npeHMYllleCTBeHHo K YCJ1yraM
OTlleJ1bHbIX CneUI1allH3I1pOBaHHbIX npa'lelIHblx ll1151 'lI1CTbIX nOMellleHI1H.
MHome H3 HHX He TOJ1bKO BbInOJ1H5IIOT 06pa60TKY Olle)J(DbI, HO H npellO-
CTaBJ15IIOT ee n0J1b30BaTeJ11O HanpOKaT, 6ep5I Ha ce65I BeCb UHKJI 06ecne-
'leHI15I Olle)J(DOH.
12.9 CocTOslHue 3,l1,OpOBbSi
11 I1ua, pa60TalOlllHe Ha npOH3BOllCTBe J1eKapCTBeHHbIX cpellCTB,
llOJ1)J(Hbl 6bITb 3ll0pOBbI.
ComaCHO rOCT P 52249-2009 (n. 2.14) Bce npI1HI1MaeMbIe Ha pa-
60TY J1I1ua llOJ1)J(Hbl npoxollHTb MellI1UI1HCKI1H OCMOTp. Ha npellnpI15IHlII
llOJ1)J(Hbl 6bITb HHCTPYKUI1I1 C nepe'lHeM nOKa3aTeJ1eH COCT05IHI15I 3110pO-
Bb5I, KOTopble MOrYT OKa3aTb BJ1I15IHHe Ha Ka'leCTBO npollYKUHI1. B cJ1Y'la-
5IX, CBmaHHblX C npOH3BOllCTBeHHOH He06xOllHMOCTbIO HJ1H COCTmlHMel\1
3ll0pOBb5I, COTPYllHHKH 1l0J1)J(HbI npoxollHTb nOBTopHbIH MellI1UHHCKMii
OCMOTp.
11I1ua C I1HeKUI10HHbIMI1 3a60J1eBaHI1}IMI1 11 nOl3pe)J(DeHI15IMI1 Ha
OTKpbITblX Y'laCTKaX TeJ1a He .llOnYCKalOTC5I K npOI1JBOllCTBY J1eKapCTBeH-
HbIX Cpe.llCTB. n0J10CTb pTa 1l0J1)J(Ha 6blTb CaHI1pOBaHa.
Oc06bIe Tpe60BaHI15I npe.ll1>5IBJ15IIOTC5I K COCT05IHI11O 3110POBM( .1IIli.
pa60TalOlllI1X B lfucmbLX nOMeenuRX. KaweJ1b, III1XaHI1C, BbllleJ1eHI1}1 H 3
Hoca 11 ma3 pe3KO BJ1I15IIOT Ha ypOBeHb 'lI1CTOTbI. KO)J(a .llOJ1)J(Ha 6b1Tb
3110pOBOH. 11I1ua C repneCOM 11 YPYHKYJ1aMI1, CTpallalOlllI1C ce60pecii
(nepXOTblO) 11 aHallOrJ1lIHbIMI1 1a60J1eBaHI1}IMI1 K pa60Te B lJI1CTbIX nOI\1C-
WeHI1}(X He .llOnYCKaIOTC5I. nOllp06Hee Tpe60oaHI1I K 3.ll0pOBbIO llaHbI B
KHI1re «LJHcTbIe nOMelllCHH5I') L 12].

319
fJIaBa 13
06YQEHHE nEPCOHAJIA
KaK H Ha J11060M npellnpH5ITHH, nepCOHall, 3aH5ITbIH B npOH3BOll-
CTBe J1eKapCTBeHHbIX cpellCTB, 1l0J1)J(eH I1MeTb He06xOllI1MYIO npocf:>eccHo-
HallbHYIO nOllroToBKY. Ho npaBHJ1a G M P npellD5IBJ15IIOT CneUI1allbHbIe
Tpe60BaHI15I, CB5I3aHHbie C oc06ennocmRMu npou360dcmea .IleKapCm6ennbLX
cpedcm6, paCCMaTpHBa5I ero KaK UCK.IllOltUme.llbnO om6emcm6eHnblii pO.ll
lle5ITeJ1 bHOCTH.
npH OpraHI13aUHH 06YIIeHI15I B03HI1KaeT HeCKOJ1bKO BonpOCOB:
- KOro Y'lI1Tb,
- 'leMY Y'lHTb,
- file YlJHTb,
- KTO MO)J(eT I1J1H 1l0J1)J(eH Y'lI1Tb,
- KaK Y'lHTb,
- C nOMOlllblO 'lero Y'lI1Tb.
13.1 Koro H IJeMY HYJKHO Y'lHTh?
Y'lI1Tb HY)J(HO Bcex: PYKoBOllI1TeJ1eH, cneUI1allI1CTOB H pa60'lHX, npH-
'leM He TOJ1bKO TeOpeTI1'leCKI1, HO 11 Ha npaKTI1Ke, H3YlJa5I onbIT llPymx
npe.llnpI15ITI1H.
I1CXOll5I H3 3TOro, HY)J(HO CTpOHTb nporpaMMY 06Y'leHH5I.
06Yllenue PYK060dume.lleii npednpUJImuii
MHome llI1peKTOpa llYMaIOT, 'lTO OHH Bce 3HaIOT. Koe-KTo BepI1T,
'lTO OH - HCTHHa B nOCJ1ellHeH I1HCTaHUI1I1. 3TO TpYllHa51 K<neropI1H. 11H-
peKTOPY pellKO KTO MO)KeT YKa3aTb Ha npo6eJlbl B 3HaHHIX, a TO 11 Ha
6e3rpaMOTHOCTb.
Ho HMeHHO .llI1peKTOp npI1HI1MaeT peWeHI15I 11 onpe.lleJ15IeT CYllb6y
npe.llnpI15ITH5I. Ka)J(DbIH llI1peKTOp I1MeeT c06CTBeHHoe npe.n.CTaBJleHHe 0
TOM, KaK pa3BHBaTb npOH3BO.llCTBO 11 'lTO TaKoe GMP. npellCTaBJ1eHHe
3TO Y MHOrI1X pa3Hoe 11 3a'laCTYIO I1CKa)KeHHoe.
OHO HMeeT nOll co60H OCHOBY. B CTpaHe, me npOUBeTaeT cf:>allbCI1-
ct:>HKaUI15I, file MHOro pa3roBopoB 11 3a5IBJleHI1H, HO MallO AeJ1a, file npa-
BI1J1a np0I13BO.llCTBa J1eKapCTBeHHbIX cpellCTB HOC5IT He06l3aTeJ1bHbIH xa-
paKTep (Ha HalI<UlO 2012 r.), a I1MelOlllI1HC5I peKOMeH.llaTeJlbHbIH 1l0KY-
MeHT no GMP - fOCT P 52249 6bIJ1 npI1H5IT nOCJ1e MHoroJleTHI1X 60CI3,
MHome l3ep5IT, lITO pa60TbI B YC110Bl'UIX xaoca Ha I1X neK XBaTI1T.

320
[,1060 13
ECJ1I1 PYKOBOllI1TeJ1b I1MeeT TaKYIO TO'lKY 3peHH5I, ll<UlbHeHWHH pa3-
roBOp MO)J(HO He BeCTI1. Pa3roBop I1MeeT CMbICJ1 TaM, file PYKOBOllHTeJ1b
nOHHMaeT, 'lTO xaoc 11 allbCI1I1KaUH5I - lleJ10 HeHOpMallbHOe H HX
HY)J(HO npeO.llOJ1eTb, 'lTO pa60TaTb Cl1e.llyeT TOJ1bKO UI1BI1J1I130BaHHO, a
3Ha'lHT no nepe.llOBblM HopMaM.
OnbIT roBOpI1T, 'lTO MepI1J10M nepcneKTHBHOCTI1 npellnpH}ITH5I 5IBJ15I-
eTC5I ero opuenmau.UR na pacwupenue npou360dcmea, na npuopumem Ka-
lIecm6a u 6bLXod na 3apy6eJICnbie pbIHKU. 3T0 nOllTBep)J(DaeTC5I MI1pOBOH
npaKTI1KOH.
LI.n5I nOBbIWeHH}I KBallI1I1KaUI1I1 PYKOBO.llHTeJ1eH npellnpI1HTI1M MO-
)J(eT 6bITb npellJ10)J(eHa CJ1en.YlOllla5I nporpaMMa:
npOfPAMMA
nOBbllUeHlUI KB3JlH4>HK3U,HH PYKOBOAHTeJleii BblClUero 3BeU3
(npHMep)
N! TeMa KOl1-BO 'JaCOB
I COBpeMeHHblH pblHOK l1eKapCTBeHHblX CpeJ1CTB. 1-2
COCTOHHl1e 11 nepCneKTI1BbI
2 n paBI111a G M P 1-2
D.pyme HopMamBHble J10KYMeHTbI. <t>apMaKOne51
3 CI1CTeMbI 06ecne4eHI1H Ka'JeCTBa. 1-2
Pa3JII1'Jl1e Me)l(llY npaBI111aMI1 G M P 11 CTaHJ1aPTaMI1
cepl1l1 I1ca 9000.
apraH113aU110HHO- TeXH0110rn'leCKa51 J10KYMeHTaUI151.
4 nOJ1roToBKa npoI13BOJ1CTBa. 1-2
npOeKTl1poBaHl1e. HOBoe CTpol1Tel1bCTBO 11
peKOHCTpYKUI1H (nepenJlaHl1pOBKa).
npaBI111bHaH TeXHOl1omH - OCHOBa np0l13BOllCTBa no
GMP.
5 411cTbie nOMCllleHI1H: 1-2
- 0611acTb npl1MeHeHI1H;
- OCHOBHble Tpe60BaHI1H:
- npOeKTl1pOBaHl1e, MOHTa)l( 11 3Kcnl1yaTaUI1H.
6 ATTeCTaUI1H (I1CnbITaHI151) npoueCCOB 11 060pYJ10BaHI1H 1-2
7 AYJ1I1T 11 I1HCneKTl1poBaHl1e np0I13B0J1CTB 33 py6e)l(oM 1-2
8 a6MeH MHeHmlMI1 1-2
Bce ro 8-16
3TO n0J1e3HO H He06xOllI1MO He TOJ1bKO PYKOBO.llI1TeJ1HM. 3TO Hy)((HO
c06CTBeHHHKaM 11 I1HBeCTopaM. 11M HHO 3HaTb OCHOBbl COBpeMeHHl>IX
Tpe60BaHI1H 11 MeTO.llbI I1X peallI13aUHH, I1MeTb npe.llCTaBJIeHI1e 0 1'03-
MO)J(HbIX TPY.llHOCT5IX 11 HeO)((I1.llaHHOCT5IX.
nporpaMMa MO)((eT 6bITb pa36I1Ta Ha HeCKOJ1bKO llHeH, nOCKOJ1l>KY
I1HOpMaUI1I1 B KOHUeHTpI1pOBaHHOH opMe MHOro. fJ1aBHOe - CJ1ywa-
TeJlI1 He 1l0J1)1(Hbl nponycK,Ub 3aHlnIH, KaK 6bI :no HI1 6bl110 TPYDHO.
DblBaIOT KYPbC3bl.

06YlfeHue nepCOHOJ1O
321
npHMep
Ha 0J1H0I-1 113 KOH<j)epeHUI1H J1l1peKTOp HOBOH He6011bWOH <j)l1pMbl
(6aHKOBCKI1H pa60THI1K B npoUIJlOM) 6oHKO J10KJIaJIblBaJI, 'JTO «)I(el1e3KI1 -
3TO epYHJ1a, rnaBHOe - YMeTb npoJ1BI1HYTb npoll.YKU111O Ha pblHKe, a Bce 3TH
G M P - HeHY)I(Ha51 J1aHb, KOTOpylO npeJ1npl151TI1H J1011)1(Hbl nl1aTI1Tb').
aH nOKa3aJI <j)OTOrpa<j)111O cBoero np0I13B0J1CTBa: y onepaTOpa, pa60-
TalOlllero C l1aMI1HapHblM WKa<j)OM, CaHTI1MeTpoB Ha J1BaJIuaTb BblrnHJ1blBaJII1
pYKaBa WepCT5IHoro CBI1Tepa. KOMMeHTapl1l1, KaK roBOpI1TC5I, 113lll1WHI1.
3TO np0l13BOll.CTBO MO)l(eT CYllleCTBOBaTb TOllbKO 6llaroJ1ap51 TOMY, 'JTO B
CTpaHe OTCYTCTByeT I1HCneKUI151 no GMP.
Lla, lleHCTBHTeJ1bHO, YMeTb npOllaTb npOllYKUHIO - Ba)J(HOe lleJ10, PMI1
KOTOpOro npellnpI1HHMaTeJlb 3aH5IJ1C5I np0I13BOllCTBOM. OHO Tpe6yeT HaXOll-
'lI1BOCTI1, mepfI1I1 H cBoe06pa3Horo TallaHTa. Ho 3TO - lleJ10 1l06pOB0J1b-
HOe. npellnpI1HI1MaTeJl5I HI1KTO He npHHY)J(DaeT BbmYCKaTb J1eKapCTBeHHbIe
cpellCTBa. A BOT opraHH30BaTb npOH3BOllCTBO HallJIe)J(alllHM 06pa30M - ero
065I3aHHOCTb. 3T0 TO YCJ10BHe, KOTopoe npellnpHHHMaTeJ1b 1l0J1)J(eH BbI-
nOJlHHTb, eCJ1H OH XO'leT 3aHHMaTbC5I llaHHbIM BI1ll0M lle5ITeJ1bHOCTH.
DOJ1bWHHCTBO PYKOBOllHTeJ1eH llYMaIOT, 'lTO maBHoe - npOllaTb
npOllYKUI11O Ha BHYTpeHHeM pbIHKe. B CTpaHe, file HeT 065I3aTeJ1bHbIX
npaBHJ1 GMP, 3aHHMaTbC5I HMI1 cepbe3HO He CTOHT.
Ho )J(H3Hb MeH5IeTC5I. CerOllH5I B POCCI1H MO)J(HO npOllaTb 'lTO yroll-
HO. 3aBTpa - 6YlleT HeJ1b35I. Cnpoc 3a Py6e)J(oM Ha npOllYKUHIO npeLl-
npI15ITI15I Bcema 6bIJ1 nOKa3aTeJleM ero pa60TbI. npe.llnpH5ITHe, He CTpe-
M5IWeeC5I BbIHTH Ha 3apy6e)J(HblH pbIHOK, 6ecnepcneKTHBHO.
npHMep
B npoW110M DJI51 np0I13B0J1CTB l1eKapCTBeHHblX cpeJ1CTB B OD.HOH 113
a311aTCKI1X CTpaH 6bIJIl1 xapaKTepHbl:
- HI13KI1H ypOBeHb,
- nOli Hoe npeHe6pe)l(eHI1e Me)l(JlYHapOJ1HbIMI1 npaBI111aMI1.
CTpaHa, D.eHCTBI1Tel1bHO, 6e3 3a3peHI1H COBeCTI1 KOnl1pOBaJla 'JY)l(l1e
pa3pa60TKI1, HI1KOMY He nl1aTI111a 3a naTeHTbI. 3a 3TO eH rp03111111:
- 3To HexopOlllO, Mbl Bac HaK8)I(eM - He nYCTI1M Ha CBOI1, UI1BI111I130-
BaHHble pblHKI1.
aTBeT 3BY'JaJI npl1MepHO TaK:
- 11 He HanO. Mbl npo)l(l1BeM 11 6e3 Bawl1x pbIHKOB.
aHa BOBCIO, B MaCCOBOM MacwTa6e, np0I13B0J1I111a He3aKOHHO CKOnl1-
pOBaHHbie l1eKapcTBeHHble CpeJ1CTBa. 11 npoJ1aBaJIa y ce651 11 B cTpaHax Tpe-
Tbero Ml1pa, me HI1KTO He CnpaWI1BaJI 0 naTeHTax 11 CepTI1<j)I1KaTax. 3anan C
3TI1M HI1'Jero nOJ1el1aTb He MOr. He Mor J10 TOH nopbl, nOKa npeD.npI1HI1Ma-
Tel1l1 He nepeWl1l1 Ha Cl1eJ1YlOlllYIO CTaJIl1lO pa3BI1TI151, He nOHHJll1, 'JTO 11M
BblroJ1HO npOJ1aBaTb npOlIYKUl11O Ha 3anan, B TOM 'II1CJIe B AMepI1KY.
llodzom06Ka PYK0600ume.lleii cpednezo 36ena U cneu,UQ./lUCm06
3TI1 pa60THI1KI1 .llOJ1)J(HbI I1MeTb 06111I1e, HO 1l0CTaTOIIHO WI1pOKI1e
3HaHI15I no GMP, 11 DeTaJ1bHble, my60KI1e 3HaHI15I no npOI1J11O cBoeH
lle}ITel1 bHOCTI1.

322
[;1060 13
I1x nO.llroToBKY ueJ1eC006pa3HO opraHH30BaTb no llBYXYPOBHeBOH
CHCTeMe.
llepeblii ypoeenb - o6uii KYpC
EllI1HbIH 06111I1H KYpC HY)J(HO npOHTI1 BceM, nOCKOJ1bKY OCHOBHble
BonpOCbl opraHH3aUI1I1 np0I13BO.llCTBa, pa60TbI KOHTpOJ1bHbIX J1a60paTO-
PHH, oc06eHHOCTI1 CI1CTeM BeHTI1J1HUHH H KOHllI1UI10HI1pOBaHI1I 11 T. ll.
HHTepeCHbI BceM.
MbI B Te'leHI1e 20 J1eT npOBO.llHM 3TO 06Y'leHHe KaK B MocKBe, TaK 11
C BbIe3110M Ha npellnpH5ITH5I. D.BYX-TpeX.llHeBHbIH ceMHHap Ha npennpI15I-
THH C 065I3aTeJ1bHbIM OTpbIBOM OT npOH3BOllCTBa PYKoBollHTeJ1eH 11 cneUH-
allHCTOB llaeT nOJ1HOTY OXBaTa 11 Ha 3TOH OCHOBe n03B0J15IeT nOCTpOHTb
HJ1I1 pa3BHTb c06CTBeHHYJO CI1CTeMY 06Y'leHH5I.
npOfPAMMA
o6rn,ero KYPC3 nOArOTOBKH no GMP )I,JUI PYKoBOAHTeJleH H CneQH3JlHCTOB
(npHMep)
TeMa KOll-BO
'JaCOB
nepBblH COBpeMeHHblH pbIHOK l1eKapCTBeHHblX CpeJ1CTB. 24
)),eHb HOBbIe TeXH0110rl111 np0I13B0J1CTBa 11 ynaKOBKI1. TeHJ1eH-
UI1I1 pa3BI1TI1H.
npaBI1J1a G M P. I1CTOpl151, COCT05IHl1e, nepCneKTI1BbI.
CI1CTeMa HOpMaTI1BHblX J10KYMeHTOB no npOI13BOJ1CTBY 2'J
l1eKapCTBeHHblX CpeJ1CTB.
faCT P 52249 «npaBI111a np0I13BOJ1CTBa 11 KOHTpol1H Ka-
'JeCTBa l1eKapCTBeHHblX CpeJ1CTB') (GMP EC).
apraHl13aUI151 np0I13B0J1CTBa l1eKapcTBeHHblX CpellCTB B
COOTBeTCTBl111 C Tpe60BaHI1HMI1 G M P.
CTpYKTypa npaBI111 GMP.
Me)l(JlYHapO.llHbie OpmH113aUI1I1.
CI1CTeMa 06ecne'JeHI1SI Ka'JeCTBa. 2 'I
Pa3lll1'Jl1e Me)l(Jly G M P 11 CTaHJ1apTaMI1 I1ca 9000.
faCT P 52537 «np0I13BOlICTBO l1eKapCTBeHHblX CpeJ1CTB.
CI1CTeMa o6ecne'JeHI151 Ka'JeCTBa. a6111l1e Tpe60BaHI1H')
AHaJlI13 pI1CKOB.
D,oKYMeHTaUI1H B COOTBeTCTBl111 C Tpe60BaHI1HMI1 GMP.
I1H<j)opMaUI151 0 npeJ1npI1Hml1. CneUI1<j)I1KaUI1I1, perl1a-
MeHTbl. I1HCTPYKUI1I1. npoTOKOl1bl Cepl1H.
Tl1noBble <j)OpMbl 11 npl1Mepbl 3anOl1HeHI1H.
faCT P 52550 «np0I13B0J1CTBO lleKapCTBeHHblX CpeJ1CTB.
apraHI13aUI10HHO- TeXHOl1om'JeCKaH J10KYMeHTaUI1H».
411CTbie nOMellleHI11. OCHOBHble nOmITI1H 2 'I
KOMnl1eKc CTaHJ1apTOO fOCT P MCO 14644.
KnaCCI1<j)I1KaUI151 'JI1CTbIX nOMeweHI1i1.
Tpc6oBaHI151 K 'JI1CTbIM nOMeWeHI1HM npl1 npOI13BOJ1CTBC
l1eKapCTBeHHblX cpellCTB.

06"V'feHUe nepCOHOJlG
323
BTOpOH npl1HUl1nbl nOCTpOeHI151 1ll1CTbiX nOMellleHI1H. 2 'J
.aeHb CI1CTeMbl BCHTI111HUI1I1 11 KOHJ1I1UI10Hl1pOBaHI11.
<1>l1llbTpbl O'JI1CTKI1 B03J1yxa.
113011l1pY101ll11e CI1CTeMbl.
nOBeneHl1e nepCOHaJla B 'JI1CTbIX nOMellleHI1HX.
nOJ1roToBKa npoI13B0J1CTBa l1eKapCTBeHHblX CpeJ1CTB. 2'J
npOeKTl1pOBaHl1e np0I13B0J1CTB. HOBOe CTpOI1Tel1bCTBO.
PeKoHcTPYKUI151. nepennaHl1poBKa.
npl1HUl1nl1aJ1bHble peWeHI1H (KoHUenUI1H) npoeKTa. Co-
CTaB 11 3Tanbl pa3pa60TKI1 npoeKTa.
TexHol1orWleCKI1H pa3J1el1 - OCHOBa npoeKTa.
nOTOKI1 nepCOHaJla, MaTepl1aJ10B, roTOBOH nPOJ1YKUI111.
aC06eHHOCTI1 npoI13B0J1CTB HCCTCpl111bHbIX <j)OpM. 2'J
faCT P 52896 «np0I13B0J1CTBO l1CKapCTBeHHblX cpenCTB.
TeXHOllOrH'JeCKoe 060PYJ10BaHl1e DJI51 npol13BO.llCTBa
TBepJ1blX l1eKapCTBeHHblX <j)OpM. a6111l1e Tpe60BaHI151'),
aC06eHHOCm npoI13B0J1CTB CTCpl111bHbiX <j)OpM.
nOJ1roTOBKa nepCOHaJla. 2'J
aJ1e)l(Jla. nOpHJ10K nepeOJ1eBaHml. npa'le'JHbIe.
TpeTHH nOJ1roTOBKa BOJ1bl. 2'J
.aeHb KOHTpol1bHble l1a60paTOpl1l1.
Tpe60BaHI151 K nepCOHaJlY. 2'J
a6Y'JeHl1e nepcOHaJla.
3Kcnl1yaTaul151 'JI1CTbIX nOMellleHI1H.
Y60pKa 11 J1e3I1H<j)eKUI151 'JI1CTbIX nOMellleHI1H.
ATTeCTaUI151 (I1CnbITaHI151) npoueCCOB 11 o60pynoBaHI151. 2'J
I1HcneKTl1pOBaHl1e, aynl1T 11 CepTI1<j)I1KaUI151 npOI13BOJ1CTO
l1eKapCTBeHHblX Cpe.llCTB
Tl1nl1'JHble 3aMe'JaHI151.
AY.llI1T 11 I1HCneKTl1poBaHl1e npol13BOnCTB B POCCI1I1 11 3a
py6e)l(oM
ATTeCTaUI151 'JI1CTbIX nOMelllCHI1H. 2'J
KOHTpol1b napaMeTpOB 'JI1CTbIX nOMellleHI1H.
C'leT I Il1KI1 'laCTI1U B B03J1yxe 11 )l(11J1KOCTHX.
a6MeH MHeHI1HMI1.
Kompo.JIbHble BOnpOCbl.
Bmopoii yp06enb - cneu,UQ./lU3au,UJI
nOMHMO 06111ero Kypca ueJ1eC006pa3HO nOBbIwaTb KBaJ1I1I1KaUHIO
B COOTBeTCTBHI1 co CBOI1M npOI1J1eM Ae5ITeJ1bHOCTH. 3a py6e)J(OM
ClIO)J(HJ1aCb CI1CTeMa npOBe.lleHI15I CeMI1HapOB no TeMaM:
npoeKTHpOBaHI1e, CTpOHTeJ1bCTBO H BBOll B 3KCnJ1yaTaUHIO
npOH3BO.llCTB;
- npOH3BOllCTBO CTepI1J1bHbIX J1eKapCTBeHHbIX cpellCTB;
- np0I13BO.llCTBO TBep.ll,bIX OPM;
- CI1CTeMbl BCHTI1J15IUHI1 H KOHllI1UHOHHpOBaHH5I B03llyxa;
- nOllroToBKa BOllbI,
- aTTeCTaUI1H (I1CnbITaHH5I) npoucCCOB H 060pY.llOBaHI15I,

324
[;1060 13
- pa60Ta KOHTpOJ1bHbIX J1a60paTOpHH;
- aneCTaUH5I aHallI1TI1'leCKI1X MeTO.llOB;
- Be.lleHI1e 1l0KYMeHTaUHH B 3J1eKTpOHHOH OpMe H MHoroe llpyroe.
llodzom061(Q HenOCpedCmeeHHbLX ucno.llnume.lleii
OnepaTOpbI, annapaT'lHKI1, pa60THI1KI1 KOHTpOJ1bHbIX J1a60paTOpI1H,
nepCOHall, 3aH5ITbIH TeXHH'leCKI1M 06CJ1Y)J(HBaHHeM 11 peMOHTOM, pa60T-
HHKI1 BCnOMOraTeJ1bHbIX CJ1Y)J(6 - BCe OHI1 1l0J1)J(HbI 3HaTb CBOIO npoec-
CHIO, YMeTb BbInOJ1H5ITb CBOIO pa60TY, 3HaTb H BbInOJ1H5ITb Tpe60BaHI15I
GMP.
B CB5I3H C 3THM nOllroToBKa HenOCpellCTBeHHbIX HCnOJ1HI1TeJ1eH
1l0J1)J(Ha npOBOllI1TbC5I B CJ1ellYlOllll1X HanpaBJ1eHH5IX:
- 06Y'leHHe pa60Te Ha CBOeM pa60'leM MeCTe;
- nOllroToBKa no 06111HM Tpe60BaHI15IM GMP H TeXH0J10fHI1 'lHCTOTbI;
- 06Y'leHHe H, eCJ1H Tpe6yeTC5I, TpeHI1pOBKa no BbInOl1HeHHIO KOH-
KpeTHbIX lleHCTBHH, CB5I3aHHbIX C Tpe60BaHI15IMH GMP (nepeOlleBaHI1e
ll11H pa60TbI B 'lHCTOM nOMellleHHH, MbITbe PYK, y60pKa nOMerueHHH 11
060pYllOBaHH5I H np.).
J1Y'lWHH npenOllaBaTelIb ll1I5I pa60'lero - ero PYKOBOllHTeJ1b HJ1I1
llpyroH CneUHallHCT npellnpH5ITI15I, 3HalOlllHH npOH3BOllCTBO, YMelOlllI1ti
061>5ICHHTb 11 KOHTpOJ1HpOBaTb HCnOJ1HeHHe.
He06xOllHM HenOCpellCTBeHHbIH H peryJ15IpHbIH KOHTaKT 06Y'lalOllle-
roC5I c PYKOBOllHTeJ15IMH H CneUHallI1CTaMI1, Ha npaKTHKe 3HalOlllI1MI1
npe.llMeT 06Y'leHH5I. J1Y'lWI1H MeTOll - He6011bWHe rpynnbI BHYTPH uexa
no OT.lleJ1bHbIM BonpocaM.
MO.llOdble cneu,UQ./lUCmbl
OTe'leCTBeHHa5I Y'le6Ha5I 6a3a He MO)J(eT llaTb Tpe6yeMoro ypOBHSI
nOllroToBKH.
MorYT paCCMaTpHBaTbC5I TPH nYTI1 nOllrOTOBKH OTe'leCTBeHHbIX cnc-
UI1allHCTOB:
- OpraHI13aUI15I 06Y'leHI15I 3lleCb, B POCCI1H C npHfllaWeHI1eM 3apy-
6e)J(HbIX npenOllaBaTeJ1eH (KOHCYJ1bTaHTOB) H 03HaKOMI1TeJ1bHbIMH noeJ.ll-
KaMH 3a py6e)J(;
- nOllroToBKa CneUI1allHCTOB 3a py6e)J(OM C nOCJ1ellYlOweH CTa)l(lI-
pOBKOH (pa60TOH) Ha BellYlllHX 3apy6e)J(HbIX HpMax;
- nOllroToBKa Ha HOBbIX pOCCI1HCKI1X npellnpH5ITH5IX, nOCTpoeHHblX U
COOTBeTCTBHH C GMP.
I1ep6blii nymb - TynHKoBbIH.
npH'lI1HbI:
- TOJ1KOBbIX cneUI1allI1CTOB 3a py6e)J(OM He TaK MHOro; OHH Bce I1MelO l
XOPOWYIO nOCT05IHHYlO pa60TY, 3a HI1MI1 «OXOT5ITC5I,) pa60TOllaTeJ1H;

06YLleHue nepCOHOJIG
325
- B POCCI11O 11 .IIPYfI1e CTpaHbI (He 3anMHbIe) ellYT pa3Horo pOLla
KOHCYJ1bTaHTbI, KOTopbIe caMH 'laCTO 11 Me lOT cJ1a6ylO nOllroToBKY H He.llO-
CTaTO'lHbIH onbIT pa60TbI;
- 06Y'leHHe CneUHallI1CTOB Ha 6a3e lleHCTBYlOlllHX npellnpH5ITHH He
TOJ1bKO 6eCn0J1e3HO, HO 11 BpellHO; Ha OTCTallOM npe.llnpI15ITHH npI1 J11O-
60M KOJ1I1'leCTBe KOHCYJ1bTaHTOB 11 J11060ti I1X KBallI1I1KaUI1I1 HaY'lHTb
HI1'leMY xopoweMY HeJ1b35I.
3TOT TynHKoBbIH nYTb Y)J(e npOWJ1I1 HeKOTopbIe HaWH KOJ1JlefI1 113
6J1H)J(Hero 3apy6e)J(b5I.
Bmopoii nymb COCTOI1T B CJ1ellYlOllleM:
- OT60p cnoc06HbIX CTY.lleHTOB apMaUeBTH'leCKI1X 11 XI1MI1KO-
TeXH0J10fI1'leCKI1X HHCTHTYTOB;
- 06Y'leHHe I1X aHfllHHCKOMY 5I3bIKY ilO OKOH'laHHH HHCTI1TYTa;
- cpa3Y )J(e nOCJ1e OKOH'laHH5I I1HCTHTYTa HanpaBJ1eHHe HX Ha nOCJIe-
BY30BCKoe 06pa30BaHHe B EBpony HJ1H CWA Ha OllHH-llBa rolla;
- nOCJIe OKOH'laHH5I 06Y'leHH5I B EBpone I1J1I1 CWA - pa60Ta B Te-
'leHHe O.llHOro-llBYX J1eT Ha 3apy6e)J(HoH HpMe, J1HueH3I1pOBaHHoH EC
HJ1H FDA CWA.
Tpemuii nymb 03Ha'laeT pa60TY cpa3Y Ha OTe'leCTBeHHOM npellnpH5I-
THH, OTBe'lalOllleM Tpe60BaHH5IM GMP, nOll PYKOBOllCTBOM CneUHallI1-
CTOB, npOWeLlWI1X np0I13BOllCTBeHHYIO WKOl1Y 3a py6e)J(oM. Ba)J(Ho, 'lTO-
6bI 3TO npellnpH5ITI1e lleHCTBHTeJlbHO pa60TallO no G M P, 6e3 ynYllleHHH
H nOCJ1a6J1eHHH.
BTopoH 11 TpeTI1H nYTI1 - peallbHa5I B03MO)J(HOCTb B HCTOpI1'leCKI1
KOpOTKHH CpOK YKOMnJ1eKTOBaTb HaWH npellnpI15ITH5I (H Ha1l30pHbIe op-
raHbI) CneUHallHCTaMH C cOBpeMeHHoH nOllroToBKOH.
3a BpeM5I 06Y'leHH5I CneUHallHCT llOJI)J(eH OCBOHTb BeCb KOMnJleKC
AOKYMeHTaUI1I1, OTHOC5IlllI1HC5I K opraHH3aUI1I1 11 TeXH0J10fI1I1 npOH3BOll-
CTBa, npH06pecTH npaKTI1'leCKI1H OnblT 11 6bITb roTOBblM K nepeHOCY
3TOro OnbITa B POCCHIO.
MO.llodoii cneu,ua.llucm nu odn020 iJnR ne dO.llJICen pa60mamb na
cmapoM npeiJnpuRmuu!
3mo - KpUmUlteCKOe YC.ll06ue!
OnbIT nOKa3bIBaeT, 'lTO J1Y'lWI1H nepCOHall - 3TO nepCOHall 6e3
npOWJ1oro OTpI1uaTeJ1bHoro OnbITa pa60TbI. 3TO nepCOHall, KOTOpblH
06Y'lI1J1I1, KaK HMO pa60TaTb, 11 .llallI1 cxeMY, OpraHI13aUHIO pa60TbI,
cHa611I1B np0I13BO.llCTBO oTpa60TaHHOH CI1CTeMoHlloKYMeHToB.
He TaK Ba)J(HO Y'lI1Tb pa60TaTb «no GMP,). KaK He I1MeTb OnbITa pa-
60TbI «He no GMP,).
3TO - xopowee, HO I1.lleallbHOe YCJ10BHe, .llalleKO He Bcema BbInOJ1-
HI1Moe. Ha npaKTI1Ke MbI I1MeeM .lleJ10 C TeMI1 11IO.llbMI1, KOTopbIe eCTb pe-
3JlbHO. C Y'leTOM 3TOro 11 HY)J(HO CTpOI1Tb 06Y l leHI1e 11 nO.ll60p Kallpoo

326
FJ1oeo 13
13.2 rAe Y'lHTh?
06Y'leHHe MO)J(eT 6bITb opraHH30BaHO:
- ueHTpaJ1I130BaHHO B ueHTpe 06Y'leHH5I B MocKBe HJ1I1 llPyroM
ropO.lle;
- Ha caMOM npellnpI15ITI1I1;
- 3a py6e)J(OM.
l(enmpQ./lU306annoe 06yltenue
B CTpaHe lleHcTByeT HeCKOJ1bKO OpraHI13aUI1H, npellJIaralOlllHX 06YlIe-
HI1e no GMP. ACI1HKOM BelleT 3ry pa60ry npI1MepHO 20 J1eT. 3a 3TO
BpeM5I HaKonneH OnpelleJ1eHHbIH onbIT. Ha CeMI1HapaX B MocKBe npOWJ1I1
nO.llroToBKY 60J1ee 1200 CneUI1allHCTOB.
nporpaMMbI 06Y'leHH5I npHBe.lleHbI B pa3ileJ1e 13.1. B03Mo)l(HO cne-
UHallH3HpOBaHHoe 06Y'leHHe, HanpHMep, no npoeKTHpOBaHHIO, CTpOI1-
TeJIbCTBY 11 BBOllY B 3KCnJ1yaTaUHIO npoH3BollCTB, pa60Te KOHTpOJ1bHbIX
J1a60paTopHH H np.
Ha TaKHe 3aH5ITH5I ueJ1eC006pa3Ho HanpaBJ15ITb PYKoBOllI1TeJ1eH H
cneUI1allI1CTOB, KOTopbIe 3aHHMalOT KJIIO'leBbIe n03HUI1I1 H caMH 1l0J1)J(HbI
npOBOllHTb 06Y'leHHe y ce65I Ha npellnpI15ITH5IX.
Opzanu3au,UJI 06yltenUJI na npednpUJImuu
UeHTpallH30BaHHoe 06Y'leHHe 5IBJ15IeTC5I orpaHH'leHHbIM no cBoeti
CYTH H He MO)J(eT OXBaTHTb Bcex pa60THHKOB npellnpH5ITH5I.
Ho npaBHJ1aM pa60TbI no GMP CJ1ellyeT Y'lHTb Bcex, npH'leM llOJl)J(-
HO 6bITb opraHH30BaHO KaK nepBOHa'lallbHOe, TaK H nOBTopHO-
nepHOllH'leCKOe 06Y'leHI1e.
C 3TOH ueJ1blO Ha npellnpHHTHI1 CJ1ellyeT opraHH30BaTb cucmeMY
06yltenuJl nepconQ./la.
B 3aBI1CI1MOCTH OT pa3MepOB npellnpI15ITI15I H cneUHHKI1 ero .lleH-
TeJ1bHOCTH 3TO MO)J(eT 6bITb CneUI1allbHbIti OTlleJ1, BbIlleJ1eHHbIH COTPY.ll-
HHK I1J1H CneUHallI1CT no GMP, BbInOJ1H5IIOUlHH 3ry YHKUHIO B III1CJ1C
npO'lHX 065I3aHHOCTeH.
npe)J(}Je Bcero, HHO C03llaTb CHCTeMY 06Y'leHHH opraHH3aUHOHHO:
- on pe.lleJ1HTb, KTO, Koma 11 me npOXOllI1T 06Y'leHHe B CTOpOHHU\.
opraHH3aUH5IX, y6ellHTbC5I, 'lTO Ka'leCTBO 06Y'leHI15I 11 TeMbI 3aH5ITI1ii B
3THX opraHH3aUH5IX COOTBeTCTBYIOT 3Ma'laM pa60TbI no GMP;
- OnpelleJ1HTb nOp5I.llOK 06Y'leHI15I BHYTpH npe.llnpI15ITI15I KaK C npu-
BJ1e'leHI1eM CTOpOHHI1X cneUI1allI1CTOB, TaK 11 c06CTBeHHbIMI1 CI1J1aMI1;
- pa3pa60TaTb nporpaMMbI 06Y'leHI1H Bcex KaTeropI1H COTPYllHHKOB;
- OnpelleJ1I1Tb COCTaB npenO.llaBaTeJ1eHllJIH npOBelleHI15I 06YIIeHI11 Ha
caMOM npellnpI1HTHI1, BKJIIO'la5I npI1rl1aWeHHbIX CnCUJ1(UlI1CTOB;
- nOllrOTOBI1Tb TeXHI1'leCKI1e Cpe.llCTBa 06YIIeHI15I 11 nOMellleHI1e;
- nOllrOTOBI1Tb MCTO.llI1'lCCKI1e nOC06I1H 11 MaTepI1aJ1bI, Bbl.llaBaCMbl C
cJlywaTel1S1 M;

06Y/.feHUe nepCOHQ1l0
327
- COCTaBI1Tb 11 YTBepllI1Tb rpaI1K 06Y'leHI15I BCeX KaTeropI1H COTPYll-
HI1KOB;
- OpraHH30BaTb CI1CTeMY Y'leTa npOXO)J(DeHI15I 06Y'leHH5I 11 npOBepKI1
3eKTI1BHOCTI1 06Y'leHH5I.
06yqenue 3a py6eJICoM
n0J1e3HOH OpMOH 06y<IeHH5I 5IBJI5IeTC5I OpraHH3aUI15I ueJ1eBbIX no-
e3ll0K 3a Py6e)J(. UeJ1eBbIX, nOTOMY 'lTO 6eCCMbICJ1eHHO eXaTb KY.lla-TO,
'lT06bI YCJ1bIWaTb MaTepHall, KOTOpbIH MO)J(HO nOJ1Y'lHTb 311eCb, B POCCHI1.
HellOCTaTKOM MHomx noe3ll0K 5IBJl5IeTC5I TO, 'lTO HHOCTpaHHbIe npe-
nOllaBaTeJ1I1 nO'lTI1 Bce BpeM5I 3aTpa'lI1BaIOT Ha I13J10)J(eHHe llaBHO H3-
BeCTHbIX I1CTI1H 11 neperpY)J(alOT MaTepHall BTopOCTeneHHOH HJ1H Bo06111e
He OTHOC5I1lleHC5I K lleJlY HHopMaUHeti. TpYllHO CKa3aTb, 'leM 3TO BbI-
3BaHO: c06CTBeHHbIM orpaHH'leHHbIM ypOBHeM JleKTopa HJ1I1 HellooueH-
KOH CJ1ywaTeJ1eH. Bo BpeMH TaKHX noe3ll0K HaWH CneUHallI1CTbI He pa3
CTaBHJ1H B TynHK npenOllaBaTeJ1eH H KOHCYJ1bTaHTOB np5IMbIMH Bonpoca-
MH (no TeMe 06CY)J(DeHH5I).
3TO HHO nOHHMaTb H 'leTKO oroBapI1BaTb nporpaMMY 06Y'leHH5I.
nponHCHbIe HCTHHbI HHO HCKJIIO'lHTb, a OCHOBHoe BHHMaHHe
Y.lleJ1HTb npaKTH'leCKOMY 03HaKOMJleHI11O C 3apy6e)J(HbIM OnbITOM. TaM
eCTb, 'lTO nocMoTpeTb, 11 eCTb, 'lTO nepeH5ITb. MO)J(HO cpaBHHTb c06-
cTBeHHbIti ypoBeHb C 3apy6e)J(HbIM 11 YBI1lleTb OTJ1H'lH5I.
Ba)J(Ho npaKmUlteCKU 03HaKOMHTbC5I C npellnpH5ITH5IMH, 60Jlee rJlY-
60KO nOH5ITb CneUHallbHbIe BonpocbI, HanpHMep, nOp5IllOK npoBelleHHH
HHcneKUHH H aYllHToB, BelleHH5I 1l0KYMeHTaUHH, HCnbITaHHH CTepHJ1H3a-
TOpOB, CHCTeM nOllroToBKH BOllbI H IIp.
n0J1e3HO 11 He06xollHMO nocelllaTb cneUI1allI13I1pOBaHHble ceMHHapbI,
HanpHMep, no aHallI1TH'leCKHM MeTollaM, pa60Te KOHTpOJ1bHbIX Jla60paTO-
pHH, I1CnbITaHI15IM pa3JII1'lHoro 06oPYllOBaH 1151 , MeTOllaM O'lI1CTKI1 11 T. ll.
YCJ10BI1eM llJl5I 3TOro 5IBJl5IeTC5I 3HaHI1e aHfllI1HCKoro 5I3b1Ka. CeH'laC 6e3
3TOro He 060HTI1Cb. CneUI1allHCTblllOJl)J(HbI BJ1MeTb aHfllHticKI1M.
13.3 KTO MO}KeT U AOJDKeH Y'JUTb?
ECTb WYTJ1HBa5I noroBopKa: «Tom, Kmo HU/.fe20 He YMeem, Y/.fum OPY-
2UX; Kmo He YMeem Y/.fUmb, Y/.fum, KOK HOOO Y/.fUmb').
YBbI, 3Ta WYTKa nopoH oTpa)J(aeT lleHCTBI1TeJ1bHOcTb. npe)J(De 'leM
HllTH KYlla-To Y'lI1TbC5I I1J1H KOro-TO npI1rJ1aWaTb, HMO nOI1HTepeCOBaTb-
C5I, a 'lTO 3TO 3a Y'lHTeJ1b, 11 KaKOB y Hero onbIT pa60TbI.
npellnpHHTH5I, KOTopbIe pa60TalOT Ha.II BHellpeHI1eM npaBHJ1 GMP,
paCWI1pHIOT CBOIO cepy lle5ITeJ1bHOCTH 11 OCBaI1BaIOT HOBbIe np0I13BOll-
CTBa, HY)J(DaIOTC5I B KOHcYJ1bTaUI15Ix. KOHcYJ1bTI1ponaHHe pacnpOCTpaHeHO
Be311e, pa3BHOaeTC5I OHO 11 Y Hac.

328
fJ1060 13
XOPOWHH KOHCYJ1bTaHT - 3TO, KaK npaBHJ10, 6bIBWHH HHcneKTOp
GMP, PYKOBOllHTel1b CJ1Y)J(6bI Ka'leCTBa I13BeCTHOH I1pMbI, HJ1H .IIPyroH
cneUHallHCT, I1MelOlllHH J1H'lHbIti MHoroJ1eTHHH npaKTH'leCKHH onbIT pa-
60TbI B 06J1aCTH, B KOTOpOH OH B35IJ1C5I KOHCYJ1bTHpOBaTb. TaKI1e J1IO.llH B
3peJ10M B03paCTe opraHH3YIOT CBOI1 KOHCYJ1bTaUI10HHble HpMbI. 11M
MO)J(HO BepI1Tb.
K CO)J(alleHHIO, Y HaC CnJ10Wb 11 p5I.llOM 3a lleJ10 KOHCYJ1bTHpOBaHI151 11
npenO.llaBaHH5I 6epeTC5I J11060H. Oc06eHHO aKTI1BHbI OKa3aBWI1eC5I He Y
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3TO 03Ha'laeT, 'lTO pa3pa60TKa H .llallbHeHWa5I >KI13Hb HopMaTHBHoro 1l0-
KYMeHTa - ilHHaMI1'lHbIH npouecc. B nepBoM I1311aHI1I1, cpa3Y, pellKo no-
JIY'laeTC5I XOPOWHH 1l0KYMeHT. KaKI1M OH CTaHeT B 6YllYllleM - 3aBHCHT
OT npaKTHKOB, pa60TalOlllHx no 3TOMY .llOKYMeHTY H TOro, HaCKOJ1bKO
JIeHCTBeHHa 06paTHa5I CB5I3b Me)J(DY pa3pa60T'lHKaMH 1l0KYMeHTa 11 nOJ1b-
30BaTeJ15IMH.
3aH5ITH5I C npoH3BollcTBeHHHKaMH - 3BeHO 3TOH 06paTHoH CB5I3I1.
XopOWO, Koma npenollaBaTeJ1b c06HpaeT MHeHH5I CJ1ywaTeJ1eH 11
HanpaBJI5IeT I1X B COOTBeTCTBYlOlllI1H opraH, B 'laCTHOCTI1 B TeXHI1'leCKI1H
KOMI1TeT no CTaH.llapTH3aUHI1 TK 458 «np0I13BOllCTBO 11 KOHTpOJ1b Ka'le-
CTBa J1eKapCTBeHHbIX cpellCTB», npellCeJIaTeJ1eM KOTOpOro 5IBJ15IeTC5I aBTOp
KHHrH. MbI OCTpO HY)J(DaeMC5I B MHeHHI1 npOH3BOllCTBeHHI1KOB.
HY)J(HO onpOBepraTb pacxo)J(ee MHeHI1e 0 TOM, 'lTO HH HopMaTHBHbIe
llOKYMeHTbI, HH CI1TyaUI11O Bo06111e nOnpaBI1Tb HeJ1b35I. HellOCTaTKI1 11
llecPeKTbI nOTOMY 11 CYllleCTBYIOT, 'lTO J1IO.llH CMHpHJ1HCb C HHMI1.
13.6 CpeAcTB3 06y<1eHHJI
Ha2JlJldnbie MamepUQ./lbl
YCBOeHI1e CJ1ywaTeJ15IMI1 MaTepI1alla 3aBI1CI1T He TOJ1bKO OT KBallI1-
cPHKaUHH npenOllaBaTeJ15I 11 ero YMeHI15I 'lI1TaTb JIeKUI1I1.
BCTpe'laIOTC5I opaTopbl, BJ1allelOUlI1e BHI1MaHI1eM ny6J1I1KI1, HO nOCJIe
BbIcTynJ1eHI15I KOTOpbIX CJ1ywaTeJ1I1 He BbIHOCHT HH'lero. n0J1e3HbIM pe-
3YJ1bTaTOM J11060ro 3aH5ITI15I HBJ15IeTC5I He TOJ1bKO TO, 'leMY Y'lHJ1H, a TO,
'lTO H KaK YCBOHJ1 CJ1ywaTeJ1b.

338
FJ1060 13
YCTHa5I I1HOpMaUI15I 3anOMI1HaeTCH CJlywaTeJ15IMI1 Ha 10%. 3pI1-
TeJ1bHa5I naM5ITb HaMHoro 3eKTHBHee CJ1YXOBOH. npI1 I1Cn0J1b30BaHI1I1
HamMHbIX Cpe.llCTB CJ1ywaTeJ1H YCBaHBalOT .llO 50% HHopMauHH.
«OOHO KopmUHKO J1YIJU1e 1000 CJ1oe» - 3Ta MbICJ1b OTpa)J(aeT onblT
MHOfHX npenollaBaTeJ1eH. MaTepHall 3anOMHHaeTC5I J1Y'lwe, eCJlI1 CJ10Ba
HJ1J1IOCTPHPYIOTC5I H306p3)J(eHI1eM 11 06Y'lalOlllI1HC5I caM KOHCneKTI1pyeT
HaI160J1ee Ba)J(HbIe MbICJ1H, T. e. aKTHBHO Y'laCTByeT B npouecce 06Y l le-
HH5I. npI1 3TOM K CJ1YXOBOH H 3pI1TeJ1bHOH naM5ITH 1l06aBJ15IeTC5I MeXaHI1-
'leCKa5I, MOTOpHa5I naM5ITb. I1cnoJ1b30BaHI1e I1J1bMOB ellle 60J1bWe no-
BbIwaeT 3eKTI1BHOCTb 06Y'leHI15I.
Hal./lJlOnble cpeiJcm6a OpMI1PYIOT B C03HaHI1I1 3pUme.llbnblii 06pa3,
KOTOpbIH MO)l(eT 1l0J1ro Yllep)J(HBaTbC5I B naM5ITI1.
Ba)J(HbIM aKTOpOM 5IBJ15IeTC5I Ka'leCTBO Ham5IllHbIX MaTepI1allOB.
HaH60J1ee pacnpOCTpaHeHa .lleMOHCTpaUI15I MaTepHana Ha 3KpaH C no-
MOlllblO MYJ1bTHMellHHHoro npoeKTopa I1J1I1 OBepX311-npoeKTOpa. npI1
3TOM BeCb TeKCT pa311eJ15IeTC5I Ha OTlleJ1bHbIe H306p3)J(eHH5I (CJ1aHllbI).
Ham5IllHbIH MaTepHall npeCJ1ellyeT TPH ueJ1H:
- np06Y)J(DeHHe I1HTepeCa CJ1ywaTeJ15I,
- I1J1J1IOCTpaUH5I maBHOH MbICJ1H,
- lleTallI13aUH5I MaTepI1alla.
llOdzomoeKa K 3aHJImUJI.M
npI1 nO.llroToBKe K BbICTynJ1eHHIO n0J1e3HO Y'leCTb CJ1ellYlOlllee:
- H306p3)J(eHHe nOJ1)J(HO 6bITb npOCTbIM ll1151 BOCnpH5ITHH;
- He nOJ1)J(HO 6bITb CJ1HWKOM MHoro I1HOpMaUI1H (TeKCTa, UHP,
MeJ1KHX lleTalleH);
- I1HOpMaUI15I llOJ1)J(Ha BocnpHHHMaTbC5I npI1 6emOM B3m5Ille H3
3KpaH;
- eCJ1I1 TeKCT MeJ10K H H306pa)J(eHI1e neperpY)J(eHO I1HOpMaUI1eH, TO
BHHMaHI1e CJ1ywaTeJ1eH 6YlleT paCceI1 BaTbC5I , 11 YCK0J1b3HeT MbICJ1b, p.1ll1l
KOTOpOH aBTOp roTOBI1J1 BbIcrynJ1eHI1e;
- HaI160J1ee Ba)J(HbIe CJ10Ba H UI1pbI n0J1e3HO BbI.lleJ15ITb )J(I1pHbl1
WpI1TOM, KypCI1BOM I1J1I1 UBeTOM, 'lT06bI aKueHTI1pOBaTb Ha HI1X BHU-
MaHHe CJ1ywaTeJ1eH;
- n0J1e3HbI KapTHHKI1, B TOM 'lHCJ1e BbInOJ1HeHHbIe caMHM npenO.lla-
BaTeJ1eM, MorYT I1Cn0J1b30BaTbC5I KapHKaTypbI (KOHe'lHO, B Mepy).
OpraHI13aUH5I 06Y'leHI15I - O'leHb lleJ1HKaTHa5I 11 I1HllHBI111YallbH.UI
np06J1eMa. MO)J(HO llaBaTb COBeTbI H peKOMeHllaUHH, HO OpMbI H MeTO.llbI
06y<IeHI15I 1l0Jl)J(Hbl BbI6paTb caMO npellnpI15ITI1e 11 caM npenO.llaBaTeJ1b.

339
fJlaBa 14
06ECllEQEHHE KAQECTBA
14.1 CT3H1l3pThI B 06JJ3CTH K3'1eCTB3
06eCne'leHI1e KalIeCTBa - HenpOCTa5I JMa'la. BOKPyr Hee C03llaH
p5Ill HOpMaTI1BHbIX 1l0KYMeHTOB, HanI1CaHO MHO)J(eCTBO KHHr, nOCT05IHHO
npOBO.ll5ITC5I KOHepeHUI1I1 11 CeMI1HapbI.
Ka'lecTBo - 3TO 06111a5I xapaKTepHCTI1Ka J11060H npOllYKUHH. OHa
5IBJl5IeTC5I npe.llMeTOM BHI1MaHH5I Bcex, B TOM 'lI1CJ1e 11 pa3pa60T'lI1KOB
CTaHllapTOB. Ho He Bce CTaHllapTbl no Ka'leCTBY npI1rollHbI ll1151 npaKTH-
'leCKoro npI1MeHeHH5I. HeKOTopbIe 113 HI1X OKpY)J(eHbl TYMaHOM H BbI3bI-
BalOT HellOYMeHHe.
HopMaTHBHbIe 1l0KYMeHTbI B 06J1aCTH Ka'leCTBa MO)J(HO pa311eJ1I1Tb Ha
HeCKOJ1bKO rpynn:
1) CTaHllapTbI HCO 9000, KOTOpbIe HOC5IT 06uii xapaKmep 0./lR ecex
6U006 npOllYKUHH H YCJ1yr; 3TO CJ1I1WKOM 06111He 1l0KYMeHTbI, OHI1 3any-
TbIBalOT npaKTHKOB H CJ1Y)J(aT CKopee I1HTepeCaM cepTHcPHKaTopoB H 6pa-
KOlleJ10B, IIeM Ka'leCTBY npOllYKUHI1;
2) Cneu.UQ./lU3Up06annble cmandapmbl B 06J1aCTI1 Ka'leCTBa ll1151 OT-
lleJ1bHbIX BI1110B npOllYKUI1 11 , HanI1CaHHbIe Ha ocn06e cmandapm06 HCO
9000. npHMepbI:
- CTaHllapT I1CO 15378 H ero MO.llI1I1KaUHSI Ha PYCCKOM 5I3bIKe
fOCT P 53699-2009 «nepBI1'lHbIe ynaKOBO'lHbIe MaTepI1aJ1bI ll111 J1eKap-
CTBeHHbIX cpellCTB. lJacTHbIe Tpe60BaHH5I no npI1MeHeHI11O I1CO 9000-
2008 C Y'leTOM npaBI1J1 GMP,);
fOCT P 13485-2004 «113lleJ1HSI MellI1UHHCKHe. CI1CTeMbI
MeHell)J(MeHTa Ka'leCTBa. CI1CTeMHbIe Tpe60BaHI15I llJl5I ueJ1eH
perYJ1I1pOBaH 1151».
OHH 6J1I1)1(e K npaKTI1Ke. HO BCe-TaKI1 O'leHb 3acopeHbI HMYMaHHbI-
MH pa3aMI1 113 I1CO 9000 (npI1J1o)J(eHI1e 4);
3) npa6U.1la GMP - npaBHJ1a npOH3BO.llCTBa J1eKapCTBeHHbIX cpellCTB,
SIBJl5I101llHeC5I cneu.UQ./lU3Up06annbLM PYKOe()(JcmeoM (B POCCHI1: fOCT P
52249-2009 - GMP EC); B 2007 r. n05IBHJ1HCb npaBI1J1a GMPc - npaBI1-
1Ia np0I13BOllCTBa KOCMeTI1'leCKOH npOllYKUHH, B CWA lleHcTBYIOT npa-
Bl1J1a G M P llJl5I npOH3BO.llCTBa npollYKTOB nI1TaHH5I (maBa 18).
npaBI1J1a GMP 6bIJ1H C0311aHbI .ll0 CTaHllapTOB I1CO 9000, I1X I1C-
TO'lHI1KOM 6bIJ1H HY)J(DbI np0I13BOllCTBa H KOHKpeTHbIe 3a.IIa'lI1 06ecne l le-
HH5I 6e30naCHOCTI1 npOllYKUI1I1. OHI1 5IBJ1HIOTC5I PYKOBOllCTBOM K lleH-
CTBI110 H KpI1TCpI1eM OUCHKI1 np0I13BOllCTB;

340
[;1060 14
4) PyKoeodcm60 lCH QI0 «Pharmaceutical Quality System» - «CI1-
CTeMa Ka'leCTBa Ha apMaUeBTI1'leCKHX npe.llnpI1HTI15IX'). 3TO 06111I1ti 1l0-
KYMeHT, B KOTOpOM C.lleJlaHa nOnbITKa Onl1CaTb Tpe60BaHI1H K Ka'leCTBY
Ha Bcex 3Tanax «)J(I13HeHHoro UHKJIa,) J1eKapCTBeHHoro Cpe.llCTBa. OH HO-
CHT onHCaTeJ1bHblH xapaKTep 11 He 5IBJ15IeTC5I PYKOBOllCTBOM K lleHCTBI1IO;
5) CneUI1allI13HpOBaHHbIH pOCCHHCKI1H CTaHllapT rOCT P 52537-
2006 «llpou36oiJcm60 .IleKapCm6ennbIX cpeiJcm6. CucmeMa 06ecneltenuJl
Kalfecm6a. 06ue mpe606anUJl' 6bIJ1 pa3pa60TaH aBTopOM KHI1fH npl1
nOllllep)J(Ke 'lJ1eHOB ACI1HKOM. Ero ueJ1b - llaTb npaKTH'leCKOe
PYKOBOllCTBO B pa3BHTHe 06WHX TPe60BaHHH GMP.
CTaHllapTbI I1CO 9000 nOJ1Y'lHJ1H WHpOKoe pacnpOCTpaHeHHe,
OllHaKO I1X CMbICJ1 11 npaKTI1Ka npI1MeHeHHH llalleKO He 6eCCnOpHbI. OHI1,
CKopee, YBOll5IT B CTOPOHY, 'leM nOMoralOT CTpOI1Tb CI1CTeMY
06ecne l IeHH5I Ka'leCTBa. B aHrJ1HHCKOM OpHfHHalle 3TI1 CTaHllapTbl
I13J10)J(eHbI nYTaHO H nJ10XO, I1CKYCCTBeHHbIM 5I3bIKOM, .llalleKI1M OT
npaKTMKH. HeYlla'lHbIH nepeBOll ellle 60J1ee ycyry6I1J1 .lleJ1o. YBbl,
Kalfecm60 CllMUX cmandapmoe no «altecm6Y OCTaBJ15IeT )J(eJ1aTb J1Y'lwero.
ABTOp nOllp06HO nI1WeT 06 I1CO 9000, 'lTo6bI 6bIJ10 5ICHO: 3TOT
CTaHllapT - I1HeKUH5I, OT KOTOpOH HY)J(Ha BaKUHHa. 3Ta BaKUHHa -
nOHHMaHI1e npellMeTa H co6CTBeHHa5I TO'lKa 3peHH5I.
14.2 liTO T3Koe K3'1eCTBO?
TepMun «KalteCm60»
Ka'leCTBO - OllI1H 113 KJlIO'leBbIX TepMHHOB npaBHJ1 GMP 11 opraHU-
3aUHH J11060ro np0I13BO.llCTBa. OH I1MeeT CJ10)J(HYIO npHpO.llY. Ero CMbICJ1
MeH5IeTCH, YTO'lH5IeTC5I, B 3aBHCHMOCTH OT 06J1aCTI1 npHMeHeHI15I. 3T11
YT0'lHeHHSI 11 OTTeHKI1 MOryr I1MeTb npI1HUHnHallbHOe 3Ha 1 IeHI1e llJ15I no-
HHMaHH5I TepMI1Ha 11 ero I1Cn0J1b30BaHH5I.
Ba)J(HoH oTnpaBHoH TO'lKOH 5IBJ15IeTC5I TO, 'lTO TepMI1H «KalteCm60»
HMeeT pa3HbIH CMbICJ1ll115I pblHKa I1ll1151 npou36oiJcm6a.
PaCCMOTpI1M OnpelleJleHI15I K TepMI1HY «Ka'leCTBO').
3) CJlOB3pb pYCCKoro H3bIK3 C. 11. O*eroB3
KalteCm60: TO I1J1I1 I1HOe CBOHCTBO, .llOCTOI1HCTBO, CTeneHb npI1ro.cl-
HOCTH Koro-'lero-HI16Yllb.
b) AHrJlOH3blIJH3H JlHTep3Typ3
WI1pOKOe pacnpoCTpaHeHI1C I1MeeT cJ1e.llYlOwee OnpelleJ1eHI1e:
«Quality: degree of excellence», T. e. KalIeCTBO - 3TO CTeneHb npe-
BOCXO.llCn3a.
B npI1MeHeHI1I1 K J1eKapCTBCHHbIM Cpe.llCTBaM 11 npaBI1J1aM GMP WII-
pOKO I1CnOJlb3YCTC51 CJlC.llYlOwml (OPMYJlI1pOBKa: «product must fit for in-
tended use,) - IlpOdYK1(UR ()o,lJICHO ('oomeel1lCl1l6060l1lb C60eJ\lY H03HO'leHlIIO.

06eCne'leHUe KO'leCm60 34 J
c) rOCT P "CO 9000-2008
Kallecm60: CTeneHb COOTBeTCTBI1S1 cOBoKynHOCTI1 npI1CYlllI1X xapaK-
TepI1CTI1K Tpe60BaHI15IM.
KOMMeHT3pH"
npH pa3pa60TKe rOCT P 52537-2006 MbI npOBeJ1I1 aHallH3 3THX
OnpelleJleHHH H conOCTaBHJ1H HX C npaKTHKoH.
JlI1TepaTYPHbIe H 6bIToBbIe OnpelleJ1eHI15I Ha PYCCKOM H aHfllHHCKOM
5I3bIKaX (n.n. a H b) TeXHH'leCKH He 5ICHbI. OHH HOC5IT HHTYHTHBHbIH xa-
paKTep, I1MeIOT 0606111eHHbIH HJ1H J1HpH'leCKHH OTTeHOK. no HI1M HI1'lero
HeJlb35I npOBepI1Tb.
OHI1 ro1l5ITC5I ll1151 peKJIaMbl, pbIHKa, C0311aHH5I 06pa3a Y nOTpe6HTeJ15I.
CaMa OPMYJ1I1pOBKa «COOTBeTCTBOBaTb CBoeMY Ha3Ha'leHHIO') llJ15I
npOH3BOllCTBa 11 KOHTpOJl5I Ka'leCTBa HH'lerO He rOBopHT. HY)J(Ha I1c'lep-
nbIBalOllla5I xapaKTepI1CTHKa C nepe'lHeM nOKa3aTeJ1eH 11 I1X 3Ha'leHI15IMI1.
TOJ1bKO B 3TOM cJlY'lae Ka'leCTBO MO)J(HO «3aD.aTb') 11 npOBepI1Tb.
B 3TOM COCTOHT KJIIO'leBOe pa3J1H'lHe nOHI1MaHH5I TepMHHa «Ka'le-
CTBO') nOTpe6I1TeJ1eM (npOllaBUOM, peKJIaMHbIM areHTOM) H np0I13BO.ll-
CTBeHHHKOM HJ1H pa3pa6oT'lI1KOM.
D.n5I pblHKa U nompe6ume.lleii Ka'leCTBO MO)J(eT nOHHMaTbC5I KaK
«cmeneHb Y006J1em60peHHocmu OJICUOOHUU nompe6umeJleu,) I1J1I1 «coomeem-
cm6ue npOOYKl{UU ceoeMY HG3HO'IeHUIO». 3TI1 OnpelleJ1eHH5I HMelOT cKopee
HJ10COCKHH xapaKTep, 'leM TeXHH'leCKHH. B ccfJepe peKJIaMbI H pa60TbI
C nOKynaTeJ15IMH WHpOKO I1Cn0J1b3YIOTC5I nCHX0J10fH'leCKHe npI1eMbI,
HaueJ1eHHbIe Ha 06pa3Hoe MbIWJ1eHHe 'leJ10BeKa.
Ho BbInycKaTb npollYKUI1IO, n0J1b3Y5ICb TaKHM lleBH30M, H KOHTpO-
J1HpOBaTb ee Ka'leCTBO, HeB03MO)J(HO. lJT06bI np0I13BOllHTb npollYKUI11O H
lleJ1aTb ee JlY'lwe H JlY'lwe, HY)J(HO 'leTKO OnpelleJ1HTb ee cfJaKTH'leCKOe
COCT05IHHe H 3allaTb, 'lTO TaKoe «J1Y'lwe,).
Pa3pa60T'lI1KaM npollYKUI1H, np0I13BOllCTBeHHI1KaM 11 Ha.ll30pHbIM
opraHaM HY)J(HbI KpI1TepI1I1 Ka'leCTBa, OOpMJ1eHHble .llOKYMeHTallbHo.
D.n5I ueJ1eH npou360dcmea «coomeemcmeue npOOYKu,UU c60eMY H03HO-
'1eHUIO» llOJ1)J(HO 6bITb OnpelleJ1eHO meXnUlteCKUMU nOKa3ame./l1l.MU B KO-
JlH'leCTBeHHoH I1J1I1 CJlOBeCHOH opMe, Ha OCHOBe KOTOpbIX MO)J(HO pa3-
pa60TaTb meXnO.llOlUIO np0I13BOllCTBa 11 KOTopbIe MO)J(HO npoeepumb.
fOCT P I1CO 9000-2008 OnpelleJ15IeT Ka'leCTBO KaK «CTeneHb COOT-
BeTCTBH5I cOBoKynHocTH npHCYlllI1X xapaKTepI1CTI1K Tpe60BaHH5IM,). B
HeM eCTb pa3MbITbIe 11 He'leTKHe CJ10Ba:
- cmeneHb COOTBeTCTBI1S1;
- npucyU/,ue xapaKTepI1CTI1KI1.
lJTo 3TO 3a CTeneHb H KaK ee OueHI1Tb? ECJ1I1 ee oueHHBaTb, TO
HY}J(Ha HeKa51 WKaJ1a CTeneHI1 COOTBeTCTBI15I. llnH npaKTI1KI1 3TO HCHY)J(-
Ha5I 13Te5I. HY)J(HO 3HaTb, COOTBeTcTByeT I1311eJ1I1e 3aD.aHHbIM Tpe60BaHI1-
JIM I1J1H HeT, a eCJ1I1 He COOTBcTcTByeT, TO B 'lCM I1MeHHO.

342
FJ1060 14
B «npucyw,ux xopoKmepucmuKox» On5ITb BI111eH I1J10COCKI1H no-
'lepK, He HMelOlllI1H OTHOWeHI15I K .lleJ1Y.
ECJlI1 y6paTb J1I1pH3M H YT0'lHI1Tb, KaKI1M Tpe60BaHI15IM 1l0J1)J(HbI
YllOBJleTBOp5ITb xapaKTepI1CTHKH, TO nOJ1Y'lI1TC5I 5ICHOe onpe.lleJ1eHI1e Tep-
MHHa «Ka'leCTBO'), K KOTOPOMY MbI npI1WJ1I1 npH pa3pa60TKe CneUHallI1-
3HpoBaHHoro CTaHllapTa no Ka'leCTBY llJl5I np0I13BOllCTB J1eKapCTBeHHbIX
cpellCTB - rOCT P 52537-2006:
Kallecm60 JleKapcm6eHHOi!O cpeiJcm6a: COOTBeTCTBl1e JleKapCTBeHHoro
CpeJ1CTBa Tpe60BaHI151M cneUI1<j)I1KaUI1I1, <j)apMaKOneHHOI1 CTaTbl1 11J111
L\pyroro J10KYMeHTa.
14.3 06eCne'leHHe, ynp3BJ1eHHe, MeHe.lJ)KMeHT
« Ynpae.llenue KalteCmeOM» U./lU «06ecnellenue KalteCmea»?
B HOpMaTI1BHOH JlHTepaType 11 B 06Hxolle 'laCTO I1Cn0J1b3yeTC5I Tep-
MHH «ynpaBJ1eHI1e Ka'leCTBOM'>. OH BOWeJ1 H B 3aKOH POCCI1HCKOH cDelle-
paUHH «0 TeXHH'leCKOM peryJ1I1pOBaHHH».
TepMHH «ynpae.llenue KalteCm60M') CJlellyeT HCKJIIO'lHTb H3 ynoTpe6-
J1eHIDI H 3aMeHHTb Ha «06ecneltenue KalteCm6a,).
Ka'lecTBoM ynpaBJlHTb HeJ1b35I. HeJ1b35I no cooeMY YCMOTpeHHIO
lleJ1aTb ero HH)J(e HJ1H BbIwe. MO)J(HO 11 1l0J1)J(HO pewaTb TOJ1bKO OllHY
3alla'lY - o6ecne'lHBaTb Ka'leCTBO npOllYKUHH, T. e. 06eCne'lI1BaTb ec
COOTBeTCTBHe 3allaHHbIM Tpe60BaHI15IM.
TOJ1KOBbIH CJ10Bapb PYCCKOro 5I3blKa C. 11. O)J(eroBa llaeT CJ1ellYIO-
lllHe onpe.lleJ1eHH5I TepMHHY «ynpa6.1lHmb'):
- HanpaBJ15ITb XOll, llBH)J(eHHe 'lero-J1H60, PYKOBOllHTb lleHCTBI1HMIl
Koro-'lerO-J1H60;
- PYKOBOllHTb, HanpaBJl5ITb lleHCTBH5I Koro-'lero-JlI160.
CYlllecTBYIOT pa3J1H'lHbIe OnpelleJ1eHI15I TepMHHa «ynpaBJleHHe,) B
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lleJ10 H 06J1aD.alOlllI1M 1l0CTaTO'lHbIM KPyro30pOM.
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KTO B35IJ1C5I 3a pa3pa60TKY 06111I1X CTaHllapTOB no Ka'leCTBY?
KaK OTMe'lallOCb Bblwe, pa3pa60TKoH nepBbIX CHCTeM Ka'leCTBa 3dHI1-
M3JlHCb nepBOKJIaCCHbIe CneUHallHCTbI, 3na6ULue npeiJMem 11 nOHI1MaBWI1e
CBOIO omeemcmeennocmb 3a 06eCne'leHHe 6e30nacHocmu U nadeJICnocmu
np o llYKUHI1. Pa60Tbi B 3T0i1 06J1aCTH HHaHCI1pOBallI1Cb XopOWO.
3aTeM n05IBI1J1aCb I1HI1UI1aTI1Ba pa3pa60TaTb Ha I1X OCHOBe CTaH.llapT
I1CO no ynpaBJ1eHI11O Ka'leCTBOM. npI1 3TOM J1IO.llI1. B35IBWI1eCH 3a pa3-
pa60TKY CTaHllapTa, nOCTaOI1J1I1 3alla l IY C0311aTb 06111I1HlloKYMeHT.

348
FJ1060 14
ill I1pOKI1e cepbI, HaX01l5IlllI1eC5I llalleKO 3a npe.lleJ1aMI1 060POHHbIX
OTpaCJ1eH, YKOMnJ1eKTOBaHbI BbICOKOKBallHI1UHpOBaHHbIMI1 cneUI1allI1-
CTaMI1 3Ha'lI1TeJ1bHO xY)J(e. 3aTo 3TOT pbIHOK OTKpbIT .llJI5I Bcex )J(eJ1alO-
lllHX, B TOM 'lHCJ1e H npOXOilI1MUeB, CJ1eTaIOWI1XC5I CO BCeX CTOpOH Ha
3anaX lleHer.
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J10Cb K pa60Te Ha Cpe.llCTBa KOHCYJ1bTaUHOHHbIX H CepTHI1KaUHOHHbIX
HpM, 3aHHTepeCOBaHHbIX B paCWI1peHHH nOJ15I lle5ITeJ1bHOCTH, )J(eJ1a-
TeJ1bHO 6e3 OC06bIX Tpe60BaHI1H K 3HaHI15IM.
3TO 3allO)J(HJ10 OCHOBY npHHUI1nI1allbHO I1HOro ypOBH5I pa60TbI, 'leM
npI1 C03llaHI1I1 npaBHJ1 GMP 11 CHCTeM Ka'leCTBa B 060POHHbiX OTpaCJ15IX.
B pa3pa60TKe HOpMaTHBHbIX .llOKYMeHTOB I1CO 9000 ,lI,OMI1HHPYIO-
llleH J1HHHeH CTall YXOll OT KOHKpeTHbIX OPMYJ1HpOBOK, CTpeMJ1eHHe K
0606111eHI15IM. 3TO npHBeJ10 K YTpaTe CMbICJ1a.
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npHro.llHblX K HCnOJlb30BaHHIO. I1x HY)J(HO yrMbIBaTb 11 1l0MbICJ1HBaTb.
C03llaBWa51C5I CI1TyaUH5I nOpO)J(DaeT HeOnpelleJ1eHHOCTb, TaK KaK pa3HbIe
JllOllI1 «llOMbICJ1I1BaIOT,) no-pa3HOMY. A eCJ1H 3TH J1Hua - npOH3BOllCTBeH-
HHK 11 HHcneKTOp (aYllI1TOp), TO nO'lBa llJ15I Hellopa3YMeHHH HallHUO.
Ha 3anM npaBHJ1a GMP npHWJ1I1 paHbwe, 'leM CTaHlJ,a(ITbI I1CO 9000.
OCTallbHOH MHp, B TOM 'lHCJ1e H POCCI15I, 3Ha'lHTeJ1bHO OTCTaeT B
OCBoeHHH npaBHJ1 GMP. B 3THX CTpaHax aKTHBHO pa60TalOT nponaraH-
.llHCTbl I1CO 9000 H ycnewHo HX HaCa)J(DaIOT.
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npOH3BOllHTeJ1e J1eKapCTBeHHbIX cpellCTB B OllHOH 113 CTpaH C «pa3BHBa-
lO111eHC51') 3KOHOMHKOH, YBI1lleJ1 y BXOlla Ha npellnpH5ITI1e KpaCO'lHbIi
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nOKa3allO, 'lTO TaM HeT HH OllHOro ::meMeHTa GMP. KOMMeHTapI1H, KaK
roBOpHTC5I, I13JlHWHI1.
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p5ITb I1CO 9000, 'leM rpaMOTHO H ueJ1eHanpaBJ1eHHO OCBaI1BaTb pa60TY
no GMP.
Bo Bcex 3TI1X pa3roBopax BOKpyr Ka'leCTBa 3a6bIBaeTC5I KJIIO'leo.HI
np06J1eMa - om6emcm6ennocmb 3a Ka'leCTBO, T. e. 3a COOTBeTCTl3lIC
npO.llYKUHH 1l0KYMeHTaUHH. 3a HeBbInOJ1HeHHe npaBHJ1 G M P B CTpaHax.
me OHH 06maTeJ1bHbI, npellYCMaTpHBaeTC5I OTBeTCTBeHHOCTb, BnJ10Tb .llO
yroJ10BHOH.
CepmI1KaUI15I no I1CO 9000 HHKaKOH OTBeTCTBeHHOCTI1 HC
npe.llYCMaTpI1BaeT. B pe3YJ1bTaTe MbI Ha Ka)l(JlOM wary 13I1.llHM, lITO
CepTI1HKaT I1CO 9000 Ha CHCTeMY Ka'leCTBa eCTb, a caMoro Ka'leCTBa HeT.
npaKTI1Ke HY)J(HbI SlCHble 1l0KYMeHTbI, SlBJUIIOWHeC5I PYKOBO.llCT130M K
lleHCTBI110 11 H.lnI1CaHHble cneUI1allI1CT<lMI1, 3HalOlllI1MI1 np0I13BOllCTBO I1J
JlJ1lIHOrO onblTa.

06eCne'feHUe KO'feCm60
349
14.5 npHuIUfnbl o6ecne'leUUH K3QeCTB3
06eCne'leHHe Ka'leCTBa J1eKapCTBeHHbIX Cpe.llCTB H J11060H llPyroH
npOllYKUI1I1 OCHOBaHO Ha CJ1ellYlOlllI1X npI1HUHnaX (fOCT P 52537-2006):
I) lJeTKoe OnpelleJ1eHHe 0613annocmeii U omeemcm6ennocmu PYKO-
BO.llI1TeJ1eH 11 Bcex pa60THHKOB npellnpH5ITH5I. nOHI1MaHI1e BceM KOJ1J1eK-
TI1BOM nepBoCTeneHHoH pOJ1H 06eCne'leHH5I Ka'leCTBa.
2) J1.oKYMenmQ./lbnOe otjJopM.IlenUe Bcex npoueCCOB npOH3BOllCTBa H
KOHTpOJ15I Ka'leCTBa B KOHKpeTHoH, I1C'lepnbIBalOweH H nOH5ITHOH llJ15I
Ka)J(Doro pa60THHKa opMe C lleTallH3aUHeH Ka)J(DOH onepaUHH HJ1H
Ka)J(Doro Tpe60BaHH5I TaK, 'lT06bI J11060e lleHcTBHe BbIn0J1H5IJ10Cb B COOT-
BeTCTBHH C llOKYMeHTOM H lleHCTBH5I no YCTHbIM pacnOp5I)J(eHH5IM HJ1H no
JIH'lHOH TpaKTOBKe I1CKJIIO'lallHCb.
3) Op2anU3al{UJI npou360iJcm6a B COOTBeTCTBI1I1 C lloKYMeHTaUI1eH
npellnpH5ITH5I H lleHCTBYlOlllHMH HopMaTHBHbIMI1 .ll0KYMeHTaMH.
4) llpoc.IleJICUeaeMOcmb Bcero npouecca npOH3BO.llCTBa H KOHTpOJ15I
Ka'leCTBa 3a C'leT nO.lln020 iJoKYMenmup06anUJl BbInOJ1HeHH5I Bcex onepa-
UHH H nOJ1Y'leHHbIX pe3YJ1bTaTOB OT npHeMa MaTepHallOB 110 BbInYCKa
npOllYKUHH.
5) KOnmpO.llb I1CXOllHbIX H ynaKOBO'lHbIX MaTepHallOB, npOMeO'l-
HOH H roTOBOH npOllYKUHH B nOJ1HOM COOTBeTCTBI1I1 C YCTaHOBJ1eHHbIMI1
Tpe60BaHH5IMH. I1CKJIIO'leHHe HCn0J1b30BaHH5I HHbIX MaTepHallOB.
6) BbInoJIHeHHe Tpe60BaHHH GMP K nOMeenUJlM, 060pyiJ06anuIO U
npol{eCCllM .llOCTHraeTC5I HallH'lI1eM npoeKma npOH3BOllCTBa, COOTBeTCTBY-
lO111ero HopMaTHBHbIM llOKYMeHTaM, H ero 1l0J1)J(HOH peallH3auHeH.
7) YKOM1l.IleICm06annocmb npOH3BOllCTBa nepCOnQ./lOM, HMelOlllHM He-
06XOllHMYIO nOllroToBKY H llHCUHnJ1HHY.
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HeHHe nepCOHallOM CBOHX 065I3aHHOCTeH, npHKa30B H pacnOp5I)J(eHI1H H
llPymx 1l0KYMeHTOB, a TaK)J(e I1HOpMHpoBaHHe PYKOBO.llCTBa 0 CI1TyaUH-
5IX, CB5I3aHHbIX C HeBbInOJ1HeHHeM nOPY'leHHoro .lleJ1a.
He06xollHMbIM YCJ10BI1eM 5IBJ15IeTC5I ICOnmpO.llb HCnOJ1HeHH5I.
9) llOCmOJlnnblii anQ./lU3 KatteCm6a npoiJYKl{UU, CJ1Y'laeB omK./lonenUJI
om cnel{utjJuKal{uii (DOC) 11 npH'lHH peKJIaMauHti, OpraHI13aUI15I OT3bIBOB
npOllYKUHH, He COOTBeTCTBYlOweH Tpe60BaHH5IM; aHallH3 pI1CKOB 11
onpe.lleJ1eHHe KpI1TH'leCKHX TO'leK, npOBelleHHe caMOHHCneKUI1H, T. e.
HallI1'lHe nOCT05IHHOH 06paTHOH CB5I3I1 Me)J(DY pe3YJ1bTaTaMH pa60TbI, C
OllHOH CTOpOHbI, H TeXH0J10fH'leCKHM npoueCCOM, nepCOHallOM, MaTepH-
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- 'lHCTOTa Ha npe.llnpI15ITI1I1 (TeppI1TOpI1H, B npOH3BOllCTBe, BcnOMO-
raTeJIbHbIX, CKJIMCKHX 11 6bITOBbIX nOMellleHI15IX 11 np.);
- JlI1'lHa5I fHfHeHa, aKKypaTHocTb H np.;
- KYJ1bTYPa B3aI1MOOTHOWeHHH (KoppeKTHa5I pa60Ta PYKOBOllI1TeJ1eH, CO-
3JJ.aHHe 6.rIaronpI15ITHoro nCI1XOJIOrI1'leCKoro MI1KpOK.llI1MaTa Ha Bcex ypOBHIX).

350
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14.6 npH'IHHbl HU3Koro K3'1eCTB3
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HbIX H 3apy6e)J(HbIx np0I13BOilCTB n03B0J1I1J1I1 C(OPMYJ1I1pOBaTb OCHOBHbIe
npH'lI1HbI HI13KOro Ka'leCTBa npOllYKUI1H (B nOTpe6HTeJ1bCKOM CMbICJ1e)
HJ1I1 HeCOOTBeTCTBH5I npO.llYKUI1H JMaHHbIM Tpe6oBaHI15IM (B TeXHJ1lIe-
CKOM 11 npOH3BOllCTBeHHOM CMbICJ1e).
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1 npOU3BO,ll,CTBO
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THH npoH3BollcTBeHHoH nporpaMMe)
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1l0Jl)J(Ha 6bITb CHCTeMa, 06eCne'lHBalOllla5I 06HapY)J(eHHe npH'lHHbI, BI1-
HOBHOro H nOp5IllOK npHBJ1e'leHHH K OTBeTCTBeHHOCTH
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3 nepCOH3JI
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p5IllKa BXOLla B 'lHCTOe nOMellleHHe)
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KYJ1bT III1CTOTbI H nOp5IDKa, 03eJleHeHI1e H 6J1aroycTpoHCTBO TeppHTopHH)
5.2 H I13Ka5I .llI1CUHnJ1I1Ha.

06eCne'feHUe KO'feC/1160
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fOCT P 52537-2006, npHJ10)J(eHHe G, peKoMeHllyeT npellYCMaTpI1-
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npOH3BOllCTBe J1eKapCTBeHHbIX cpellCTB:
I OpraHH33IU10HHble Mepbl
1.1 npl1H5Ime peweHI151. 113J1aHl1e npl1Ka3a;
1.2 <1>opMl1pOBaHl1e COBeTa GMP;
1.3 Pa3pa60TKa 11 YTBep)l(JleHl1e nnaHa-rpa<j)I1Ka;
1.4 <1>opMl1pOBaHl1e nOJll1mKI1;
1.5 Pa3pa60TKa (o<j)opMJIeHl1e) oprCTpYKTypbl;
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JlOfl1'JeCKOH 1l0KYMeHTaUI1I1;
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1.8 aTpa60TKa nOp5lJ1Ka BelleHI151 npoTOKOJIOB cepl1i1;
1.9 nOJ1roTOBKa I1H<j)opMaul1l1 0 npeJ1npl151ml1;
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l.ll a$:>pMJleHl1e CI1CTeMbl CaMOI1HCneKUI1H;
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2.1 3aJ1aHl1e Ha pa3BI1me npoI13BOJ1CTBa (npoeKmpOBaHl1e);
2.2 Pa3pa60TKa npoeKTa;
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2.4 PeaJIl13aUI1H npoeKTa;
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3 AYllHT H nOllfOTOBKa K HHcneKUHH
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Me)J(YTO'lHoti H roTOBOH npollYKUI1H, OTKJIOHeHHH OT cneuHHKaUI1H,
peKJIaMaUI1I1 11 np. He pe)J(e OllHoro pa3a B ro.ll CJ1ellyeT BbInOJ1H5ITb KOH-
TpOJ1b cTa6I1J1bHOCTI1 npenapj:\TOB, npOBOllHTb nJ1aHOBbIe I1CnbITaHI15I 11
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60TbI 11 nJ1aHOM Ha 6YllYWI1H nepI1011.

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TaTOB I1X paCCJ1e.llOBaHH5I 11 oueHKY 3eKTHBHOCTH npe.llnpI1HI1MaeMbIX
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nuii om cneu,ufjJuKau,uii (Out-oj-Specificotion - ODS) nepBOCTeneHHoe
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3TOMY Bonpocy.
B CWA .lleHCTByeT PYKOBOllCTBO FDA no aHallI13Y OTKJIOHeHI1i1 OT
cneumtmKauHti [31]. OHO BKJIIO'laeT B ce65I CJlellYlOlllHe pa311eJ1bI:
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A. AHaJlI13 npOJ1YKUI1I1;
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C. a<j)OpMJleHl1e pe3YJlbTaTOB aHaJll133.
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A. aUeHKa pe3YJlbTaTOB paCCJIeJ10BaHI151;
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C. npen:OCTaBJleHI1e OTlJeTa.
TepMHH «OTKJIOHeHHe OT cneuHcf>HKaUHH') pacnpOCTpaH5IeTC5I Ha Bee
pe3YJlbTaTbI KOHTpOJ15I, KOTopbIe BbiXOll5IT 3a npelleJ1bI cneUHHKaUI1il
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X01l5IlllI1M 3a 1l0nYCTI1Mble npe.lleJ1bI.
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llla51 BHI1MaHl1e Ha Jla60paTopHbie OWI16KI1.
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nYllleHHble cepl1u.
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'JI1HOH OTKJIOHeHI1H.
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He MeHee onblTHblM, 'JeM nepBblH.
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J10Jl)l(Ha 6blTb OTKJIOHeHa I1JII1 3a1J.ep)l(aHa J10 npOBeJ1eHI151 paCCJIeJ100aHI1H.
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DJI51 OueHKI1 Ka'JeCTBa Cepl1l1. TaKoe MO)l(eT 6bITb, Hanpl1Mep, KOma pe3YJlb-
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OWI16KI1. aTJlI1'JI1H MOryT 6blTb CJleJ1CTBl1eM OTKJIOHeHI1H B COCTaBe npoJ1YK-
Ta 11J111 MaTepl1aJ1a.
Jla60paTOpl151 J10Jl)l(Ha I1MeTb MeTOJ1I1KY aHaJlI13a Ha CJlY'JaH pe3KO OTJlI1-
'JalOlllI1XC5I pe3ynbTaTOB. MeTOJ1I1Ka 1I0n)l(Ha 6bITb onpeJ1eJleHa HOpMaTI1BHblM
J10KYMeHTOM, JlI160 pa3pa6aTblBaeTC5I CaMI1M npe.llnpl1HTl1eM. npl1MepoM MO-
)l(eT CJII1Tb MeTOJ1I1Ka KOHTpOJl51 6110JIOm'JeCKI1X npenapaTOB, KOTopaH J1aHa
B CTaTbe (Ill) <):IapMaKOnel1 COeJ1I1HeHHblx WTaToB - USP [54].
V 3aKJIIOQeHHe
no OKOH'JaHI1I1 I1CCJleJ10BaHI151 OTKJIOHeHI1H OT cneUI1<j)I1KaUI1H J10Jl)l(HO
6blTb CIleJlaHO 3aKJIIO'JeHl1e, B KOTOpOM 6blJll1 6bl YKa3aHbl:
- pe3YJlbTaTbI I1CCJIeJ10BaHI151 C YKa3aHI1eM npl1'JI1HbI OTKJIOHeHI1H;
- oueHKa Ka'JeCTBa cepl1l1;
- pellleHl1e 0 BbInYCKe 11J111 OTKJIOHeHl111 cepl1l1.
14.9 TexHoJlofIDI 3HaJlU33 npOu.eCC3 (PAT)
B 2004 r. FDA CiliA H3llalla PYKOBO.llCTBO no meXHO.l102UU anQ./lU3a
npou.ecca - Process Analytical Technology - PAT [32]. PYKOBO.llCTBO 5IBJI5I-
eTC5I 1l06pOB0J1bHbIM llJ15I npHMeHeHI15I, HO, B TO )J(e BpeM5I, OTpa)J(aeT
TO'lKY 3peHH5I FDA Ha llaHHbIH npellMeT. HeCMOTp5I Ha rpOMKoe Ha3Ba-
HHe H MHO)J(eCTBO 06111I1X CJ10B B PYKOBOllCTBe, CYTb PAT npOCTa:
- Ka'leCTBO 3aKJI3llbIBaeTC5I npI1 pa3pa60TKe npOllYKTa 11 TeXH0J10fI1-
'leCKoro npouecca;
- npouecc 1l0J1)J(eH 6bITb YCTOH'lI1BbIM K He3Ha'lI1TeJ1bHbIM I13MeHe-
HH5IM napaMeTpOB;
- He06xo.llI1M HenpepblBHbIH KOHTPOJ1b napaMeTpOB B XOlle npouecca;
- cpellCTBa aBTOMaTI13aUI1I1 .llOJ1)J(HbI 3aWHwaTb npouecc 11 npO.llYKT
OT OWH60K 'leJ10BeKa.
HY)J(HO 3HaTb:
- caM npouecc:
- MexaHH3M HJ1H TeHlleHUI1I1 I13MeHeHH5I napaMeTpOB B XYllWYIO CTO-
POHY, T. e. 3a npelleJ1blllonYCTI1MbIX 3Ha'leHI1H;
- BJ1I15IHHe Ka'leCTBa MaTepI1allOB Ha Ka'leCTBO npOllYKUHH;
- OCHOBHble (KpHTH'leCKHe) npI1'lI1HbI I13MeHeHI15I napaMeTpOB;
- KaK peafI1pyeT npouecc Ha H3MeHeHI15I napaMeTpOB.
PAT COCTOI1T B KOHTpOJ1e KpHTH'leCKHX napaMeTpOB npou.ecca B XO.lle
ero BbInOJ1HeHI15I, a He B KOHTpOJ1e npOilYKUI1I1. TaKoH KOHTpOJ1b MO)J(eT
6bITb HenpepbIBHbIM I1J1I1 nepHOllH'leCKHM. Ero OTJ1I1'lHe OT 06bl'lHOro
nOilXO.lla COCTOI1T B TOM, 'lTO KOHTpOJ1I1pYIOTC5I napaMeTpbl npouecca B
peQ./lbnOM Macwma6e epe.Menu, BJ1I15IIOlllHe Ha Ka'leCTBO npOllYKUI1H, a ne
pe3Y.llbmam npou.ecca - npOMe)J(YTO'lHbIH HJ1H roTOBbIH n POllY KT.

358
FJ1060 14
KOHTpOJlb npouecca MO)J(eT 6bITb OpraHI1JOI33H TpeM5I cnOC06aMI1:
- 6He .IlUHUU (at line), Koma oT6I1paeMmI np06a BbIHOCI1TC5I 3a npe-
IleJlbI 060PYlloBaHI15I .llJ15I aHallI13a; B 3TOM CJ1Y'lae eCTb pI1CK 3arp5I3HeHI151
np06bI oKPY)J(alOllleH cpeIloH, eCJ1I1 He npI1H}ITb CneUI1allbHbIX Mep;
- na .Ilunuu (on-line), Koma aHallI1TH'leCKI1H npI160p nO.llKJIIO'lCH K
JlI1HI1I1 H np06a oT6HpaeTCH 11M HenOCpe.llCTBeHHO 113 060PY.llOBaHI1}I 11
MO)J(eT B03BpalllaTbCH CHOBa B npouecc (npI1 I1Cn0J1b30BaHHI1 6aHnac-
HbIX, T. e. COe.llHHeHHH);
- 6.1lUnUU (in-line), Koma ceHCOp BCTpoeH B caMO 060PYllOBaHI1e.
npHMepbI
l. npl1 npoI13B0J1CTBe mepJ1blX <j)OpM CJle.llyeT npOBO.lll1Tb BHYTpl1npO-
113B0J1CTBeHHbIH KOHTpoJlb oCTaTo'JHoH BJIafl1 B rpaHYJl5lTe, KOTOpblH MO)l(eT
BbInOJlHHTbC5I KaK «Ha JlI1HI1I1'), TaK 11 «B JlI1HI1I1').
2. CTepl1J1I133TOp 1l0Jl)l(eH I1MeTb BCTpoeHHble TepMonapbl J1JlH Henpe-
pblBHOro KOHTpoJl51 TeMnepaTypbI B npouecce CTepl1J1113aUI1I1, T. e. I1MeTb
<j)YHKUI1IO KOHTpoJlH «B JlI1HI1I1').
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pOB, CMeCel1 11 np.
OCHOBHbIe npI1HUl1nbl PAT COCT05IT B CJlenYlOllleM:
- 3HaTb npouecc 11 BbI6paTb KpHTI1'leCKI1e napaMeTpbl, KOTOpbIC
BJ1H5IIOT Ha Ka'leCTBO H YKa3bIBalOT Ha HCCTa6I1J1bHOCTb npouecca;
- opraHH30BaTb KOHTpOJ1b 3THX napaMeTpOB 11 3anI1Cb pe3YJ1bTaTOB;
- opraHH30BaTb CHCTeMY pearHpOBaHI15I Ha BbIXO,ll. napaMeTpOB 3a
1l0nYCTI1MbIe npelleJ1bI. nOHCK H YCTpaHeHHe npH'lI1H. BbI3bIBalOlllHX 3TII
OTKJIOHeH 1151.
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OllH'leCKHH KOHTpOJ1b no Ka3aTeJ1eH, KOTopbIe He nOllJIe)J(aT aBTOMaTH'IC-
CKOMY KOHTpOJ1IO.
Bce 3TO n03BOJl5IeT OnpelleJlHTb I13MeHeHI15I napaMeTpoB:
- npI1 nOJ1Y'leHI1I1 MaTepI1allOB OT pa3Hbix nOCTaBlllI1KOB;
- B XO.lle np0I13BOllCTBa OllHOH cepI1I1;
- npI1 nepexo.lle OT cepI1I1 K cepI1I1.
DJ1aroIlap5I 3TOMY MO)J(HO npOBO.llI1Tb aHallI13 TeH.lleHUI1H, npC.llBII-
IleTb 11 npeIlynpe)J(DaTb BblXOll napaMeTpoB 3a .llOnYCTI1MbIe npe.lleJ1bI. 11_151
TOro, 'lT06bI npaBI1J1bHO nOCTpOHTb PAT, HY)I(HO 3HaTb npouecc. B CBOIO
O'lepeIlb, PAT n03B0J15IeT my6)J(e nOH5ITb npouecc.
BbtnYClC no napllMempllM
npaBI1Jla GMP .llOnYCKalOT B03MO)J(HOCTb BbInYCKa npoIlYKUI1I1 no
napaMeTpaM (npI1J1o)J(eHI1C 17 K rOCT P 52249-2009 [I]). B ncpnyio
OllCpe.llb 3TO OTHOCI1TC5I K np0I13BOllCTBY I1H(I)Y3I10HHbIX pacTBopoB, no.ll-
Jle)l(alllI1X I1HI1WHOH CTepI1J111 JaUI111. BLmycK cepI1I1 MO)l(eT 6bITb pa3-
PCWCH .llO n0J1Y I ICHI151 PC3YJlbTaTOB KOHTpOJl1 CTepI1J1bHOCTI1 no 3H1'ICH 11-
}IM napaMCTpOB - TeMncpaTypLI BHYTpI1 KaMcpbl CTCpl1JlIIJaTOpa B TC'IC-
W1C BCCro 1U1KJIa CTCpI1JlI1Jamm.

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359
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Hap5IIlY C TepMHHoM «BbInYCK no napaMeTpaM') HCn0J1b3yeTC5I TepMI1H
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14.10 KOHTpOJIbHbIe JI36op3TOPH"
npaBI1J1a GMP (fOCT P 52249, 4aCTb I. pa3IleJ1 6) YCTaHaBJlHBalOT
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OpraHI13aUI1I1 pa60TbI, .llOKYMeHTaUI1I1, oT60PY np06, npOBeIleHI1IO I1CnbI-
TaHI1H, nporpaMMe nOCJleIlYlOlllI1X HCnbITaHHti cTa6HJ1bHOCTI1.
Pa60Ta J1a60paTopHH CJlY)J(HT npellMeTOM oco60ro BHHMaHH5I
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- npHMeHeHHe aTTeCTOBaHHblX MeTOllOB 11 060PYlloBaHI15I (maBa II);
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JlI1Tb OT OWI160K B np0I13BO.llCTBe;
- KBallI1I1KaUI15I nepCOHalla 11 .IIp.
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60BaHI15I K KOTOpbIM nOllp06HO H3JlO)J(eHbl B fOCT P 52249. B 20 II r.
PDA I13llallO CneUHallbHbIH TeXHI1'leCKHH OT'leT NQ53 «Guidance for In-
dustry: Stability Testing to Support Distribution of New Drug Products,) «< Py-
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AHQ./lU3 mendenll,uii - OllHa H3 Ba)J(HbIX 3alla'l OTIleJ1a KOHTpOJ15I Ka'le-
CTBa. AHallH3 TeHlleHUI1H npOBO.llI1TC5I Ha OCHOBe aHallI13a nepBH'lHbIX
IlaHHbIX 0 napaMeTpax H nOKa3aTeJ15IX. Ha OCHOBe 3TOro BbI5IBJ15IIOTC5I Y3-
KHe MeCTa, pa3pa6aTbIBalOTC5I npellynpellI1TeJ1bHbIe 11 KOppeKTI1pYlOlllI1e
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KOTopoe HY)J(HO OTJ1I1'laTb OT CJ1Y'laHHbIX K0J1e6aHI1H B npe.lleJ1ax llony-
CTI1MbIX 3Ha'leHHH. AHallI13 TeH.lleHUI1H CJ1ellyeT paCCMaTpHBaTb npH
eJICeZOOnOM anQ./lU3e KalteCm6a.
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npI1 C03IlaHI1I1 11 YHKUI10HI1pOBaHI1I1 CI1CTeMbI PAT nOJle3HbiM
cpeIlCTBOM aHallI13a 5IBJl5IeTC5I I1HopMauI1oHHa5I CI1CTeMa J1a60paTOpI1I1
- Laboratory Information Management System - LIMS. OHa npeIlHa-
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CI1CTCMa LI MS n03B0J15IeT:
- nOBbICI1Tb KalICCTBO aHallI13a .llaHHbIX;
- OnpCIleJ1HTb TCHlleHUI1H I13I\1CHCHI15I napaMCTpOB H pcrJ1("pI1pOnaTb IX;

360
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- npOCJ1e)J(HBaTb pa60TY J1a60paTOpI1I1;
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3Ha'leHH5I np06 11 Y'leTa HX IlBH)J(eHHH B Jla60paTOpI1H.
llp06epKa .Ila60pamopuii
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KJIa.ay I1HCneKTOpa FDA TOMaca ApHcTa (Thomas J. Arista) Ha KOHe-
peHUHH PIC/S B DpaTI1CJ1aBe, 2003 r. «GMP B cfJapMaUeBTH'leCKI1X Jla-
60paTOpI15IX KOHTpOJ15I Ka'leCTBa - B3rJ15IIl I1HCneKTopoB FDA,) «<GMP in
the Pharmaceutical Laboratories for Quality Control - FDA Inspectors
View» ).
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- nOp5I.lI.OK oT60pa np06;
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- nopMOK 06pa60TKH H xpaHeHH5I llaHHbIX;
- aTTecTaUI1IO/KallH6poBKY 060PYlloBaHI15I;
- HCn0J1b3yeMbIe CTaHllapTbI H HCTO'lHHKH I1X nOJ1Y'leHH5I;
- pa60TY nepCOHalla.
nepCOHallY 3MalOTC5I npOCTbIe BonpOCbI:
- 'lTO BbI lleJ1aeTe?
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- MO)J(eTe J1H BbI nOKa3aTb 060PYlloBaHHe, Ha KOTOpOM BbI pa6OTae-
Te, nOMellleHHe H np.?
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BeIleHI1e 1l0KYMeHTaUHH. KaK npaBI1J10, HHcneKTOp FDA 3MaeT HC-
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npOBep5IeTC5I COOTBeTCTBI1e IlaHHbIX, npellCTaBJ1eHHbIX B FDA, II
nepBI1'lHbIX .llaHHbIX no 1l0KYMeHTaUI1I1 npCIlnpI1S1TI15I.

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CTpaXOBbIMI1, CB5I3aHHbIMH C OTKa3aMI1 060PYllOBaH, H5I 6e30nacHocTbIO
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ee nOCTaBI1J111 B HeJ10nYCTI1MOM MeCTe - rpy6a51 OWI16Ka.
2. B fJlaBe I roBOpI1TC5I 0 npeJ1npI1HTI1I1, B KOTOpoM BO BpeM1 naBOJ1Ka
BOlla nO.llHI1MaJlaCb BbIwe ypOBHH nOJla (3J1aHl1e HaX0J1I1J10Cb B 30He pa3JII1na
peKI1). 31"0 O'JeBI1J1HbIH pl1CK 11 YCTpaHeHl1e ero TaK)l(e O'JeBI111HO: pa3Me-
lllaTb np0l13BOllCTBO B 30He 3aJ111BHbiX JlyroB HeJlb3H.
ECTb llPyrHe cHTyaUI1I1 - neOlte6udHble, Koma npI1'lI1Ha 5IBJ151eTC1
CKpblmoii 11 Tpe6YIOTC5I my60KI1e 3HaHI151 11 CneUI1allbHbIe MepbI 3alllHTbl.
npHMepbl:
1. anaCHblM C06blTI1eM 51BJ151eTC5I HaJll1'Jl1e OCTaTKOB J1eTepreHTOB (Jl)-
10111I1X CpeJ1CTB) B npO.llYKUl111 113-3a nJlOXOH npOMblBKI1 060PYllOB<IHIUI.
npoueCC npOMblBKI1 npOCT TOJlbKO Ha nepBblH B3fJ1HJ1. B 060PYJ10BaHI1I1 1\10-
ryT 6blTb CKpblTble 11 TPYJ1H0J10cTynHble MecTa, B KOTOpblX Moryr CKanJIII-
BaTbC5I 3arp5l3HeHI1H 11 .lleTepreHTbl. 4T06bl I1CKJ1IO'JI1Tb I1X nOnaJ1aHHC n
npOJ1YKT, HY)I(HO p,l3pa60TaTb npouecc O'JI1CTKI1. KOTOpblH 06ecne'JI1B<Ul 61>1
HaJ1e)l(HOe YJ1aJ1eHl1e J1eTepreHTOB, 11 3KCnepl1MeHTaJlbHO J10Ka3aTb, lITO OH
rapaHTl1pYeT HY)I(HYIO 'JI1CTOTY, T. e. aTTeCTOBaTb npouecc (rJlaoa 10).
2. a6H3aTeJIbHbiM Tpe60oaHI1eM K CTepl1J1bHblM JleKapCmeHHblM cpCJl-
CTBaM 51BJI5IeTC5I I1X CTepl1J1bHOCTb, T. e. OTcyrcTOl1e )l(I1BbIX 11J111 )l(113HeCnO-
C06HblX OpraHI13MOO. Lln51 HalIe)l(HOH CTepl1J1I1JaUI1I1 napOM Tpe6yeTc1 nl>l-
J1ep)l(Ka npOllYKTa npl1 TeMnepaType 121T B Te'JeHl1e 15 I\1I1H. [10]. Ho npo-
J1YKT nOMeweH B ynaKOOKY, KOTOpa}l npenHTcTByeT nporpeBY, H ynaKonOI<.
MO)l(CT 6bITb MHOro. K3K 06eCne'II1Tb paBHoMepHblH nporpeu 11 UbInOJlHCHIiC
YCJlOIUlH CTepl1JII13aUHII B caMOH XOJlOLlHOH TO'IKC KaMepbl 11 BHyrpl1 YlIa-
KonKII'! KaK HaHTI1 .ny TO'IKY? 3TI1 11 lIpyme nonpOCbl pelllalOTCH npl1 pa j-
pa60TKc npouecca CTCpHJU13aUI1I1, ero I1CnblTaHlUlX 11 1I,UleKO HC O'leUHJ1Hbl.

AHOJ1U3 PUCK06
363
Bo BCeX nO.ll06HbiX CJ1Y'laHX Tpe6yeTcH IleTallbHblH aHallHJ B03MO)J(-
HblX npI1'lHH OnaCHbIX cHTyaUI1H H pa3pa60TKa CneUI1<lJ1bHbIX Mep npe-
llynpe)J(DeHI15I 11 3aWHTbi.
06eCne'leHI1e 6e30naCHOCTI1 B HeO'leBI1llHbIX CJ1YlJa5IX Tpe6yeT JHa-
HI1H, 3aHI1MaTbC5I 3TI1M MOrYT TOJ1bKO CneUHallI1CTbI. nOBepXHOCTHbIH
nO.llXO.ll, 6e3 .llOCKOHallbHOro nOHI1MaHHH npouccca B03HHKHOBeHI15I
OnaCHOH CI1TyaUI1I1 caM no ce6e onaceH. llalleKI1H OT KOHKpeTHOH cne-
UHallbHOCTH 'leJ10BeK He 3HaeT 11 MallOH TOJ1I1KI1 np06J1eM, CJlO)f(Hble Be-
lllI1 eMY Ka)J(YTC5I npOCTbIMI1 no npI1'lI1He HeKOMneTeHTHOCTI1 11 orpaHH-
'leHHOCTI1 KpyroJOpa. OH CTaHOBHTC5I onaceH, Koma ero peKOMeH.llaUI1I1
BOCnpI1HI1MaIOTC5I Bcepbe3, a TeM 60J1ee HaCa)J(DaIOTC5I IlJl5I npI1MeHeHI1H.
Palpa60mKa UJlU cepuiinoe npou36oocm60
AHallI13 pI1CKa MO)J(eT npOBOllI1TbC5I B nepcneKmU6nOM n./lalle, Koma
'leJ10BeK (I1J1I1 J11060H IlpyroH )J(HBOH opraHH3M) OueHI1BaeT CI1ryaUI11O
npeJICde, 'leM COBepWHTb neHCTBI1e. BOIlI1TeJ1b aBToM06I1J15I nOCT05IHHO
npI1HHMaeT peWeHH5I, oueHHBa5I 6bICTpO MeH5IIOlllYlOC5I 06cTaHoBKY, KOW-
Ka He CTaHeT eCTb KOpM, nOKa He y6ellI1TC5I B ero 6e30naCHOCTI1, 11 T. ll.
B nOCJ1e.llHee BpCM5I TepMI1H «aHallH3 PI1CKOB') CTallI1 npI1MeH5ITb K
llI1arHOCTI1Ke OTKa30B TeXHI1'leCKI1X CHCTeM, nOHcKY npI1'lHH OWI160K H
Bo06111e K YJlCe c6epwu6wUMCR onaCHblM CI1TyaUH5IM. 3TO I1CKYCCTBeH-
HbIH npI1eM. Koma C06bITI1e CBepWI1J10cb. aHallH3I1pOBaTb pHCKI1 He'lero.
HY)J(HO YCTaHOBI1Tb H YCTpaHI1Tb npI1'lI1HY OTKJIOHeHI1H OT HOpMbI 11 He
llonYCKaTb ero nOBTOpeHH5I. BewH HallO Ha3bIBaTb CBOI1MH HMeHaMI1:
nOI1CK 11 YCTpaHeHI1e OTKa30B, 06HapY)J(eHI1e CKpbITbIX IleeKToB 11 T. ll.
LI.n5I npeIloTBpallleHH5I OTKaJOB 11 onaCHbIX cHTyauHH npoBOIlHTC5I
aHallI1J npowJ1oro OnblTa, paCCJ1e.llOBaHHe CBepWHBWHXC5I C06bITHH.
OnacHbIe cHTyaUI1I1 llOJ1)J(HbI I1CKJIIO'laTbC5I KaK IlJlH HOBbIX TeXHI1'lC-
CKHX Cpe.llCTB Ha CTMI1I1 I1X palpa60mKu, TaK H IlJ151 I13BeCTHbIX npoI1J-
BOIlCTBeHHbIX CI1CTeM, KOMnJ1eKTyeMbIx cmandapmnblM 060Pyo06anUeM.
B nepBoM CJ1Y'lae, llO nOCT<lHOBKI1 113.lleJlI15I Ha npOI1JBOllCTBO, BbI-
n0J1H51IOTCH HaYIIHO-I1CCJ1ellOB<lTeJlbCKI1e 11 onbITHo-KOHCTPYKTopCKI1e
paJpa60TKI1, I1JroTaBJ1HBaIOTC5I MaKeTHbie 11 onblTHble 06pa3ubI, 3aTeM
YCTaHOBO'lHbIe cepHH. Ha Ka)J(DOM 3Tane npOB01l5ITC51 I1CnbITaHI15I, KOTO-
pbIe 1l0J1)J(HbI BbIHBI1Tb HeCOOTBeTCTBI15I JMaHHbIM Tpe60BaHH5IM.
Bo BTOpOM CJ1Y'lae pa3pa6aTbIBaeTC5I npoeKT B COOTBeTCTBI1I1 C .lleH-
CTBYlOlllI1MI1 HOpMaMI1 C npI1MeHeHl1eM, KaK npaBI1J10, cmandapmll020
060PYIlOB<lHI15I. PI1CKI1 y)J(e Y'lTeHbl B HOpl\IaTHBHbIX 1l0KYMeHTax. 3aIla'la
npoeKTHoH opraHH3aUI1I1, a JaTCM CTpOI1TeJ1eH 11 np0I13BO.llCTBeHHI1KOB -
BbInOJ1HHTb HOpMbI. 3a 3TI1M CJ1e.llHT HM30pHbie OpraHbI. 4TO OCTaeTCH
Ha ,lI,OJ11O aHalll13a pI1CKOB? HCYIITeHHble HOpM<lTI1BHbIMI1 1l0KYMCHTaMI1
CI1TyaUI1I1'? MO)l(eT 6blTb. Torila 06 3TOM HY)l(HO IleTKO 11 5ICHO CK<uaTb 11
npCll.JIO)J(I1Tb PCWCHI1C 3Ma l ll1.

364
[;1060 15
06J13ameAbHocmb U d06p060.llbHOCmb
B np0I13BOllCTBe J1eKapCTBeHHbIX cpeIlcTB npI1MepaMI1 pHCKOB MOfYT
CJ1Y)J(I1Tb nepenYTbIBaHI1e npO.llYKUI1H, I1Cn0J1b30BaHI1e Hero.llHbIX MaTe-
pHallOB, 3arp5I3HeHI1e npO.llYKUI1I1 H MHoroe Ilpyroe, 'lTO MO)l(eT HaHeCTI1
Ylllep6 nOTpe6HTeJ1lO.
npI1'lI1HaMH pI1CKOB MOrYT 6bITb HellOCTaTKI1 B KOHCTPYKUI1I1 060-
pY.llOBaHHSI H ero OTKa3bI, oWH6KH 'leJ10BeKa, HenpaBI1J1bHa5I nJ1aHI1pOBKa
nOMellleHI1H 11 np.
Pa60Ta Bcex CJ1Y)J(6 npeIlnpI15ITI15I, pa3pa60TlII1KOB npoeKTa 11 np0I13-
BOD.HTeJ1eH 060PYlloBaHI15I HanpaBJ1eHa Ha TO, 'lT06bI UCK.IllOlfUmb pUCK
HJ1H CBeCTH ero K MHHHMYMY TaK, 'lT06bI 3Ha'leHHH KpHTI1'leCKI1X napa-
MeTpOB He BbIXOllHJ1H 3a npeIleJ1bI 1l0nYCTHMbIX 3Ha'leHHH.
Ha 3TOM CJ1eJlaeM naY3Y 11 nOJ1YMaeM: a limo 3iJeCb H06OZ0?
Ha I1CKJIIO'JeHl1e pl1CKa DJI51 'JeJlOBeKa HanpaBJIeHbl npaBI1J1a G M p.
HOpMbl 11 CTaHJ1apTbl, B TOM 'JI1CJle CYllleCTBOBaBllll1e 3allOJlro no G M P. B
'JeM )l(e Toma HOBI13Ha 11 aKTYaJlbHOCTb aHaJlI13a pl1CKOB 11 eCTb JlI1 OHa BO-
06111e?
MO)l(eT 6blTb aHaJlI13 pl1CKOB - TOJlbKO BbIBeCKa, I1CKYCCTBeHHO CO-
3J1aHHa5I Jll1uaMI1, 3apa6aTbiBalO1lll1MI1 Ha HeH, a Bce OCTaJlbHbie ero 6e3J1YM-
HO npI1MeH5IIOT, He BJ1aBa5lCb B CYTb 11 BbInOJlH5I5I Tpe6oBaHI151 «Hall30PHbIX')
opraHOB, KOTOpblM Jlef'Je BOCnpl1HI1MaTb OT'JeTbI no aHaJlI13Y pI1CKOB, LJeM
npOBOJ1I1Tb I1HCneKUl111 no CYllleCTBY?
nonp06yeM pa306paTbC5I, CTapa5lCb HaHm I1CTI1HY, a He I1CXOJ1H 113
YCTaHOBKl1, 'JTO MeTOJ1bl aHaJlI13a pl1CKOB HY)l(HO BHe.llp5lTb BO 'JTO 6bl TO HI1
CTaJlO. nopa pa60TaTb OCMbICJIeHHO, I1Ha'Je Mbl On5lTb CKaTI1MC5I K J10rMaM 11
nYCTOMY <j)opMaJlI13MY Tl1na COUCopeBHOBaHI1H 11J111 BCTpe'JHbIX nJlaHOB 113
He O'JeHb J1aJ1eKoro npoWJIoro 11 6YD.eM 3aHI1MaTbCH I1J1JI10311ei1 neJIa BMeCTO
caMoro neJla.
B CcPepy IleHcTBHH G M P BX01l5IT, KaK npaBI1J1o:
- HeO'leBI1llHbIe C06bITI1S1 11 CJ1O)J(HbIe npoueccbI;
- cepHHHoe npoH3BollCTBO, a He HOBbIe pa3pa60TKI1;
- 065I3aTeJ1bHbIe Tpe60BaHH5I, HanpaBJ1eHHbIe Ha 06eCne'leHHe 6e3-
onaCHOCTH.
PeallbHbIH pHCK I1CXOllHT OT nJ10xoro 060PYD.OBaHH5I, nJ10xoro npo-
eKTa, HeroIlHbIx MaTepI1allOB H np. Ho 3TO - 06J1aCTb IleHCTBH5I npaBiU
GMP 11 3arpOMO)J(DaTb ee 6eCn0J1e3HbIMI1 nOHSlTHSlMI1 HeJ1b35I.
OTnpaBHOI1 TOIIKOH SlBmleTC5I YCTaHOBKa:
/.(.IlR .IleKapCm6eHHbLX cpeocm6 HUKaKoii pUCK He oonycmUM!
fOTOB5I peKOMeHIlaUI1H no aHallI13Y pI1CKOB, HY)J(HO I1CXOllI1Tb Ii3
3TOH YCTaHORKI1 11 YIIHTbIBaTb cneUI1I1KY npOH3BOIlCTBa J1eKapCTBeHHbl"
Cpe.llCTB.
nOCMOTpHM, lITO CIleJ1aHO B D.CHCTBHTeJ1bHOCTI1.

AHOJ1U3 PUCK06
365
15.2 AH3JlH3 pHCKOB no rOCT P 52249-2009
fOCT P 52249-2009 5IBJ15IeTC5I H.lleHTH'lHbIM nepeBOllOM npaBHJ1
GMP EC C OllHI1M I1CKJIIO'leHI1eM. B GMP EC roBOpI1TC5I 06 aHallH3e
pHCKOB B IlBYX MeCTax:
- 4acTH I OCHOBHOro TeKCTa (n.n. 1.5 H 1.6);
- npHJ10)J(eHHI1 20 «AHallH3 pHCKOB llJl5I Ka'leCTBa,) (Tenepb 4acTb III).
B fOCT BKJIIO'leHbI TOJ1bKO nYHKTbI 113 OCHOBHOH 'laCTI1, a npI1J10-
)J(eHI1e 20 onYllleHO BBI1llY ero HeKOHKpeTHOCTH, HenpI1rollHOCTI1 K npaK-
TI1'leCKOMY npI1MeHeHHIO, pe3KoH KPHTHKH co CTOpOHbl cneUl1allI1CTOB, B
TOM 'lI1CJ1e 3apy6e)J(HbIX, H OTCYTCTBHSI npHMepOB npHMeHeHI15I.
faCT P 52249-2009, 4aCTb I roBOpl1T:
n. 1.5. AHaJlI13 pl1CKOB 51BJlHeTC5I CI1CTeMaTI1311poBaHHbIM npoueCCOM
OueHKI1, npI1H5ITI1H peWeHI1H 11 Mep, CB5I33HHbIX C pI1CKaMI1, BJII151I0111I1MI1
Ha Ka'JeCTBO JleKapCTBeHHoro CpeJ1CTBa. aH MO)l(eT npOBOJ1I1TbC5I KaK B nep-
CneKTI1BHOM, TaK 11 B peTpocneKTI1BHOM (Ha OCHOBe npeJ1WeCTBYlOllll1X J1aH-
HbIX) nJlaHe.
1.6. CI1CTeMa aHaJlI13a pl1CKOB lI.OJl)l(Ha o6ecne'JI1BaTb:
- oueHKY pl1CKa J1J151 Ka'JeCTBa, OCHOBblBaHCb Ha HaY'JHOM nOllxone,
onblTe pa60Tbl 11, B KOHe'JHOM C'JeTe, I1CX0J151 113 3allll1Tbl nOTpe6I1TeJl5l;
- COOTBeTCTBl1e npl1HI1MaeMblX Mep 11 CTeneHb J10KYMeHTaJlbHoro
o<j)opMJleHI151 npouecca aHaJll133 xapaKTepa pl1CKa.
CMbICJ1 n. 1.5. 5ICeH, 3TOT nYHKT nOBTOp5IeT IlPYfI1MI1 CJ10BaMI1 CYTb
GMP. UeJ1blO npaBHJ1 GMP 5IBJl5IeTC5I 06eCne'leHI1e 6e30naCHOCTI1 J1e-
KapCTBeHHbIX cpellCTB, BKJIIO'la5I oueHKY, npHH5ITHe Mep 11 llOKYMeHTallb-
Hoe OcPopMJ1eHI1e. BHTHeBaToe 3a5IBJ1eHI1e 0 cHCTeMaTI13I1pOBaHHoM npo-
uecce HH'lero He ll06aBJ15IeT: pa3Be npaBHJ1a GMP - He CI1CTeMHblti .llO-
KYMeHT, a I1X C031laHHe H BbInOJ1HeHI1e He 5IBJl5IeTC5I CI1CTeMaTI13HpOBaH-
HbIM npoueCCOM? «HaY'lHOCTb') npell11araeMblX nOllXOllOB - TeMa ll1151
oc060ro pa3roBopa.
nYHKTbI 06 aHallH3e pHCKOB fOCTa HOC5IT 06uii xapaKmep H ne YKa-
3bl6alOm Ha npHMeHeHHe KonKpemllblX Memod06 aHallI13a pI1CKOB. npeIlnpI1-
5ITHe caMO BbI6I1paeT, liTO 11 Koma aHallI13I1pOBaTb 11 KaK 3TO .lleJ1aTb.
15.3 np3BHJl3 GMP EC H PYKOBO,ll,CTBO ICH Q9
LJ.0 HeilaBHero BpeMeHH B COCTaBe npaBHJ1 G M P EC 6bIJ10 npHJ10-
)J(eHHe 20 «AHallH3 pHCKOB ll1151 Ka'leCTBa». OHO npellCTaBJ15IJ10 C060H
TeKCT PYKOBollcTBa 1 CH Q9 C aHallOrI1'lHbIM Ha3BaHHeM [38]. B 2010 r.
3TO npHJ10)J(eHI1e nepeHeCJ1H B COCTaB BHOBb 06pa30BaHHoH 4aCTI1 III
GMP EC «lloKYMeHTbI, OTHOC5IUlI1eCI K GMP», 'lTO He MeHSIeT CYTI1.
KaK CJle.llyeT 113 Ha3BaHI15I, 4aCTb III He BXOIlI11 B COCTaB npaBI1J1
GMP, a JlI1Wb OTHOCI1TC5I K HI1M. Bo BBe.lleHI1I1 K npaUI1J1aM GMP EC
CKa3aHO, lITO 3TOT pa31leJl BKJIlOllaeT «JlY I IWI1H onbIT') 11 OTpa)J(aeT «0)J(I1-

366
f.J106a 15
.llaHI1e I1HCneKUI1H'), a npI1MeHI1MOCTb MeTO.llOB YKa3aHa B CaMI1X PYKO-
BO.llCTBax.
BbI60pO'lHbIH aHallI13 3TOro «JlY'tUlei!O O/lb/mo» nOKa3all J1I160 ero a6-
cypdnocmb (nOJ1HYIO HeJlenOCTb BbIBOIlOB), J1I160 mpU6UQ./lbnOCmb, Koma K
nOJ1Y'leHHOMY C nOMOlllblO «HaY'lHoro MeTO.lla,) BbIBO.llY MO)l(HO npI1HTH
OIIeBH.llHblM nYTeM. 6e3 )l(OHrJlI1pOBaHI1I opMYJ1aMI1 11 CI1MBOJ1aMI1 (CM. n.
15.6).
nO.ll'lepKHeM, 'lTO B EBpone MeTO.llbI aHallI13a pHCKOB ne Jl6.1lJllOmCJI
06J13ame.llbnbLMU llJ15I npI1MeHeHH5I. 3T0 CKa3aHO B npaBHJ1aX GMP, 3TO
'leTKO pa31>5ICHeHO B nI1CbMe EBponeHcKoro areHTCTBa no J1eKapCTBeH-
HbIM cpeIlCTBaM (Europeo/l Medical Age/lcy) OT 31 f1HBap5I 20 II r.
EMA/INS/GMP/79766/2011. PYKOBO.llCTBO ICH Q9 TaK)J(e He f1BJ15IeTC5I
065I3aTeJ1bHbIM.
PYKOBOIlCTBO ICH Q9 roBopm, 'ITO aHallH3 pI1CKOB:
- nOMoraeT pa306paTbC5I B npouecce;
- n03B0J15IeT HaHTI1 npI1'lI1HY OTKa3a;
- n03B0J15IeT OTIleJ1I1Tb maBHoe OT BTopOCTeneHHoro H npI1H5ITb npa-
BHJ1bHOe peweHHe.
3TO - MHoro06elllalOlllee 3a5IBJ1eHHe.
D.allee OHO IlaeT HenOJ1HbIH nepe'leHb MeTOllOB aHallI13a pI1CKOB:
.0CHOBHbIe MeTO.llbI aHallI13a pHCKOB (llI1arpaMMbI nOTOKOB, KOH-
TpOJ1bHbIe J1HCTbI 11 np.);
. AHallI13 BHIla 11 nOCJ1e.llCTBHH OTKa30B (Failure Mode O/ld Effects
A/lolysis - FMEA);
. AHallH3 BHlla, nOCJ1ellCTBHH H KpI1TH'lHOCTH OTKa30B (Failure
Mode, Effects o/ld Criticality A/lolysis - FMECA);
. AHallI13 .llepeBa OTKa30B (Fault Tree A/lolysis - FTA);
. AHallI13 pI1CKa B KpI1TI1'leCKI1X KOHTpOJ1bHbIX TO'lKaX (Hazard
A/lolysis o/ld Critical CO/ltrol Points - HACCP);
. AHaJ1I13 onaCHOCTH 11 pa60Tocnoc06HoCTH (Hazard Operability
Analysis - HAZOP);
. npellBapI1TeJ1bHbli1 aHaJ1I13 onaCHOCTI1 (Preliminary Hazard
Analysis - PHA);
. PaH)J(I1pOBaHI1e 11 OTceHBaHHe pHCKOB (Risk ranking and jiltering);
. BcnOMOraTeJ1bHbIe CTaTI1CTH l leCKI1e MeTOllbI (Supporling statistical
tools).
Bce 3TO nOllaeTC5I KaK HaY'lHbIH 11 CI1CTeMHbIH nOIlXOll.
PaCCI\10TpI1M ero nOIlp06Hee, no cxeMC:
- CMbICJ1 npe.llJ1o)J(eHI1H;
- npaKTI1'lCCKI1e npI1Mepbl;
- OUCHKa MeTO.llOB.
«OCHOBHbIC') MeTO.llbl paCCMOTpCHbI B n. 15.4, «llPyrI1e,) - B n. 15.5.

AH0J1U3 PUCK06
367
15.4 «OCuoBUble,) MeTO,ll,bl 3U31IH33 pnCKOB
nOMellleHHbIe B 3TOT pa3IleJ1 MeTOllbI 5IBJ1HIOTC5I OCHOBHbIMI1 comac-
HO ICH Q9. OCTallbHbIe, HaBepHoe, 5IBJ1HIOTCH BTopOCTeneHHbIMI1.
K OCHOBHbIM OTHOC5ITC5I «npocmble Jllemoobl. 06bl'1HO ucnOJ1b3yeMbie
OAR cucmeMomu30u,UlI OOHHbIX. cmpYKmypup060HUR p060mbi U 06J1ei!'1eHlIR
npUHRmUR peweHUU»:
- cxeMbI nOTOKOB;
- KOHTpOJ1bHbIe JlHCTbI;
- KapTbI npouecca;
- llI1arpaMMbl npI1'lHH H CJlellCTBHH, Ha3blBaeMbIX TaK)J(e IlI1arpaM-
MaMI1 I1CI1KaBbI I1J1I1 «pbI6b5I KOCTb').
CxeMbi nomOK06
CxeMbI nOTOKOB (flow charts) nepCOHalla, MaTepI1allOB, npOMe)J(YTO'l-
HOM H rOTOBOH npOllYKUHI1 BXOllHT B TeXH0J10rI1'leCKI1H pa3lleJ1 npoeKTa
npOH3BOllCTBa. CxeMa TeXHOJ1Of\1IIeCKHX nOTOKOB npe.llCTaBJlHeT C060M
nJ1aH nOMellleHHH C HaHeceHHeM nOTOKOB. TaM, me np0I13BOllCTBO no-
CTpoeHo no xopoweMY npoeKTY, a He no OTIleJ1bHbIM J1HCTKaM, IlallbWe
IleJ1aTb HI1'lerO He HY)J(HO - npellMeTa llJI5I aHallH3a HeT. ECJ1H npoeKTa
HeT, a npoH3BoIlCTBO KaK-TO pa60TaeT, 3TO IleHCTBHTeJ1bHO pHcKOBaHHa5I
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06XO.llHMbie pa3.lleJ1bI 11 npOBepI1Tb np0I13BO.llCTBO Ha COOTBeTCTBHe GMP.
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HI1 npI1 ..eM. HanpI1Mep, B KOHTpOJ1bHOM JlHCTe CJ1eBa MOfYT YKa3blBaTb-
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He 3HaJlI1, 'JTO OHI1 nOJlb3Y1OTC5I MeT0J10M HACCP. I1H)I(eHepbl npOCTO J1eJIaJll1
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npoeKTl1poBaHl111 CJIO)l(HblX 06DeKTOB.
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npH'lHHbI, HO HeKoTopbIe npeIlycMaTpHBalOT KOJ1H'leCTBeHHYIO oueHKY
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llallbHeHWHe lleHcTBHH HJ1H HeT.
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I. Bce pI1CKH rpynnHpYIOTC5I no KpHTepI15IM oueHKH:
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. B03MO)J(HOCTI1 06HapeHH5I - Detectobility (D).
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MapKHpOBKe, npHMeHeHH5I nJ10xoro MaTepI1alla I1J1H MHKp06HOro 3arp5I3-
HeHI15I? 3TO Bce - pHCKI1.
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pa60TY, H 3aMe'laHI15I OTHOCHJ1HCb K TeM, Y KOro IleJ1a COBceM nJ10XH.
Ha TOH )J(e KOHepeHuHH paccMaTpHBallC5I nOp5IIlOK npOBeIleHI15I
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pacn0J10)J(eHHbIX B pa3HbIX 'laCT5IX CBeTa. COCT05IJ1C5I 06MeH MHeHI15IMI1.
3TOT HHcneKTOp npOBOIlI1T Ha npe.llnpI1HTI1I1 CTOJ1bKO BpCMeHI1,
CKOJ1bKO HY)J(HO, 6YIlb TO IlBe HeIleJ1I1 11J1I1 60J1ee. OH Ha'lI1HaeT C TOro, 'lTO
CMHTC5I 3a CTOJ1, pacnOJ1araeTC5I OCHOBaTeJ1bHO 11 npOCI1T IlaTb eMY npoeKT,

382
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HanpI1Mep, CXeMbI nOllroToBKH BOllbI. llallee OH war 3a waroM, KJIanaH 3a
KJIanaHOM, WOB 3a WBOM npOBep5leT cxeMbl, I1X I1CnOJlHeHHe, npOTOKOJ1bI
HCnbITaHHH - Bce, 'lTO OTHOCI1TC5I K nO.llroToBKe BO.llbI. Ha 3TO TpaTI1TC5I
CTOJlbKO BpeMeHI1, CKOJ1bKO HY)J(HO, a He CKOJ1bKO BbIlleJ1eHO.
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npH'leM He TOJ1bKO 3HaeT, HO H YMeeT OTJ1I1'lI1Tb XOPOWHH WOB OT nJ10-
xoro. OH CMOTpI1T nepBI1'lHbIe 1l0KYMeHTbI, npOBepHeT HX npaBI1J1bHOCTb,
nOTOM CMOTpI1T npOTOKOJ1bl I1CnbITaHI1H H npOBepHeT COOTBeTCTBI1e 060-
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HMHIl)J(, HX He npOBeIleWb ropaMI1 6YMafI1.
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OTMe'lY, 'lTO 6bIJ1a He TOJ1bKO 060CTpeHHa5I peaKUH5I, 6bIJ10 YBa)J(eHI1e K
HHCneKTOpy, ero npocf>eccHOHallI13MY, 3HaHHIO npOH3BOllCTBa H YMeHHIO
HaHTH np06J1eMHbIe MeCTa.
nOH5IB Bce 3TO, CTaHOBI1TC5I 5ICHbIM, nO'leMY FDA llOBep5leT J1HWb
llBYM-TpeM HHCneKUI15IM EBponbI, a KaHMa He 1l0Bep5IeT BOBce H nOCbI-
J1aeT TYlla CBOHX I1HCneKTopOB Ka)J(DblH pa3, Ha K3)J(DOe npellnpH5ITHe.
HaM TO)J(e He CJ1eIlyeT 1l0sepSITb I1HCneKTOpaM, KOTopbIe 33 IlBa-TPI1
IlH5I npoBep5IIOT npeIlnpHSITI1e no CTonKaM 6YMafI1 Ha TeMY aHallI13a pI1CKOB.
15.9 P3QHOHaJlbHblH CMblCJI B 3HaJlH3e pHCKOB
CKa3aHHoe .llO CI1X nop KaCallOCb aHallI13a CJ10)J(I1BWeHC5I CI1TyaUI1H.
A KaK 6bITb npOH3BOIlCTBeHHI1KaM, KOTOpbIM HY)J(HO BbInOJlHSITb
HopMaTHBHble Tpe60BaHHI?
B llOJ1roBpeMeHHoH nepcneKTHBe HY)J(HO 1l06H, BaTbC5I 'lT06bl a6-
CYP.llHbIX HOpM He 6bIJ10. K CO)J(alleHI1IO, H3 npeIlnpH5ITH5IX eCTb J1IO.llIl.
KOTopbIe CaMI1 npe.llnO'lI1TaIOT np5lTaTbC5I 3a Ha.llYM3HHbIMI1 MeT01l31\HI.
nI1CaTb 6YMafI1 Jler'le, 'leM JaHI1M3TbC5I lleJlOM no CYllleCTBY. PelJb He 0
HI1X. HaM BceM HY)J(HO JaHHMaTb aKTHBHYIO n03I1UHIO H ll06HBaTbcsi
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A 'lTO .lleJ1aTb Y)J(e CeH'laC, KOJ1b CKOpO Tpe60BaHI1e aHaJ1H33 pl'IC-
KOB eCTb?
npe)J(De Bcero, HY)J(HO I1MeTb B BI1llY, 'lTO eCTb TOJ1bKO caMO Tpc6o-
BaHI1e 06 aHaJlI13e pI1CKOB, a 06H3,neJ1bHbIX MeTOllOB HeT. npeIlnpI151T1I
caMO BbI6I1paeT, KaK npOBOIlI1Tb aH,UlI13 pI1CKOB, MO)l(HO npCIlJlO>KHTb 11
c06CTBeHHbIH nO.llXOll.
Pa3 TaK, TO B aH,Ull'l3C pI1CKOB HY>KHO HaHTI1 paUI10H,UlbHbIH CMbICJI.
3TOT CMblCJI pa3J\H'JaCTCH llJl5I .llCHCTBYlOlllI1X 11 C03.llasacMbIx np0I13BOllCTI3.

AHOJ1U3 PUCK06
383
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HY)J(HO C.lleJ1aTb CJ1e.llYlOlllee:
I. npOBeCTI1 oueHKY COOTBeTCTBI15I np0I13BO.llCTBa Tpe60BaHI15IM
GMP. 3TO MO)J(eT 6bITb BHYTpeHHI1H aY.llI1T C npI1BJ1e'leHI1eM, eCJ1I1 HY)J(-
HO, CTOpOHHI1X CneUHallHCTOB no OT.lleJ1bHbIM BonpocaM. ECJ1H npe.llnpI1-
5ITI1e caMO He MO)J(eT npOBeCTI1 TaKOH aHallH3, HY)J(HO npI1maCHTb aY.llH-
Topa co CTOpOHbI. rJ1aBHOe, IIT06bI aYllI1T He 6bIJ1 nOBepXHOCTHbIM I1J1I1
HeKOMneTeHTHbIM. B 3TOM COCTOI1T pI1CK npI1 npI1rJ1aWeHI1H CTopOHHeH
HpMbI, 11 ero HY)J(HO CBeCTI1 K MI1HI1MYMY.
no pe3YJ1bTaTaM aYllHTa HY)J(HO caMHM nOH5ITb, MO)J(eT J1H lleHcrBY-
IOlllee npOH3BOllCTBO 6bITb npHBelleHO B COOTBeTCTBHe C Tpe60BaHH5IMH
GMP HJ1H HeT. ECJ1I1 MO)J(eT, TO CJ1ellyeT COCTaBHTb nJ1aH OpraHI13aUI10H-
HO-TeXHH'leCKI1X MepOnpI15ITI1H co cpOKaMH BbInOJ1HeHI15I H He06xOllH-
MbIMH pecypcaMH. CpOKH 11 pecypCbI llOJ1)J(HbI 6bITb peallbHbIMH.
ECJ1H npOH3BOllCTBO 6e3Halle)J(HO 11 ero HHO peKOHCTpYI1pOBaTb
I1J1I1 CTpOI1Tb 3aHOBO, TO CJ1ellyeT oueHHTb, KaK 1l0J1ro OHO ellle CMO)J(eT
Yllep)J(aTbC5I Ha nJ1aBY. H npHH5ITb peWeHI1e KaK 6bITb .llallbWe (npOBeCTI1
peKOHCTpYKUHIO. H3MeHHTb HOMeHKJIaTypy H T. ,lI..).
2. npHBeCTH B nOp5IllOK CI1CTeMY 1l0KYMeHTaUHH H BbInOJ1HHTb Bce
opraHH3aUHOHHbIe nJ1aHbI comaCHO GMP.
3. HallMHTb 'leTKYIO CI1CTeMY aHallH3a OTKJIOHeHHH OT cneuHHKa-
UHH (maBa 14, n. 14.8) C llOKYMeHTallbHbIM oQJopMJ1eHI1eM. 3TO Ba)J(-
HeHWHH 3J1eMeHT aHallH3a pHCKOB. OH n03B0J15IeT npe.llynpellI1Tb MHome
onaCHbIe cHTyaUI1I1, B TOM 'lHCJ1e peKJIaMaUHH.
4. HallMI1Tb pa60TY no aHallI13Y peKJIaMaUI1H, OT3bIBOB 11 B03BpaTOB
npOllYKUI1I1.
5. no pe3YJ1bTaTaM aHallH3a OTKJIOHeHHH OT cneuHHKaUI1H, peKJIa-
MaUI1H H np. pa3pa60TaTb H npHH5ITb He06xollHMbIe MepbJ H npOBepHTb,
HaCKOJ1bKO OHH CH5IJ1H np06J1eMHbIe BOnpOCbl.
6. nOCJ1e YCTpaHeHH5I npH'lHH CJ1ellyeT npOBO.llI1Tb llallbHeHWI1H
aHallH3 npouecca (oTKJIOHeHHH OT cneUI1I1KaUI1H), aHallH3 HMe)J(HOCTI1
(oTKa30B) 11 YCTpaHeHI1e HellOCTaTKOB.
OTKJIOHeHI15I He TOJ1bKO ycrpaH5IlOTC5I, OHI1 n05IBJ15I1OTC5I CaMI1.
Ba)J(Ho CBeCTI1 n05IBJleHI1e OTKJIOHeHI1H K MI1HI1MYMY. npI1'lHHbI HX
MOfYT HOCI1Tb nOCTeneHHbIH, HaKanJ1I1BalOlllI1HC5I xapaKTep HJ1I1 6bITb
BHe3anHbIMI1. B nepBOM CJ1Y 1 Iae OpMI1pOBaHHe OTKJIOHeHI1H HHO
npellBHlleTb 11 npellOTBpalllaTb, B 060HX CJ\YlIa5IX - onepaTHBHO I1X 06Ha-
PY)J(HBaTb 11 npHHHMaTb MepbI no HellonYllleHI11O HX BHOBb.
7. BclO 3TY pa60TY npOBOllHTb nOCT05IHHO, perYJ1HpHO npOB01l5I ca-
MOI1HCneKUHH. Pa3 B roll HHO BbInOJ1H5ITb peBH3I11O 1l0KYMeHTaUI1H,
OueHI1BaTb TeHlleHUHI1 B I13MeHeHI1I1 KalIeCTBa 11 COCTaBmITb nJ1aH opra-
HH3aUI10HHO-TeXHI1'leCKHX MepOnpI15ITI1H Ha CJ1e.llYlOlllI1H ro.ll.
8. BecTI1 6a3Y .llaHHbIX 06 OTKJIOHeHI15IX 11 OTKa3ax, CI1CTeMaTI13I1pO-
BaB ee no npJ1lII1HaM.

384
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3TY pa60TY HY)J(HO OpraHH30BaTb (CM. npI1Mep HpMbl Nutricio).
Koma nporpecc 1l0CTI1rHYT, OCTaHaBJ1I1BaTbC5I HeJ1b35I. HY)J(HO npo-
1l0J1)J(aTb KOHTpOJ1b 11 aHallI13. TaK KaK I13MeHeHI15I nOCTaBlllHKOB I1J1I1 Ka-
'leCTBa pa60TbI O.llHOro H TOro )J(e nOCTaBlllI1Ka, nepCOHalla, I13HOC 060-
PYlloBaHI15I, BHeCeHI1e I13MeHeHI1H H np. MOfYT 6bITb npH'lHHOH pI1CKOB.
npHMep
YJ1a'JHbIM npl1MepOM OpraHI13aUI111 pa60Tbi no aHarrl13Y pl1CKOB HBJIH-
eTC5I pa60Ta KOMnaHl111 Nutricia, HI1llepJlaHJ1bl (np0I13B0J1CTBO npollYKTOB
nl1TaHI1H DJIH J1eTei1).
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npOJ1YKUI1I1, COJ1ep)l(allla51 OCTaTKI1 J1e3I1H<j)l1uI1PYlOwl1x CpeJ1CTB. EblJlO npl1-
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TpOJIbHblX TO'JKax - CAPK.
CYTb CI1CTeMbl COCTOI1T B CJleJ1YlOweM:
- OpraHI130BaHO 36 rpynn CAPK Ha roJlOBHOM npeJ1npl151TI1I1, B COCTaB
KOTOpblX BXOJ1l1T 20 % COTPYJ1HI1KOB npeJ1npl151TI151;
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- Harr8)l(eH aHarrl13 npeTeH311H nOTpe611TeJleH;
- OpraHI130BaHO npoBeJ1eHl1e I1HCneKUI1H nOCTaBlllI1KOB;
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- nepcOHarr;
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npWII1HaMI1 pI1CKa MorYT 6bITb:
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AH0J1U3 PUCK06
385
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- 11 MHoroe llpyroe.
YCTaHOBHTb OnaCHOCTb (pHCK)
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no BceM 3THM cHTyaUH5IM Tpe6yeTC5I npOBelleHI1e aHallI13a 11 npI1H5I-
THe npoqmJ1aKTH'leCKHX Mep.
npHMep 1
PacnpocTpaHeHHOI1 npl1'JI1HOI1 npeBblWeHI151 npeJ1eJlbHblX 3Ha'JeHI1H
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npl1Mep nOCTeneHHoro OTKa3a. Bbl5lBI1Tb 3TO HapyweHl1e MO)l(HO 3a C'JeT
nepI10J1I1'JeCKoro 11J111 HenpepbIBHoro KOHTpoJl5l.
npHMep 2
B 30He aCenTI1'JeCKoro HanOJIHeHI151 113-3a He6pe)l(HOCTI1 nepCOHarra
(HapyweHl1e npaBI1J1 nOBeJ1eHI1H I1JII1 nepe0J1eB3HI151) npol130UIJlO KpaTKO-
BpeMeHHoe nOBblllleHl1e KOHueHTpaUl111 'JaCTI1U, T. e. BHe3anHblH OTKa3.
nepI10J1I1'JeCKI1H KOHTpoJlb ero 06HapY)l(I1Tb He MO)l(eT. n03TOMY npaBI1J1a
G M P Tpe6YlOT HenpepblBHoro KOHTpOJIR 'JI1CTOTbl B03lIyxa B 30He A.

386
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npHMep 3
B 80-e roJ1bl B CWA 6bIJIO YCTaHOBJIeHO, '!TO OJ1HOH 113 OCHOBHblX
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TOBKa BOJ1bl (CM. maBY 8). B Te'JeHl1e KOpOTKOro BpeMeHI1 6b1JI:
- npOBeJ1eH aHarrl13 cl1ryaUI1I1;
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npeJ1eJIeHI151 BOJ1bl o'Jl1111eHH0I1 11 BOlIbl DJI51 I1H'beKUI1H. 06ecne'JI1BalOWl1e
Tpe6yeMoe Ka'JeCTBO BOJ1bl;
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J1bl Ha JII1HI1I1 B3aMeH KOHTpOJI5I MHO)l(eCTBa napaMeTpOB B Jla60paTopl111
(nepI10J1I1'JeCKI1H KOHTpoJIb).
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J1a B BOJ1e 11 ee npOBOJ1I1Mocm. BBeJ1eHl1e B <j)apMaKOnel1 CWA 11 EBponbl
3TI1X MeTOJ1I1K n03BOJII1J10 CHHTb np06JIeMY pl1CKa 3arp5l3HeHI151 BOJ1bl. aco-
6eHHo Ham5lJ1HO 3TO np05lBJI5IeTC5I npl1 KOHTpoJIe KpaTKoBpeMeHHblx 3a-
rpH3HeHI1H. nOCJIe 33MeHbI <j)I1JIbTpOB ypoBeHb 33rp5l3HeHI1H CKa'JKo06pa3HO
B03paCTaeT, 3aTeM, no Mepe npoMbIBKI1 <j)11J1bTpa. CHI1)1(aeTC5I. 3TOT aHarrm
n03BOJI5IeT He J10nYCTI1Tb nOCTynJleHI151 33rp5l3HeHHOH BOJ1bl nOTpe6I1TeJI5IM.
npHMep 4 - napoBOH KOTeJI
anaCHblM C06blTI1eM npl1 pa60Te napoBoro KOTJla 51BJIHeTC5I ero B3pbIB.
npl1'JI1Ha B3pbIBa - BblCOKoe J1aBJIeHl1e napa B KOTJIe. Lln51 I1CKJIIO'JeHI151
3TOro C06b1TI151 npl1HI1MaIOTC5I CJIeJ1YlOllll1e Mepbl:
- YCTaHaBJII1BaeTC5I npeJ1eJIbHO J10nYCTI1Moe 3Ha'JeHl1e Kpl1TI1'JeCKoro
napaMeTpa - J1aBJIeHI151 napa DJI51 J1aHHoro KOTJla;
- npeJ1YCMaTpI1BaeTCH HenpepblBHbII1 KOHTpOJlb J1aBJIeHI151;
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npl1 J10CTI1)1(eHI1I1 J1aBJIeHl1eM HeKoToporo 3Ha'JeHI151, MeHbwe npeJ1eJlbHO
J10nYCTI1Moro;
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np06J1eMa I1CKJIIO'JeHI151 onacHoro C06b1TI151 - BbInYCKa HeCTepl1J1bHOii
npOJ1YKUI1I1 - peweHa KOHCTPYKTI1BHblMI1 MepaMI1 (KOHCTpYKul1eH 11 B03-
MO)l(HOCTblO HenpepblBHoro KOHTpOJI5I) 11 OpraHI13aUI10HHblMI1 MepaMI1 (Bbl-
nYCKOM cepl1l1 npOJ1YKUI1I1 TOJIbKO npl1 YCJIOBI1I1 COOTBeTCTBI1H TeMnepaTypbl
B KOHTpoJIbHblX TO'JK3X HOpMaTI1BHblM 3Ha'leHI151M, I1CnbITaHI151MI1 CTepl1J1l1-
3aTopoB, Karrl16poBKoH TepMonap 11 np.).

AHOJ1U3 PUCK06
387
113 npI1MepoB BI1llHO, 'lTO llJl5I I1CKJIIO'leHI15I onacHoro C06bITI1SI HHO:
I. YCTaHOBI1Tb CBH3b Me)J(DY onaCHbIM C06bITI1eM 11 ero npJ1lII1HOI1;
2. npellycMoTpeTb KOHCTPYKTI1BHble 111111 npoeKTHbIe peWeHI15I, HC-
KJIIO'lalOlllI1e onaCHoe C06bITI1e;
3. npellycMoTpeTb cpellCTBa KOHTp0115I KpI1TI1'leCKI1X napaMeTpOB;
4. Y6ellI1TbC5I B TOM, 'lTO 060PYllOBaHHe I1CnpaBHO H pa60TaeT KaK
npellYCMOTpeHO;
5. OpraHI130BaTb CHCTeMY TeXHI1'leCKoro 06c11Y)I(HBaHH5I H peMOHTa;
6. KOHTp011I1pOBaTb KpHTI1'leCKHe napaMeTpbI 11 aHallI13HpOBaTb TeH-
lleHUHI1 I1X I13MeHeHI15I (npI1'lI1HbI I13MeHeHI15I).
15.9.2 HOBbie npOH3BO,ll,CTBa
:::hanbI pa60TbI:
I. nepBbIH 11 OCHOBon011aralOlllHH war - 3TO pa3pa60TKa npoeKTa.
Ha 3TOH CTMI1I1 HCKJIIO'laIOTC5I MHOrI1e pI1CKI1 11 06eCne'lHBaeTC5I COOT-
BeTCTBI1e 061>eKTa npaBI111aM GMP.
2. nOCTpOI1Tb o6'heKT no npoeKTY 11 Bbm011HHTb nYCKOHallMO'lHbIe
pa60TbI, I1CnbITaHI15I 11 aTTeCTaUHIO.
3. C0311aTb CI1CTeMY 1l0KYMeHTaUI1H 11 npellYCMOTpeTb Bce OpraHI13a-
UI10HHbIe MepbI comaCHO GMP.
4. nOll06paTb nOCTaBlllI1KOB, 'lT06bl pI1CK lleeKTa I13-3a MaTepHa-
110B 6bI11 I1CKJIIO'leH;
5. nOllrOTOBI1Tb nepCOHall, 'lT06bI CHH3HTb HJ1H I1CKJIIO'lHTb pI1CK.
6. npOBeCTI1 aHallH3 pHCKOB no BapI1aHTY I (n. 15.9.1).
15.9.3 npaKTU'IeCKHe npHMepbl
llOpaJICeHUe .IllOdeii u yep6 oKPYJICalOeii cpede
3TOT BHll C06bITHH OTHOCI1TC5I K npOMbIWJ1eHHOH 6e30naCHOCTI1 11 He
BXOllHT B 0611aCTb npI1MeHeHI15I npaBI111 G MP. TaKHe C06bITI15I 1l011)J(HbI
6bITb HCKJIIO'leHbI. Pa3roBopbI 0 Bep05ITHOCT5IX 11 np. 311eCb HeYMeCTHbI.
npUMep
B TeXHOJlOrH'JeCKOM UI1KJIe npoI13B0J1CTBa aCKop611HOBOH KI1CJlOTbl
eCTb onepaUI151 CYWKI1 COp603bI. Pe3epByap - CYWI1J1Ka COp603bl - J10JI)I(eH
6bITb 333eMJleH.
npl1 HapyweHl111 3a3eMJIeHI151 pe3epByap HaKanJlI1BaeT 3JIeKTpoCTaTI1-
'JeCKI1H 3ap5l1I 11 npl1 B3pbIBoonaCHOH KOHueHTpaUl111 B3BeCI1 nopoWKa Cop-
603bl npoI1CXOJ1I1T B3pbIB. Lln51 I1CKJII0 1 IeHI151 3TOro C06bITI151 YCTaHOBJIeHbl
Tpe60BaHI151 K YCTpoHCTBY 333eMJleHI151, npeJ1YCMaTpI1BaeTC5I KOHTpOJlb ero
ueJlOCTHOCTI1, 11 Bce 3TO 51BJI5IeTCH npeJ1MeTOM HaJI30pa opraHOB npoMblW-
JleHHOH 6e30naCHOCTI1.
Ha CJIY'JaH B3pbIBa npeJ1YCMaTpI1BaeTC5I B3pbIBHOH KJIanaH 11 HanpaB-
JleHl1e Bbl6poca B 6e30nacHoM HanpaBJIeHI1I1. I1MeHHo TaK BbInOJIHeHbl CO-
BpeMeHHble CYWI1JIKI1.

388
[;1060 /5
Bce 3TO pemaMeHTI1pyeTC5I 065I3aTeJ1bHbIMI1 HOpMaMI1, KOTOpbIe
HY)J(HO BbInOJ1H5ITb. 3TI1 HOpMbI MOrYT n.aBaTb pa3HbIe BapI1aHTbI pewe-
HI1H, HO MeTOJ1HKa npI1H5ITI15I 3TI1X peWeHI1H 'leTKO onpen.eJ1eHa. HI1Ka-
KI1X aHallH30B pI1CKOB Ha npen.npH5ITI1I1 npOBon.HTb He HHO. EMY OCTa-
eTC5I TOJ1bKO On.HO - BbInOJ1H5ITb 3TH HOpMbI.
Henpepbl6Hblii KOHmpO.llb KpUmUlteCKUX napllMemp06
Ba)J(HbIM aKTopOM npellynpe)J(DeHH5I pHCKOB 5IBJ15IeTC5I HenpepbIB-
HbIH KOHTpOJ1b KpI1TI1'leCKI1X napaMeTpOB B KpHTH'leCKHX KOHTpOJ1bHbIX
TO'lKaX, Ha3bIBaeMbIH I1HOma MOHI1TOpHHroM.
npH OpraHI13aUI1H HenpepbIBHoro KOHTpOJ15I CJ1ellyeT onpen.eJ1I1Tb:
- KaKI1e napaMeTpbI 5IBJ15I1OTC5I KpI1TH'leCKHMI1,
- B KaKI1X TO'lKaX HY)J(HO opraHH30BaTb KOHTpOJ1b 3THX napaMeTpOB.
,il.n5I HJ1J1IOCTpaUI1I1 paCCMOTpI1M CJ1ellYIOWHe npI1MepbI.
npUMep 1. KOHmpOAb 'Iucmombl603iJyxa 6 npoU36oiJcm6ax cmepUAbHblX
JleKapcm6eHHbIX cpeiJcm6
npaBI1J1aMI1 GMP EC, npl1JlO)l(eHl1e I (raCT P 52249) YCTaHOBJIeHbI
Tpe60BaHI151 K KOHTpOJlIO KOHueHTpaUl111 'JaCTI1U B B03J1yxe 30H A 11 B npo-
113B0J1CTB CTepl1J1bHbIX JleKapCTBeHHbIX CpeJ1CTB. 3TOT KOHTpOJlb CJIeJ1yeT BbI-
nOJIH5ITb B Te'JeHl1e TeXHOJIOrn'leCKoro npouecca. Tpe60BaHl1e 3TO pa3YMHO,
TaK KaK BO MHornx CJlY'Ja5IX B6JI113I1 KpI1TI1'JeCKI1X 30H Tpe6yeTc5I npI1CYT-
CTBl1e nepCOHarra, a OH 51BJIHeTC5I I1CTO'JHI1KOM OWI160K 11 3arp5l3HeHI1I1. Ho
npaBI1J1a GMP He YKa3bIBa1OT, B KaKI1X I1MeHHO TO'JKax HY)l(HO YCTaHaBJII1-
BaTb ceHcopbI DJI51 C'JeTa 'JaCTI1U.
AHarrl13 pl1CKOB 11 npaKTI1Ka nOKa3arrl1, 'JTO TaKI1MI1 TO'JKaMI1 51BJl5IIOTC5I
30Ha BbIXOJ1a <j)JlaKOHOB (aMnYJl) 113 CTepl1Jl113aTOpa, 30Ha HanOJIHeHI151 11
30Ha YKynopKI1 <j)JlaKOHOB. B HI1X 11 HHO pa3MelllaTb ceHCOpbI. 3TO He
I1C'JepnbIBalOllla51 peKOMeHJ1aUI151. ECJlI1 B KOHKpeTHOM np0I13B0J1CTBe Ha
KOHKpeTHOM 060pYJ10BaHI1I1 BbI5IBJI5IIOTC5I J1pyrne TO'JKI1 pl1CKa, ceHcopbl
HY)l(HO YCTaHaBJII1BaTb 11 TaM.
npUMep 2
npOeKT aCenTI1'JeCKoro npoI13B0J1CTBa )l(11J1KI1X JleKapCTBeHHbIX CpeJ1CTB
BO <j)JlaKOHaX BbInOJlHeH DJI51 O'JeHb CTeCHeHHbIX YCJlOBI1H. YKynopeHHbIe 11
3aKaTaHHbIe <j)JlaKOHbI nOJ1aIOTC5I 113 30HbI A/B B nOMellleHl1e npoCMOTpa
(30Ha D) 'Jepe3 «MbIWI1HYIO llleJlb». M3 3TOro nOMellleHI151 J1Bepb BeJ1eT B
KOpl1J10p (30Ha D). nOMellleHl1e npoCMOTpa I1MeeT 1136bITO'lHOe J1aBJIeHl1e
no OTHOWeHl11O K KOpl1J10PY.
PI1CKOBaHHoH cl1Tyaul1eH 51BJI5IeTC5I OTKpWToe COCT05lHI1e J1Bepl1. 113-
BeCTHbIH Me)l(JlYHapOJ1HbIH 3KcnepT J1-p r. WI1XT, npoBOJ1I1BWI1H aTTeCTa-
UI1IO npoeKTa, a 33TeM aYJ1I1T 'JI1CTbIX nOMellleHI1H, paCueHI1JI DJII1TeJlbHOe
HaXO)l(JleHl1e J1Bepl1 B OTKpblTOM COCT05lHI111 KaK pI1CKOBaHHoe.
Lln51 CHI1)1(eHI151 pl1CKa 6blJl YCTaHOBJIeH TaHMep, BKJIIO'JalOlllI1H npepbl-
BI1CTblH 3BYKOBOH Cl1rHarr TpeBom npl1 HaXO)l(JleHl111 J1Bepl1 B OTKpblTOM CO-
CT05IHI1I1 fioJlee 15 c. 3m Mepa eCTb B Tpe60BaHmix FDA [34, IV, C).

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HO 6bIJ10 npHH5ITb 3a 3TallOH npoeKT 3anaDHoeBponeHcKoH (tmpMbI. Ceti-
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J1a o6pa3uoM 'leTKOCTH. CeH'laC H3 Hee HDYT Y)J(aCHbIe npoeKTbI, Da eme
C D030H DeMarorHH, KOTOpa5I HCXODHT H3 y6e)J(DeHH5I, 'lTO MbI - HapOD
OTCTallbIH H HeBe)J(eCTBeHHbIH, HaM MO)J(HO c6bITb Bce, 'lTO yroDHO.
npuMep
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3anaJIHa51 qmpMa CJ1aBarra KpynHbIH 6oJlbHI1'lHbIH KOMnJleKC C narraTa-
MI1 I1HTeHCI1BHOH Tepanl1l1, npeJ1Ha3Ha'leHHbIe DJI51 BbIX8)I(HBaHI151 60JlbHbIX
nOCJIe TpaHCnJlaHTaUl111 KOCTHOro M03ra. no faCT P 52539-2006 HaJI no-
CTeJlblO 60JlbHOro J10Jl)l(Ha 6bITb 30Ha C OJ1HOHanpaBJIeHHbIM nOTOKOM B03-
J1yxa KJIacca 5 MCa (KoHueHTpaUI151 LJaCTI1U C pa3MepaMI1
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cTByeT npI1H5ITOI1 60Jlee 25 JleT Ha3aJI B EBpone npaKTI1Ke H C 90-x roJ10B
npI1MeH5IeTC5I B POCCI1I1.
B J1eI1CTBI1TeJlbHOCTI1 HI1KaKoro OJ1HOHanpaBJIeHHoro nOTOKa He 6bIJIO,
B03J1YX nocrynarr B narrary OT OJ1HOro HEPA <j)l1JIbTpa (npl1MepHO 600
M3/'l), 11 HaJI nOCTeJIblO 6oJlbHOro COOTBeTCTBOBarr KJIaccy 8 MCa (<j)aKTI1'le-
CKa5I KOHueHTpaUI151 LJaCTI1U C pa3MepaMI1
0,5 MKM COCTaBJI5IJla OT 300 TbIC.
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B narraTax Ha HeCKOJlbKI1X 60JlbHbIX 6bIJlI1 pacnOJlO)l(eHbI TaK, 'lTO npeJ1nOJla-
rarrl1 nepeKpeCTHoe 3arp5l3HeHl1e. P5IJ1 J111<j)<j)Y30poB HenJlOTHO npl1J1eran K
nOTOJlKY, T. e. MeCTO npl1JleraHI151 He 6bIJlO repMeTI1311poBaHO 11 B weJl5lX
MOrJlI1 HaKanJlI1BaTbC5I 3arp5l3HeHI151.
npeJ1CTaBI1TeJlb <j)l1pMbI 3a51BI1J1, 'lTO 3TO CJ1eJlaHO npeJ1HaMepeHHO, DJI51
ryp6YJll13aUI111 nOTOKa B03J1yxa, weJlb H
Ha DJI51 YJ106CTBa J1eMOHTa)l(a
<j)11J1bTpoB. aH )l(e 3a5lBI1J1, LJTO 'Jepe3 H EPA <j)11J1bTpbI J10Jl)l(eH nOCT05lHHO
nOJ1aBaTbC5I B03J1YX, I1Ha'Je Ha CTOpOHe HEPA <j)11J1bTpa, BbIX0J151weH B 'J11-
CToe nOMellleHl1e, 6YJ1YT CKanJlI1BaTbC5I MI1KpOOpraHI13MbI. I1HTepecHO, a
pa3Be np0I13BOJ1CTBO, KOHTpOJIb, ynaKoBKa, TpaHCnOpTl1pOBaHl1e 11 MOHT8)I(
npOXOJ15lT B CTepl1JlbHOH cpeJ1e 11 npl1 pa60TalOllleM <j)11J1bTpe? Pa3Be JlaMI1-
HapHbIe wKa<j)bI He OTKJIIO'JaIOTC5I B Hepa60'JI1H nepI10J1?
3TO He npoCTO a6cYPJ1, 3TO - 3a5lBJIeHI151 npeJ1CTaBI1TeJl51 3apy6e)l(HoH
<j)I1PMbI, CTaB5Illll1e CBoeH ueJlblO BBeCTI1 33Ka3'JI1Ka B 3a6J1Y)l(JleHl1e 11 JlI060H
ueHOI1 CJ1aTb 06'beKT, HeCMOTp51 Ha J1e<j)eKTbI.
PaHbwe 6b1J10 npome. npOeKTbI 6bIJ1H XOPOWI1MI1 H DeJ1allHCb rpa-
MOTHbIMH cneUHalll1CTaM11. Bce pl1CKI1 6bIJ1I1 Y'lTeHbI HOpMaTI1BHbIMI1
ilOKYMeHTaMI1 I1 npeDYCMOTpeHbI npI1 pa3pa6oTKe 060PYDOBaHH5I. DblJ1a
rpaMOTHa5I I1 'leCTHa5I 3KCnepTI13a. CeH'laC )J(I13Hb CJ10)J(Hee. Ka'leCTBO
npoeKTOB pe3KO ynallo. J1 HI1KaKOH aHallH3 pHCKOB TYT He nOMO)l(eT.
lloBep5ITb CYDb6y np0I13B0J1CTBa MO)J(HO TOJlbKO npo
eCCI10HallaM,
ilOKa3aBWHM KalIeCTBO CBoeH pa60TbI MHoroJ1eTHeH npaKTHKoH.




390


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«aHaJIH3 PHCKOB') JIer4e, 4eM OpraHJ130BaTb pa60TY no GMP.
3TOT ClO)I(eT He HOB. B cepenHHe 60-x ronoB BblWeJl 4>HJ1bM «npe.ace-
llaTeJlb') C MHxaHJ10M YJ1bHHOBbIM B fJlaBHOH pOJ1H. B HeM eCTb cueHa H3
3ace.aaHJ1H 61Opo paHKOMa napTJ1H. B paHOHe nO'-lTJ1 roJ10.a. npo.aYKTOB HeT.
a ceKpeTapb paHKOMa roBOpHT, 4TO OHH OTCTaIOT: B paHOHe HeT HJ1 OJl,HOro
fepo51 COUJ1aJ1J1CTJ14ecKoro Tpy.aa no CBJ1HOBO.aCTBY.


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6YllCT. J11011H OT4HTaIOTC5I nOKa3aTCJI5IMH 11 MCTOllaMH, a 6C30naCHOCTb J1
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BOJl,OpO.aOM. J1 npoJ130WeJ1 B3pbIB. MJ1aJJ.WHH nepcOHaJI .aOKJ1a.abIBaJI 06 3TOH
onaCHOCTJ1, HO PYKOBOJl,CTBO He npJ1.aaJIo 3TOMY 3Ha4eHJ151 J1 Mepbl He 6bVIH
npJ1HHTbI.
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eCJ1H BbInOJ1HHTb Bce 3TH Jl,eticTBHH. a eCJ1J1 He BbInOJ1HHTb. TO OH Bpc.aeH.
TaK KaK C03J1,aCT J1J1J1103HIO pa60Tbl BMeCTO caMOH pa60Tbl. '-ITO J1 npoHJO-
WJ10 C 4eJ1J1eHJI,)I(epoM.


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HeMY llaJIeKO HC Bcema O'lCBHllCH. fJIaBHOC, 4TO 1l0JI)I(CH nOHJ1MaTb py-
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n01l1laBaTbC5I C06JIa3HY ynpoweHHoro nOllXOlla.
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KaHalla TaK)l(C npl1H5IJIa 3TH Tpc60BaHJ151. FDA CiliA Tpc6YCT KOHTpO-
JIJ1pOBaTb KpHTH4CCKJ1C napaMcTpbI H npOCJIC)I(HBaCMOCTb np0J13BOllCTBa
CCpJ1H 1lJI5I KJ1J1HJ1lICCKJ1X HCCJICllOBaHHtI.
TaKHM 06pa30M, Tpc60BaHH5I GMP HC orpaHH'IJ1BaIOTC5I CCpHHHbIM
np0J13BOllCTBOM npcnapaToB 1lJI5I KOMMCp4CCKOro BbInycKa, OHH pacnpo-
cTpaHcHbI J1 Ha 3Tan HCCJICllOBaHJ1H.
18.4 OUTOBaJi TOprOBJUI - GDP
18.4.1 npaBHJla GDP EC
ncpBoe PyKOBOllCTBO no 06paWeHJ11O JIeKapCTBeHHbIX cpellCTB B CHCTe-
Me omOOOH TOproBJIH - Good DisTribution PracTice (GDP) - 6bIJIO npHH5ITO
B Enponc B 1994 r. BO HCnOJIHCHHC Tpe60BaHH5I LIJ1pCKTJ1BbI 2001/83/EC.
B HaCT05lweC BpCM5I nOllroTOBJICH npoeKT HOBOtl pCllaKUJ1H npaBHJI
GDP EC, 06cY)I(1leHJ1e KOTOpOro 3aBcpWCHO 31 lleKa6p51 2011. npoeKT
npeBblwaeT GDP 1994 r. no 06'beMY J111eTaJIJ13J1pYCT p511l nOJIO)l(CHJ1H.
npaBHJIa GDP 6JIJ13KJ1 no CTPYKTYpC K npaBJ1JIaM GMP. HO OTpa-
)l(alOT cneuH<pHKY 06paweHHH J1eKapCTnCHHbIX cpellCTB OT npellnpJ15ITHH-
H3roTOBJ1TeJ151 110 p03HJ1 l IHOH TOproBJlH.

434
fwea 18
Tpe60BaHJ151 CB01l5lTC5I K CJICllYIOWCMY:
CucmeMa Ka.,ecm6a Y Ka)l(1loro onToBoro npOllaBua 1l0JI)I(Ha rapaH-
HIpoBaTb:
. pa60TY B COOTBeTCTBJ111 c 3aKonooameAbcm6oM;
. nOCT05lHHOC C06JIIOllCHI1C YCJIOBJ1i1 xpanellUJl J1 mpall£nopmufJ06allUJl;
. J1CKJ1104eHJ1C 3azpR3nenuii npollYKTa;
. npaBJ1JIbHbIH o6opom npoiJYKu.uu (ncpBbIM npJ1WJIO - nepBbIM
YWJIo);
. 06eCnC4eHJ1C coxpannocmu (OT XJ1WeHJ151) J1 6e30nacnocmu;
.omzpY3KY npollYKUJ1J1 TOJIbKO no HY)I(HOMY allpccy I1 B HY)I(HOe
BpeM5I;
. OmCAeJICU6anUe npOllYKUI1I1, 06HapY)I(CHJ1C JII060ro llc<peKTHoro
npollYKTa 11 OnCpaTJ1BHbIH OT3bIB npOllYKUI1I1.
Tpe60BaHI151 K nepconaAY:
. B Ka)l(1l0H T04KC paCnpellCJICHI151 npOllYKU1111 1l0JI)I(CH 6bITb npCll-
CTaBI1TeJIb allMI1HI1CTpaUI1J1, JII1'1HO OTBCTCTBCHHbIH 3a BbInOJIHCHJ1C
YCTaHOBJICHHbIX Tpc60BaHI1i1 11 J1MCIOWI1H He06xOllJ1MbIC nOJIHOM041151;
. 1l0JI)I(HbI 6bITb YCTaHOBJICHbI Tpc60BaHI151 K KBaJIJ1<pJ1KaUI1J1;
. nCpCOHaJI 1l0JI)I(CH npOXOlll1Tb 06Y'1CHHC, a OpraHl13aUI151 .n:OJI)I(Ha
I1MCTb CI1CTCMY 06Y"-ICHI151.
)1oKYMen ma u.uR
LIaHbI Tpc60BaHI151 K O<POpMJICHHIO 3aKa30B, COCTaRJ1CHHIO HHCTPYK-
UI1H: 11 npOTOKOJIOB.
lloMew,enun u o6opydo6anue
YKa3aHbI OCHOBHbIC Tpc60BaHJ151 K npl1eMKe 11 xpaHCHHIO.
OmzpY3Ka 3aKa3.,UKllM
YCTaHOBJICHO, '1TO OTrpY3Ka MO)l(CT BbInOJIH5ITbC5I TOJIbKO:
. llPyroMY onTOBoMY npOllaBUY, J1MeIOWCMY JIJ1UCH3J11O I1JII1
. p03HJ1'IHOMY npOllaBUY, HMClOweMY JII1UCH3HIO J1 peaJIJ13YlOwCMY
npOllYKUHIO HaCCJIeHJ1IO.
LIaHbI Tpc60BaHI151 K TpaHCnOpTl1pOBaHHIO.
B036pam npoiJYKu.uu
YCTaHOBJlCH nOp5I1l0K B03BpaTa npOllYKUI1H, HC I1MClOweH llC<pCKTOB,
nOp5I1l0K Cp04HOro OT3bIBa npOllYKUI1I1, paCCMOTpCHbI CJIY4al1 nO.lUleJIKJ1.
CllMOUncneKu.uu
CJICllYCT npOBOllJ1Tb CaMOJ1HCnCKUJ1J1 J1 1l0KYMeHTaJIbHO O<pOPMJI}ITb
J1X 1lJI5I KOHTp0J151 BbInOJIHCHJ151 HaCT05lWHX npaBI1JI.
HJ1)1(e llaeTCH 60JIee nOJIHblH nepe4CHb Tpe60B<lHI1H G DP EC (He
I1C'IepnblBaIOWJ1H) no OTllCJIbHblM pa311eJIaM.

GLP-GCP-GMP-...
435
flOMeUl,enUR dOJlJICnb' yd06Jlem60pRmb mpe606anURM K:
- 6e30naCHOMY 06parucHI11O 11 XpaHeH1110 JIeKapCTBeHHblX cpellCTB C
C06JIlOlleHJ1eM He06xOllJ1MbIX YCJIOBJ1H (3aWJ1TbI OT HaCCKOMbIX, rpbI3YHOB J1
llPYfI1X )l(J1BOTHbIX. n01l1lCp)l(aHJ151 napaMCTpOB MHKpOKJIJ1MaTa, OCBeWCHH5I);
- pa311CJICHJ11O 30H XpaHCHJ151, BKJ1IO'Ia51 30HbI llJI5I OTKJ10HeHHOH 11
B03BpawaCMOH npOllYKUHJ1, npOllYKUI1J1 C npCllnOJIO)l(CHJ1CM 0 <paJIbCJ1-
<pHKaUHJ1, 11 I1CKJ1104CHJ1IO HCCaHKUJ10HHpOBaHHoro 1l0cTyna B 3TH 30HbI;
- pa311eJICHJ1IO 30H npHeMKH, XpaHCHJ151 H OTrPY3KI1 npOllYKUJ1J1 C
UCJIbIO 3aWHTbI HaX01l5lweHC5I Ha CKJ1allC npOllYKUJ111 OT BJH151HJ15I noroll-
HbIX YCJIOBHH;
- CnCUHaJIbHbIM YCJIOBJ151M XpaHeHJ151 pallJ10aKTJ1BHOH H llpyroi1
onaCHOH npOllYKUJ1J1;
- '1J1CTOTC nOMCWCHJ1H;
- 6bITOBbIM nOMCWCHJ151M J1 T. 11.
06opydo6anue:
- 1l0JI)I(HO COOTBCTCTBOBaTb CBOCMY Ha3Ha4eHJ1IO J1 nOllJIC)I(aTb TCX-
HJ14CCKOMY 06CJIY)l(J1BaHHIO;
- KOMnbIOTcpHbIC CHCTCMbI 1l0JI)I(HbI I1MCTb 3aWHTY OT HCCaHKUI10-
Hl1pOBaHHoro 1l0CTyna H OT npCllHaMcpcHHOro I1JIJ1 CJIY'laHHoro nOBpc-
)I(1leHJ151; 1l0JI)I(CH 6bITb OnpCllCJICH nOp5l110K llCHCTBJ1H npJ1 c605lx B pa60-
TC J1 BOCCTaHOBJICHJ1H llaHHbIX; COXpaHCHI1C llaHHbIX 1l0JI)I(HO OCYWCCTB-
JI5ITbC5I '1CpC3 OnpCllCJICHHbIC HHTCpBaJIbI BpCMCHH; llaHHbIC 1l0JI)I(HbI xpa-
HHTbC5I HC MCHCC n5lTI1 JICT.
K6UJlufjJuKau.UR nocma6U1,UK06:
- onTOBbIH nOCTaBWJ1K HCCCT OTBCTCTBeHHOCTb 3a nOJIY'lCHHC npOllYK-
UJ1J1 TOJIbKO OT JIJ1ueH3J1pOBaHHbIX np0J13BOllHTCJICH J1JIJ1 nOCTaBWJ1KOB;
- 060POT JIeKapCTBCHHbIX CpCllCTB 1l0JI)I(CH pefJ1CTpJ1pOBaTbC5I 1l0KY-
MeHTaJIbHO, BC5I uenb 06paweHH5I JICKapCTBcHHOro cpellCTBa 1l0JI)I(Ha
npOCJIC)I(J1BaTbC5I J1 6bITb 1l0KYMCHTaJIbHO O<popMJICHa;
- nOCTaBWI1K 1l0JI)I(CH HMCTb HC06XOlll1MYIO nOllroTOBKY; nOp5l110K
BbI60pa nOCTaBWI1Ka 11 Tpc60BaHH5I K cro KBaJIJ1<pJ1KaUI1I1 1l0JI)I(HbI 6bITb
OnpelleJICHbI HHCTPYKUJ1ei1;
- CJlellYCT 06pawaTb BHJ1MaHJ1C Ha penYT<\UHIO 11 HallC)I(HOCTb naPTHcpOB.
HHlll1KaTOpaMI1 HCll06poCOBeCTHOCTJ1 51BJI5IIOTC5I:
. nOll03pCHI1C 0 <paJIbCJ1<pJ1KaUHI1;
. npCllJIO)l(CHJ1C npOllYKUJ1J1 B 60JIbWI1X 06"bCMaX, CCJIH 113BCCTHO,
'ITO OHa BbmYCKaeTC5I MaJIbIMH CepH5IMI1;
. ueHbI, BbIX01l5lWI1C 3a 06WCnp11H5ITble npClleJIbI.
K6UJlufjJuKau.UR nOKynameJleii
- onTOBblH nOCTaBWI1K MO)l(eT npOllaBaTb npOllYKUl11O TOJIbKO TeM,
KTO caM I1MeeT pa3peWCHI1C (JIJ1UCH3J11O) Ha p03HJ14HYIO J1JIJ1 onTOBYIO
npOlla)l(Y J1 T. 11.

436
FW6a /8
TlpueMKa m06apa:
- npOBcpKa 1l0KYMeHTaUJ1J1 Ha TOBap H ero nocTynJICHJ1C TOJIbKO OT
npJ13HaHHbIx nOCTaBWJ1KOB;
- npOBcpKa COCT05lHJ151 TOBapa.
Xpanenue:
- llBJ1)1(CHJ1C npOllYKUJ1J1 CJICllYCT OpraHJ130BaTb C Y'ICTOM llaTbI H3ro-
TOBJICHJ151 H cpOKa rOllHOCTH;
- nOp5I1l0K xpaHCHH5I 1l0JI)I(CH HCKJ1IO'IaTb ncpenYTbIBaHJ1C, Jarp5l3-
HCHHe H nOBpC)I(1lCHJ1C npOllYKUHH;
- HC 1l0nYCKaeTC5I XpaHJ1Tb npOllYKUHIO HcnOCpCllCTBeHHO Ha nOJIY;
- 1l0JI)I(Ha npOBOllJ1TC5I nCpHOllHlJCCKa51 HHBCHTapJ13aUH5I CKJ131l0B.
18.4.2 )J.PYfHe PYKoBo)],CTBa no GDP
PyKo6oocm6o B03 no GDP
B OT'ICTC B03 (WHO Technical Report Series, No. 957, 2010) [58]
OTpa)l(CHbI OCHOBHbIC Tpc60BaHJ151 K CT31lHH onTOBOH TOproBJ1J1. 3TJ1 TpC-
60BaHI151 pacnpOCTpaH5IIOTC5I Ha BCIO ucnb pCaJIH3aUI111 (nocTaBKI1) H
npCllYCMaTpHBaIOT, B 4aCTHOCTJ1:
- npOCJ1C)I(HBaCMOCTb npOHCXO)l(1lCHH5I H llBI1)1(CHH5I npOllYKUHH;
- YTBCp)l(1lCHHC nOCTaBWI1Ka 0<pI1UHaJIbHbIM opraHOM;
- nOp5l110K pa60TbI C TpaHcnopTHbIMH KOMnaHH5IMH.
PyKo6oocm6o PDA
B 20 II r. BbIWJIO PYKOBOllCTBO PDA Guidance for Good Distribution
practices (GDPs) For the Pharmaceutical Supply Chain. Technical Report
No. 52. Parenteral Drug Association - PDA. 201/ (PYKOBOllCTBO no GDP
1lJI5I CJ1CTCMbI 06ecne4cHH5I JICKapCTBCHHbIMJ1 CpCllCTBaMH. TCXHH4CCKHH
OTlJCT NQ 52, PDA, 20 II) [49].
OHO aHaJI0fJ14HO llPYfJ1M PYKOBOllCTBaM, HO B HCM llaIOTC5I 60JICC
llCTaJIbHbIC Tpe60BaHH5I K coxpaHCHHIO cTa6HJIbHOCTH, n01l1lCp)l(aHI1IO
TeMncparypHbIx YCJIOBHH, npJ1BOllHTC5I nOllp06HbIH KOHTpOJIbHblH JIJ1CT
no BCCM OCHOBHbIM BonpocaM.
18.5 TeXHOJlOfHH KJIeTOK H TKaHeH - GTP
J;!llCT aKTJ1BHa51 pa3pa60TKa J1 pacnpocrpaHCHJ1C TCXHOJIOfJ1H Ha OCHOl3e
KJ1eTOK J1 TKaHeH. C0311aHHe J1CKYCCTBCHHbIX opraHOB, pa3pa60TKa HOBbIX
MCTOllOB JIClIeHH5I. 3TO COBepWCHHO HOBblH MHp. OH Tpe6ycT oc060ro
nOllXOlla, B TOM 4J1CJ1C J1 OC06bIX Tpc60BaHJ1H K np0J13BOllCTBY. TaKHC
Tpe60BaHH5I C<POPMYJIJ1pOBaHbl B npaBJ1JIaX GTP - Good Tissue Practice -
npaBJ1JIaX npOH3BOllCTBa KJ1CTOK H TKaHeH H npOllYKUHJ1 Ha J1X OCHOBe.

GLP-GCP-GMP-...
437
B CiliA llCHCTBYCT KOlleKc <pCllCpaJIbHblX HOpMaTJ1BHbIX aKTOB CFR
21 Part 1271 - Human Cells. Tissues, and Cellular and Tissue Based Prod-
ucts. Subpart D - Current Good Tissue Practice (KJICTKH H TKaHJ1 lICJIOBe-
Ka J1 npollYKUJ151 Ha OCHOBC KJ1CTOK J1 TKaHcH. nOllpa311CJI 0 - npaBJ1JIa
pa60TbI C TKaH5IMJ1).
OCHOBHOH 3alla'lCH npaBHJI 51BJI5IeTC5I J1CKJ1IO'ICHJ1C 3arp5l3HeHJ1H J1JIH
ncpcKpcCTHbIX 3arp5l3HCHHH npH npoH3BollCTBC KJ1eTOK H TKaHeH H npo-
llYKUJ1J1 Ha HX OCHOBe, npclloTBpaWCHJ1C BHCCeHJ151, ncpclla4H HJIH pac-
npoCTpaHCHJ151 Ja60JICBaHHH 4epc3 HHX.
C 3TOH UCJIblO npaBJ1JIa GTP YCTaHaBJIJ1BaIOT Tpc60BaHJ151 K MaTCpJ1a-
JIaM H nOCTaBWJ1KaM, npoucccaM, nOMCWCHH5IM. 060PYlloBaHHIO. J1 T. 11.
npaBHJIa GTP 6JlJ13KJ1 no CTpYKType K npaBJ1JIaM GMP, HO llCTaJIJ13HPYIOT
P5I1l nOJIO)l(CHHH C Y4eToM cneuH<pJ1KJ1 KJ1CTOK H TKaHeH.
npaBJ1JIa GTP pacnpOCTpaH5IIOTC5I Ha oT60p H npoBcpKY 1l0HOpOB,
npoH3BollCTBO, XpaHCHI1C, MapKHpoBKY, ynaKoBKY J1 pCaJII13aUHIO npo-
llYKTOB Ha OCHOBC KJ1CTOK H TKaHcH. KOllCKC CFR 21 Part 1271 TaK)I(C
YCTaHaBJIHBaCT nOp5l110K pcrHCTpaUHH npOllYKUHH Ha OCHOBC KJICTOK J1
TKaHeH H npOBcpKH npOH3BOllCTB.
n05lCH5IIOWJ1H MaTCpJ1aJI K npaBJ1JIaM GTP COllCp)l(HTC5I B PYKOBOll-
CTBC FDA Guidance for Indust/y. Regulation of Human Cells, Tissues, and
Cellular and Tissue-Based Products (HCT/Ps) (PYKOBOllCTBO llJI5I npo-
MbIWJIeHHOCTH. npaBHJIa 06pawcHH5I C KJ1CTKaMH J1 TKaH5IMH '1CJIOBCKa 11
npOllYKUl111 Ha OCHOBC KJ1CTOK H TKaHcH).
B MHpC 6YPHO pa3BJ1BaIOTC5I KJICT04Ha51 TCpanJ151 H
pCKOHCTpYKTHBHa51 xHpyprH5I Ha OCHOBC TeXHOJIOrHH KJICTOK H TKaHCH.
CI1HTC3 TKaHCH 11 opraHOB 4CJIOBCKa HC TOJIbKO BbIBOllHT MCllJ1UHH) Ha
Ka'lCCTBCHHO J1HOH ypOBCHb, HO H nOllpblBdCT OCHOBY KPUMUHll.JlbHOZO
6u3Heca, CB5I3aHHoro C TOproBJlCH '1CJIOBC4CCKHMH opraHaMH.
18.6 GMP ,lJ,J1S1 npOH3BOJ].CTB3 npo.nyKTOB nHT3HIUI H KOCMem"leCKOH
npOMblUJJIeHHOCm
npaBHJIa GMP no npou36oiJcm6Y npoiJYKmo6 numaHUR - 21 CFR
Part I/O - Current Good Manufacturing PracTice in ManufacTuring,
Packing. or Holding Human Food - «npaBHJIa npOH3BOllCTBa, ynaKoBKH J1
06paWCHJ151 C npOllYKTaMH nJ1TaHJ151 llJI5I 4CJIOBCKa,> 117], CiliA, YCTa-
HaBJIJ1BaIOT 06wJ1c Tpc60BaHH5I H llalOT J1X KOHKpCTJ13aUJ11O no pa311CJIaM:
- flepCOHll.Jl;
- 3iJaHuR U npou36oiJcm6eHHbie 1l.tlow.aiJKu
YKa3aHo, B lIaCTHOCTJ1. lITO He06xOllJ1MO:
· YllaJIeHJ1C Mycopa J1 OTXOllOB np0J13BOllCTBa. nOllpC3aHJ1C TpaBbl
B HenocpellCTBeHHOH 6JIH30CTJ1 OT 311aHJ1H J1 coopY)l(eHJ1H. lITO-
6bl He c0311aBaTb YCJIOIJJ1H (HOp) 1lJI5I paJMHO)l(eHHH Bpe.aHTeJ1eH;

438
[JW6a 18
. YCTPOHCTBO 11 non.ncp)l(aHJ1C B nOp5l11KC llopor, llBOpOB H napKO-
BOK aBTOM06J1JIeH, 'U06bl 3arp5l3HeHJ151 OT HHX HC nona.aaJIl1 B
30Hbl, filC HaX01l5lTC5I npOllYKTbI nHTaHH5I;
. YCTPOHCTBO llpCHa)l(eH llJl51 npCllOTBpaweHH5I 3arp5l3HeHH5I npo-
llYKUJ1J1 J13-3a npOTC'ICK, BHeCeHJ151 3arp5l3HCHHH Ha nOllOWBe
06YBH J1 60pb6bI C BpCllHTCJI5IMJ1 H T. 11.;
- CUCmeMbl 6enmUAJlII,Uu U KoniJUII,UOnUp06UHUJI
3TJ1 CHCTCMbI npCllHa3Ha4eHbI llJI5I CBelleHJ151 K MJ1HHMYMY 3anaXOB H
npCllOTBpaWCHJ151 3arp5l3HCHJ15( npollYKUJ1J1;
- OlplVlCiJenUJI
Orpa)l(1lCHJ151 npCllYCMaTpJ1BaIOTC5I llJI5I 3aWJ1TbI OT BpCllJ1TCJICH
(npJ1 Hc06xOllJ1MOCTJ1).
- llPOu36odcm6o U KonmpOAb KO.,ecm60
YCTaHOBJICHbI Tpc60BaHH5I (npI1MepbI) K:
. CbIpbIO H llPYnlM HHrpCllHCHTaM, nOp5l11KY HX KOHTpOJI5I 11
xpaHeHH5I, B TOM '1J1CJIe B XOJIOllHJIbHHKaX J1 MOp03J1JIbHI1KaX;
. 3aWHTC OT 3arp5l3HCHJ1H J1 napaMCTpaM MI1KpOKJ1HMaTa;
. naCTepH3aUI1J1 I111PyroH 06pa6OTKC;
. aHaJIH3Y Ha HaJIH4HC TOKCH4HbIX BeWCCTB;
. BbInOJIHCHJ11O TCXHOJIOnl'lCCKHX oncpaUHH;
. CKJ1allaM 11 nOp5l11KY peaJIJ13aUJ1H.
PaCCMmpeHbI CCTCCTBeHHbIC HJIJ1 HeJ136e)l(HbIC llC<PeKTbI B npOllYKTax.
KOTOpbIC HC npellCTaBJI5IIOT yrpo3bI llJI5I 31l0pOBb5l; FDA YCTaHaBJIHBaCT llJI5I
HJ1X npellCJIbHO 1l0nycTHMbIC 3Ha4CHH5I, npH4cM 3TJ1 ypOBHJ1 MOIyr H3MC-
H5ITbC5I no MCpe pa3BHTH5I TeXHOJIOnlH H nOJIY4cHH5I HOBOH HH<popMaUHH.
YCTaHOBJICHbI TaK)l(C Tpc60BaHJ151 K:
- CaHHTapJ1J1 H nlnICHC;
- 3KCnJIyaTauHH 060PYlloBaHH5I H non.ncp)l(aHJ11O cro B 4J1CTOTe;
- BOllOCHa6)1(CHHIO J1 KaHaJIJ13aUJ151;
- TYaJIeTaM J1 YMbIBaJIbHJ1KaM.
AHaJIOnl'lHbIC npaBJ1JIa CCTb J1 llJI5I llHCTH4CCKHX 1l06aBoK 21 CFR Part
J II - Current Good Manufacturing Practice in Manufacturing. Packaging, Label-
ing or Holding Operations for Dietary Supplements - npaBJ1JIa npoH3BOllCTB<1.
ynaKOBKJ1, MapKHpOBKJ1 J1 06pawcHH5I C llHeTH4CCKHMH 1l06aBKaMH.
GMP iJJUI KOCMemU.,ecKoii npOMblUUleHllOcmu
B 2007 r. 6bIJI npJ1H5IT CTaHllapT ISO 22716:2007 Cosmetics. Good
Manufacturing Practices (GMP). Guidelines on Good Manufacturing Practic-
es 01CO 22716:2007 npaBJ1JIa GMP llJI}I npOH3BOllcma KOCMeTH4eCKHX
CpCllCTB). OH B KpaTKoH <POp Me YCT<lHaBJlJ1l3aeT Tpe60BaHJ151 K npOH3BOll-
CTI3Y KOCMeTJ1lleCKHX cpellCTB. BKJ1IO'ta51 ncpCOHcUl, nOMeweHH51, 060py-
1l0BaHJ1C, 1l0KYMCHTaUHIO J1 np.. no aHaJIOrJ1H C npam1JIaMJ1 GM P llJI51
nnmnnOLlCTBa .1CKapCTBCHHLIX CpC.aCTI3.

439
fJlaBa 19
llHCnEKIJ,llll1l AY,lJ;IlT
Mamepua/l i!/Ia6bl OCH06aH Ha oOKYMeHmax EC U ClllA. aHa/lU3e rPaK-
mUl.feCKU npo6eoeHHbix UHCneKl(uil. o6w,eHUU a6mopa C UHcneKmopaMU U
cnel(UaJlucma.MU.
19.1 npoBepKa COOTBeTCTBIDI Tpe60BaHIDIM GMP
Ll.JI5I TOro 4T06bI npOlHBOllCTBa JICKapCTBeHHbIX CpCllCTB pa60TaJIJ1
no GMP, OllHJ1X 06513aTeJIbHbIX 11 rpaMOTHbIX HOpMaTI1BHbIX 1l0KYMCHTOB
MaJIO. HcH KOHTpOJIb COOTBeTCTBJ151 3Tl1M 1l0KYMCHTaM.
CywecTBYIOT llBe <pOpMbI KOHTpOJI5I COOTBCTCTBI151: J1HCneKUI1J1 11
aYllJ1T. Pa3JIJ14J1e MC)I(1ly HJ1MJ1 HOCI1T npl1HUl1nl1aJIbHbIH xapaKTep.
HHcneKquu npOB01l5lTC5I zocydapcm6eHHblM opzanOM, KOTOpbIH BbInOJI-
H5ICT <PYHKUI1IO HaIl30pa 11 HaIlCJICH npaBOM BbIllaBaTb JIl1ueH31111 Ha npo-
113BOllCTBO JICKapCTBCHHbIX CpCllCTB, OTKa3bIBaTb B I1X BbIlla4C I1JII1 OT3bI-
BaTb J1X. PCWeHJ1e, OTHOC5IWCCC5I K JII1UCH3I1pOBaHI1IO, npJ1HI1MaCTC5I Ha
OCHOBe npOBCpKI1 1l0KYMCHTOB 11 <paKTl14CcKoro COOTBCTCTBJ151 np0J13BOll-
CTBa Tpc60BaHI1HM G MP.
MHCnCKUl10HHbIH KOHTpOJIb 51BJI5ICTC5I o6R3ameJlbHblM. nOllp06HO no-
p5l1l0K J1HCneKTJ1pOBaHJ151 paCCMOTpCH B n. 19.2.
AyiJum MO)l(eT BbInOJIH5ITbC5I JII06bIM IOpJ111I1'1CCKI1M I1JII1 <p113114C-
CKI1M JII1UOM, 3a5lBl1BWCM 0 CBOCH cnoc06HOCTI1 J1 )l(CJIaHI1J1 3aHI1MaTbC5I
3TI1M BI1110M llC5ITCJIbHOCTI1. AYlll1T npOBOllI1TC5I Ha do6p060JlbHOii OCHOBC
npellnpl151TJ1C MO)l(CT Ha CBOC YCMOTpCHl1e BbI6J1paTb aYllJ1TOpa J1JIJ1 BO-
06wc He npl16eraTb K ero nOMOWI1.
AYlll1TOp HC MO)l(CT llaTb HJ1KaKI1X rapaHTI1H TOro, 4TO np0l13BOllCTBO
ycnewHo npOHlleT J1HCnCKTJ1pOBaHl1c. OH llaCT C06CTBCHHOC 3aKJ1IO'ICHJ1e
o COOTBeTCTBJ1J1 np0J13BOllCTBa Tpc60BaHJ15IM GMP. HacKoJIbKO 3TO 3a-
KJI104eHJ1e COBnalleT C MHCHl1eM I1HCnCKTopa 3aBJ1CI1T OT KBaJIJ1<pI1KaUJ1J1
aYllJ1TOpa (npellnOJIaraCTC5I, '1TO npI1WCllWJ1H 3a HJ1M J1HCnCKTop 51BJI5IeT-
C5I KOMnCTCHTHbIM J11106pOCOBCCTHbIM JIJ1UOM).
nOllp06HO nOp5l110K npOBCllCHI151 aYlll1Ta paccMOTpcH B n. 19.7. 3a
py6e)l(oM TCpMJ1H «aYllJ1T'> I1HOma I1CnOJIb3YCTC5I KaK CJ1HOHJ1M TCpMJ1Hd
('I1HCneKTJ1pOBaHJ1C'). HO YCTOH4l1BOH npaKTJ1KOH 51BJI5IeTC5I 4eTKOC pa3-
llCJIeHJ1C 3TJ1X nOH5ITJ1H.
CywCCTByeT TaK)I(e TepMI1H cepmuf/JuKaquR. KOTOpblH I1CnOJIb3YCTCH
KaK oqmUJ1aJIbHO, Ha1l30pHbIMJ1 opraHaMI1, TaK 11 aYllI1TOpaMJ1, B 1l06po-
BOJIbHOM nopHllKC.

440
{jwea 19
Mock inspection (penemuu,UR uHcneICu,uu)
nOJIe3HOH <pOpMOH aYllJ1Ta HBJ151eTC5I «mock inspection'> J1JIJ1 peneTHUH5I,
I1MJ1TaUH5I J1HCnCKUJ1H. OHa TaK )l(C npoBOllHTC5I HerocYllapcTBcHHOH opra-
HH3aUJ1CH J1JIJ1 cnCUJ1aJIJ1CTOM. Ec OTJIJ14J1TCJIbHOH OC06CHHOCTblO 51BJ151CTC5I
TO, 4TO OHa npOBOllHTC5I no TOH )l(C CXCMC, 4TO J1 caMa J1HCnCKUJ151 J1 3a-
BcpWaCTC5I OT4CTOM no <PoPMC OT4eTa HHCneKUJ1J1. 3TO J1CKJ1IO'IJ1TeJIbHO
npOllYKTJ1BHa5t <popMa nOllroToBKJ1 K roCYllapCTBeHHOH HHCneKUJ1H.
Ha 3anallC npOBCllCHJ1C «mock inspections,> WJ1pOKO pacnpoCTpaHcHo.
\IIMJ1 3aHHMaIOTC5I JIHua, paHcc pa60TaBWJ1C HHcncKTopaMH GMP FDA
J1JIJ1 EC. 3TO 06CT05lTeJIbCTBO 04CHb Ba)l(HO. LIoroBapHBa5lCb 0 npoBcllc-
HJ1J1 «mock inspection,> HY)I(HO BbI5ICHHTb, KTO HMeHHO 6YllCT cc npoBo-
.LlHTb J1 KaKOB nOCJIY)I(HOH CnJ1COK 3TOro CneUHaJIJ1CTa.
CepmU(jJuICau,uR
'-IacTo BCTpe'laCTC5I nOH5ITJ1C «cepmufjJuICau,uR Ha coom6emcm6ue
GMP». 3TO 3anYTaHHbIH Bonpoc, OCTaHOBHMC5I Ha HCM nOllp06HCC.
B POCCHH CYWCCTBYCT llBa BI111a CCpTH<pI1KaUHH: 06513aTCJIbHa51 H
1l06pOBOJIbHa5I.
Tpc60BaHH5I GMP He omHocRmcR K c<pepe o6R3ame.llbHoii cepmufjJu-
ICau,uu, KOTOpa51 pacnpOCTpaH5ICTC5I TOJIbKO Ha YTBCp)l(1lCHHbIH «EllHHbIH
nCpC'ICHb npOllYKUJ1J1, nOllJIC)I(aWCH 06513aTCJIbHOH CCpTJ1<pJ1KaUHH'>.
BBOllHTb 06513aTeJIbHYIO CepTJ1<pJ1KaUJ1IO npOH3BOllCTB JIeKapCTBeH-
HbIX CpCllCTB 6bIJIO 6bI 60JIbWOH OWJ16KOH no TpCM npH411HaM:
Bo-nep6blX, npOBcpKa Ha COOTBeTCTBJ1e G M P Tpc6YCT my60KJ1X
CnCUHaJIbHbIX 3HaHHH. KpaHHC COMHHTCJIbHO, 4TO COJ1CKaTCJIJ1 Ha aK-
KpCllHTaUJ1IO opraHa CCpTI1<pJ1KaUHH Ha COOTBCTCTBJ1C G M P 06JI31lalOT
XOTb MaJIOH TOJIJ1KOH 3TJ1X 3HaHJ1H. ABTop nHWCT 06 3TOM C nOJIHOH OT-
BeTCTBeHHOCTbIO, BH1l5l, KTO J1 KaK nOJIY4aeT aKKpCllHTaUHIO B llaHHoH
06JIaCTJ1 no JIJ1HJ1J1 1l06pOBOJIbHOH CCpTH<pHKaUHH.
BO-6mopblx, CCpTH<pHKaUH5I - 3TO pbIHOK. OpraHbI no cepTJ1<pJ1KaUHH
KOHKYpJ1pYIOT llPyr C llPyroM B 60pb6e 3a JaKa34J1Ka, npOllaBa51 cepTJ1<pJ1-
KaTbl. CroBOp'lHBbIM «CCpTH<pHKaTop», BbIllaBa51 <j"JaJlbWJ1BbIC CCpTJ1)HKa-
TbI, 6YllCT HMCTb KJ1HCHTOB, a npJ1HUJ1nJ1aJIbHbIH - HeT. LIoJIro 3TO He
npOT5IHCTC5I, nOCKOJIbKY HHCnCKUJ151 BbIBCllCT BCCX Ha 4HCTYIO BOllY. Ho
<paKT HaJIHUO: CCpTH<pI1Kary BCpJ1Tb TPYllHO. MbI CnJIOWb J1 p5l110M BH.lU1M
peKJIaMHbIC 06"b5lBJICHI151 «cepmurjJuKamb/: J/106b/e, 6b1cmpo. oeUJeeo».
B-mpembux, 06513aTCJIbHa51 CCpTH<pJ1KaUH5I 03Ha4aJIa 6bI lly6JIHpOBa-
HJ1C <PYHKUJ1H HHCnCKUJ1J1. 3TO COBCpWCHHO HC HY)I(HO H BpCllHO. 0651-
3aTeJIbHa51 npOBcpKa COOTBeTCTBH51 Tpc60BaHJ1HM GMP - llCJIO CJIHWKOM
OTBeTCTBeHHOC.
Hy)I(HO JIJ1 OpraHJ130Bb1BaTb d06p060JlbHYIO cepmufjJul«lu,ulO B 3TOM lleJIc?
'-IT06bI OTBeTJ1Tb Ha 3TOT Bonpoc, nOllYMaCM, '-leM OTJIJ1 l laeTCH 1106-
pOBOJIbHaH CepTH(J1KaUJ151 OT aYllJ1Ta. AYllJ1TOpa HHKTO HC Ha3Ha ' laeT
(aKKpCllJ1TyeT), a opraH 1l06pOBOJIbHOH cepTH<pHKamlJ1 npOXOJIHT aKKpc-
llHTaUHIO B YCTaHOBJleHHOM nOp5IJIKC.

J1HcneKlI,Ull U aYOllnl
441
nPOXO)l(1lCHJ1e npouellypbl aKKpellJ1TaUJ1J1 He 03Ha4aeT, 4TO opraH
CCpTJ1<pJ1KaUI1J1 6YllCT KOMneTeHTCH B npaBJ1JIaX GMP. no OllHOH npo-
CTOH npJ14I1He: CaMI1 aKKpClll1TYIOWl1e JIJ1ua HC KOMneTeHTHbI B llaHHOM
Bonpocc. n03TOMY npJ111aBaTb aYllJ1TY <POPMY 1l06pOBOJIbHOH CCpTJ1<pJ1Ka-
UJ1J1 CMbICJIa HCT, CCJII1 OT6pOCJ1Tb pCKJlaMHbIH 51pJIbIK caMoro TepMJ1Ha
«1l06pOBOJIbHa51 CC pT 11 <p11 KaUJ151 '>.
LJacTo BCTpC'IaIOTC5I 3a5lBJIeHIUI, 4TO np0J13BOllCTBO «cepTJ1<pJ1UJ1pO-
BaHO'> 3apy6e)l(HOH <pl1pMOH I1JII1 nOJIY4I11I0 e6poneiicKuii cepmu,pUKam
coom6emcm6UR GMP.
ECJII1 roBOpJ1Tb 0 EBpone, TO B03MO)l(HbI llBa CJIY4a5l:
I. CCpTJ1<pJ1KaT BbillaH Ha1l30pHbIM opraHOM (UHcneKu,ueii GMP) 011-
HOH J13 CTpaH-4JICHOB EC. 3TO 0<pJ1UJ1aJIbHbIH 1l0KYMCHT, BbIllaHHblH
roCYllapCTBCHHbIM opraHOM. EMY MO)l(HO BCpJ1Tb, OC06CHHO CCJIJ1 OH BbI-
llaH J1HCnCKUJ1CH C 60JIbWI1M onblTOM pa60TbI. nOp5l110K I1HCneKTl1pOBa-
HJ151 11 <popMa CCpTJ1<pJ1KaTa llaHbI B npI1JIO)l(eHJ151X 6 11 7.
2. CCpTJ1<pJ1KaT BbillaH «BaJII111aUI10HHOH') <pl1pMOH I1JIJ1 llPyroH He-
rocYllapcTBcHHOH CTPYKTYPOH. 3TI1 <pl1pMbI npI1MCH5IIOT aHml1HCKOC
CJIOBO «certification», HC CB5I3bIBa51 ero C aKKpCllI1TaUJ1CH rocYllapcTBeH-
HbIM opraHoM. CJIOBO «audit» 3aMCH5ICTC5I CJIOBOM «certification», KOTOpOC
nOTOM nCpCBOllI1TC5I Ha PYCCKI1H KaK «cepTI1<pI1KaUJ151') J1 1l0BCp411BbIMI1
JIlOllbMJ1 BOCnpJ1HJ1MaeTC5I Bcepbc3. TaKa51 «CCpTI1<pI1KaUJ151» nocTpocHa
Ha J1rpc CJIOB 11 HI1KOrO HI1 K 4eMY He 06513bIBaCT.
PaCCMaTpI1Ba51 CCpTJ1<pJ1KaT GMP. HY)I(HO Y5ICHI1Tb, KCM 11 Ha KaKOM
OCHOBaHJ1J1 OH BbIllaH. nOJIC3HO npOBCpJ1Tb cro no pceCTpy CCpTI1<pI1KaTOB.
3a Py6C)I(OM CJIOBO «CCpTI1<pI1KaUI151'> J1MCCT 3Ha4J1TeJIbHO 60JIce WJ1-
pOKJ1H CMbICJI. 4CM Y Hac. 3TO MO)l(CT BBCCTJ1 B 3a6JIY)I(1leHJ1C, oc06eHHo
npJ1 HCnpaBJ1JIbHOM nepcBollc.
Ha TaMO)l(He a3ponopTa MIOHxeHa eCTb Ha.anl1Cb «export certification».
3TO HHKaKa5I He cepTH4>HKauHH B HaweM nOHI1MaHHH. a Bcem J1J1Wb
o4>opMJ1eHJ1e 3KCnOpTHOH .aeKJ1apaUJ1J1.
B POCCI1I1 11 B CTpaHax «TpCTbCro Ml1pa,>. He C0311anWI1X CI1CTCMY pa60-
TbI 11 J1HCneKTl1pOnaHI151 no GMP, I1MeeT XO)l(1leHJ1e CCpTJ1<pJ1KaUJ151 no
J.1 CO 9000. Koc- KTO nblT<lCTC5I CBeCTI1 G M P K «MCHell)l(MCHTY') Ka'lCCTI3<L
3ro KOMMep4eCKmi 3aTC5I, HC J1MelOwa51 HJ1KaKoro OTHOWCHI151 K Ka4eCTBY.
MHorHC npJ1MCpbI B POCCJ1J1 11 3a Py6C)I(OM nOKa3bIBa1OT. 4TO npellnpl151TJ151
C CepTl1<pJ1KaTOM J;JCO 9000 MOfYT HC J1MCTb HJ1 OllHOro 3JICMCHTa GMP.
nOTpe6J1TeJI5IM HY)I(HbI HC CJ1CTCMbI «MCHell)l(MeHTa,) Ka4CCTBa, a caMO
Ka4eCTBO, KOTOpOC 06CCne'lJ1BaeTC5I BceM KOMnJIeKCOM pa60T no BHCll-
pCHJ110 GMP (maBa 14 J1 npI1JIO)l(CHJ1C 4).
npoBepKa Ha COOTBeTCTBJ1e G M P, Ha OCHOBaHJ1J1 KOTOpOH llaeTC5I
npaBO Ha BbInYCK J1 npOlla)l(Y JICKapCTBeHHoro cpellCTBa. BO BceM Ml1pe
npOBOllJ1TC5I TOJ1bKO <>ocyoapcm6ellllblM op<>aHOM - uHcneKu,ueii.

442
lJw6a /9
LIpyroc lleJIO, 4TO npJ1 nOllroToBKe K J1HCneKUJ111 J1 Bo06we npl1
nOllroTOBKC K pa60Te no G M P HY)I(HbI 3HaHI151, onblT J1 KBaJIJ1<pJ1UJ1pO-
BaHHa51 nOMOWb.
npoBepKa Ha COOTBCTCTBI1C GMP - llCJIO roCYllapCTBa. TaK npJ1H5I-
TO BO BceM MJ1pC. ECJIJ1 llYMaTb J1Ha'lC, TO HY)I(HO OTBeTJ1Tb Ha Bonpoc: a
3a4CM roCYllapCTBO HY)I(HO Bo06we. eCJII1 OHO nYCKaeT Ha caMOTCK TaKOH
KJII04CBOH Bonpoc KaK 6C30naCHOCTb JICKapCTBeHHblX CpCllCTB?
BepHeMCH K 'feMe cepTH(J)HKaJJ.HH.
OpramnaUH5I HJ1H J1HUO, BbInOJ1HHlOwee .a06pOB0J1bHYIO CepTJ14>J1Ka-
UJ110 Ha COOTBeTCTBHe Tpe60BaHJ1HM GMP. Haxo.aYlTC5I B .aeJ1J1KaTHOM n0J10-
)l(eHYlJ1. npoH3BO.aCTBO J1eKapCTBeHHbIX Cpe.aCTB HeC0J13MepJ1MO CJ10)l(Hee
J11060ro OT.aeJ1bHO B3HTOro H3.aeJ1H5I. n01llle)l(awero CepTJ14>J1KaUHH.
LlnH TOro. 4T06bl OueHJ1Tb npOH3Bo.aCTBO B nOJ1HOM 06DeMe. HHbl
my60KJ1e J1 pa3HOCTopoHHYle 3HaHYl5I J1 O'leHb MHOro BpeMeHJ1. HHcneKUHH
J1 He npoBepHeT np0J13Bo.aCTBO B nOJ1HOM 06'beMe.
npOBepKa Be.aeTCH 6bl6opOIIHO.
Ay.aJ1TOp (opraH .a06POB0J1bHOH cepm4>Y1KaUHH). 4T06bl He nonaCTb
BnpocaK. .aOJ1)1(eH npOBo.aYlTb nOAUYIO npo6ep"y. ECJ1Y1 npOBO,UJ1Tb Bbl60po4-
HYIO npouepKY. TO J1HCneKUJ151 MO)l(eT 06PaTHTb BHHMaHHe Ha nponyweH-
Hble 3J1eMeHTbI. HaJlJ1UO KOH4>J1J1KT. n0J1Ha51 npOBepKa ay.aJ1TopoM CTOJ1T
04eHb .aoporo J1 Tpe6yeT 3Ha4J1TeJ1bHbIX pacxo.aOB BpeMeHH (OT HeCKOJ1bKYlX
MeC5IueB .ao ro.aa. B 3aBJ1CHMOCTH OT COCTOHHJ1R J1 CJ10)l(HOCTJ1 06DeKTa). 3TO
He 04eHb peaJIbHO. D.3)I(e nOCJ1e nOJ1HOH npOBepKJ1 ay.aJ1TOpOM Bcer.aa cywe-
cTByeT onaCHOCTb, 4TO 4TO-TO ynyweHo J1 HHCneKTOp Ha 3TO MO)l(eT 06pa-
TJ1Tb BHJ1MaHJ1e J1J1J1 npJ1.aaCT nOBblweHHoe 3Ha4eHJ1e, Ka3aJ10Cb 6bl, He3Ha-
'1Y1TeJ1bHOMY C06b1THIO.
BbIBO.a npoCT: ay.aJ1T H .a06pOB0J1bHaH cepTH4>HKauHH He HBJ1HIOTCH ra-
paHTHeH ycnewHoro npOXO)l(.ll,eHYlH J1HCneKTJ1poBaHH5I. AY'uJ1Topbl .aOJ1)1(Hbl
oroBapHBaTb 3TO C 3aKa34HKOM, eCJ1H He XOT5IT nO,UBeprHYTbC5I wTpa4>HblM
CaHKUJ1RM H Bo06we npeCJ1e.aOBaHJ1IO.
19.2 I1HcneKLlHH
19.2.1 KTO npOBO.ll.HT HHcneKLlHH?
KaK OTMC4aJIOCb BbIWC, I1HCnCKTJ1pOBaHI1C np0J13BOllCTB JICKap-
CTBCHHbIX cpellCTB 51BJ151eTC5I <PYHKUJ1CH rOCYllapCTBeHHoro H31l30pHOro
opraHa. B EBponc, CWA, 51noHJ1J1, ABcTpaJII1J1 I111PyrI1X cTpaHax 3a no-
CJIellHJ1C 40-50 JICT CJIO)l(J1JIaCb CJ1CTeMa J1HCnCKTl1pOBaHJ151 Ha COOTnCT-
CTBJ1e G M P J1 HaKOnJIeH 6011bWOH onbIT. POCCJ151 HaXOllI1TC5I B HH'laJII>-
HOH <pa3C CTaHORTJCHJ151 TaKOH CI1CTeMbI.
UeJIblO npOBCllCHJ151 J1HCneKUJ1J1 51BJI5IeTC51 YCTHHOlliIeHl1e COOTBC r-
CTBJ151 np0J13BOllCTBa Tpe60BaHJ1HM GMP llJI5I npJ1HHTJ1H peWCHJ1H 0 131>1-
lla4e JIJ1ueH3J1J1 Ha np0J13BOllCTBO J1 npana Ha pCaJIl13aUl11O npollYKmllI
Ha TeppJ1TOpl1l111aHHOH CTpaHbl (rpynnbl cTpaH). HI1KaKoHllPyroH opraH
(B03, PIC, npo<peCCl10HaJIbHbIe OpraHJ13aUI1J1 J1 np.) TaKJ1MJ1 nOJIHOI\IO-

J1HcneKu,uu u aYOUnl
443
llJ151MJ1 HC 06JI alla lOT, n03TOMY J1X 3aKJ1104eHJ151 HOCHT JIJ1Wb J1H<popMa-
UJ10HHO-pCKOMCHllaTCJIbHbIH xapaKTep.
B CTpaHax, filC npaBJ1JIa GMP J1MCIOT 06513aTCJIbHYIO CJ1JIY. J1H-
CnCKTJ1pOBaHJ1e BbInOJIH5ICTC5I HaUJ10HaJIbHbIM opraHOM, JIJ160 opraHOM
llpyroi1 CTpaHbI, C KOTOpOH 3aKJ1104CHO COrJIaWCHJ1C 0 63QUMHOM npu-
3HQHUU J1HCneKUHi1.
npJ1MepOM B3aJ1MHoro npJ13HaHJ151 J1HCnCKUHH 51BJIHeTC5I EBponci1-
CKJ1H Co 103. PC3YJIbTaTbI J1HCneKTJ1pOBaHJ151 OllHOH J13 CTpaH-4JICHOB EC
06513aTeJIbHbI llJI5I npJ13HaHJ15111PyroH CTpaHOH-4JIeHOM EC.
Ll.JI5I TaKoro B3aJ1MHoro npH3HaHJ151 HY)I(HbI llBa <paKTopa:
- 3KBHBaJICHTHOCTb npaBHJI GMP;
- OllJ1HaKOBbIH ypOBeHb npOBelleHH5I J1HCneKUJ1H.
B EBponc 3K6U6lL1leHmHOCmb HOpM 06ecne4CHa TCM, 4TO llCHCTBYIOT
CllJ1HbIC npaBJ1JIa GMP EC.
C yp06HeM npo6eiJeHUJI HHCnCKUJ1H lleJIO 06CT0J1T CJIO)l(HCC. CaMa
EBpona HeOllHopOllHa. ECTb CTpaHbI C 6YKBaJIbHO nOJI5IpHbIM ypOBHCM
pa3BHTH5I. nOKa3aTCJIbHO OTHOWCHHC CiliA: I1HCnCKUHJ1 OllHJ1X CBpO-
nCHcKHx CTpaH OHH npJ13HalOT, llPYfHX - HCT.
np06JICMa B3aHMHoro npJ13HaHH5I I1HcncKUHH HcnpocTa H pace MOT-
pCHa B rJIaBC 23 B OTHOWCHHJ1 CI1CTCMbI PIC.
COOTBCTCTBI1C Tpc60BaHH51M GMP npOBCp5lCTC5I nYTeM npOBelleHJ151
HHCnCKUHI1 caMoro npOH3BOllCTBa. Ha MCCTC. I1HcncKuH5I npOBCp5leT
npOH3BOllCTBO HC TOJIbKO CBodi CTpaHbI, HO J1 CTpaH-J1MnOpTepOB JIeKap-
CTBCHHbIX CpCllCTB.
B '1CM OTJIJ1'1J1C G M P J1HCnCKUJ1H EC 11 FDA OT aYllJ1TOB B03.
PIC/S J111PYfHX opraHH3auHH'?
OTJIJ14J1C COCTOHT B TOM, 4TO COOTBCTCTBHC G M P FDA HJIH EC J1
ycncwHoc npOXO)l(1lCHHC HHCnCKUHJ1 oTKpbIBacT llopory Ha pbIHKH 3THX
CTpaH H llPyrJ1X CTpaH, npH3HalOWHx J1HCneKUHH CWA J1 EBponbl.
AYllJ1T B03 J1JIH PIC/S Ha COOTBCTCTBHC GMP 3TJ1X opraHH3auHi1 HHKO-
ro HH K '1CMY HC 06513bIBaeT J1 51BJI5IeTC5I JIHWb llcKJ1apaUJ1CH.
POCCJ1i1cKJ1e npellnpJ151TJ15I nOllJIC)I(aT HHcncKTHpoBaHHIO HallJOpHbIMJ1
opraHaMJ1 POCCHH, a npH nOCTaBKC JICKapCTBcHHbIX CpCllCTB 3a py6e)l( -
Ha1l30pHbIMJ1 opraHaMJ1 cTpaH-nOTpc6J1TCJICH. Hc CJIY4aHHo ACI1HKOM
C Ha4aJIa 90-x rOllOB 1l06J1BaeTC5I BBCllCHH5I B POCCHH npaBJ1JI G M P EC
CooTBeTCTBJ1e J1M OTKpbIBaCT llopory Ha 3apy6c)I(HbIC pbIHKJ1, 1aWHwaeT
BHYTPCHHHH pbIHOK OT HCll06poKa4ccTBcHHoro HMnopTa J1 nOllHJ1MaCT
pa60TY OTC4eCTBCHHbiX npellnpJ151TJ1H 110 ncpclloBOro ypOBH5I.
B POCCJ1H npJ1H5ITbI npaBJ1JIa G M P EC B Ka4CCTBC HaUHOHaJIbHOro
cTaHllapTa rOCT P 52249, HMClOwcro peKOMeHllaTCJIbHYIO CJ1JIY (Ha MO-
MeHT J1311aHH5I KHJ1rJ1). npJ111aHJ1e HM 06513aTeJIbHoro cTaTyca - 06"beK-
THBHO He06xollHMblH war, KOTOpblH MO)l(HO J1 HY)l(HO 6blJIO CllCJIaTb ewe
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JI5IIOWJ1X JIeKapCTBCHHbIC CpCllCTBa B POCCJ1IO.
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CHCTCMbl HHCneKTJ1pOBaHJ151 XopOWO pa3BHTbI B CWA J1 EBponc H
paccMoTpCHbI B n. 19.5, 19.6 J1 npHJIO)l(CHJ151X 6-10.
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JICKapCTBcHHbIX CpCllCTB B CiliA. npOHll51 npOBcpKY FDA J1 ncpcxoll51 B
pa3p5l11 cTpaH C BbICOKOTCXHOJIOrJ14HbIMJ1 np0J13BOllCTBaMJ1.
19.2.2 nOllroToBKa K HHCneKIJ,UU
UCJIb J1HCnCKUHJ1 - npOBepKa COOTBCTCTBH5I np0J13BOllCTBa Tpc60-
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KOMnCTCHTHa. HI1 B KOCM CJIY4ac HCJIb351 npI1rJIaWaTb llC5ITCJIeM J13 06JIa-
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rpynny no nOllroToBKC K I1HCnCKUI111 nOlI PYKOBOllCTBOM llHpCKTopa no
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roBOpJ1Tb. AYllJ1T - He nOJIJ1UeHCKa51 npOBepKa. OH HC BJIe4eT 3a c060ii
HJ1KaKI1X CaHKUJ1i111JI5I npCllnpI151T1151 J1 3TJ1M npJ1HUJ1nJ1aJ1bHO OTJIJ1'IaCT-
C51 OT npOBCpKJ1 H,l1l30pHb1M opraHOM. OH 1l0JI)I(CH 6blTb OTKpblTblM 11
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HCllOCTaTOK He cyweCTByeT. npJ1 npOBelleHJ1J1 BHYTPCHHCro aYllJ1Ta
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BCCTHOH J1HCneKTOpy. J1Y4we npJ1H5ITb MCpbI 110 cro npJ1C311a.
nOJIC3HO npOBCCTJ1 6HeUIHuii aydum, T. C. aYllJ1T CJ1JIaMH CTOpOHHCH
opraHH3aUHH HJIH cnCUJ1aJIJ1CTa.
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CTBH5I npaBHJIaM G M P, 3aTeM OUCHHTb, COOTBCTCTBYCT JIH npOH3BOllCTBO
npOCKTY, paCCMOTpCTb CJ1CTCMY 1l0KYMCHTaUJ1J1 J1 T.ll., no BCCM Bonpo-
caM, KOTOpbIC pcmaMCHTJ1pYIOTC5I npaBJ1JIaMJ1 G M P.
Bcc COTPYllHJ1KH, npJ1 ' taCTHbIC K npOBCllCHJ11O HHCnCKUJ1J1. 1l0JI)I(HbI
6bITb npcllynpC)I(1lCHbl 0 HCH. K HX 'IJ1CJIY. Hap5l11Y co CJIY)l(60H Ka4CCTBa,
npOH3BOllCTBeHHbIMJ1 nOllpa311CJIeHJ151MJ1 H J1H)I(eHepHOH CJIY)l(60H, OTHO-
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KallpOBa51 H llpymc CJI6bI. PCKOMeHllYCTC5I npcllynpcllHTb nOCTaBWI1-
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OnbITC npOWJIOH pa60TbI, Ha 4TO OH, KaK npaBHJIO, 06pawacT BHHMaHHC
no OnbITY npCllbIllYWHX npOBcpOK.
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roTOBO HC TOJIbKO B nJIaHC COOTBCTCTBH5I Tpc60BaHH5IM GMP, HO H B
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60THHKOB, OTCYTCTBJ1C llJ1CUHnJIHHbI, cy60pllJ1HaUJ1J1 H 3JIeMCHTapHoH
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BP5I11 JIJ1 COOTBeTCTBYCT 3JIeMCHTapHbIM Tpe60BaHJ1HM GMP.
ECJIJ1 J1HCneKUJ151 npOBOllJ1TC5I llBYM5I-TPCM5I HHcneKTOpaMJ1, TO CJIe-
llyeT npellYCMOTpeTb llJI5I HHX OTlleJIbHble nOMCWCHH5I, 4T06bl C0311aTb
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446
F.w6a 19
2. lloMeU(enue 1l0JI)I(HO 6blTb noiJlom06JlenO, 6bITb 4J1CTbIM, J1MCTb
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TbI pa3MepOB. CTOJI 1lJI5I 1l0KYMCHTOB npellnpH5ITH5I J1 oprrCXHHKY (MYJIb-
TI1MCllHHHbIH npoeKTOp C 3KpaHOM llJI5I llCMOHCTpaUJ111 HarJI5IllHbIX MaTC-
pl1aJIOB, KOMnbIOTCp, 1l0CKY C <pJIOMacTepaMH I1JIJ1 MCJIOM, nJIaHWCT C OT-
KJ111HbIMI1 JII1CTaMI1 H np.).
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nOMHI1Tb, 4TO B KOHUC Ma5l-I1IOHC UBCTYT TOnOJI5I J1 npJ1 OTKpblTbIX OKHax
KOMHaTa 6bICTpO 3anOJIH5ICTC5I nYXOM. npCllnpJ151TJ1C, KOTOpOC npCllO-
CTaBJI5IeT KOMHaTY neperoBopoB co cnepTbIM B0311YXOM 11 TCMncpaTYPoH
JIeTOM 30°C, caMO pJ1CYCT CBOH nopTpCT C ncpBbIX waroB HHCnCKTOpa Ha
CBOCH TCppl1TOpl1l1.
3. Bcc 060PYlloBaHJ1C 1l0JI)I(HO 6bITb J1CnpaBHbIM J1 npOBcpCHO ncpell
Ha4aJIOM pa60Tbl. ECTb J13BCCTHbIH «3aKOH nooJ/ocmu». COrJIaCHO CMY HC-
npH5ITHOCTI1 CJIYl./aIOTC5I B caMbIH HenOllX01l5lWJ1H MOMCHT. Ho 3TOT 3a-
KOH JII0611T nJIOXO opraHH30BaHHbIe CHCTeMbI, KOfila MHOroC nYWCHO Ha
caMOTCK, BOJIIO CJ1Yl./a5l, «Ha aBOCb'> 11 HC KOHTpOJIJ1pYCTC5I. TaM, filC CCTb
'1CTKa51 OpraHl13aUI151 11 OTBCTCTBCHHOCTb, filC BCC CBOCBpCMCHHO npoBe-
p5leTC5I, H CJIY4aHHOCT5IM HCT MccTa, «3aKOH nooJ/ocmu» HC pa60TacT.
4. n04CMY-TO Ha HCKOTOpbIX npCllnpl151TI151X 60JIe3HeHHbIM Bonpo-
COM 51BJI5IeTC5I n01l1lep)l(aHI1C 3JICMCHTapHbIX Tpc60BaHI1H lUluenbi B Tya-
JICTax. Pe4b HllCT He TOJIbKO 0 4I1CTOTC. LIOJI)I(HbI 6bITb TYaJICTHa51 6YMara.
YCTpOHCTBa 1lJI5I paCnpCllCJICHI151 MbIJIa 11 CYWKJ1 PYK (<pCHbI, CaJI<pCTKJ1 11
np.). HHOfila I1C4C3alOT TOJ1bKO l./TO 3anpaBJICHHbIC B llep)l(aTeJIb PYJIOHbI
TYaJICTHOH 6YMarl1. 3a HaJIl1'1I1CM 3TI1X HCXI1TPbIX MaTCpHaJIOB HY)I(HO
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YCJIOBI1H, TO HJ1 0 KaKJ1X G M P HC MO)l(CT 6bITb J1 pC4J1.
Cocma6 YlfacmnUK06
Ha COBCwaHJ151X J1 B npJ1CYTCTBJ111 I1HCnCKTopOB He 1l0JI)I(HO 6bITb
,1J1WHJ1X JIlOlleH. HO 06513aTCJIbHbIH MJ1HI1MYM PYKOBOllI1TeJIci1 11 cnCUJ1a-
JII1CTOB. cnoc06HbIX OTBCTI1Tb Ha B03HJ1KaIOWJ1C BonpOCbI, 1l0JI)I(CH 6bITb.
KpaHHe HenpmlTHa CJ1TyaUJ151. KOfila llJI5I OTBCTa Ha Ka)l(1lblH BTOpOH BO-
npoc Ha4J1HaIOTC5I nOHCKJ1 HY)I(HOro pa60THI1Ka.
IIJ HCnCKTOp npJ1eXaJI HC 1lJI5I TOro, 4T06bI Tep5lTb BpCM5I Ha O)l(I111aHJ1e
J1 Ha6JIIOllaTb HCOpraHJ130BaHHOCTb COTPYllHI1KOB npellnpJ151TI151. KOHC'IHO,
B03MO)l(Hbl BonpOCbI, 1lJI5I OTBCTa Ha KOTOpblC Tpe6yeTC5I BpeM5I. Ho TaKI1X
BonpOCOB, KaK npaBHJIO, HeMHoro. J1crKo OTJIJ1'1I1Tb Bonpoc, Tpc6YIOWI1M
nOllroToBKJ1, OT Tom, Ha KOTOpbIH OTBCT 1l0JI)I(eH 6blTb llaH cpa3Y.

J1HcneKlI,UU U ayoum
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19.3 npOBe.lJ.eHHe HHCneKl.\HH
CJICllyeT 3apaHee Y3HaTb HJIH OnpClleJIJ1Tb:
- UCJIb npOBClleHH5I HHCneKUJ1H;
- npOllOJI)I(HTeJIbHOCTb HHCneKUJ1J1 (4J1CJIO llHeH);
- COCTaB COTPYllHHKOB npCllnpJ151TJ151, npHHHMaIOWJ1X Y4aCTJ1C B HH-
cnCKUHH.
3TOT COCTaB 1l0J])I(CH 6bITb MJ1HHMaJIbHbIM, HO npellCTaBHTeJIbHbIM J1
BKJ1IO'IaTb B ce651 PYKOBOllJ1TCJICH J1 maBHbIX CnCUHaJIJ1CTOB OCHOBHbIX CJI6.
B CiliA HHCnCKUJ1H MOryr 6bITb BHC3anHbIMJ1, B EC 0 HJ1X npcllynpe-
)J(J]alOT .
PCKoMeHllyeTC5I, 4T06bI npCllnpH5ITJ1C caMO 1l0KYMCHTaJIbHO o<pop-
MJ1J10 PC3YJIbTaTbI npoBcpKH, HC 3aBHCHMO OT llCHCTBHH HHcncKTopoB. B
COCTaB 3Toi1110KYMcHTauHH 1l0JI)I(HbI BXOllHTb, KaK MJ1HHMYM:
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- COCTaB HHcncKTopoB;
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- nCpC'ICHb paccMoTpCHHbIX 1l0KYMeHTOB npCllnpJ151TI151;
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onpowcHHbIX J1HU;
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- 3aMe4aHH5I HHCnCKTOpoB.
no 3aBcpWCHHIO Ka)J(J]oro llH5I pa60TbI HHcnCKTopOB H nOCJIC HX
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4aHI151, KOTopbIe MorYT 6bITb YCTpaHCHbI K CJICllYIOWCMY llHIO HJIH 110
OTbC311a J1HCnCKTopOB, 1l0JI)I(HbI 6bITb YCTpaHCHbI 6bICTpO H PC3YJIbTaT
CJ1CllYCT nOKa3aTb J1HCnCKTOpy. npHMepaMH MOfYT CJIY)I(J1Tb HCnpaBJICHHC
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cnCKTOp YBJ11lHT, 4TO npCllnpH5ITJ1e nOllXOllJ1T ccpbe3HO K YJIY4weHHIO
CBoeH pa60TbI.
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UbI, B KaKOH MaWHHe ero B03J1Tb J1 np. Bcc 3TO BTopOCTcnCHHbIC HJIJ1
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448
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EblBalOT KpaHHOCTJ1, KOTOpblX 1l0nYCKaTb HeJIb35I.
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aBl1aJ1J1HHH H npH6blTb B y.aaJIeHHblH ropo.a. Ero TaM TO)l(e HHKTO He BCTpe-
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no Ka4eCTBY, KOTOpblH 1l0J1)1(eH 6bIJ1 ero npHHHTb, yexaJI Ha .aBe HelleJ1H Ha
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npl1 6efJIOM OCMOTpe 6blJ1 06HapY)l(eH peaKTOp .D.J151 npJ1roT0BJ1eHI151 paCTBO-
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CI1MYM Yll06cTBa llJI5I OTllbIXa B Hcpa60'lce BpCM5I. nOJIC3HO Y411TbIBaTb
I1HllI1BI111YaJIbHbIC OC06CHHOCTI1. Hanpl1Mcp, 11 HcnCKTopbI 113 OTllCJIbHbIX
CTpaH O)l(l1llalOT. 4TO 6YllyT pa3MCWCHbI B n5lTI13BC31104HOM OTeJIC.
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npellnpl151TJ151 C HJ1MJ1.
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CBCllCHl110 J1 I1CnOJIHCHJ110. nbITaTbC5I nepcy6Clll1Tb I1HCnCKTOpa, Koma
HCllOCTaTOK 04CBI111CH, 11 BbIllaTb 4CpHOC 3a 6CJIOC - 331la'-la Hc6JIarollap-
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npoc palnblM pa60mnuKOM M cpaBHMBaIOT MX OTBCTbI. OTBCTbI TaK)l(C
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06l>eMY H co.aep)l(aHJ110. npe.anpJ151THe C HJ1M COfJIaCJ1J10Cb. K CJ1e.aYlOweH
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3HaHJ151MI1 no BceM BonpocaM, HO OTllCJIbHbIe 3HalOT B COBcpweHCTBC,
Hanpl1Mep aHaJIJ1TJ14eCKJ1C MCTOllbI, MJ1Kp06110JI0fJ14CCKJ1H aHaJIJ13, 3a-
WJ1TY OT nepeKpCCTHbIX 3arp5l3HCHJ1H 11 np.
B TO )l(C I3pCM5I J1HCnCKTopbI FDA J1MCIOT WJ1pOKJ1i1 Kpyr03op, I1X
roTOB5IT K pa60Te. FDA I1MeCT PYKOBollcTBa no J1HCnCKTJ1pOBaHI1IO pa3-
JII1'1HbIX 06"beKTOB 11 npoucccOB. 3TJ1 PYKOBollcTBa 1l0CTynHbI B CCTJ1 J1H-
TCpHCT J1 51BJI5IIOTC5I XOPOWJ1M nOllcnopbcM npJ1 BHYTpeHHeM aYllJ1TC J1
nOllroToBKC K BJ13J1TY I1HcncKTopa.
Hepa60llee 6pe.MfI
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rocTenpl1l1MCTBa: npl1maCI1Tb I1HCnCKTopa Ha 06ell J1JIJ1 Y)I(I1H, npCllJIO-
)l(I1Tb KYJIbTYPHYIO nporpaMMY. I1HcncKTop caM PCWI1T, npl1H5ITb npJ1-
maWeHl1e J1JII1 HeT. HI14Cro 3a30pHoro B npl1H5ITI1I1 npl1rJIaWeHJ15I HCT. B
UJ1BI1JII130BaHHOM Ml1pe 3TO He BOCnpJ1HI1MaCTC5I KaK nOJIY4eHJ1C B351TKI1.
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BpCM5I MOfYT npl1H5ITb llBYCMbICJICHHbIH OTICHOK.
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OC06CHHO, CCJIJ1 pa3HHua B '1aCOBbIX n05lcax BCJII1Ka. HHCnCKTOp Ha
npCllnpl151TI1I1 pa60TacT Hanp5l)l(CHHO, 11 06wcHI1e C pa60THHKaMJ1 B HC-
pa60'lce BpeM5I MO)l(eT 6bITb 1lJI5I HCro YTOMI1TCJIbHbIM.
ABTop C'II1TaCT, 4TO KOHTaKTbI B BC4CpHCC BpCM5I JIY4we OrpaHJ14J1Tb
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HaCTpOCHJ1e J1 )l(CJIaHJ151 J1HCneKTopOB H HC np05lBJI5ITb 4pC3MCpHOH
HaCTOH4HBOCTJ1.
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HCJIb35111CJIaTb BO BpeM5I J1HCnCKUJ1H:
HYJKHO HeJlb3H
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3aKJII04CHHC HHcneKTopa HC roBOpHT 0 TOM, '1TO BCC np0l13BOllCTBO CO-
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MCp no YCTpaHCHJ1IO HellOCTaTKOB 11 1l0Ka3aTCJIbCTBaMI1 CBoeH npaBOTbI B
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MepbI no KJ1104CBbIM BonpocaM. \.1HcnCKTOp 1l0JI)I(eH BJ11I,CTb, KaKJ1C J1MCH-
HO MepbI 6YllYT npJ1H5ITbI, J1 n04CMY Tpc6yeTC5IllOnOJIHI1TCJIbHOC BpCM5I.
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MO)J(HO 6paTbC5I 3a OCTaJIbHoe.

456
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466 MJIpll. 1l0JI. CWA. 3TO COCTaBJI5ICT 60% 06DeMa llCC5ITI1 BCllYWI1X
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pOBaHl111 BbInOJIH5IeTC5I npoBcpKa Ha COOTBCTCTBI1C Tpe60BaHI151M KOlleKca
<pCllCPaJIbHbIX npaBI1JI 21 CFR Part 210/211, 600, 808, 812 11 820.
nOCKOJIbKY pbIHOK CWA 51BJI5ICTC5I Hal160JIcc CMKI1M. a npoucllypa
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roTOBbIM K I1HCnCKTl1pOBaHl11O 3TI1M opraHoM.
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np0I13BOllCTBO;
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· OT3bIBOB npOllYKUJ1I1;
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MO)l(eT 06'b5lCH5ITbCH lleJ1UJ1TOM BpeMeHI1 1lJI5I npOBeneHJ151 nOJIHOH npo-
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J1HcneKlJ,UU U ayiJum
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113MCHCHH5IMH TCXHHKJ1, TCXHOJIOfJ1H J1 HOpMaTJ1BHbIX Tpc60BaHHH.
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458
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B CWA lleHcTBYcr AKT «0 cBo60.ae J1H4>opMaUHH» - «Freedom of In-
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know), 4TO .aeJ1aeTCH B CJ1CTeMe ynpaBJ1eHJ151 rocy.aapcTBOM H HBJ1HeTCH oc-
HOBOH OTKpblTOro 06weCTBa. ny6J1J1KaUJ1H B HHTepHeTe nHceM-
npe.aynpe)l(.D,eHI1H - npJ1Mep pa60Tbl 3Toro AKTa.
ABTopoM BbInOJIHCH aHaJIH3 Bcex nJ1CeM-npcllynpC)I(1lCHJ1H FDA 3a
2010 r. CBOllHbIC llaHHbIC aHaJIH3a npJ1BCllCHbI B rJIaBC 20. nCpCBOll H<I
PYCCKHH H3bIK OllHOro 113 nI1CCM-npcllynpC)I(1lCHJ1H B npHJIO)l(CHHH 10.
Om3bl6 Jluu,eH3uu (npoiJYKu,uU)
ECJIH 06HapY)l(eHHbIc FDA HapYWCHH5I HaCTOJIbKO CCpbC3HbI, I.JTO
pHCK 1lJI5I nOTpc6HTCJICH HC MO)l(CT 6bITb YCTpaHeH npocTbIMH MCpaMI1.
BbIHOCHTC5I PCWCHHC 0 3anpcTc 1l0nYCKa llaHHoH npollYKUHH Ha pbIHOK H
06 OT3bIBC npOllYKUHH C pbIHKa (Revocation of approval).
lloMew.eHue 6 «lfepHblU cnucOK'>
B CJIYI.Jae 3anpCTa npOllYKUJ1J1 K pCaJIH3aUHJ1 FDA MO)l(CT BHCCTJ1 1\
CBOH «4CpHbIH CnJ1COK'> OTBCTCTBCHHbIX JIJ1U, npJ1'1aCTHbIx K cc BbInYCKY
(Debarment). J1J1ua, nOnaBWJ1e B 3TOT CnJ1COK, He 1l0nYCKaIOTC5I K npo-
J13BOllCTBY JICKapCTBeHHbIX CpCllCTB, npCllHa3Ha'leHHbIX 1lJI5I pblHK<I
CWA. CnHCOK ony6JIHKOBaH Ha caHTC: www.fda.gov.org .pa311CJI <<FDA
Debarment Lis!».
llpu6J1elfeHue K om6emcm6eHHocmu
J1J1ua, HapYWJ1BWHe 3aKOH, npJ1BJleKaIOTC5I K OTBCTCTBCHHOCTH B cy-
llc6HOM nOp5l11Ke BnJIOTb 110 yroJIOBHOH (Trial).

HHcneKu,uu u ayounl
459
19.6 HHCneKI.{HH B EBpone
nOp5l110K npOBelleHJ151 I1HcncKUHH no G M P B EBponc YCTaHOBJIeH
EBponeHcKJ1M areHTCTBOM no JICKapCTBeHHblM cpellCTBaM EMA (Europe-
an Medicinal Agency). nepcBoll OTlleJIbHbIX nOJIO)l(CHHH 3TOro 1l0KYMCHTa
npJ1BCllCH B npJ1JIO)l(eHJ1J1 6.
HJ1)1(e paCCMaTpJ1BaIOTC5I OCHOBHbIC Tpc60BaHH5I K npOBClleHHIO HH-
CnCKUJ1H B EBponc. HCnOJIb30BaH YKa3aHHbIH 1l0KYMCHT 11 OnbIT HauJ1o-
HaJIbHOro areHTCTBa no JICKapCTBCHHblM CpCllCTBaM <1>J1HJI5IHllJ1J1 (National
Agency for Medicines - NAM) no MaTCpJ1aJIaM cCMHHapa B XCJIbCHHKH 6
CCHT5I6p51 2006.
ECTb pa3HbIC <pOpMbI npOBellCHH5I HHcncKUHH:
- npOH3BOllCTBa B UCJIOM;
- npOH3BOllCTBa OTllCJIbHbIX BHllOB npOllYKUHH;
- OTlleJIbHbIX npoueCCOB (CTepHJlH3aUHI1, npOBCllCHJ151 aHaJIH30B H np.)
llpeiJMemllMU UHCneKII,uii no GMP 51BJI5IIOTC5I:
- npOH3BOllCTBa JIeKapCTBCHHbIX CpCllCTB;
- npOH3BOllCTBa H JIa60paTopl1l1, pa6OTaIOWJ1C no KOHTpaKTY;
- np0l13BOllCTBa aKTHBHbIX <papMaUCBTH'ICCKHX cy6cTaHUHH;
- npOH3BOllCTBa JICKapCTBCHHbIX cpellCTB 1lJI5I KJ1HHWICCKJ1X J1CCJIC-
1l0BaHHH;
- <pHpMbI-nOCTaBWHKH JICKapCTBeHHbIX CpCllCTB, HaX01l5lWJ1eC5I 3a npc-
llCJIaMH EC.
npOB01l5lTC5I J1HCnCKUI1H mpex 6UiJ06:
- nepBOHa4aJIbHa5l;
- nCpHOllI14CCKa5l;
- CnCUHaJIbHa5l.
llep60HQlttlAbHllR UHcneKII,UR (Pre-GMP Inspection) BbInOJIH5ICTC5I:
- 110 npJ1H5ITH5I peWCHJ151 0 BbIlla'lC JIHueH311H Ha np0l13BOllCTBO
(pa3pCWCHH5I Ha pCaJIJ13aUHIO);
- npH BHcceHHH KpHTH4ecKHx H3MCHCHI1H B JIHUCH3HIO Ha np0J13-
BOllCTBO (pa3pcwcHHe Ha pCaJIH3aUJ1IO).
llepuoiJultecKllR UHcneKII,UR (Routine follow-up GMP Inspection) npo-
BOllHTC5I OllHH pa3 B llBa-TpH rolla.
Cnell,UtlAbHllR UHcneKII,UR (Special Case GMP Inspection) npOBOllJ1TC5I
npI1 He06xollHMOCTJ1.
PaccMOTpCHJ1C 3a}/BKJ1 Ha BbIlla'lY JIHUCH3HH Ha np0J13BOllCTBO 3a-
HI1MaeT 90 llHeH, 3a5lBKJ1 Ha BHeCeHJ1e J13MeHCHJ1H - 30 llHCH.
CpOK Bbl.ll.a4H oqmUJ1aJIbHoro OT'leTa no GMP YCTaHaBJIJ1UaeTC5( J1H-
CneKUJ1eH.

460
[J1a6a 19
Kmo npo6oiJum Ullcnel(u,uu 6 E6pone?
OpraHJ13aUJ151 HHcnCKUHM Ha COOTBCTCTBl1e G M P HMCCT B EBponc
CBOH oc06eHHOCTJ1. EllJ1HOro Ha1l30pHoro opraHa llJI5I Bcero EBpOCOlO3a
HCT. HHcnCKUHH npOB01l5lT opraHbI CTpaH-'1JICHOB EC no YTBep)l(1lCHHO-
MY CnJ1CKY. B 60JIbWJ1HCTBC CTpaH llCHCTBYCT OllHa J1HCnCKUJ151 Ha BCIO
CTpaHY. J;!CKJII04eHHeM 51BJI5IeTC5I rCpMaHJ151, B KOTOpOH J1CTOpH4CCKJ1
JIHUCH3J1H Ha npaBO np0J13BOllCTBa JICKapCTBCHHbIX cpellCTB BbIllalOTC5I
3CMJI5IMJ1. 3TOT nOp5l110K coxpaHeH H B EC.
J1106a51 J13 3THX J1HCnCKUJ1H MO)l(eT BbillaBan CCpTJ1<pJ1KaT Ha COOT-
BCTCTBJ1C GMP OT J1MCHJ1 EC.
Omllem Ullcnel(mopa
OT4CT HHcnCKTopa 1l0JI)I(CH BKJIIO'IaTb:
- nporpaMMY npOBCllCHH5I HHCnCKUJ1H;
- 06WHC llaHHbIC 0 npCllnpJ151THI1;
- Ha6JIIOllCHH5I HHCnCKTOpOB 11 3aMC4aHH5I co CCbIJIKOH Ha nYHKT
npaBJ1JI GMP, CTaHllapTa J1JIH llPYroro HOpMaTI1BHoro 1l0KYMCHTa, KOTO-
pbIH HapYWCH;
- YKa3aHI1C Ha KpHTH4CCKHC HCllOCTaTKJ1;
- 3aKJIIOYCHHC 0 COOTBCTCTBHJ1 npOH3BOllCTBa Tpc60BaHI151M GMP,
CllCJIaHHOC B KOHKpCTHOH H '1eTKOH <pOpMC;
- PCKOMCHllYCTC5I YKa3aTb CpOKH, B KOTOpbIC np0J13BOllJ1TCJIb npCll-
CTaBI1T nJIaH MCpOnpH5ITHH no YCTpaHCHl110 3aMC4aHHH C YKa3aHI1CM
CpOKOB BbInOJIHCHH5I.
<1>opMa OT4eTa llaHa B npHJIO)l(CHI1H 8.
no pC3YJIbTaTaM HHcneKUHH H31l30pHbIM opraH npHHHMaCT pCWeHJ1C,
3aBHC5Iwee OT xapaKTcpa 3aMe4aHHH. B03MO)l(HO Ha3Ha4CHHC HHCnCKUJ1H
B paHHJ1C CpOKH llJI5I npOBcpKH BbInOJIHCHJ151 YCTpaHeHJ151 3aMC4aHHH.
OT4CT HanpaBJI5ICTC5I B 31lPCC npCllnpH5ITH5I B TC4eHJ1C 30 llHeM no-
CJIC npOBCllCHJ151 HHCnCKUJ1J1. OTBCT Ha 3aMC4aHHC 1l0JI)I(CH 6bITb nOJIY-
'1eH HHCnCKUI1CH B TC'ICHJ1C 30 llHCH C npCllJIO)l(CHJ151MJ1 H CpOKaMJ1
YCTpaHCHJ151 3aMCyaHHH.
ECJIH OTBeT 6YllCT npl13HaH HHcneKUHeH YllOBJICTOOpHTCJIbHbIM. TO
CCpTH<pHKaT COOTBeTCTBJ151 G M P 6YlleT BbillaH CHOBa.
Tpe606aHUR I( ullcneKmOpllM
B EC YCTaHOBJICHbI CJICllYIOWJ1C Tpe60BaHH5I K J1HCnCKTopaM:
1. J;! HCnCKTOp 1l0JI)I(eH C0311aBaTb OTKPbITYIO H HenpJ1HY)I(1lCHHYIO
aTMOC<pCPY. OH 1l0JI)I(eH OTBC4aTb Ha oonpocbI no npellMeTY J1HCnCKUHH
J1 llaBaTb n05lCHeHH5I, pacKpbIBalOlllHe CYTb 3aMe4aHHM. HO HC npcl3pa-
WaTbC5I B KOHcYJIbTaHTa J1JIJ1 npenOllaBaTCJI5I.
Pa60THJ1KJ1 npellnpJ151TJ151 1l0JI)I(Hbl J1MeTb 1l0cTaT04HYIO nOllroToBKY
H 3HaTb Tpe60BaHJ1H G M P.

JfHclleKlI,UU U aYOUnl
461
2. MHcneKTop 1l0JI)I(CH 6bITb 3peJIbIM J1 ypaBHoBeWCHHblM JIJ1UOM,
nOHJ1MaTb CJIO)l(HOCTb np0I13BOllCTBa, llaBaTb 06beKTI1BHbie 11 060CHO-
BaHHblC 3aKJ1IO ' ICHJ151, YMeTb I1X 1l0Ka3aTb, 6bITb HacToH4I1BbIM, HO J1
YMeTb BJ11leTb pCaJIbHOCTb CI1TyaUI1J1.
3. OH 1l0JI)I(eH 6bITb KOMnCTeHTHblM J1 YMeTb J13JIaraTb npCllMeT B
51CHOH <pOpMC KaK YCTHO, TaK 11 nJ1CbMeHHO, 0<pJ1UJ1aJIbHbIM 513bIKOM.
4. MHcncKTop 1l0JI)I(CH 3HaTb <papMaUeBTJ14CcKYIO npOMbIWJICH-
HOCTb, B TOM 4J1CJIC:
- npaBJ1JIa G M P;
- 3aKOHbI, HOpMaTI1BHbIC 11 npaBOBbIC 1l0KYMCHTbI, OpraHJ13aUHIO CJ1-
CTCMbI Ha1l30pa B CBOCH 06JIaCTI1, CTPYKTYPY 11 npJ1HUJ1nbI pa60TbI KOM-
Mep'lCCKJ1X OpraH113aUI1H, pbIHOK 11 nOp5l1l0K 1l0nYCKa Ha HCro J1 np.;
- MJ1Kp06110JIOrl1lO, TCXHOJI0fl14CCKI1e npoueCCbl J1 CI1CTCMbI BCHTJ1-
JI5IUI1I1, npl160pbI 11 aHaJII1Tl1lICCKJ1C MCTOllbI, KOMnblOTcpHbIC CI1CTCMbI,
I1CnbITaHJ151 J1 aTICCTaUl110 npOUCCCOB, OT60p J1 aHaJII13 np06;
- onTOBYIO TOproBJIIO JICKapCTBCHHbIMI1 cpellCTBaMJ1;
- nOp5l1l0K npOBellCHJ151 J1HCnCKUJ1H, aYlll1TOB 11 BbIlla411 JIJ1UCH3J1H;
- 3HaTb npJ1HUl1nbI 06CCne4eHI151 Ka4CCTBa 11 np.
)l(CJIaTCJIbHO, 4T06bI I1HCnCKTOp I1MCJI KBaJIl1<pI1KaUI1IO ynOJIHOMO-
1JCHHOro JIl1ua.
F060pn «pamKO, uncneKmop aOIlJICen:
- 3HaTb npCllMCT I1HCnCKTJ1pOBaHH5I H UCJIb;
- 3HaTb Tpc60BaHI151 11 6bITb KOMnCTCHTHbIM;
- 3HaTb CBOJ1 npaBa J1 06513aHHOCTI1;
- nOllroTOBI1Tb nporpaMMY npOBCllCHI151 J1HCneKUJ1J1;
- 6bITb 1l06po)l(CJIaTCJIbHbIM J1 KOppeKTHbIM.
HHCnCKTOPY CJICllyeT nOMHI1Tb, 4TO ero 3aKJ1104CHI1C 1l0JI)I(HO 6bITb
06bCKTJ1BHbIM. npJ1 nOJIY4CHJ1J1 OTKa3a Ha OCMOTp nOMCWCHI1H J1JII1 03Ha-
KOMJICHJ1C C 1l0KYMCHTaMI1 I1HCnCKTOp MO)l(CT nOTpc60BaTb, 4T06bI OTKa3
6bIJI llaH B nJ1CbMCHHOH <pOpMC. B CJIY4ac HC06XOlll1MOCTI1 OH MO)l(CT npJ1-
6CrHYTb K nOMOWI1 nOJII1UJ1I1.
B <1>I1HJI5IHllJ1J1, KaK npaBI1JIO. Tpc6YCTC5I, '1T06bI J1HCnCKTOp J1MCJI
YHI1BCpCJ1TCTCKOC 06pa30BaHI1C B 06JIaCTJ1 <papMaUI1J1 J1 npaKTI14CCKJ1H
OnbIT pa60TbI HC MCHec OllHOro-llBYX JICT B npOMbIWJICHHOCTJ1 J1JIJ1 CB5I-
3aHHbIx C GMP 06JIaCT5IX.
KOMMeHTapHH aBTOpa
06513aTeJ1bHble MOpaJIbHO-3TJ1'1eCKJ1e Tpe60BaHJ1H K J1HCneKTopaM 11
J1106b1M 4HHOBHHKaM - 3TO TO. 4TO KpaHHe He06xOllJ1MO POCCHI1.
HHcneKTop-xaM HJ1H CH06 - 51R11eHH5I a6cOJ1IOTHO HenpJ1eMJ1eMble.
l.JBaHCTBO. <j)aHa6epHH H BblcoKOMepHa51 HeKOMneTeHTHOCTb 4HHOBHJ1KOB -
3TO Haw HaUHOHaJlbHblH n030p. HHCneKTOp, KaK J1 J11060H 4HHOBHHK.
HaXOllHTCH Ha COllep)l(aHHH 06weCTBa. )l(HBeT Ha cpellCTBa HaJloronJ1aTeJ1b-
WHKOB H .aomKeH YBa)I(aTb HX. HHcneKTOp IlOJ1)1(eH nOHHMaTb 3Ha4HMOCTb
cBoeH poJ1H. HO H He BbIXO.aJ1Tb 3a 1l0nYCTHMble paMKH. 3HaTb CBoe MeCTO B
06weCTBe.

462
FJ/aRa 19
19.7 AY,lJ,HT
19.7.1 BH)J,bI aY,lI,HTa
AYlll1T, B OTJIJ1'1J1e OT HHCnCKTHpOBaHJ151, npOBOllJ1TC5I Ha 1l06pOBOJIb-
HOH OCHOBe.
KaK ynoMHHaJIOCb B n. 19.2.2, CCTb CJIellYIOWJ1e BJ11I.bI aYllHTa:
- BHYTPCHHJ1H aYllJ1T (caMoHHCnCKUJ1J1), BbInOJIH5ICMbIH CHJIaMH ca-
MOro npCllnpJ151TH5I;
- BHCWHHH aYllHT (aYllHT), npOBOllJ1MbIH CTOpOHHHMH HC3aBHCHMbIMH
OpraHJ13aUJ151MH H JIHuaMH, HC pa60TalOwHMH Ha llaHHOM npCllnpH5ITHJ1.
AYllHT, npOBOllJ1MbIH pa60THJ1KaMJ1 06'bellHHeHJ151 (opraHH3aUJ1J1), B
COCTaB KOToporo BXOllHT llaHHOC npellnpH5ITHe, J1JIJ1 KOTOpOC 51BJI5ICTC5I
C06CTBCHHJ1KOM (OllHHM H3 C06CTBCHHJ1KOB) llaHHoro npCllnpH5ITJ151. 11
HC OTBC'IaIOWI1H Tpc60BaHH5IM HC3aBHCHMOCTH, HC 51BJI5ICTC5I BHCWHHM.
K BHCWHCMY aYlll1TY HC OTHOCHTC5I TaK)l(C aYllHT, npoBollHMbIH JIl1uaMJ1,
HC pa60TalOWHMH Ha llaHHOM npCllnpH5ITI111 nOCT05lHHO, HO CB5I3aHHbIMH
C HHM TpYllOBbIMI1 OTHOWCHI151MI1.
19.7.2 lJ,eJIb aY,lJ,HTa
UCJIbIO aYllHTa 51BJI5ICTC5I YCTaHOBJICHHC COOTBeTCTBH5I npOH3BOllCTBa
Tpc60BaHJ151M GMP (rOCT P 52249) H llPymx OTHOC5IWHXC5I K HCMY
CTaHllapTOB J1 npaBHJI.
npCllMCTOM aYllHTa MO)l(CT 6bITb npOH3BOllCTBO B UCJIOM JIH60 cro
OTllCJIbHbIC 3J1CMCHTbI (llOKYMcHTaUH5I, npOUCCCbI, 060PYlloBaHJ1e, no-
MCWCHH5I. J1a60paTopHH 11 np.), 4TO YKa3bIBaCTC5I B nporpaMMC aYllHTa.
npCllMCTOM aYllHTa MOfYT 51BJI5ITbC5I TaK)l(C npCllnpl151TI151 J1 PC3YJIbTaTbI
pa60TbI OTllCJIbHbIX JIHU no 1l0roBopaM C 3aKa3'-1HKOM aYllJ1Ta (HanpHMcp,
pallHaUHOHHa51 CTepHJIH3aUH5I, 06pa60TKa OllC)I(1lbI 1lJI5I 4J1CTbIX nOMewc-
HJ1H, npOBelleHHC aHaJIH30B H np.)
PC3YJIbTaTbI BHCWHcro aYllHTa MOrYT J1CnOJIb30BaTbC5I Ha1l30pHbIMH
11 J1HbIMJ1 OpraHaMI1 npl1 npI1H5ITHH peWCHI151 0 BbIlla4e I1JIJ1 OT3bIBC JIJ1-
ueH31111 Ha np0I13BOllCTBO.
19.7.3 AY,lI,HTOpbI
BHewHI1H aYlll1T (aYllJ1T) npOBOllJ1TC5I HC3aBI1CHMbIMJ1 OT llaHHoro
npellnpl151TI151 OpraHJ13aUHCH HJIJ1 JIJ1UOM, J1MCIOWJ1MH 1l0cTaTo'IHbIH
onbIT pa60Tbl B llaHHoH 06JIaCTJ1.
Ba)l(HblM YCJIOBJ1CM 51BJI5ICTC5I pcnYTaUJ151 J1CnOJIHHTeJI5I.
OH 1l0JI)I(eH 6bITb HC 3aMClIeH B <PaJIbCJ1<pI1KaUI151X, BBCllCHl111 B 3a-
6JIY)I(1lCHI1C J1 np.

HHCneKlI,UU U ayiJum
463
19.7.4 npOBel\eHHe aY)J.HTa HeCKOJlbKHMH opraHH3all.IDIMH
npJ1 npOBCllCHJ1J1 aY1lI1Ta HCCKOJIbKJ1MI1 OpraHJ13aUJ151MJ1 J1JIM HC3a-
BJ1CJ1MbIMJ1 <pJ13M'IeCKJ1MM JIJ1UaMM CJIellyeT onpCllCJIJ1Tb rCHCpaJIbHOro
aYllMTopa, KOTOPOMY nOCTynalOT MaTCpJ1aJIbI OT llpyrMx aYllMTopOB (cy6-
aYllI1TOpOB).
TaKoH aYllMT HOCI1T KOMnJICKCHbIH xapaKTCp J1 paCCMaTpMBaeT pa3-
HbIe CTOpOHbI llC5ITCJIbHOCTM npCllnpM5ITM5I.
reHepaJIbHbIH aYllJ1TOp HCCCT OTBCTCTBCHHOCTb 3a Ka4CCTBO M He3a-
BJ1CMMOCTb aYllMTOpCKJ1X npOBcpOK, BbInOJIH5ICMbIX cy6aYllJ1TOpaMJ1.
LIOroBOpbI C cy6aYllMTopaMM MoryT 3aKJ1104aTbC5I reHepaJIbHbIM
aYllMTopOM, JIM60 HcnocpellCTBCHHO 3aKa34MKOM. Bo BTOpOM CJIY4ae rc-
HepaJIbHbIH aYllMTOp 1l0JI)I(CH J1MCTb B03MO)l(HOCTb KOHTpOJIMpOBaTb pa60-
TY cy6aYllMTopOB B Hc06xOllMMOM 06bCMC, BKJ1104a51 nOJIY'lCHJ1C nCpB114-
HbIX llaHHbIX (aKTOB J1CnbITaHI1H) M Ha6JIIOllCHI1C 3a pa60ToH cy6aYllMTOpa.
19.7.5 nOpSl,lJ,OK npoBe)J.eHIDI aY)J.HTa
AYllMT npOBOllI1TC5I B CJICllYIOWCM nOp5l11KC:
a) nOllaeTC5I 3a5lBKa Ha npOBCllCHMC aYllMTa (n. 19.7.6);
6) MCnOJIHMTCJIb roTOBJ1T nporpaMMY aYllMTa (n. 19.7.7), OnpCllCJI5I5I
npM He06xollMMOCTM cy6aYllMTopOB, COCTaB KOTOpbIX COrJIaCOBbIBaCTC5I C
3aKa34MKOM; B CJIY'lae. CCJII1 '-IaCTb pa60T no aYllMTY C BbInOJIHCHbI
TpCTbMMM opraHM3aUJ151MJ1 MJIM npCllnOJIaraCTC5I MX npJ1BJIC'-ICHMC, opraH,
BbInOJIH5IIOWMH aYllJ1T, OUCHMBaCT 3TM opraHM3aUMM M npMHMMaeT OllHO
113 TpCX peWCHMH:
- npM3HaTb 3aKJII04CHM5I 3TMX opraHM3aUI1H,
- OTKJIOHMTb MX,
- nOCTaBMTb YCJIOBMC CnCUJ1aJIbHOro paCCMOTpCHM5I MaTCpJ1aJIOB,
npCllCTaBJICHHbIX 3TMMM opraHM3aUJ151MM;
B) nporpaMMa COrJIaCOBbIBaCTC5I C 3aKa34MKOM;
r) MCnOJIHMTeJIb roTOBMT 1l0roBOp Ha npOBelleHJ1e aYllJ1Ta. KOTOpbIH.
B CJIY'lac COmaCJ151, nOllnl1CbIBaeTC5I 3aKa34MKOM;
11) J1CnOJIHJ1TCJIb, npM HC06XOllJ1MOCTJ1, 3anpaWMBaCT 11 J13Y'-laCT
.n.aHHbIC 0 nOllJIC)I(aweM aYllMTY 06'bCKTC;
c) 3aKa3'1J1K BbInOJIH5ICT nOllroTOBKY K aYlll1TY (n. 19.7.8);
)I() aYllJ1T npOBOllJ1TC5I B YCTaHOBJICHHbIC CpOKI1;
3) J1CnOJIHJ1TeJIb roTOBMT OT4eT 0 npOBCllCHJ1J1 aYllMTa;
J1) YKa3aHHbIH OT4CT ncpellaeTC5I IaKa3'1J1KY J1 npOBOllI1TC5I cro 06-
cY)l(1leHJ1C;
K) pa3pa6aTbIBaCTC5I KOMnJIeKC Mep, HanpaBJICHHbIX Ha YCTpaHCHJ1C
3aMC'IaHI1H (npJ1 J1X HaJIJ14J1(1);
JI) npJ1 He06xOllJ1MOCTI1 npOBOllJ1TCH nOBTopHbIH aYllJ1T.

464
FiW6a /9
19.7.6 3aJlBKa Ha npOBe,lJ,eHHe aY,lJ,HTa
OCHoBaHHcM 1lJI5I Ha'laJIa pa60TbI 51BJI5IeTC5I 3a5lBKa 3aKa34HKa Ha
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ny6JIHKYCTC5I no MaTCpHaJIaM J1HCnCKUJ1J1 GMP <1>HHJI5IHllHH, npell-
CTaBJIeHHbIM Ha CCMHHapc ACMHKOM B XCJIbCHHKJ1, CeHT5I6pb 2006 r.
llpOu36oocm6o u npo6eoeHue aHOJIU306 no KOHmpOlcmy
Cy6nOllp5l11 B npOH3BOllCTBe JICKapCTBCHHbIX CpCllCTB, T. C. BbInOJIHC-
HHC OTllCJIbHbIX TCXHOJI0fJ14CCKHX oncpauHM J1JIJ1 npOBCllCHJ1C aHaJIH30B
CTOpOHHCH opraHH3aUJ1eH no 1l0roBOPy (KoHTpaKTY) npCllCTaBJI5ICT no-
BbIWCHHbIH pJ1CK J1 Tpc6yeT oc060ro BHHMaHH5I KaK co CTOpOHbI 3aKa3-
'1I1Ka 3TI1X YCJIyr, TaK 11 co CTOpOHbI Ha1l30pHbIX opraHOB. B 3TOM nJIaHC
<pI1HCKOH I1HcnCKUHCH OTMC4CHbI CJICllYIOWHC HCllOCTaTKJ1:
- KOHTpaKT (comawcHHc MC)I(1ly 3aKa34HKOM H HCnOJIHJ1TeJICM) HC-
1l0CTaT04HO KOHKpCTeH;
- He4eTKO OnpCllCJICHO pa311CJICHHC OTBCTCTBCHHOCTH;
- He npOBOllHTC5I OUCHKa pHCKa, CB5I3aHHoro C HOBbIM npOllYKTOM;
- OTKJ10HCHJ151 HC aHaJIH3J1pYIOTC5IllOJI)I(HbIM 06pa30M;
- 3aKa34HK HC nOJIY4aCT HH<popMaUJ1H 06 OTKJ10HeHJ151X;
- CHCTeMa KOHTpOJI5I H3MeHeHJ1H OTCYTCTBYCT H1IH HCllOCTaT04Ha,
3aKa34HKa He HH<POPMHPYIOT 06 H3MCHeHJ151X.
npHMep I
OpraHJ130BaHa BTOpl1'lHa51 ynaKoBKa J1HDeKUHOHHbIX npenapaTOB, no-
J1YlJaeMblX B 6aJ1K-4>opMe OT npoH3BO.aJ1TeJ151 B TpeTbeH CTpaHe. npH 3TOM
He npoBe.aeHa oueHKa napTHepa.
npHMep 2
3Tan 4>J1HHWHOH CTepl1J1H3aUHH /leKapCm6eHHblX cpedcm6 nepe.aaH
4>HpMe, cneuHaJlH3HpYlOweHcH Ha CTepJ1J1J13aUI1H Me.aI1UHHCKHX H3.aeJ1HH.
npouecc CTepHJ1H3aUHJ1 He COOTBeTCTByeT GMP 11 BbIl10J1HeHJ1e 3TOro
Tpe60BaHlliI He oroBopeHo B KOHTpaKTe.
npHMep 3
3aKa3lJJ1K (npoH3Bo.aHTeJ1b npo.aYKUHJ1 B 6aJ1K-4>opMe) 3aKJ1lOlJJ1J1 He-
CKOJ1bKO KOHTpaKTOB C .apyrHMI1 clmpMaMI1 Ha BbIl10J1HeHHe cyweCTBeHHblX
3TanOB pa60T (pl1c. 19.1). 3Ta cxeMa CJ1HWKOM CJ10)l(Ha H He KOHTpOJ1HPy-
eMa. fapaHTHpooaTb KalJeCTBO npH pa60Te no TaKOH cxeMe HeJ1b351.

470
!'.JW6a 19
Pa3)],eJleHHe OTBeTCTBeHHOCTH
npH pa60Te no KOHTpaKTaM: pa60TaeT JlH OHO?
CTeplUlbHble nepBI1Hble
ynaKOBQIJHbie
MaTepltaJIbl
I1cxollHble
MaTepHaJI bl
3aKa3'1HK pa60T no
KOHTpaKTaM
npOlIJBOllInellb
HepacljJacoBaHHO" nponYKuml
(6aJ1K-nponYKUI1I1)
PJ1C. 19.1. CxeMa pa60TbI no KOHTpaKTaM, KOTOpylO TPYllHO KOHTPOJIJ1pOBaTb
llOMeUl,eHUJI
B np0l13BOllCTBC CTCpl1JIbHbIX npenapaTOB:
- KOHTpOJIb KOHUCHTpaUl111 "-IaCTI1U B B0311yxe npOBOllI1TC5I JII1Wb
Olll1H pa3 B rOll, nepI1011I1'1CCKI1H KOHTPOJIb '1aCTI1U C pa3MCpaMI1 5 MKM
HC npOBOllI1TC5I COBceM;
- KOHTpOJIb "-IaCTI1U HC 51BJI5ICTC5I HcnpcpbIBHbIM 11 KpI1TI1"-1CCKI1C CTa-
111111 npouccca HC KOHTpOJIl1pYIOTC5I;
- nOMCIUCHI1C 1lJI5I MOHKI1 aMnYJI KJIaccl1<pI1Ul1pOBaHO KaK 30Ha F;
TaKa51 KJ1aCCI1<pI1KaUI151 OTCYTCTBYCT B GMP EC.
llepCOHll./l
Y5I3BI1MbIM MCCTOM 51BJI5ICTC5I nOllroToBKa nCpCOHaJIa, Hanpl1MCp:
- JIl1ua, BbInOJIH5IIOWI1C y60PKY 411CTbIX nOMCWCHI1H, HC 06Y"-ICHbI
nOBellCHI1IO B HI1X;
- oncpaTopbI HC 06Y"-lCHbI nop5I1lKY nepeOllCBaHI1511lJI5I pa60TbI B 411-
CTbIX nOMeWCHI151X; npouccc ncpCOllCBaHI151 HC aTTCCTOBaH.
HanO/lHeHue CpedaMU (acenmuliecKoe npOU3BoikmBO)
ACCnTI14CCKOC np0l13BOllCTBO - 3TO np0l13BOllCTBO C BbICOKI1M
pJ1CKOM 1lJI5I npOllYKUI1J1. HHCnCKUI151 YllCJI5ICT eMY oc060c BHI1MaHI1C 11
OTMe4aCT CJIellYIOWl1e HCllOCTaTKI1:
- KBaJIl1<pI1KaUI151 nepCOHaJIa HC 1l0CTaTO'lHa;
- JIl1ua, pa60TaIOWl1e B aCCnTJ14eCKOH 30HC, HC npOWJIJ1 I1CnbITaHI151 B
npoucccax C HanOJIHeHI1CM cpellaMI1 (B I1CnbITaHJ151X 1l0JI)l(HbI Y4aCTBOBaTb
Bce onepamopbl);
- He Bce <pJIaKOHbI, HanOJIH5ICMbIC cpellaMI1, npOWJII1 I1HKY6aUI1IO;
- KpI1TJ1'1eCKl1e BMCWaTeJIbCTBa B npouccc HC BbInOJIH5IJIJ1Cb npl1
HanOJIHeHJ111 cpellaMI1 (llOJI)I(HbI BbInOJIH5ITbC5I Bce 6MemameJlbCmBa).

J1HcneKlI,UU U ayoum
471
TeXHOl102UH
npJ1MepbI HCllOCTaTKOB:
- CTepJ1JII13YlOwa51 <pJ1JIbTpaUI151 BbInOJIH5IeTCSI HC HenocpellCTBeHHO ne-
pell HanOJIHeHI1CM (llOJI)I(Ha BbInOJIH5ITbC5I Henocpedcm6eHHO ncpCll HI1M);
- npouecc MOHKI1 <pJIaKOHOB He aTICCTOBaH.
CmeplLllU3alJ,UH
3aMe ' taHJ151 K npoueccaM CTepJ1JII13aUI1J1 MaTCpl1aJIOB J1 roTOBOH
npOllYKUJ1J1:
- He npOB01l5lTC5I nOBTOpHbIC I1CnbITaHI151, KaK Tpc6YlOT G M P;
- He npOB01l5lTC5I nOBTopHbIC J1CnbITaHI151 CTCpl1JII13aTOpOB Olll1H pa3
B roll1lJI5I K3)I(1l0ro npouccca CTCpJ1JII13aUI1I1.
I1TaJIHJI
HJ.1)1(e npJ1B01l5lTC5I llaHHbIC 0 3aMC4aHJ151X no PC3YJIbTaTaM 40 J.1H-
CnCKUJ.10HHbIX npOBepOK aCCnTJ.14CCKJ.1X np0J13BOllCTB B HTaJIJ.111 (B Ka)l(-
1l0H npOBcpKC 6bIJIO llaHO HCCKOJIbKO 3aMe4aHJ1H), npJ.1BCllCHHbIX B 110-
KJ131lC J1HCneKTopa GMP MTaJIJ1J.1 Ha CJ1Mn03I1YMc ASSCA B MMJIaHc,
H05l6pb 2006 r. (pl1c.19.2) [18]:
npHIJHHa KOJI-BO %
I LloKYMeHTauHH 50 15,9
2 PHCK 3arp5l3HeHJ1H 33 10,5
3 nepCOHaJI 28 8,9
4 nOMeweHHH (npoeKT J1 3KCnJ1yaTaUI151) 22 7,0
5 KOHTpoJ1b Ka4eCTBa 19 6,1
6 ATTecTaUJ1H npoueCCOB (HanOJ1HeHJ1e cpe.aaMJ1) 19 6.1
7 T eXHOJ10fJ151 18 5.7
8 060py.aoBaHHe (KOHCTPYKUJ1H J1 3KcnnyaTauHH) 18 5.7
9 CHCTeMa BeHTJ1J1HUHJ1 J1 KOH.aHUJ10Hl1poBaHH5I 18 5.7
10 KOHTpoJ1b oKpalOweH Cpe.abl 15 4.8
II AHaJlJ13 OTKJ10HeHHH OT cneuH4>I1KaUI1H 14 4.5
12 06ecne4eHHe Ka4eCTBa I3 4.2
13 PeKJ1aMaUI1J1 H OT3blBbl npo.aYKUJ111 II 3,5
14 KaJlJ16pOBKa npJ160pOB 9 2.9
15 HCnblTaHHH (aTTeCTaUJ151) 06opy.aoBaHHH: IQ-OQ-PQ 8 2.5
16 ATTecTaUHH npoueCCOB 04J1CTKI1 7 2.2
17 nO.aroToBKa BO.abl 7 2.2
18 HecooTBeTcTBJ1e J1J1ueH3J1J1 5 1.6
Bcero 314 100,0%

472 1a6a 19
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PMc.19.2. 3aMC'laHI151 no pe3YJIbTaTaM MHCnCKUI1H B HTaJIJ1M
no npMe311Y Ha npCllnpM5ITMC MTaJIb5lHCKI1H I1HCnCKTOp YllCJI5ICT
nepBOCTcnCHHOC BHMMaHMe:
- 1l0KYMCHTaUJ1M;
- PMCKY 3arp5l3HcHMti;
- 06Y4CHJ11O nCpCOHaJIa M cro nOBellCHJ1IO.
19.8.3 THnH'IHble He)J.OCTanrn B POCCHH
K TMnM'IHbIM HCllOCTaTKaM B POCCJ1J1 (no OnbITY aBTopa M ero KOJI-
JIcr) OTHOC5ITC5I:
I. OTcyrcTBHe npoeKTa H npHHHnHaJlbHble OlUH6KH B HeM
nOllp06HO 3TOT Bonpoc paCCMOTpCH B rJIaBC 3.
PacnpocTpaHeHHblM 51BJIeHMeM B 1990-e rollbI 6blJI0 CTpOJ1TCJIbCTBO
Bo06wc 6C3 npOCKTa. 3aTeM CTaJIM CTpOI1Tb no npOCKTaM, HC COOTBCT-
CTBYIOWMM GMP C HCnpaBMJIbHbIMJ1 nJIaHl1pOB04HbIMJ1 peWeHJ1HMH,
OWI16KaMM B CMCTCMax BeHTJ1JI5IUJ1J1 J1 KOHilJ1UMOHJ1pOBaHM5I J1 np.
2. .n.OKYMeHTalUI:
- OTCYTCTByeT \I1H<popMaUJ151 0 npCllnpH5ITMH (llOCbC npCllnpmITJ1H);
- OTCYTCTByeT 1l0KYMeHTaUJ151 B nOJIHOM 061>CMe;
- HeT nJIaHOB nOMCWCHJ1M C paCCTaHOI3KOH 060pYllol3aHJ151;

HHCneKlI,UU U aydum
473
- HeT TeXHOJI0fJ14eCKJ1X cxeM;
- HCT cneuJ1<pJ1KaUJ1H 060PYllOBaHJ151;
- HeT 1l0KYMCHTaUJ1H Ha J1H)I(eHCpHbIC CJ1CTCMbI (BCHTHJI5IUHH H
KOHllJ1UHOHJ1pOBaHHC, nOllroToBKY BOllbI 04HWCHHOH J1 BOllbI 1lJI5I HHl>-
eKUHH, C)I(aToro B0311yxa H np.);
- HeT J1HCTPYKUHH HJIH OHI1 npCllCTaBJIeHbI B HenOJIHOM 06l>eMC;
- HaHMCHOBaHHC HHCTPYKUHH He COOTBCTCTBYCT COllCp)I(aHJ1IO;
- J1HCTPYKUH5I ncpcrpY)I(CHa HCHY)I(HOH J1H<popMaUJ1CH, KOnH5IMJ1
MaTCpHaJIOB rOCToB, HO HC COllCp)l(J1T J1H<popMaUHJ1 no CYWCCTBY;
- HHCTPYKUJ1IO HCB03MO)l(HO BbInOJIHJ1Tb;
- 1l0KYMCHTaUH5I He COOTBcTcTByeT <paKTJ14CCKOH TeXHOJIOfJ1H, B Hec
He BHOC5ITC5I J13MeHeHJ151;
- npOTOKOJIbI CepJ1H BCllYTC5I HCYllOBJICTBOpJ1TCJIbHO.
3. M.cnblTaHIDI, a-rreCTaUIDI:
- HCT MCTOllJ1K J1CnbITaHI1H;
- HC BbIllCJICHO KpI1TJ14CCKOe 060PYlloBaHJ1C, Ha Bonpoc «KaKOC
060PYlloBaHJ1C 51BJI5ICTC5I KpHTH4CCKHM?'> pa60THI1K OTBC4aCT: «Bce 060-
PYllOBaHHC'>;
- 1l0KYMCHTaUH5I no HCnbITaHJ151M nOllMCHCHa 06WJ1MH paCCY)I(1lCHH-
51MH, MHOro KonHpOBaHHbIX MaTCpJ1aJIOB 113 CTaHllapTOB. KHJ1r 6C3 npJ1-
B5I3KH K CBoeMY npOH3BOllCTBY;
- npOTOKOJIbI HCnbITaHJ1H HC nOJIHbI, HC COOTBCTCTBYIOT MCTOllI1KaM,
<PaJIbCH<pHUl1pOBaHbI HJIH OTCyrCTBYIOT COBCCM.
4. PUCK 3arpJl3HeHUH:
- HC HCKJII04CHbI ncpCKpCCTHbIC 3arp5l3HCHHH;
- HC npCllYCMOTpCHa CnCUHaJIJ13aUH5I 060PYllOBaHJ151, filC 3TO Hc06-
XOllHMO;
- 04J1CTKa 060PYllOBaHH5I npOBOllJ1TC5I He YllOBJICTBOpHTCJIbHO;
- MCTOllbI O'lJ1CTKJ1 HC aTTCCTOBaHbI;
- ynaKOBO'-lHbIC MaTCpHaJIbI HMCIOT 3arp5l3HCHH5I;
- 4HCTbIe nOMCWCHH5I 3KCnJIyaTJ1PYIOTC5I C HapYWCHJ151MJ1 npaBJ1JI
I1JII1 BbInOJIHCHbI C oWH6KaMJ1.
5. 3KcnJlyaTauuJI:
- nOMCWCHH5I y6J1paIOTC5I nJIOXO;
- HeT rpa<pHKoB J1 )l(ypHaJIOB TCXHJ14CCKOro 06CJIY)I(I1BaHH5I;
- nCpCOHaJI HC 06Y4eH.
6. KOHTpOJIbHbIe Jla6oparopHu:
- aHaJIJ1TJ14eCKHC MCTOllJ1KH HC aTTeCTOBaHbI;
- nOMCweHH5I He COOTBeTCTBYIOT 3JICMeHTapHblM HopMaM, B TOM no
'-II1CJIY KBallpaTHblX MeTpOB nJIOwallH Ha OllHoro 4CJIOBeKa;
- HCT JIaMJ1HapHbIX WKa<pOB, a TaM, mc eCTb, HC BbInOJIH5IIOTC5I Tpe-
60BaHH5I K J1X nepJ1011J1'IeCKHM J1CnblTaHJ1HM H pa60Te C HHMJ1.

474
rJ1a6a 19
7. nepCOH3JI:
- HC OnpelleJICHa OTBCTCTBeHHOCTb nepCOHaJIa;
- HCT nOp5l1lKa lleHCTBJ1H nepCOHaJIa B 3KCTpCMaJIbHbIX CJ1TyaUJ151X;
- HCT CI1CTCMbI 06Y4eHI151 nepCOHaJIa;
- COTpYllHJ1KJ1 He 3HalOT npaBI1JI pa60TbI, HC BbInOJIH5IIOT Tpe60Ba-
HI151 no BCllC H 1151, fHfHCHbI, nepeOlleBaHI151 11 np.;
- oncpaTopbI HC Onp5lTHbI, 6bIJI CJIY4aH pa60TbI oncpaTopa B accn-
Tl14CCKOH 30HC C <PYPYHKYJIOM Ha JII1UC 11 T.ll.
8. KalJeCTBO, aH3JIH3 OTKJlOHeHHH:
- MHOro 06wl1x CJIOB 6e3 pCaJIbHOro CMbICJIa;
- HCT aHaJIJ13a OTKJIOHeHI1H OT cncuJ1<pI1KaUI1H;
- HCT llaHHbIX 0 Mcpax no YCTpaHeHJ110 npl14l1H OTKJ10HCHJ1H;
- HCT nJIaHa 11 HCT 1l0KYMCHTaJIbHOro nOllTBCp)l(1lCHI151 pa60TbI no-
BbIWeHl110 Ka'lCCTBa.
npl1BellCHHbIe 3aMC'laHI151 51BJI5IIOTC5I OTllCJIbHbIMI1 npl1MCpaMJ1 J1 HC
npCTCHllYIOT Ha nOJIHOTY. HIDKC paCCMOTpl1M llPYfHC CJIY'lal1.
npHMep 'fOro, 'I'fO HHCneKTOp «He YBH,D,eJIa»
HaM nOKa3aJ1J1 J1a60paTOpJ11O MHKp06J10J10fJ14ecKoro KOHTp0J151 KaK
06pa3uoBoe no.apa3.aeJ1eHJ1e npe.anpJ1HTHH cnycTH KopoTKoe BpeM5I nOCJ1e
ero nOCeweHJ15I J1HCneKTopoM. .lJ.eHCTBJ1TeJ1bHO, CTeHbl J1 nOT0J10K 6blJ1J1
oWTYKaTypeHbl J1 nOKpaweHbl, YCTaHOBJIeHbl nJ1aCTJ1KOBble OKHa J1 .aBepJ1,
CJ10BOM, BbInOJ1HeH «eBpopeMoHT».
Mbl 06paTJ1J1J1 BHJ1MaHJ1e Ha TO, 4TO npJ1roTOBJ1eHJ1e H p03J1HB nHTa-
TeJ1bHOH Cpe.abl B '1aWKJ1 neTpl1 BbInOJ1HRJ1C5I B 06bl4HOM nOMeweHJ1J1. 6e3
J1aMJ1HapHoro wKa4>a. CO CJIOB nepCOHaJla J1a60paTOpJ1J1 y HJ1X HJ1KOf,D,a He
6blJ10 npo6J1eM C TeCTaMJ1 Ha MJ1Kp06H0J10rJ14eCKYIO 4J1CTOTY J1 CTepJ1J1b-
HOCTb. 3TO CTpaHHo. Ha nJ1TaTeJ1bHYIO cpe.ay OTKpblTOH 4aWKJ1 B 06bl<JHOM
(He '1J1CTOM) nOMeweHJ1J1 06H3aTeJ1bHO OC5IJJ.YT '1aCTJ1Ubl C MJ1KpOOpraHJ13-
MaMJ1, T. e. B03MO)l(eH J10)l(HOn0J10)l(J1TeJ1bHbIH pe3YJ1bTaT.
nepCOHaJI J1a60paTopJ1H 6blJ1 o.aeT B 06b14Hble XaJlaTbl, B0J10Cbl 6blJ1J1
OTKpblTbl, KOCMeTJ1Ka npJ1CYTCTBOBaJla B 6oJ1bwJ1x K0J1J14eCTBax, T. e. caM
nepcOHaJI B.a06aBOK K He CJIJ1WKOM '1J1CTOMY B03.ayxy nOMeweHJ1R BHOCHJ1
cyweCTBeHHble 3arp5l3HeHJ1R. B TaKJ1X nOMeweHJ151X KOHueHTpaUHH MHKpO-
opraHH3MOB .aocmraeT 400-500 KOE/M 3 . L\,J1H TOro, <JT06bl B np06y HH'lero
He OceJ10, B03.ayx .aOJ1)l(eH 6blTb CTepJ1J1bHbIM.
J1aMJ1HapHbIH wKa4> .D,J151 TOro J1 HeH. 4T06bl J1CKJ1104HTb npHBHece-
Hl1e 3arp5l3HeHJ1i1 .ao J1 nOCJ1e oT6opa np06. ECJ111 B OT4eTaX 0 npoBe.aeHJ1H
aHaJlJ130B 6e3 J1aMJ1HapHoro wKa4>a .aaHHble 6J1arOn0J1Y4Hbl, TO CJ1e.ayeT no-
Tpe60BaTb npoBe.aeHJ1R KOHTpOJIbHblX aHaJlJ130B J1 pa306paTbCH B TaKOM <lJe-
HOMeHe. rpH3HblH B03.ayx B J1a60paTOpl1l1 J1 <JJ1CTble np06bl - 51BJ1eHHe
HaCTOp3)l(J1 BalOwee.
PaCXO)l(.ll,eHHe Me)l(.ll,y HCTHHHblMH pe3YJ1bTaTaMJ1 KOHTpoJ151 J1 TeM. <JTO
nl1wYT B .aOKYMeHTax, 6blBaeT Be3.ae. lI.3)I(e B CWA. B YCJ10BJ1HX )l(eCTKoro
KOHTpoJ151 CO CTOpoHbl FDA BCTpe<JaIOTC5I CJ1Y'1al1 c13aJ1bCH4>I1KauHH npoToKo-
J10B aHaJlH30B (maBa 20).

J1HcneKlI,UU U ayiJum
475
npHMep cJIam.CHcJlHKaIUIH HcnblTaHHH
Ewe O.aI1H npJ1Mep, KaCaIOWJ1HCH J1aMJ1HapHbIX IllKa4>oB.
Hallla J1a60paTOpl151 6blJ1a npl1mallleHa .D,J151 aTTeCTaUJ1J1 npl1MepHO .ae-
C5ITI1 J1aMI1HapHbIX wKa4>oB C ropJ130HTaJlbHblM nOTOKOM B03.ayxa Ha O.aHOM
113 KpynHblx npe.anpJ1HTJ1H. Ha Ka)l()].OM IllKa4>y 6blJ1a 3TJ1KeTKJ1 C Ha.anJ1CblO
«BaJIl1.aJ1pOBaHO') 11 .aaTOH Ha He.aeJ11O paHbwe Halllero npJ1e3.aa. HEPA
4>11J1bTpbl J1aMJ1HapHbIX IllKa4>oB He npoCTO TeKJ1J1, OHJ1 nponYCKaJlJ1 mraHT-
CKoe '1J1CJ10 '1aCTJ1U. npJ1CTaJlbHblH OCMOTp nOKa3aJ1, '1TO B MeCTe CTblKa
4>J1J1bTpYlOwero MaTepJ1aJ1a C paMOH MaTepJ1aJ1 6blJ1 npo.apaH no BceH .nJII1He.
OKa3aJIOCb. '-ITO nepCOHaJI J1a60paTOpJ1J1 pellll1J1 04J1CTJ1Tb 4>J1J1bTpbl TpHnKOH
nepeJl. HalllJ1M npJ1e3.aoM.
BbIBO.abl: nepcoHaJI npe.anpJ1HTJ151 He 06Y4eH 3J1eMeHTapHb1M npJ1eMaM,
a .aOKYMeHTaUJ151 0 «BaJlJ1.D,aUJ1J1» 4>aJlbCH4>J1UJ1poBaHa.
CYXOJKapoBOH llIKacJI
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60JIOTa, B KOTOpOM OHa HaXOllJ1TC5I.
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I1JII1 PYKOBOllCTBa «The Office of Management and Budget s Bulletin No. 07-
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20 10 r.
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B c<pcpy llCHCTBI151 FDA BXOlll1T KOHTpOJIb:
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- B cepTII<pI1KaTe Ha cy6CTaHUI11O OT nOCTaBWI1Ka HeT I1aHHbIX 0
pe3YJlbTaTax KOHTpOJUI Ha HaJlH'll1e paCTBOpl1MblX OCTaTKOB
3 OTCYTCTBYIOT :na1l0Hbl (CTaHII3pTbl) I1JUI KOHTponl1pyeMblx cy6cTaH- I
UI1M, nonY'leHHble 113 0<pIIUl1aJ1bHbIX I1CTO'lHI1KOI3
Bcero 3aMe'laHHH no MaTeOHaJlaM H nOCTaOIUHKaM 8
2 KOHTDOJlb Ka'leCTBa
2.1 OmeJ1 Ka'leCTI33 pa60T3eT HeYIlOB1IeTBOpl1TenbHO, HeT 1I0KYMeHT3UI111 I
o npllrollHOCTI1 IICXOIlHblX 11 yn3KoBo'IHb1X M3Tepl1<UlOB, npOMe)KY-
TO'IHOM 11 roT0I30H npOIlYKUl111 I1nl1 I1X OTKJ10HeHIlIl
2.2 HeT HaY'IHO 060CHOBaHHblX 11 Tpe6yeMbix cneUIH!mKaulliL CTaHlIap- 15
TOB, nnaHOB oT60pa np06 II MeTOilOB KOHTpOJ1H 1l1ISI 06ecne'leHIUI
1I1IeHTI1'IHOCTl1. 3<pcpeKTIIBHOCTI1. K3'1eCTI3a II '1IICTOTbl neKapCTBeH-
HblX cpellCTB
2.3 OTlIeJ1 KOHTpOJ1S1 Ka'leCTBa He paCCMaTpl1BaeT npOTOKonbl Cepl1M 3
2.4 HeT IIHCTPYKUI1I1, npeIlycMaTpl1BalOweii paCCMOTpeHl1e CTaHlIapTOB 3
Ka'leCTBa He pe)Ke OilHOro pa3a B roll
2.5 HeT I10J1)KHOro KOHTponSi Ka'leCTBa 3
npHMepbl:
- He I3blnOJ1HSleTCSI KOHTponb I3cex cepllii no I3CeM nOKa3aTenSiM B
na60paTopl111 I1nSI I10Ka3aTeJ1bCTBa COOTI3eTCTlHHI Ka)l(J10H cepl1l1 Tpe-
60BaIillSlM;
- OTKnOHl1nl1 cepl1lO 113-3a TOro. '1TO cy6cTaHuI1S1 3arpSl3HeHa no-
CTopOHm1M M,nepl1anOM, HO 113 TOM )Ke cy6cTaHUI111 Cilenanl1 I1pyrylO
Cepl1lO, KOTOpasl 6blna peaJ11130BaHa:
- 13 ceplHI npoIlYKUl1l1 6blJIII 06HapY)KeHbl 'laCTllUbl 11 06yrnl1B-
Wl1ecs! MaTepl1anbl, HO cepl1S1 He 6bl1la OTKJ10HeHa
2.6 HeT nOOTOKonOB Ha Ka)l(J1VIO cepl1lO I1nl1 I1X HeT COBceM 3

482
f"1w6a 20
2.7 HeT MeTOlU1K BHYTpl1npOI1JBOllCTIJeHHoro KOHTpOJ1H (Bn K). 4
BnK He COOTBeTcTByeT TPe60BaHI1HM, npoueccy 11J111 npOllYKTY
2.8 HeT nOJlHoro Jla60paTopHoro KOHTpOJl51 Ha l111eHTI1'-1HOCTb 11 3<p<peK- 3
TI1BHOCTb llJ1H Ka)l(]lOH cepl1l1 11 np.
2.9 HeT aHaJll1Ja npellbIllyweH pa60Tbi I
2.10 HeT I1HCTPYKUl1ti OTlleJla Ka'-leCTBa (OK). aTe. KOTopble eCTb. He Bbl- 3
nOJ1HHIOTCH. HeT 1l0KYMeHTaUI111 no OTBeTCTBeHHOCTI1 B OK.
2.11 He Bbll10JlHHIOTCH I1HCTPYKUI1I1 OTlleJla Ka'-leCTBa, B T. '-I. no aHaJlI1TI1- 7
'-IeCKI1M MeTOllaM.
npHMepbl:
- He npOBOlll1TCH nOBTopHblti aHaJll1J KOMnOHeHTOB. KaK YKaJaHO B
11 HCTPYKUI1 11 ;
- He BbIl10JlHHIOTC5I I1HCTPYKUI1I1 DJlH OTlleJla Ka'-leCTBa, Hanpl1Mep.
o HaHeCeHl111 Ha KapTY (cxeMY) TeMnepaTYP B ne'-ll1, nOllroToBKe BO-
llbl O'-ll1WeHHoti, oT60oe no06, I1CnblTaHI1HX, 06Y'leHHI1
2.12 HeT OueHKI1 roTOBOti npo.aYKUHH (HeT TlllaTeJ1bHoro aHaJll1Ja COOT- 5
BeTCTBHH cepl1l1 cneUWbI1KaUI151M)
2.13 He OTKJ10HHIOTCH (l1onycKaIOTc5I B peaJIl1JaUI1IO) J1eKapCTBeHHble 3
cpellCTBa (J1C), He COOTBeTCTBYIOWl1e cneuwjmKaul111
2.14 He npOBOlll1TCH aHaJll1J peKJ1aMaUI1M 11 )((aJl06. HeT I1HCTPYKUI1M no 4
I1X paccMOTpeHI1IO. He npellnpl1HI1MalOTCH MepbI no YCTpaHeHl110 I1X
npl1'-1I1H.
npHMep:
- He BbIl10J1HHIOTCH I1HCTPYKUI1I1 no pa60Te C nl1CbMeHHbIMI1 11 YCT-
HblMI1 )((aJl06aMH (Hanpl1Mep, 45 )((aJl06 OCTaBJleHbI 6eJ BHI1MaHI1H)
2.15 He BbIl10JlH5IeTC5I OTJblB Cepl1H npOllYKUl111 B cJlY'-lae 06Hapy)((eHI151 I
HeCOOTBeTCTBI1H Tpe60BaHI1HM
2.16 He oT6paKoBbIBalOTcH cy6CTaHuI111 11 KOMnOHeHTbl, I1MelOWl1e OT- 3
KJ10HeHHH OT cneUH<pI1KaUl1ti. B T. '-I. no peJYJ1bTaTaM Bn K
2.17 OTlleJ1 Ka'-leCTBa He npOBepHeT J1eKapCTBeHHble cpellCTBa, I1JroTOB- I
JleHHble no KOHTPaKTY
2.18 CpOKI1 rollHOCTI1 npo.aYKUI1H He nOllTBep)l(]leHbI I1CnblTaHI1HMI1 Ha 2
cTa611J1bHOCTb. He Bbll10JlHHeTCH TeCT Ha CTa611J1bHOCTb
2.19 HeT MeTOlll1K OueHKI1 cTa611J1bHOCTI1 llJ151 OnpelleJleHI151 YCJlOBI1H xpa- 2
HeHI1H 11 cpOKa rollHOCTI1. J11160 I1HCTPYKUI1H eCTb, HO He BbIl10J1HH-
eTCH.
npHMep:
- eCTb I1HCTPYKUI151 "Stability Protocol", KOTopaH Tpe6yeT JaBep-
WeHI1H I1CnblTaHl1ti Ha cTa611J1bHOCTb 110 Bbll1YCKa npOllYKUI1I1; B
lleMCTBI1TeJlbHOCTI1 II Cepl1H Bbll1yweHo 110 JaBepWeH115! I1CnblTaHI1M
Ha CTa611J1bHOCTb;
- 6 Mr cy6cTaHuHI1 "Flash beads - Grape Flavour" OTrPYJI1J1I1110
Ha'-laJla I1CnblTaHl1ti Ha cTa611J1bHOCTb
2.20 nOMeweHl1e DJlH npOBe.aeHI1H I1CnblTaHI1H Ha cTa611J1bHOCTb He COOT- I
BeTcTByeT npellHIBJlHeMblM K He MY Tpe60BaHI1HM.
npHMep:
3a Tpl1 HelleJlI1 110 npl1eJ.aa I1HCneKTopOB mjJl1CHOe nOMeWeHl1e
6blJlO BbllleJ1eHO llJ1H npOBelleHI1H I1CnblTaHI1M Ha cTa611J1bHOCTb.
npl1 3TOM:
a) nOlUlep)((aHl1e TeMneparypbl 11 BJla)((HOCTI1 He 6blJlO 06ecne'leHo;
b) I1CnOJlbJOBaJll1Cb Tpl1 6bITOBbiX YBJIa)((HI1TeJl1 11 6bITOBOii 060rpe-
IJaTeJlb, He 06eCne'-ll113alOWI1e Tpe6yeMoro pe)((I1Ma;

0630p nuceM-npedynpe:JK:deHuu FDA ClllA
483
c) KapTa TeMnepaTypbl 11 BJla)l(HOCTI1 He COCTaBJlHJ1aCb;
d) 06paJUbI XpaHI1J1I1Cb BO BceM 06'beMe nOMellleHI1H OT nOJ1a 1I0
nOTOJlKa;
e) lIBepl1 11 KPblwa nOMellleHI1H He 6bIJlI1 repMeTI1Jl1pOBaHbl
2.21 OTlIeJ1 Ka4eCTBa He npOBep5leT Y4aCTOK ynaKOBKI1 11 3TI1KeTl1pOBaHI151 I
HenocpelICTBeHHO nepe.a pa60Toti, 4T06bI y6elIl1TbCH B TOM, 'ITO BCH
npelibIllYlllaH npOlIYKUI1H YlIaJIeHa, B TOM '1I1CJle C 060PYlioBaHI1H
2.22 ECTb nporpaMMa 60pb6bl C nepenYTbIBaHl1eM, HO HeT OueHKI1 ee I
3QJ<beKTI1BHOCTI1 - MHOro )l(aJl06 OT nOTpe611TeJleti
2.23 XpaHeHl1e KOHTpOJ1bHbIX 06Pa3UOB OpraHI1JOBaHO HeYliOlilleTBOpl1TeJlbHO I
2.24 KOHTpOJlb I1JMeHeHI1H He YliOBJIeTBOpI1TeJleH. I
BOJMO)l(HO HeKOHTpOJll1pyeMoe 11 HeCaHKUI10HHpOBaHHoe HJMeHeHl1e
peJYJ1bTaTOB KOHTpOJ1H MeTOliOM xpOMaTorpaQJI1I1.
HeT OrpaHI14eHI1H K 1I0CTyny B 6aJY lIaHHbIX 0 KOHTpOJle
2.25 He npelIYCMOTpeHbI KoppeKTl1pYlOllll1e 11 npo<bl1J1aKTI14eCKl1e Mepbl I
2.26 He JaBepWeHO npOBelIeHl1e 178 aHaJlI130B Ja 30 lIHeH C oQJopMJleHI1- I
eM OT4eTOB
2.27 HeT Kpl1Tepl1eB npl1eMJleMOCTl1lIJlH omopa np06 11 KOHTpOJ1H I
2.28 HeT BOJMO)l(HOCTI1 111IeHTI1QJI1UI1pOBaTb OTKJlOHeHHbIe MaTepl1aJ1bl. I
Haxo.aHllll1eCH B KapaHTI1He
Bcero no KOHTpOJIIO Ka'leCTBa 76
3 )),oKYMeHTaUHH
3.1 L!.oKYMeHTauI1H OTcyrcTByeT 11J111 HenOJ1Ha5l. 9
npHMep:
- OTCYTCTBYIOT Tpe6yeMbie I1HCTPYKUI1I1 D.J151 npOI1JBOlICTBa 11 KOH-
TpOJ1H npouecca. B T. 4. no KOHTpOJ11O MaTepHaJlOB, pa6oTocnoco6-
HOCTI1 06opYlioBaHI151, TexHI14ecKoMY 06CJ1Y)l(I1BaHI1IO (TO), QJI1J1b-
TpaUHI1
3.2 HeT HHCTPYKUl1ti no O'II1CTKe 11 TO 11J111 OHI1 He nOJ1HbI 3
3.3 HeT HHCTPYKUHti no nepepa60TKe Cepl1H npOlIYKUl111 4
npHMep:
- He YliOBJIeTBOpI1TeJ1bHbl I1HCTPYKUI1I1 no nepeynaKoBKe, nepepa-
60TKe 11 npl1CBOeH111O HOBbIX HOMepOB Cepl1H 11 I1X BbmOJlHeHl1e
3.4 npOTOKOJ1bl Cepl1M He XpaH5ITCH I
3.5 nyraHI1Ua B .aOKYMeHTaUI1I1, eCTb npOTI1BOpe411H B I1HCTPYKUI1HX, He 2
HCHO. KaK I1MH nOJlbJOBaTbCH
3.6 HCnOJlbJVIOTCH npOCP04eHHbie pemaMeHTbl I
3.7 npOTOKOJl cepl1l1 He nOlInl1CaH I
Bcero no )J,OKYMeHT3UHH 21
4 OrKJIOHeHHH OT cneUH!\JHK3UHH (OOC)
4.1 He npOBOlll1TCH aHaJll1J ooe, B T. 4. D.J151 cepl1ti npOlIYKUI1I1. 24
HeT CI1CTeMbl pefl1CTpaUl111 OTKJlOHeHI1H
4.2 HeT aHaJll1Ja nOJlO)l(l1TeJlbHblX TeCTOB Ha CTepl1J1bHOCTb I
4.3 He npOBOlII1TC5I aHaJll1J npl1411H OTKJlOHeHI1H cepl1ti I
4.4 PeJYJ1bTaTbI KOHTpOJ1H MI1Kpo6110Jl0fl14eCKOM 4HCTOTbI npenapaTa I
D.J151 HapY)I(Horo npl1MeHeHI1H. npOBelIeHHbIe J1a60paTop"eti npelI-
npl151TI1S1 11 HeJaBI1CI1MOH Jla60paTopl1eti, CYllleCTBeHHO paJJlI14aIOTCH.
AHaJll1J npl1411H paJJI 11 'I 1151 He BbmOJlHeH
4.5 He npOBelieH aHaJlI1J BblXOlia Ja npelIeJlbI cneUI1QJI1KaUl1ti 25 np06 1
nOlibI O'lI1111eHHOH
Bcero no OTKJlOHeHHHM OT cneUHdIHK3UHH 28

484
[;W6a 20
5 CKJla,abl. xpaHeHHe
5.1 HeT HaLlJ1e)l(allll1X YClIOBI1H XpaHeHI1. 4
HeT KOHT)JOJlH YCJlOBI1H XpaHeHI151 I1CXOllHblX MaTepl1aJ10B 11 JlC. B T. 'I.
TeMnepalYPbl. BlIa)l(HOCTI1 11 OCBellleHHOCTI1.
5.2 CpOK rollHOCTI1 He COOTBeTcTByeT YClIOBI1M XpaHeHI1 11 He nOll- I
TBep)l(lleH I1CnblTaHI1MI1 Ha cTa61111bHOCTb npl1 onpellelleHHbIX YClIO-
BI151X XpaHeHI1
Bcero no CKJla,aaM 5
6 HcnblTaHHH, arreCTaUHH
6.1 HeT OueHKI1 npoeKTa. aTTeCTaU1111 060pYlloBaHI1H 11 npoueCCOB 3
6.2 He npOBOlll1TCH aTTeCTaUI1 CTepI111113YI01lll1X dJlfllbTPOB I
6.3 HeT npOTOK0J10B I1CnblTaHI1H. nOKa3bIBalO1lll1X BJlI1Hl1e pa3Mepa ce- 2
pl1l1 Ha Ka'leCTBO npollYKUJ1J1.
npHMepbl:
- I1CnblTaHJ1H npoBelleHbl 1I1I OllHOro pa3Mepa cepHH. B lleticTBI1-
TeJ1bHOCTI1 BbIl1ycKalOTc5I cepl1l1 llPYfl1X pa3MepoB;
- npl1 I1CnbITaHI1HX He Y'ITeH pa3Mep cepl1J1
6.4 He nOKa3aHO. npl1 KaKHX 3Ha'leHI1HX napaMeTpOB 06eCne'lI1BaeTCH 1
OllHOPOllHOCTb CMeWI1BaHI1H MaTepl1aJ10B
6.5 ATTeCTaUI1H He COOTBeTcTByeT lleHCTBI1TellbHOCTI1 I
6.6 HeT nOJ1HOH 1l0KYMeHTaUJ111 06 I1CnbITaHI151X aBTOKllaBOB I
6.7 ATTecTaUHH He npOBelleHa nOllHOCTblO 11J111 'IaCTI1'1HO 2
6.8 HeT MeTOllHK KOHTp0J151 11 aTTeCTaUl111 npoueCCOB 3
6.9 HeT aHaJlJ13a BlIJ1HHJ1H J13MeHeHJ1ti napaMeTpOB Ha Ka'leCTBO I
n POllYKUI1 J1
6.10 He npOBOllHTCH aTTeCTaUH5I npoueccoB O'lI1CTKI1 060PYlloBaHJ1H. Me- 3
TOllbl OueHKJ1 'IHCTOTbl He YllOBJleTBOpl1TellbHbi.
npHMepbl:
- He aTTeCTOBaHbl npoueCCbI O'lHCTKJ1 060pYllOBaHJ1H C UeJ1blO
npellOTBpallleHJ1H nepeKpecTHoro 3arpH3HeHI151. B TOM 'IJ1CJle npellHa-
3Ha'leHHoro 1I1IH BbIl1YCKa pa3HOH npOllYKUI1I1;
- BbIl10J1HeHHaH aTTeCTaUJ1H npoueCCOB O'II1CTKI1 HeCneUJ1aJ1I13J1-
pOBaHHoro 060pYllOBaHJ1H He nOKa3blBaeT CHI1)1(eHI151 OCTaTKOB HJ1)1(e
.aonYCHIMoro ypOBH;
- aHaJlI13 3<p<peKTI1BHOCTJ1 omopa np06 (recovery) MeTOllOM Ma3-
KOB npOlJelleH He YlloBJleTBopl1TellbHo
6.11 ATTeCTaUI1H npoueCCOB nepeynaKolJKI1 He npOlJelleHa I
6.12 nlloxo BelleTCH .aOKYMeHTaUJ1H 06 J1CnbITaHJ151X, B 'IaCTHOCTJ1. B 2007 r. I
OT'IeT 06 I1CnbITaHJ1HX npouecca 6bIJ1 YTBep)l(lleH 'Iepe3 'IeTblpe MeCHua
noclIe J1X npOBelleHJ1H
6.13 npl1 J1CnbITaHJ1HX He nOllTBep)l(lleHa CTa6HlIbHOCTb npouecca (npl1 1
np0l131J01lCTBe Tpex KOHTpOllbHbIX Cepl1tillOll)l(Hbl 6bITb nOllY'leHbl
BOCnpOI1JBOlll1Mble pe3YllbTaTbI)
6.14 He npOBelleHa aTTeCTaUJ1H CJ1CTeMbl nOllroToBKI1 BOllbl lleJ10HJ130- I
BaHHoH. I1CnOllb3yeMoH 111151 npl1roToBlleHI1S\ nOllbI 111151 I1HbeKUJ1H.
He YKa3aHbi TO'lKI1 oT60pa np06 11 lIeT MeTOlll1KI1 aTTeCTaUl111
Bcero no HCnblTaHHHM 22
7 AuaJIHTH'IeCKHe MeTo,abl
7.1 HeT MeTOlll1KI1 oT60pa np06 3
7.2 nOIJTOpHble aH,UUl3bl llalOT paJHble pe3YllbTaTbi. I
AHaJlJ1TH'leCKl1e MeTOllbl He aTTeCTOBaHbl

0630p nuceM-npeoynpeJICdeHuu FDA ClllA
485
7.3 He YllOBJleTBOpl1TeJ1bHbl MeTOlUlKIf KOHTpOJlH If MeTOllbl 5
oT60pa np06.
npHMepbl:
- TeCT Ha cneUlfcPlf'lHOCTb apOMaTIf'JeCKoro MaCJ1a, 06J1er'JalOwe-
ro 60J1b, nplf3HaH He aaeKBaTHbIM, nOCKOJ1bKY He nOKa3aHO, 'JTO OH
06HapY)KIfBaeT B03MO)KHble 3arpH3HeHIfH; nplf aHaJllf3e cTa61fJ1bHOCTIf
H KOHTpOJ1e ceplflf 6blJllf 06HapY)KeHbI HeCKOJlbKO nIfKOB, HO He 6bl-
JlO ClleJ1aHO nOnblTOK 06b5lCHlfTb If X npOIfCXO)K1leHlfe;
- nplf aHaJllf3e IfCnOJlb3YIOTCH wnplfUbl 10 MJI, B TO BpeMH KaK
nplfHHTbIH MeTOll aHaJllf3a Tpe6yeT 06beMa IfHbeKUlfoHHOro npe-
napaTa 0.2 MJI; npellnplf5lTlflO npellJlO)KeHO npellCTaBIfTb 1l0Ka3a-
TeJ1bCTBO TOro, 'JTO wnplfU 10 MJI MO)KeT TO'JHO OTMep5lTb 0,2 MJ1
paCTBopa;
- He npOBOlllfTCH TeCT Ha pa60Tocnoc06HOCTb MeTOlla ra30BOH
xpoMaTOrpacPlf1f (suitability test); PYKOBOllIfTeJ1b J1a60paTOplflf 06b5lC-
HIfJ1. 'JTO 3TOT TeCT He BbmOJlHHeTCH BBlfllY TOro, 'ITO nplf aHaJllf3e
cy6CTaHUIf51 BBOlllfTCH MeTOllOM If Hbe KUIf If 6e3 pa36aBJIeHlfH If 3cP-
cPeKTIfBHOCTb oueHIfBaeTCH no nJ10Waalf nlfKa; npellnplfHTlf10 pa3b-
51CHeHo, 'JTO npellYCMOTpeHHbIH TeCT Ha pa60Tocnoc06HOCTb 06H3a-
TeJleH. B npOTIfBHOM CJ1Y'Jae CXO.aHMOCTb (precision) MeTOlla He 06ec-
ne'JIfBaeTCH;
- nOp5l110K omopa np06 He YllOBJIeTBOpHTeJleH; nplf BXOllHOM
KOHTpOJ1e cy6CTaHuIflf npellYCMOTpeH OT60p 'JeTblpex np06 He3aBIf-
CIfMO OT oa3Meoa nOCTaBJleHHoti ceOHIf
7.4 MeTollbl KOHTpOJ1H He aTTeCTOBaHbl. 4
npHMepbl:
- He 060CHOBaHlfH nplfMeHeHIfH aHaJlIfTIf'JeCKIfX MeTOllOB;
- He npOBo.aI1TCH npOBepKa pa60TOcnoc06HOCTIf MeTOlla BbICOKO-
3cPcPeKTI1BHOH )K1111KOCTHOti xpOMaTOrpacPlf1f (H PLC)
7.5 HeT MeTOlll1K OueHKI1 cTa61fJ1bHOCTIf llJlH OnpelleJ1eHIfH YCJlOBl1ti xpa- 2
HeHIfH H COOKOB rollHOCTIf
Bcero no aHaJlHTH'IeCKHM MeTo,naM 15
8 nOMellleHHH
8.1 nOJ1bI, CTeHbI 11 np. He nPlfcnoc06J1eHbI K O'JI1CTKe I
8.2 nJ1aHl1pOBo'JHble peweHIfH nOMeweHHH He cooTBeTCTBYIOT 2
Tpe60BaHI1HM.
npHMepbl:
- He BbIlleJ1eHbI 30Hbl llJIH npellOTBpaweHIfH 3arp5l3HeHlfii If nepe-
nYTbIBaHI1H nplf acenTH'JeCKI1X onepaUI1HX;
- HeT pa311eJlbHblX 30H 1fJ11f llPYflfX Mep no npellOTBpaweHlf1O ne-
peKpeCTHbIX 3arpH3HeHlfH If nepenYTbIBaHIfH; JllOlllf If MaTepl1aJ1bI
MOryT CB06011HO nepeMeWaTbC5I Me)K1lY nOMeweHIfHMIf If OCTaJ1bHbIM
311aHlfeM
8.3 HeT BbIlleJ1eHHblX 30H llJISI nOOIf3Bo.aCTBa If KOHTPOJl51 I
8.4 He pa31leJ1eHbl 30Hbl nepeynaKoBKIf neHIfUIfJlJ1IfHa OT ,nPyroii npo- I
llYKUlf1f
8.5 He 1l0CTaTO'JHa BbITH)KKa. ClfcTeMa BeHTIfJlSlUlf1f If KOHllIfUIfOHlfpO- I
BaHIf51 BbmOJlHeHa HenpaBIfJ1bHO
Bcero no nOMellleHHHM 6
9 qHcTble nOMellleHHH
9.1 nepenaa llaBJIeHIfSl B KpIfTIf'JeCKIfX 30Hax He n01l1lep)KIfBaeTc5I. 3
OrcvTcTBveT HennenbIBHbIH KOHTOOJlb neoenaaa llaIJJ1eHIfSl

486
fJ/a6a 20
9.2 C'IeT '1aCTI1U B npouecce np0l13BOllCTBa He BelleTCSI. 2
He YllOBJleTBOpI1TeJ1eH MOHI1TOOI1Hr oKPY)I(alOWeH cpellbl
9.3 TO'lKI1 oT60pa np06 He YKa3aHbi I
9.4 HHCTPYKUI1I1 no 06ecne'leHI1IO CTepHJlbHOCTI1. B T. 'I. no nOlJe.neHI1IO 2
nepCOHaJla, He BbInOJlHSlIOTCSI.
ECTb I1HCTpYKUHSI no nOBelleHl11O nepCOHaJla, Tpe6YIOwaSl MellJ1eHHO-
ro l1BI1)1(eHI1S1. B .neHCTBI1TeJlbHOCTI1 OHa He BbInOJ1HSleTC5I
9.5 O.ne)l(1la llJI5I '1I1CTbIX nOMeweHl1til1MeeT l1emeKTbl 113roTOBJIeHI151 I
9.6 HeT rapaHTl111 TOro. '1TO Ol1e)l(1la OCTaeTCH CTepl1J1bHoti npl1 HaXO)l(- I
l1eHl111 Ha nOJ1Ke B KOMHaTe nepeOl1eBaHI1S1.no ee I1CnOJ1b30BaHI151
9.7 HeT I1HCTPYKUHI1 no npOHOCY panl10TeJle$oHa B aCenTH'IeCKOe no- t
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10.2 HeT .aoKYMeHTaJlbHoro o$opMJ1eHI1H Bcero I
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MI1 cepl1ti B OTHOWeHl111 KpI1TH'IeCKI1X naoaMeTpOB
10.7 B03MO)l(HO nepenYTblBaHHe MaTepHaJlOB H/I1J1H npOl1YKUl111 I
10.8 HenpaBI1J1bHO ynaKoBblBalOTC5I '1YBCTBI1TeJlbHble K CBeTY Ta6J1eTKI1 I
10.9 He CXO.aSlTCSI.naTbl B .noKYMeHTax. I
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- He CX01l5lTC5I l1aTbl B .nOKYMeHTax (6paK nOKpbITI1H Ta6J1eTOK 113-
3a OTKJlIO'IeHI1S1 3J1eKTp03HeprMH 06HapY)I(eH 8 MaSl 2009 r.. a OT'leT
06 I1CnoaBJIeH1111 60aKa .aaTl1pOBaH 7 MaH 2009 r.)
10.10 ECTb paCXO)l(1leHI1S1 B KOJ1I1'1eCTBe 113paCXOllOBaHHblX MaTepl1aJ10B. I
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Master Production and Control records, 113 KOTOpblX Bl1l1Hbl pacxo)l(1le-
HI1H B KOJlI1'1eCTlJe MaTepl1aJ10B, He06xol111MblX llJISI npl1roTOBJleHI1S1
roTOBblX $OpM 121CFR 21 I. I 86(b)(4)]; Hanpl1Mep, HeKoTopble npo-
l1YKTbl I1MeJlI1 npeBblWeHl1e co.aep)l(aHI1S1 aKTI1BHblX I1Hrpe.nl1eHToB:
npel1npH5ITl1e COCJlaJlOCb Ha nOTepl1 B npouecce, HO HI1KaKI1X 06bSlC-
HeHl1ti. nO'leMY 3TO npOI1CXOl1I1T, 11 HI1KaKoro .noKYMeHTaJlbHoro
no.aTBep)l(1leHI1S1 nOTepb He 6blJ10 .naHo
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npHMepbl:
- OT.neJlOM Ka'leCTBa 6blJla B03BpaweHa cepl1S1 npenapaTa .nJlSl 06-
pa60TKI1 yrpeH B BI1.ny HeCOOTBeTCTBI1S1 ee cneUI1$I1KaUI1I1; 3Ta cepl1S1
6blJla nepepa60TaHa 6e3 110KYMeHTaJlbHoro o$opMJ1eHI1S1 11 npel1CTaB-
JleHa KaK roTOBblH noo.nVKT
Bcero no npOH3BOCTBY I3

0630p nuceM-npeoynpeJICOeHUU FDA CiliA
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II TeXHOJlOrHlJeCKHH npOLlecc
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CKOpOCTI1 npl1 aTTeCTaUl111 npouecca
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OTCYTCTByeT
11.3 UBeT KanCYlI He COOTBeTcTByeT cneUI1<!)J1KaUI1I1. I
nOI1'1I1HbI He BbIHCHeHbl
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12.2 B npOllYKUl111 06HapY)l(eHbl '1aCTI1UbL npl1'1I1Hbl He YCTaHoBlIeHbL 3
npHMepbl:
- B I1HbeKUI10HHbIX paCTBopax eCTb nOCTOpOHHl1e BKJ1IO'IeHI1H;
- npl1 KOHTpOJ1e ma3HbIX Kanellb B WeCTI1 e.aI1Hl1uaX npOllYK-
UI1I1 06HapY)I(eHbI '1aCTI1Ubl;
- B npOllYKUl111 o6HapY)I(eHbi KOMapbI, MOWKI1. naYKI1 11 I1X '1a-
CTI1; npH'II1Ha nOSlBlIeHI151 3TI1X 3arpH3HeHI1H He I1CCJlellOIJaHa (npo-
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B lloyroti nOOllYKUl111
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npHMep:
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UI1I1 no I1CKJ1IO'IeHI1IO 3TI1X C06bITI1H.
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npOllYKUI1I1, KOTopaH 1l0J1)1(Ha 6blTb CTepHJ1bHoti
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pa60TKa CI1CTeMbI nOllroToBKI1 BOllbl
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nepMOlIM'IHOCTblO, J1M60 neOMOllM'IHOCTb He YCTaHOBJ1eHa
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JlaCKMBaHMH MMKcepOB DJlH npMroTOBJ1eHMH HeCTepMJlbHOH npOlIYKUMM
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3MYJlbCMH 3arpH3HeHo '1aCTMuaMM;
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- MCnOJlb3yeMbIe B npoM3BolIcTBe HaKOHe'lHMKM MMelOT CJlelIbI
p)l(aB'IMHbI. pa3pyweHMH M OCTaTKOB npolIYKUHM;
- nepCOHaJI He 06Y'leH M lIP.
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Bcero no 060PY.lI.OBaHHIO 16
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YKynopeHHbIe npOlIYKTbI
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16.4 He npoBepHeTcH OlIHOpO.aHOCTb CKOpOCTM OlIHOHanpaBJleHHoro no- 3
TOKa B0311yxa, B T. 'I. no nYTM CJlelIOBaHM5I (OTKpbITOro) npo.aYKTa B
aCenTM'IeCKoi1 30He. He npOBOlIMTC5I BM3YaJIH3aUMH lIbIMOM
16.5 He npelIYCMOTpeHbI MeponpMHTMH no npelIoTBpaweHMIO MMKp06HbiX 2
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B 30HY 5 I1CO (30HY A) 6e3 HaLl06HOCTM, M He BbIl10JlH5IeT Tpe60Ba-
HHH lIMCUMnJ1MHbl. 3a nepCOHaJlOM HeT lIOJl)l(HOro KOHTp0J151 co CTO-
pOHbI CJlY)l(6bI Ka'leCTBa, HeT oueHKM 3<j:J<j:JeKTMBHOCTM 06Y'IeHMH pa-
60Te B aCenTM'IeCKOH 30He (npOBepKH TOro, 'Ie MY pa60THMKa Y'lMJlM).
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onaCHbIe lIBM)I(eHMH M lIei1cTBM5I: HaKJIOHbl Hall OTKpbITblM npOllYK-
TOM M JlHHMei1 HanOJlHeHHH)
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peaJIbHoro npouecca H He Y'lMTbIBaeTC5I BJ1HHHHe nepCOHaJla M lIPy-
mx <j:JaKTopOB pMCKa Ha 3arpH3HeHMe npOlIYKuMM: npM pa3pa60TKe
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BJ1MHIOWMX Ha CTepMJlbHOCTb npOlIYKUMM <j:JaKTopoB
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oneoaTopOB (pY'IHble onepaUHH) M npelICTaBJl5IeT BbICOKHi1 pMCK
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1610 HeT MHCTPYKUHH no aTTCCTaUHM oncpcnopOIl, pa60TalOwHx II acen- I

0630P nuceM-npeoynpeJKOeHUli FDA CiliA
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17 06Y'feHHe
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aHfJll1HCKl1ti R3blK HBJ151eTCH O<pI1Ul1aJ1bHbIM). OnepaTOp J1I1HI1I1 no
npOH3BOllCTBY nJ1aCTbIpeti He BJlaIleJ1 aHfJlHHCKHM 11 He Mor nOJ1b30-
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npellHa3Ha4CHHbIMJ1 llJI5I nOCTaHOBKI1 llJ1arH03a, JIC4CHI151, 06JICr4CHI151
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PCKJ1aMI1PyeMbIc npOllYKTbI He npJ13HaHbI 6C30naCHbIMI1 11 3<P<PCK-
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2.1 HeT CHCTeMbl Ka'-leCTBa I
2.2 HeT pa60Tbl C pCKJlaMaUH5IMH I
2.3 OTCYTCTBYCT CJ1CTCMa e)l(cro.aHoro aHaJlH3a npo.aYKUHH I
2.4 nYTaHHUa B .aOKYMCHTaUHM no npoBe.aeHJ11O aHaJlH30B I
2.6 He onpe.aeJ1CHbl rpaHJ1Ubl OTBeTCTBCHHOCTJ1 B OTlI.eJ1e Ka4eCTBa J1 2
OTBeTCTBCHHOCTb 3a BbInOJ1HeHJ1C Tpe60BaHJ1H GMP
2.7 HeT .aOKYMeHTaJlbHoro 04>oPMJ1eHM5I lI.CHCTBMH. OTHOC5IWHXC5I K I
Ka4CCTBY, cpa3Y nOCJ1e J1X BbInOJ1HCHJ1H
2.8 OT.aCJ1 KalleCTBa He OTKJlOHHeT cy6cTaHuHH, 3arpH3HeHHblC no- I
CTOpOHHHMJ1 BeweCTBaMJ1
2.9 HeT YBCpeHHOCTH. 4TO npoUCHT co.aep)l(aHM5I aKTHBHoro HHrpc- I
.aJ1eHTa B CCpJ1J1 COOTBcTcTByeT cneuM4>HKaUMM. '-ITO MO)l(eT npH-
BeCTJ1 K OTpJ1uaTCJ1bHbIM KJlMHM4eCKJ1M nOCJ1c.aCTBMHM
Bcero no KOHTDOJlIO Ka'leCTBa 9
3 .D:oKvMeHTaI\HH
3.1 HeT CJ1CTCMbl .aOKYMeHTaUMJ1 (KOHTpOJ1H H3MeHeHHH. aHaJlM3a I
OTKJlOHeHHH OT cneuM4>MKauHH, OT napaMeTpOB npouecca)
3.2 B cneuH4>HKaUJ1HX Ha cy6cTaHuHH OTCYTCTBYIOT npe.aeJ1bHO .ao- I
nYCTMMblC KOHUCHTpaUHH 3arp5l3HeHHH
3.3 npOTOKOJ1bl cepMH He nOJ1Hble I
3.4 HeT CJ1CTeMbl KOHTp0J151 HJMeHeHHH 2
3.5 ECTb npoTMBope4HH B HHCTPYKUHHX no 04HCTKe I
3.6 He nepeCMaTpJ1BaIOTCH J1 He ymep)l(.D,alOTCH .aOKYMCHTbl. OTHO- I
C5IWJ1eCH K Ka'-leCTBY
3.7 npOTOKOJ1bl CepJ1H He BKJlIO'-IaIOT Bce CT31lHM npoJ13Bo.aCTBa I
3.8 HeT KOHTpoJ151 3a 06paweHHeM .aOKYMeHTOB I
(MX pacnpoCTpaHeHHeM. OTMeHOH H np.)
Bcero no 1I.0KVMeHTaI\HH 9
4 OTKJlOHeHHH OT CneI(HHKaI(Hii (OOC)
4.1 He npono.aHTCH aHaJlH3 OOC. D T. '-I. KpHTH'-IeCKHX 6
Bcero no OTKJlOHeHHHM OT Cllel\HHKaI(HH 6
5 CKJl3,lJ.bI, XDaHeHHe
5.1 HeT B03MO)l(HOCTH OTJ1H4MTb B03DpaweHHblC cy6cTaHuHH OT I
ro.aHbIX. M TC H lI.Pyme xpaHHTCH BMeCTe
Bcero no CKJla.aaM 1

492
ffla6a 20
6 I1cnblTaHuH, aTfeCTaU,HH
6.1 npoueccbl He aTTeCTOBaHbl 3
6.2 ATTecTaUI1H MeTo.aOB 0411CTKI1 Hey.aOBJ1eTBOpI1TeJ1bHa I
6.4 He nOKa3aHO. '-ITO KpHTI14eCKJ1e napaMeTpbl onpe.aeJ1eHbI I
11 aTTeCTaUJ1H npOBe.aeHa
6.5 HCnblTaHI1H HOBoro 060py.aOBaHJ1H He npOBO,D,HTCH I
Bcero no UCnblTaHUHM 6
7 AuaJIUTU'lecKue MeTO,D,b1
7.1 He BbInOJ1HHTCH KOHTpOJ1b cTa611J1bHOCTH. HeT MeTo.aJ1K KOH- 5
TpOJ1H cTa6J1J1bHOCTJ1.
flpuJrte'laHue:
B nporpaMMe npOBepKJ1 Ha cTa6J1J1bHOCTb .aOJ1)1(eH 6blTb npe.ay-
CMOTpeH KOHTpOJ1b cTa6HJ1bHOCTH no KpaHHeH Mepe O.aHOH ce-
pJ1J1 cy6cTaHul111 B ro.a. HO 3TOro HeT
7.2 He nOKa3aHO. 4TO Bce MeTo.abl oT60pa npo6 "HaY'lHO 06ocHoBaHbl" I
7.3 He npOBO,D,HTCH TeCTbl Ha pa60Tocnoc06HoCTb MeTo.aOB I
(suitability) no BceMY npoueccy, rapaHTI1pY51 ee T04HOCTb J1
Ha,D,e)l(HOCTb
7.4 HeT Ha.D,JIe)l(aweH CJ1CTeMbl 11 MeTO.aJ1K oT60pa npo6 2
7.5 MeTo.abl KOHTpOJ1H He aTTeCTOBaHbl 4
UpuMep:
- He aTTeCTOBaHbl aHaJlJ1TJ14eCKJ1e MeTo.abl (KOHTpOJ1H MJ1KpO-
6J10J10fJ14eCKOH '-IJ1CTOTbl, 3HlIOTOKCI1HOB, cTa6HJ1bHOCTJ1. npo-
BepKJ1 pa60Tocnoc06HOCTI1 MeTo.aOB xpoMaTorpa4>J1J1)
7.6 HeT CJ1CTeMbl KOHTpOJ1H J13MeHeHJ1H aHaJlI1TI1'-1eCKHX MeTo.aHK I
Bcero no aHaJIUTUlJeCKUM Mero.aaM 14
8 3.aaHuH U nOMelQeHUH
8.1 3.aaHI1H J1 nOMeweHHH He nOMep)l(J1BaeTCH B Ha.LIJIe)l(aweM no- 3
p5l.aKe C ueJ1blO npe.aOTBpaweHI151 3arpH3HeHJ1H.
UpuMep:
- B6J1J13H TeXH0J10fJ14ecKoro 060py.aoBaHI1H eCTb rp5l3b, Kpac-
Ka OT 6J1HCTepOB, p)l(aB4J1Ha, KanJ1H MaCJ1a;
- Ha nOJ1Y rpmb, 06PbIBKI1 ynaKoBo4HOH J1eHTbI 11 np.
8.2 B nOMeweHI151X J1eTalOT KOMapbl I
8.3 3KCnJ1yaTaUJ151 31IaHI151 Be.aeTC5I nJ10XO, nOMeweHI1H He npJ1cno- I
C06J1eHbl K y60pKe.
ECTb onaCHOCTb nepeKpecTHoro 3arpH3HeHHH npo.aYKL\I1J1
8.4 npJ1 y60pKe J1Cn0J1b3yeTc5I rpH3HaH Bo.aa I
Bcero no 3.aaHUHM u nOMelQeHUHM 6
9 qucTble nOMelQeHUH
9.1 He se.aeTC5I C4eT '-IaCTHU H aHaJlH3 I
Bcero no IJUCTbIM nOMelQeHUHM 1
10 UPOU3BO.aCTBO
10.1 npl1 CMeHe npo.aYKUHH He BbIl10J1HHeTCH O'-lHCTKa y.aOBJ1eTBOpH- I
TeJ1bHblM 06pa30M (060py.aOBaHl1e HeCneUHaJlH3HpOBaHHoe, Ha
HeM BbInYCKaeTCH pa3HaH npo.aYKUI1H), a B )l(ypHaJlax OTMe'-leHO
npOBe.aeHl1e O'-lI1CTKI1
Bcero no npOU3Bo.aCTBY 1

0630p nuceM-npeoynpeJfCOeHUii FDA ClllA
493
12.1 3arpH3HeHHH npo,ll,YKHH
12.1 Hey.aoBJ1eTBopI1TeJ1bHbl Mepbl no npe.aOTBpaweHI1IO MI1Kp06HblX I
3arpH3HeHJ1H
12.2 nblJ1b 11 .ae6pHc Ha npo.aYKUJ111 I
12.3 06HapeHbl 3arp5l3HeHHH. 3anl1CaHo. 4TO OHO npJ1BHeCeHO npH I
J1a60paTopHoM KOHTpOJ1e, HO npl14J1Ha He HaH.aeHa
12.5 B cy6cTaHUI1J1 06HapeHbl KYC04KI1 KpaCKI1 I
Bcero no 3arp5l3HeHHHM B npo,D,yKI\HH 4
14 JIa60paTOpHH
14.1 Pe3YJ1bTaTbl aHaJlHTH'IeCKoro KOHTp0J151 He nOlITBep)l(.D,eHbl I
BTOpOH no.anJ1CblO
14.2 He npe.aOTBpaweHbl MaHJ1nYJ151UI1I1 C nepBH4HbIMJ1 .aaHHbIMJ1 I
npJ1 aHaJlI1TI1'1eCKOM KOHTpOJ1e
14.3 HeT MeTo.aOB KOHTpOJ1H cy6cTaHUJ1H, no.aTBep)l()].alOWI1X I1X co- I
OTBeTCTBl1e CTaH,D,apTaM
14.4 HeT nepBI1'1HblX .aaHHbIX (pe3YJ1bTaTOB aHaJl1130B) I
14.5 HeT a.aeKBaTHoro J1a60paTopHoro KOHTpOJ1H J1 npOTOKOJ10B I
14.6 HeT .aOKYMeHTaUI1J1. no.aTBep)l()].alOweH, '1TO J1a60paHTbl BbIl10J1- I
H5IIOT aHaJlJ1TH4eCKHe MeTo.abl no USP (4)apMaKOne51 CWA)
Bcero no na60paTOPHHM 6
15 060py.ao B aHHe
15.1 He aTTeCTOBaHbl MeTo.abl 04J1CTKI1 I
15.2 HeT .aOKYMeHTaUJ1J1 0 npOBe.aeHI1I1 O'lJ1CTKJ1 I
15.3 npl160pbl He KaJlJ16pOBaHbl 2
15.4 HeT CJ1CTeMbl KaJlJ16pOBKH J1 TeXHJ14ecKoro 06CJIJ1BaHI1H KPH- I
TI14ecKoro 060py.aoBaHJ151
15.5 060py.aoBaHJ1e He npJ1cnOC06J1eHO K 04J1CTKe J1 He npe.aYCMaT- I
pl1BaeT y.a06CTBO 3KCnJ1yaTaUHJ1 11 TeXHI1'1eCKoro 06CJ1Y)l(J1BaHJ1H,
He06xo.aJ1Mble .D,J151 .aaHHoro BJ1.aa npOJ13Bo.aCTBa
15.6 Bo.aa I
Ka'leCTBO BO.abl Hey.aOBJ1eTBOpHTeJ1bHO.
He pa3pa60TaHbl H He aTTeCTOBaHbl I1HCTPYKUHH no KOHTpOIO
napaMeTpOB BO.abI.
He nOKa3aHO. 4TO ypOBeHb MI1Kp06HOH '1HCTOTbl BOlIbl y.aOBJ1e-
TBopHeT Tpe60BaHJ1HM.
FDA O)l(H.aaeT OT npoH3Bo.aI1TeJ1eH HeCTepHJ1bHbIX cy6cTaHUJ1H,
'1TO npl1 np0J13Bo.aCTBe cy6cTaHUI1H, npe.aHa3Ha'leHHbIX.D,J1H
npJ1roTOBJ1eHI1H napeHTepaJIbHblX J1eKapCTBeHHbIX cpe.aCTB, Bo.aa
Ha nOCJ1e.aHI1X CTa.aI1H no.aroToBKH H O'lJ1CTKJ1 1I0J1)1(Ha KOHTpO-
J1l1pOBaTbCH Ha 06wee co.aep)l(aHHe MHKpOOpraHI13MOB, co.aep-
)l(aHl1e cneUI14>I1'1eCKI1X MHKpOOpraHJ13MOB 11 3H,D,OTOKCHHOB
Bcero no 060py.aoBaHHIO 7
16 AcenTH'IeCKOe npOH3Bo.aCTBO cy6cTaHI\HH
16.1 HeT J1HCTPYKI.\HH no npe.aOTBpaweHI1IO MI1Kpo6HblX 3arpH3He- I
HI1H Cy6CTaHUHH, KOTopble .aOJ1)1(Hbl 6bITb CTepHJ1bHbIMJ1
16.2 npl1 HcnbITaHH5IX C HanOJ1HeHl1eM CpelIaMI1 He BbIl10J1HHIOTCH I
TeXH0J10rH'IeCKHe onepaUI1I1. npe.aYCMOTpeHHble npoueCCOM
16.3 He BbInOJ1HeHbl Tpe60BaHHH K nHTaTeJ1bHblM cpe.aaM. I

494
r lG6a 20
npH HanOJ1HeHHH cpe.aaMJ1 (nJ1aue60) CJ1e.ayeT oueHHBaTb:
. HX cnoc06HOCTb no.a.aep)l(HBaTb pOCT MHKpoopraHH3MOB.
. HX HHm6HPYIOwee lleHCTBHe Ha MHKpoopraHJ13Mbl
16.4 He npoBo.aJ1TCH BH3YaJIH3aUH5I llblMOM .D.J1H .aeMOHCTpaUJ1H TOro. I
4TO nepCOHaJI He npHBHOCHT 3arpH3HeHHH B CTepHJ1bHYIO cy6-
CTaHUJ110 npH aCenTl1'leCKOM HanOJ1HeHHH
Bcero no aCenTH'leCKOMY npOH3BO.lI.CTBY 4
17 06yqeHHe
17.1 CHcTeMa 06Y'1eHJ1H OTCYTCTByeT 2
17.2 HenocTaT04Ho nepCOHaJla. 06Y'1eHHoro npoH3Bo.aCTBY cy6CTaH- I
UJ1H B COOTBeTCTBHH C Tpe60BaHHHMJ1 GMP
Bcero no 06yqeHHIO 3
18 nepcoHa.rt
18.1 O.ae)l(.D,a He COOTBeTCTBYcr Tpe60BaHHHM. I
nepCOHaJI HOCHT o.ae)l()].y HenpaBl1JlbHO.
Bcero no nepCOHa.rty I
20 OTcyrcTBHe pa3pemeHHH Ha npHMeHeHHe I
npHMep
- He Bce cy6cTaHuHH 3apemCTpHpOBaHbl B CWA.
Bcero 3aMe'laHHH 82
KJIacCH<pJ1KaUH5I 3aBHCJ1T OT CTCnCHJ1 llCTaJIJ13aUI1I1 3aMe4aHJ1H npH
npoBCllCHHJ1 aHaJIH3a, TCM HC MCHee, BbInOJIHeHHbIH aHaJIH3 llaCT UCJIb-
HYIO KapTHHY HeCOOTBCTCTBH5I Tpc60BaHH5IM G M P H CB5I3aHHbIX C HHMH
npJ1'1HH.
20.5 npOU3BO.ll.CTBO np0.llYKTOB "UTaHUSI
B CWA np0J13BOllCTBO npollYKTOB nHTaHJ151 TaK)I(C pcmaMCHTJ1pyeT-
C5I npaBI1JIaMI1 cG M P [17]. HellOCTaTKJ1 H rpy6bIC llC<pCKTbI B 3THX npo-
113BOllCTBax CXOllHbI C llc<pcKTaMH B npoH3BollCTBC JICKapCTBcHHbIX
CpCllCTB. B 2010 r. nHCbMa-npcllynpC)I(1lCHJ151 nOJIY4J1JIJ1 172 npOH3BOll-
CTBa npOllYKTOB nJ1TaHJ151.
npHMep
.D.aHHbIH npHMep OTHOCI1TCH K 3aroToBKe M0J10K MOpCKJ1X e)l(eH. HO
CYTb 3aMe4aHHH cxo.aHa C OCTaJlbHblMH npOH3Bo.aCTBaMH (nHCbMO-
npe.aynpe)l(1leHJ1e OT 02 .aeKa6pH 2010 r.):
- HeT KOHTpOJ1H naToreHHblX MHKpoopraHH3MOB B KpHTH4eCKJ1X KOH-
TpOJ1bHbIX T04Kax. KOTOpblH npe.aYCMOTpeH J1MelOweHC5I CHcTeMoti aHaJlH3a
pHCKOB;
- He C06J1IO.aaeTCH nepHo.a114HOCTb KOHTpoJ1H .D,J151 TeMnepaTYPbl B KPH-
TJ14eCKHX T04Kax .D,J1H JaMopo)l(eHHOH. CBe)l(eH H roTOBOH K ynoTpe6J1eHHIO
npo.aYKUHJ1;
- HeT .aOKYMeHTaUHH 0 caHHTapHOM COCTOHHHJ1 BOllbl, conpHKacalO-
weHCH C npo.aYKTOM H nOBepXHOCT5IMH. BCTynalOwHMH B KOHTaKT C npo-

0630p nuceM-npeoynpe.)/coeHuu FDA ClllA
495
.aYKTOM. '1HCTOTe 3THX nOBepxHocTeH, npe.aOTBpaweHJ1H nepeKpeCTHblX 3a-
rpH3HeHJ1H;
- He Bbll10JTHHIOTCH Tpe6oBaHH5I K MapKJ1poBKe. XpaHeHJ110 J1 J1CnOJ1b-
30BaHHIO TOKCH'IHbIX KOMnOHeHTOB;
- HeT .aOKYMeHTaUHH 0 npOBe.aeHHH 04J1CTKJ1 (y60pKH);
- HeT CJ14>OHOB B CHCTeMax Bo.aOOTBe.aeHJ1H .D,J1H npe.aOTBpaweHHH npo-
THBOTOKa BO.abl;
- MHoropa30Bble pe3J1HOBble nep'laTKH .D,J151 pa60Tbl C npo.aYKUJ1eH xpa-
HHTC5I B 6eCnOp5l.aKe Ha p)l(aBblX MeTaJlJ1H'IeCKHX paM ax. wKa4>ax. B paKOBJ1-
Hax .D.J1H MblTbH PYK, Ha pa3HbiX KplO'IKaX H B J1106b1X MeCTax npoJ13BO.a-
CTBeHHOH 30Hbl; pe3HHOBble 4>apTYKH H KOM6J1He30Hbl xpaHHTC5I B 6ecno-
p5l.aKe J1J1J1 npHHOCHTC5I H3 JlOMa;
- J1HCTpYMeHTbl J1 o60Py.aoBaHJ1e .D,J1H 06pa6oTKJ1 roTOBblX K ynoTpe6-
J1eHJ11O B nHWY npo.aYKTOB He MOIOTC5I CHCTeMaTH'IeCKH H He O'lHwaIOTCH
nepe.a MbITbeM;
- nepCOHaJI. 06pa6aTbIBalOwHH roTOBYIO K ynoTpe6J1eHJ11O npo.aYKUHIO,
MoeT B TOH )l(e o.ae)l(1le 6eTOHHbIH nOJ1 H npJ1KaCaeTC5I K rp5l3HblM npe.aMe-
TaM. MoeT rpH3Hble pe3J1HOBble nep4aTKH nepe.a pa60TOH (a He nOCJ1e Hee);
- )l(eHWHHbl B 30He ynaKOBKJ1 HOCHT cepbm J1 uenO'lKJ1 Ha wee H T. .a.
20.6 npOH3BO.aCTBO KOpMOB H co.aep)K3HHe 1KHBOTHbIX
FDA npOBCp5lCT COOTBCTCTBMe KOpMOB llJI5I )l(MBOTHbIX YCTaHOBJICH-
HbIM Tpe60BaHJ151M, B T. 4. no OTCYTCTBMIO nOCTopOHHMX BKJ1IO'ICHMH.
npHMep
nHCbMo-npe.aynpe)l(1leHJ1e OT 12 MaH 2010 r.
B napTHJ1 ceMHH XJ10nKa. nOCTaBJIHBWeHCH B Ka4eCTBe KopMa .D.J151 )l(H-
BOTHbIX, 6blJ1H 06HapeHbl nOCTopOHHHe BKJ1104eHH5I. HanOMJ1HaBWHe KY-
CO'lKH pe3HHbl OT aBToM06HJ1bHbIX nOKpbIweK H npOB0J10KH. EblJ10 YCTa-
HOBJIeHO, '1TO rpY30BJ1K, nepeB03HBWHH KOpM, J1Cn0J1b30BaJlC5I TaK)l(e .D,J1H
nepeB03KH JlPymx rpY30B. Bo.aHTeJ1b He O'lJ1WaJI KY30B nOCJ1e nepeB03KH
rpY3a. He npOBep5lJ1 ero '1HCTOTY nepe.a CJ1e.aYIOweH norpY3KOH J1 He 6blJ1
npOHHCTPYKTHpoBaH BbIl10J1HHTb 3TJ1 .aeHCTBJ151. HHCTpYKUHH no O'lJ1CTKe
aBTOM06HJ151 OTCYTCTBOBaJla.
HapyweHMH nOp5l11Ka COllCp)l(aHJ151 )l(MBOTHbIX OTHOCMJIMCb K:
- HenpaBJ1JIbHOMY npMMCHCHJ110 BCTcpMHapHblX npcnapaTOB, BCllY-
llleMY K J13MeHeHJ11O COCTaBa M5ICa (HaJIM4MIO B HCM HCllonYCTMMoro KO-
JIM4eCTBa JIeKapCTBCHHbIX CpCllCTB: Q)JIYMJ1KCJ1Ha, nCHJ1UJ1JIJIHHa, HCOMM-
UMHa H np.);
- J13MeHCHMIO COCTaBa MOJIOKa no TOM )l(C npJ1'IJ1He;
- OTCYTCTBJ11O 1l0KYMCHTaUJ1M M KOHTpOJI5I 3a BBCllCHJ1CM npenapaToB;
- aHTMcaHMTapHoMY COCT05lHJ11O <pepM.
COCT05lHJ1C )l(J1BOTHbIX nepell np01l3)l(CH llJIH Ja60H 1l0JI)I(HO YllOBJIC-
TBOp5lTb YCTaHOBJIeHHblM Tpe60BaHJ15IM M npOBCp5lTbC5I Ha <pepMe.

496
[J106a 20
TaKoH KOHTpOJIb BbI51BJl5lCT HenpaBJ1JIbHOe npJ1MeHCH MC BeTepJ1Hap-
HblX npenapaTOB. KOTopoe BellCT K npeBblWCHJ110 KOHUCHTpaUMJ1 aKTJ1B-
HbIX MHrpCllJ1eHTOB B OpraHJ13MC )l(MBOTHOro J1 KOTOpOC HC 1l0nYCTJ1MO.
llpHMep I
HanpaBJ1eHHblH .D,J1H 3a60H TeJ1eHOK, npe.aHa3Ha4aBllmHcH .D,J1H npJ1ro-
TOBJ1eHI151 npo.aYKTOB nI1TaHHH, co.aep)l(aJI npenapaT 4>J1YMJ1KCJ1H. BBe.aeHl1e
3TOro npenapaTa TeJ1HTaM B TaKJ1X CJ1Y'Ia5IX 3anpeweHO.
npJ1'1J1HOH HBJ1J10Cb OTCYTCTBJ1e KOHTpoJ151 Ha 4>ePMe 3a npJ1MeHeHJ1eM
npenapaTa. J1HCTPYKUJ1H no npJ1MeHeHJ11O C YKa3aHHeM HaHMeHOBaHJ151 npena-
paTa. .a03bl. cnoc06a npJ1MeHeHJ1H J1 np. ComaCHO n. 402(a)(2)(C)(ii) AKTa, 21
USe.  342(a)(2)(C)(ii), KOpM C4J1TaeTCH 4>aJlbCJ14>J1UJ1poBaHHbIM. eCJlH OH
co.aep)l(HT HOBblH BeTepJ1HapHbIH npenapaT. npJ13HaHHb1H He6e30nacHblM. J11160
HaxO.aJ1J1CH B aHTHcaHHTapHblX YCJ10BJ151X.
llpHMep 2
B nI1CbMe-npenynpe)l()].eHJ1J1 OT 01 LleKa6pH 2010 r. npl1BO.D.5lTCH 4>aKTbl
rpy60ro HapyweHI1H nOp5l.aKa npJ1MeHeHJ1H npenapaToB J1 nI1TaHJ151 )l(J1BOT-
HbIX, BBJ1LlY '1ero J1X M5ICO OKa3aJ10Cb He npHro.aHO J])l51 ynoTpe6J1eHH5I B
nJ1WY.
B '1aCTHocrn. co.aep)l(aHJ1e OCTaTKOB npenapaTOB B TKaHHX TeJ1eHKa 3Ha4J1-
TeJ1bHO npeBblWaJlO .aonycrnMble HOpMbl (ppm - onHa MI1JlJIJ10HHa5I 4aCTb):
I llpenapaT 06HapYJKeHO TKam .lI.OnyCTHMblH npe)l.eJl
[H eoM J1uJ1H 16,36pP111"l nO'lKJ1 1 - J.. ppm
[C YJ1b 4>a.aHMeTOKCJ1H I 1,51 ppm I n e4eH  0, I ppm
[CYJ1b<pa.aHMeToKcHH T 1,21 ppm ---r- MblWUbl I 0, f ppm
B CBH3H C 3TJ1M MHCO TeJ1eHKa npl13HaHO <paJlbCl14>I1UJ1pOBaHHbIM
(adulterated).
npH'IHHOH HBJ1J10Cb OTCYTCTBJ1C LlOJ1)1(HOH .a0KYMeHTIlUJ1J1. B TOM 4J1CJ1e 0
4>aKTJ1'1CCKOM BSC.aCHJ1J1 npenapaTOB. HapYWCHJ1C J1HCTPYKUJ1H no I1X npJ1MC-
HeHJ110 J1 COnCp)l(3HJ1C )l(HBOTHblX B aHrnCaHHTapHblX YCJ10BJ151X. npl1 KOTOpblX
B03MO)l(HO HeKOHTpoJ1l1pYCMoe nona.aaHJ1C npenapaTOB B KOpM.
llpHMep 3
B nI1CbMe-npe.aynpe)l(1leHJ1J1 OT 02 HIOJ1H 2010 r. YKa3aHo 0 Henpa-
BJ1J1bHOM npJ1MCHeHJ1J1 pHLla npcnapaTOB (CYJ1b4>a.aJ1MCTOKCI1H. OKCHTeTpa-
UHKJ1HH H np.) .D,J1H .aOHHbIX KOpOB, '1TO Hc.aonYCTI1MO BBI1LlY onaCHOCTH J13-
MCHeHJ1H COCTaBa M0J10Ka.

497
rJIaBa 21
Cl>APMAKOnE» II GMP
Ha3HaIJeHHe 4>apMaKoneH H ee OTJIH1IIDI OT GMP
npaBHJIa GMP roBOp5lT, KIlK COe.llamb JICKapCTBCHHoe cpellCTBO, H YCTa-
HaBJIHBaIOT T))C60BaHJ151 K npOH3BOllCTBY, nOMCweHJ15IM, 060PYllOBaHHIO, 110-
KYMCHTaUHH, nCpCOHaJIY J1 np. npH BbInOJIHCHJ1J1 3THX T))e60BaHJ1H rapaHTH-
PYCTC5I COOTBeTCTBJ1C JICKa)JCTBeHHOro CpellCTBa 3aL1aHHbIM Tpe60BaHJ151M.
<1>apMaKOnC5I roBOpJ1T. KOKUM OOJlJICno 6blmb JIeKapCTBCHHOC CpCll-
CTBO H KOK elO KOnmpOJlUp060mb. C 3TOH UCJIblO <papMaKOnC5I YCTaHaB-
JIJ1BaCT Tpc60BaHH5I K:
- COCTaBY JICKapCTBcHHOro CpCllCTBa;
- ero 4HCTOTC (CTCpHJIbHOCTH);
- HHrpCllHCHTaM (coCTaBJI5IIOWHM) JICKapCTBcHHOro cpellCTBa;
- ynaKOBO'lHbIM MaTCpHaJIaM;
- BOllC, napy H llPYrHM MaTCpHaJIaM, J1CnOJIb3YCMbIM B npOH3BOllCTBC;
- MCTOllaM KOHTPOJI5I HCXOllHbIX MaTepHaJIOB, roTOBOH npOllYKUJ1J1 H T. 11.
06a BMa Tpc60BaHHH «KaK coenamb npoOyKlI,UIO» H «KaKUM mpe606aHu-
RM OHa OOJ1J1CHa yiJo6J1em60pRmb» HaX01l5lTC5I B llHaJICKTH'IeCKOM CllHHCTBe.
<1>apMaKOnC5I YCTaHaBJIHBaCT Tpc60BaHI151 K cocm06Y U MemoiJllM
KOnmpOJlH JICKapCTBcHHOro CpCllCTBa, a npaBI1JIa G M P - nOpJldOK npoU3-
6odcm60, loponmuPYIOUJ,uii BbInOJIHeHHe Tpc60BaHJ1H <papMaKonCH.
Tpe6oB3HI151 K
JleKapCTBeHHblM
CpCllCTIJaM
<1>apMaKOne51
J1eKapcTBeHHble
cpeIlcTBa
Tpe6oBaHI1S1 K
n p0l13BOIlCTBY
n paBI1J1a G M P
PJ1C. 21.1. <1>apMaKOnC5I H npaBJ1JIa G M P
B KOMnCTCHUJ1IO npOH3BOllCTBeHHJ1Ka HC BXOllHT pa3pa60TKa COCTa-
Ba JICKapCTBcHHOro CpCllCTBa H MeTOllOB cro KOHTpOJI5I. OHH np0J13BOll-
CTBCHHJ1KY 331la1OTC5I <papMaKoneeH J1JIJ1 llPYrHM 1l0KYMCHTOM J1 51BJI5IIOT-
C5I 1lJI5I Hcro HCXOllHbIMJ1 llaHHbIMJ1. B CBOIO 04epellb, pa3pa60T'IJ1KJ1
(apMaKOnCJ1 J1 JIeKapCTBeHHbIX CpCllCTB HC 3aHJ1MaIOTC5I llCTaJI5IMH npo-
J13BOllCTBa - 3TO llpyra51 c<pcpa lle5lTeJIbHOCTJ1, KOTOpa51 Tpe6yeT npJ1BJIe-
lleHJ151 llPyrJ1X cneUJ1aJIJ1CTOB.

498
f..w6a 2 I
Mbl 20 JICT 1l06J1BaCMC5I BBCllCHJ151 B POC01H npaBI1JI GMP EC J1
onpCllCJICHHblC PC3YJIbTaTbI eCTb, 6JIarollap51 TOMY, 4TO caMH, HJ1 Y KOro
He cnpaWHBa51 pa3pCWCHH5I, nCpeBeJIJ1 J1X, H311aJIH OTlleJIbHOH KHJ1roH, a
3aTeM npOBCJII1 B Ka'lCCTBe rOCTa P 52249.
npJ1MepHO C 2000 r. MbI CTaBHM 3allaI.JY np5lMoro BBCllCHH5I B Poc-
CI1I1 EBponcHcKoH <papMaKOneJ1. PC3YJIbTaT paBCH HYJIIO. nOXO)l(C, '1TO
I1HTCpCCbI HaCeJIeHJ151 HC HY)I(HbI HJ1KOMY: HJ1 4HHOBHJ1KaM, HH «HaYKe,>.
HH npOMbIWJIeHHOCTH. OllHH HC 3HalOT 11 605lTC5I ncpCllOBbIX PCWCHHH,
nOHHMa5l, 4TO B 3110pOBOH CJ1CTeMe J1M MCCTa HCT, llPYrHe 6CCCOBCCTHO H
6CCCTbIllHO nOTpc6JI5IIOT 6I01l)I(CTHbIC CpCllCTBa Ha J1306pCTCHHC «BCJIOCH-
nella,>, TpCTbJ1 HC XOT5IT BHCllpeHJ151 COBpCMCHHbIX 06'bCKTJ1BHbIX MCTOllOB
KOHTpOJI5I, nOCKOJIbKY J1M J1 TaK XopOWO.
nO-npe)l(HCMY HaB5I3bIBaIOTC5I <papMCTaTbH, KOMnJ1JIJ1pYIOWI1C COOT-
BCTCTBYIOWHC pa311eJIbI 3apy6c)I(HbIX <papMaKonCH C BHCCCHHCM B HHX
COBCpWCHHO HconpaBllaHHbIX OTJIJ14J1H.
B Ml1pC llCHCTBYIOT pa3HbIC <papMaKonCH. BHa4aJIC Ka)l(1la51 CTpaHa
HMeJIa C06CTBCHHYIO <papMaKoncIO, 3aTCM I.JCTKO 0603Ha4HJIaCb 3alla4a
BbIpa60TKI1 Clll1HbIX nOllXOllOB.
B HaCT05lWCC BpCM5I OCHOBHbIMH <1>apMaKOnC5IMH 51BJI5IIOTC5I <1>apMa-
KOne51 COCllJ1HCHHbIX WTaTOB H EBponcHcKa51 <papMaKOnC5I.
<l>apMaKOneJl COe.lJ,HHeHHbIX lIITaToB
HcmopUR u cmamyc
I 51HBap51 1820 r., n04TH llBCCTH JICT TOMY Ha3all, II Bpa4cti-
npaKTI1KOB Ha BCTpC4C B KanJ1TOJIHH npHH5IJI11 peweHHC 0 C0311aHJ1H
<1>apMaKOnCI1 COCllJ1HCHHbIX WTaTOB. OHH nOCTaBHJIH UCJIb pa3pa6OTaTb
CBOllHbIH 1l0KYMCHT Ha JIY4WHC H HaH60JIcc XopOWO oTpa60TaHHbIe JIC-
KapCTBeHHbIC CpCllCTBa, llaTb HM Yllal.JHbIC HaHMeHOBaHJ151 H pcucnTbI
npHroTOBJIeHH5I. npHMCpHO 4CpC3 roll, 15 llcKa6p51 1820 rolla BbIWJIO B
CBCT ncpBoe H311aHHC <1>apMaKoncH CocllHHeHHbIx WTaToB (The Pharma-
copoeia of the United States - USP).
C TC4CHHCM BpCMCHJ1 COllCp)l(aHHC USP MeH5IJIOCb. 1-13 C60pHHKa
pcucnTOB OHa npCBpaTJ1JIaCb B CBOll 1l0KYMCHTaJIbHO O<pOpMJICHHbIX
cTaHllapToB Ha HllCHTH4HOCTb J1 Ka4CCTBO co CCbIJIKaMJ1 Ha cTaHllapTbl
cpaBHCHJ151, HCnOJIb3yeMbIc npJ1 KOHTpOJIC. nCpJ1011J14HOCTb ny6JIJ1Ka-
UHH USP TaK)l(C MCH5IJIaCb. C 1820 no 1942 r.r. OHa ncpeH311aBaJIaCb
OllHH pa3 B 10 JICT, C 1942 no 2000 roll OllJ1H pa3 B n5lTb JICT, a Ha4 J1-
Ha51 C 2002 r. C)I(erollHO.
CJ1e.ayeT pa3J1H'IaTb:
- USP - OpraHJ13aUJ11O «<DapMaKoneH Coe.aHHeHHblx WTaToB;
- USP (KYPCHB) - CBO.a .aOKYMeHTOB «<DapMaKoneH Coe.aHHeHHblx
WTaTOB».

(]JapMaKoneR u G M P
499
B 1888 r. llPyra51 opraml3aUI151 - AMcpJ.1KaHcKa51 <1>apMaueBTJ14eCKa51
AccoUJ1aUJ151 (American Pharmaceutical Association) ony6JIJ.1KOBaJIa nepBbIH
HaUJ10HaJIbHbIH <1>OPMYJI5IP (National Formulary - N f) 1lJI5I HeOljJuu,ulLIlb-
HblX npcnapaTOB. KaK USP, TaK 11 NF 6bIJIJ1 npJ13HaHbI B 1906 r. <1>cllc-
paJIbHbIM aKTOM no npOllYKTaM nJ.1TaHJ.151 J1 JICKapCTBCHHbIM cpellCTBaM
(Federal Food and Drug Act) B 1906 r. J1 <1>cllCpaJIbHbIM aKTOM no npo-
llYKTaM nJ1TaHJ.151, JICKapCTBCHHbIM J.1 KOCMCTJ14CCKJ1M CpCllCTBaM (Federal
Food, Drug and Cosmetic Act) B 1938 r.
B 1975 r. OpraHJ13aUJ151 «<1>apMaKOne51 COCllJ.1HCHHbIX WTaToB'>
(USP) npJ.106peJIa HaUJ.10HaJIbHbIH <1>OPMYJI5Ip, KOTOpbIH Tcncpb COllCp-
)l(J.1T CTaHllapTbI Ha 1l06aBKJ1. C Tex nop J1311aCTC5I CllJ1HbIH 1l0KYMCHT
United States Pharmacopoeia - National Formulary (USP-NF).
B WTaT USP BX01l5lT OKOJIO 600 Y4CHbIX, cnCUJ1aJIJ1CTOB J1 allMJ1HJ1-
CTpaTI1BHbIX pa60THJ.1KOB, KOTopbIe pa60TaIOT B wTa6-KBapTJ.1pC OpraHJ.1-
3aUI1J.1 B Po KBJ.1JIJIC, M3pJ.1JICHll (Rockvi//, Maryland), CWA, B WBcHua-
pl1J.1 11 JIa60paTOpl151X HHilJ.1J.1, KJ1TaC J1 Epa3J.1JIJ.1J.1.
06H3ameAbHa AU (/)apMaKoneH CoeiJuHeHHblX lllmamo6?
BCTpC4aIOTC5I ny6JIJ1KaUJ1J.1 J.1 pa3roBopbI 0 TOM, 4TO <1>apMaKOnC5I Co-
CllJ.1HCHHbIX WTaTOB Hc06513aTeJIbHa, nOCKOJIbKY pa3pa60TaHa HcroCYllap-
CTBCHHOH OpraHJ.13aUJ.1CH. K CO)l(aJICH 11 10. p5l11 J.1311aHJ1H J.1 CCMJ.1HapOB
O'-/CHb 3acopCH llC3J1H<popMaUJ1CH, KOTOpa51 BBOllJ.1T JIIOllCH B 3a6JIY)I(1lCHJ1C.
LIa, <1>apMaKOnC5I COCllJ.1HCHHbIX WTaTOB pa3pa60TaHa J.1 J.1311aeTC5I
06'bCllI1HeHJ.1CM cnCUJ1aJII1CTOB, HcroCYllapCTBCHHOH OpraHJ.13aUJ1eH, aHa-
JIOroM HaWJ.1X HCKOMMCp4CCKI1X naPTHcpCTB J.1JIJ.1 06WCCTBCHHbIX OpraHJ.1-
3aUJ.1H. Pa3BC 3TO nJIOxo? Pa3BC 3TO Xy)I(C, 4CM HaWJ.1 CHJ.1nbI, CaHnJ.1-
HbI, OCTbI J1 np., C0311aBaCMbIC Ha3Ha4CHHbIMJ.1 1lJI5I TOro OpraHJ.13aUJ.151-
MJ.1 J.1JIJ1 JIJ1uaMJ1?
OTBeT Ha 3TJ.1 BonpOCbI 04CBJ1,LI,CH J1 01lH03Ha4eH, eCJIJ1 CpaBHJ.1Tb Ka-
4CCTBO YKa3aHHbIX 1l0KYMCHTOB J1 <1>apMaKonclO COCllJ1HCHHbIX WTaTOB.
a TaK)l(e llPYfJ.1X pa3pa60TOK, CllCJIaHHbIX HcrOCYllapCTBeHHbIMJ1 OpraHJ1-
3aUJ.151MI1: ypOBCHb pa60Tbl 3TJ1X HcroCYllapCTBCHHblX OpraHJ13aUJ1H
HCCpaBHJ1MO BbIWC.
Bonpoc, Kmo pa3pa6omlLll UJlU U3iJlLIl <papMaKonclO - HC maBHbIH
rJIaBHOC, KaK K 3TOMY omHocumCH zocyiJapcm6o. ECJIJ.1 rocYllapCTBO CBO-
J.1M PCWCHJ.1CM npJ13HaJIO 3TOT 1l0KYMeHT 06513aTCJIbHbIM, .If,aJIbHCHWJ.1C
pa3roBopbI HCYMCCTHbI.
<1>apMaKOnC5I COCllJ1HCHHbIX WTaTOB - USP - npU3HaHa 3alWHOM BO
MHOfJ.1X CTpaHax. B CWA OHa J.1MCCT 3aKOHHYIO CJ.1JIY comaCHO <1>ellc-
paJIbHOMY aKTY no npOllYKTaM nJ1TaHJ151. JIeKapCTBeHHbIM J1 KOCMeTJ1'1C-
CKJ1M cpellCTBaM 1938 r. 3TJ.1M aKTOM OnpCllCJICH TCpMJ1H «O<pJ1UJ1aJIbHOC
PYKOBOllCTBO') (official compendium), K KOTOpbIM OTHOC5ITC5I O<pJ1UJ1aJIbHa51
<1>apMaKOne51 COellJ1HeHHbIx iliTaToB (USP), 0<pJ1UJ1aJIbHbIH HauJ1oHaJIb-
HblH ct>OPMYJIHp (Nf) J.1 0<pJ1UJ1aJIbHa51 rOMeOnaTJ1 ' leCKa51 <1>apMaKoneH
COellJ1HeHHblx WTaToB (Homeopathic Pharmacopoeia of the United States).

500
FoW6a 21
J1cKapCTBeHHOC CpCllCTBO C HaI1MCHOBaHJ1eM. YKa3aHHblM B USP-NF,
1l0JI)I(HO COOTBCTCTBOBaTb Tpe60BaHJ151M K J11lCHH1'IHOCTJ1 COrJIaCHO USP.
a TaK)l(C Tpc60BaHJ1HM K 3<p<peKTJ1BHOCTM, Ka4CCTBY J1 4J1CTOTC. CCJIJ1 Ha
3TJ1KCTKC He YKa3aHbI BCC OTJIJ14MTCJIbHbIe <paKTOpbI. He0<pJ1UMaJIbHble
HaJ1MeHOBaHI151 1l0JI)I(HbI MMeTb 51CHbIe OTJIM4M5I OT HaI1MCHOBaHJ1H no
O<pMUl1aJIbHOMY 1l0KYMCHTY. J1cKapcTBeHHbIc CpCllCTBa C HaJ1MeHOBaHM5I-
MM no USP-NF. HC COOTBCTCTBYIOWMe CTaHllapTOM Ha ynaKOBKY M Map-
KJ1pOBKY. C4I1TaIOTC5I HCnpaBI1JIbHO MapKJ1pOBaHHbIMI1, 4TO 3anpCWCHO.
<1>apMaKOnC5I COClll1HeHHbIx WTaToB npJ13HaHa J1 WMpOKO I1C-
nOJIb3YCTC5I BO BCCM MJ1pe, nOCKOJIbKY OHa OCHOBaHa Ha ncpCllOBbIX
1l0CTJ1)1(eHJ151X, 06JIallaCT aBTopMTeTOM, nOp5l110K cc pa3pa60TKI1 npo-
3pa'lCH J1 3aCJIY)l(J1BaCT 1l0BepJ151 (www.usp.org).
COOepJICaHUe C/JapMaKoneu CoeiJuHeHHbLX llimamo6
<1>apMaKOnC5I COellJ1HCHHbIX WTaTOB USP 34 J1 HaUJ10HaJIbHbIH
<POPMYJI5Ip NF 29, BCTynMBWI1C B CI1JIY C I Ma51 20 II r., J1311aHbI B TPcx
TOMax, 3aTCM BbIWJIO HeCKOJIbKO 1l0nOJIHCHJ1H [54].
COllCp)l(aHl1e TpCX TOMOB USP 34 M NF 29:
TOM I
- 06waH J1H4>opMauHH H Tpe6oBaHJ151;
- 06WJ1e pa3.aeJ1bl:
. 06WHe J1CnblTaHJ1H H aHaJlJ13bl;
. 06WHe Tpe60BaHH5I K HCnblTaHJ1HM J1 aHaJlJ13aM;
. 060py.aoBaHHe .D.J151 npoBe.aeHJ151 J1CnbITaHJ1H J1 aHaJlJ130B;
. MeTo.abl MHKp06J10J10fJ14ecKoro KOHTp0J151;
. MeTo.abl 6H0J10rJ14ecKoro KOHTp0J151 H npoBe.aeHJ1H aHaJlH30B;
. MeTo.abl XHMJ11-lecKoro KOHTpOJ1H H npoBe.aeHJ151 aHaJlJ130B;
. MeTo.abl 4>H3J11-lecKoro KOHTp0J151;
. 06wa51 HH4>opMaUJ151;
. llHeTJ14eCKHe .a06aBKH;
- PeareHTbl, HH.aHKaTopbl H paCTBopbl:
. CneuH4>HKaUJ1H Ha peareHTbl;
. HH.aHKaTopbl H HH,D,HKaTOpHa5I 6YMara;
. PacTBopbl;
. XpoMaTorpa4>J1'1eCKJ1e K0J10HKJ1.
- Ea30Bble Ta6J1HUbl;
- llHeTJ1'1ecKJ1e .a06aBKJ1.
HaLlHOHaJIbHblH cJIoPMYJlJlp NF 29
- 1l0noJ1HeHJ151;
- BcnoMOraTeJ1bHble BeweCTBa;
- 04>J1UJ1aJ1bHble CTaTbJ1 NF 29.
TOM 2
04>HUHaJlbHble CTaTbH USP 34
TOM 3
0<tJHUJ1aJIbHble CTaTbH USP 34

(/)apMaKoneR u GMP
501
J(pyzue i)oKYMeHmbl
XpoMaTOrpaclIH'IeCKHe KOJlOHKH (Chromatography Columns) - nOJ1HbIH
CBO.a HH!f>opMaUJ1J1, He06xo.aHMOH .D,J1H npOBe.aeHJ151 xpoMaTorpa4>H4ecKoro
aHaJlJ13a no USP-NF.
<l>apMaKOneH USP,D,JIH ameKapeH (USP Phannacists Phannacopeia) J13-
.aaeTCR C Y'leTOM H 4>apMaueBToB-npaKTHKoB, pa60Ta1OWJ1X B anTeKax.
Co.aep)l(J1T OTHOC5IWJ1HCH K HHM TeKCT USP-NF H .apyrylO 04>J1UJ1aJ1bHYIO
J1H4>0pMaUJ1IO.
CJlOBapb USP (USP Dictionary) co.aep)l(HT cOBpeMeHHble HaHMeHOBa-
HJ1H J1eKapCTBeHHblx cpe.acTB, npHHHTble B CWA, o4>HL!J1aJ1bHble HaHMeHO-
BaHJ151 no USP-NF. HaJ1MeHOBaHH5I XJ1MJ14eCKJ1X BeweCTB, rpa4>w.lecKHe
0603Ha4eHJ151. XJ1MJ14eCKJ1e 4>OPMYJ1bl, Beca J1 T. .a.
PyKOBO.aCTBO no ,lJ,Hem'leCKHM .a06aBKaM USP (USP Dietary Supplement
Compendium) - c60pHJ1K CTaH.aapTOB Ha .aJ1eTJ14eCKJ1e .a06aBKJ1.
Ko.aeKc XHMH'leCKHX Bell(eCTB, npHMeHHeMblX B npo.nyKTax nHTallHH
(Food Chemical Codex) - CBO.a npJ13HaHHb1X B Me)l(1lYHapollHOM c006WeCTBe
CTaH.aapTOB J1 MeTOllOB KOHTp0J151 4J1CTOTbl J1 Ka4eCTBa J1Hrpe.aJ1eHTOB .D,J151
npo.aYKTOB nJ1TaHJ151. HanpHMep. KOHcepBaHTOB, apoMaTH3aTopoB. KpaCHTe-
J1eH J1 nJ1TaTeJ1bHbIX BeweCTB.
EBpOneHCKaH apMaKoneH
KOHBCHUI151 06 OCHOBaHHH EBponcHcKoH <papMaKOnCJ1 (European
Pharmacopoeia) 6bIJIa OCHOBaHa nOlI 3rl11l0H COBcTa EBponbI H BCTYnl1JIa
B llCHCTBI1C B 1964 r. EBponeHcKa51 <papMaKOnC5I YCTaHaBJIHBaCT Clll1HbIC
Tpc60BaHH5I K JICKapCTBCHHbIM CpCllCTBaM H CllHHbIC MCTOllbI KOHTpOJI5I.
B KOHBCHUI1IO BX01l5lT 36 CTpaH-'lJICHOB EC J1 caM EBponcHcKI1H Co-
103. Ha6JIIOllaTCJI5IMI1 51BJI5IIOTC5I BccMHpHa51 OpraHI13aUJ151 311paBooxpaHCHH5I
(B03) H 22 cTpaHbI, BKJ1104a51 ABCTPaJIHIO, E>pa3I1JIHIO, KaHallY, KHTaH,
POCCHHCK)'IO <1>cllcpaUJ11O H CWA. TaKHM 06pa30M, EBponcHcKa5I <papMa-
KOnC5I nOJIY'll1JIa pacnpoCTpaHcHHc Ha 60JIbwCH 4aCTH nJIaHCTbI.
EBponcHcKa51 <papMaKOnC5I 51BJI5IIOTC5I 06513aTCJIbHOH 1lJI5I CTpaH-
4JICHOB EC H npoucccOB pcrYJIHpOBaHH5I B EBponcHcKoM CO/03e.
C 2011 r. llCHCTBYCT 7-c J1311aHJ1C EBponeHcKoH <papMaKoncH [23]. B
HaCT05lWCC BpCM5I OHa nCpCJ1311aeTC5I OllJ1H pa3 B TpJ1 rolla. TpJ1 pa3a B
roll BbmYCKaIOTC5I 1l0nOJIHCHJ151, KOTopbIe OTpa)l(alOT pa60TY KOMJ1CCHH
no EBponcHcKoH <papMaKoncc, 3KcncpTOB H pa60'lJ1x rpynn.
UeJIblO EBponeHcKoH <papMaKoncH 51BJI5ICTC5I oxpaHa 3110pOBb51 JIIO-
lleH nYTCM npCllOCTaBJICHH5I CTaHllapTOB, CJICllOBaHHC KOTOpbIM n03BOJI5I-
eT 06CCne'-lHTb Ka'lCCTBO JICKapCTBCHHbIX CpCllCTB. 3TJ1 CTaHllapTbI 51BJI5I-
IOTC5I OCHOBOH 6e30nacHoro J1CnOJIb30BaHJ151 JIeKapCTBCHHbIX CpCllCTB.
EBponcHcKa51 <papMaKOne5l:
- cnoc06CTByeT cB06011HOMY llBH)I(eHHIO JICKapCTBeHHblX CpCllCTB B
EBpone;
- llaCT OCHOBY 1lJI5I 06CCne4eHJ151 Ka4eCTBa JIeKapCTBeHHblX Cpe.llCTB J1
HX KOMnOHeHTOB, HMnOpTJ1pyeMblx B EBpony J1J1J1 3KCnOpTJ1pyeMblx H3 Hee.

502
J:W6a 2 I
OHa npellHa3Ha4eHa 1lJI5I I1CnOJIb30BaHJ151:
- Hall30pHbIMJ1 opraHaMJ1;
- BCeMJ1, KTO CB5I3aH C KOHTpOJICM Ka4eCTBa JIeKapCTBCHHbIX CpCllCTB
M J1X KOMnOHeHTOB;
- np0J13BOllJ1TeJICH JIeKapCTBCHHblX CpCllCTB J1 MaTCpMaJIOB 1lJI5I HMX.
7-e J1311aHMC EBponei1cKoH <papMaKOnCJ1 COCTOJ1T M3 TOMOB, KOTO-
pblC COllCp)l(aT 06WMC M CnCUl1aJIbHbIC CTaTbM (monographs).
POCCHHCKaH apMaKoneD
B POCCJ1J1 0 GMP roBOp5IT MHOro M llaBHO.
Ho GMP - 3TO TOJIbKO 4aCTb llCJIa.
np5lMOC BBClleHJ1C EBponcHcKoH <papMaKoneM nOllMCHCHO C0311aHJ1-
CM POCCI1HCKOH <papMaKOnCI1, KOTOpa51 Ha caMOM llCJIC HJ1KaKa51 He pOC-
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PaCCMOTpl1M 11133 npMMcpa: TeeT Ha nl1pOrCHHOCTb J1 TCCT Ha aHO-
MaJIbHYIO TOKCJ1'IHOCTb. TCKCTbI 06eJ1x pOCCMHCKI1X <papMCTaTeH (O<1>C
42-0061-07 11 O<1>C 42-0060-07) 1lJI5I 3TJ1X MCTOllOB nOBTOp5llOT 1l0CJIOBHO
TeKCTbI COOTBeTCTBYIOWI1X CTaTCH EBponcHcKoH <papMaKoncM. OTJIJ14J151
nOKa3aHbI B Ta6JIl1uax 21.1 11 21.2.
Ta6J/ut(a 21. I
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rJ1y6HHa BBe.aeHI1H TepMO- npl1MepHO OT 5.a0 7,5 CM
MeTpa B npHMYIO KJ1WKY 5 CM
Ta6J1Ut(a 21.2
AHoMaJlbHa51 TOKCJ14HOCTb
EBponeHCKaJl POCCHJI
nOKa3aTeJlb <I>apMaKOneJl 7.0 O<DC 42-0060-07
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BBe.aeHHe paCTBopa B TelJeHHe Co CKOpOCTblO
15-30 C 0.1 MJ1jC
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503
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Maccc MbIWJ1, nOp5I1lKY BBCllCHH5I paCTBopa J1 nCpJ1011Y Ha6JIIOllCHJ151.
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JICKapCTBCHHbIC CpCllCTBa, 1l0nYCKaCMbIC K peaJIH3aUJ1H B POCCJ1J1, HC3a-
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'IeCKUe 6apbepbl 6 mOpl06.1le, Ha YCTpaHCHJ1C KOTOpbIX HanpaBJICHO cnc-
UHaJIbHOC COrJIaWCHJ1e BCCMHpHOH TOproBOH OpraHI13aUHH. B onpaB-
llaHHbIX CJIY4a5lX 6apbCp MO)l(CT 6bITb, HO OH 1l0JI)I(CH 6bITb 06'b5lCHJ1M.
ECJIJ1 OHH KaCaIOTC5I TOJIbKO pOCCHHCKOro npOH3BOllCTBa, TO pOC-
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HCBbInOJIHHMbIC YCJIOBH5I, nOTOMY 4TO llHana30H MaCCbI MbIWH «OT 19110
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LIaJIbWC - XC. EBponcHcKa51 <1>apMaKOnC5I npJ1 npOBClleHJ1J1 TCCTa
Ha aHOMaJIbHYIO TOKCH4HOCTb npcllycMaTpHBacT BBCllCHHC pacTBopa B
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KOTOpbIC XOT5IT (<nOBCp5lTb'> 3TO npJ160p. Hc OT HHX JIJ1 J111eT 3TOT nOCTO-
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npcllHaMepcHHoe YCTaHOBJICHI1C 60JIec )l(CCTKHX Tpe60BaHHH 1lJI5I
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HaHeceHHC BpClla CTpaHC. nOH5ITHO JIH 3TO? 11 HC nopa JIH 3TJ1M 3aH5ITb-
C5I TCM. KOro npHH5ITO Ha3bIBaTb «KOMnCTCHTHbIMH opraHaMI1».
HY)I(HO ClleJIaTb ncpBbIH war - BBCCTH «llBOHHOH CTaHllapT'>, TO CCTb
pa3pCWHTb npellnpH5ITI151M nOJIb30BaTbC5I Ha BbI60p JIH60 OTC4CCTBCHHOH
<papMaKoneeH, JIJ160 CBponCHCKOH. BBOll EBponcHcKoH <papMaKonCH
1l0JI)I(CH npOJ1CXOllJ1Tb B TC )l(C CpOKH, 4TO H BBOll npaBJ1JI G M P.
HHoma 3BY4aT 3a60TJIJ1BbIC HOTbI: npCllnpJ151TH5I HC MOfYT KOHTpO-
JIHpOBaTb Ka4eCTBO no EBponeikKoH <papMaKonec, Y HHX HeT llJI5I 3TOro
cpellCTB. A BOT TYT. rocnolla, He4cro pcwaTb HJ1 3a npCllnpJ151TJ151, HH 3a
nOTpe6J1TCJIei1.
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np0J13BOllcTBa.

504
f!laRa 22
CTAH,lI,APTbI II TIPABIIJIA
CT3H)J.3PTbI. CBH33HHbie C GMP
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BaTb npellnpJ151TH5I, BbI6J1paTb 060PYlloBaHJ1C 11 OpraHJ130BbIBaTb npOH3-
BOllCTBa, HY)I(HO 3HaTb, KaK 3TO lleJIaTb. Hc06xOllHMbIC KpHTepHJ1 H TpC-
60BaHH5I 1lJI5I 3TOro llaIOTC5I B CTaHllapTax, npaBI1JIaX, PYKOBOllCTBax.
npaBHJIa GMP - 06WHH CHCTcMo06pa3YIOWHH 1l0KYMeHT, KOTOpbIH
YCTaHaBJIHBaCT OCHOBHbIC Tpc60BaHI151 6C3 HX llCTaJIH3aUHH no BI111aM
npOUCCCOB, 060PYlloBaHH5I, MCTOllOB KOHTpOJI5I H np., KOTOpa51 pCWaCTC5I
CnCUJ1aJIH3HpOBaHHbIMHllOKYMeHTaMH (pHC. 22.1):
06H3aTeJlbHblH .lI.OK)'MeHT no GMP
faCT P 52249 (,npaBHJla npOH3Bo.aCTBa H KOHTpOJIH
Ka'JeCTBa JleKapCTBeHHblX Cpe.ll.CTB"
06wIC 06wllc 06wllc
CTCplll1l1JaUIIR Kl1aCclII!>IIKaulIR Tpc6oB<IH II R Tpc60BaHIIH Tpc60mlllllH 06Y'ICHIIC
<l>lIl1bTpaUIIH npOCKTllponamlc npOIlCCCbl OTlUl0HCHIIH OT I1HCTPYKUIIII II
OJ1cJKJIa
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KOHTpOl1>1 noncllcHllc
TIICPllblC 01ntCTK3 .aOKYMCIITI.! II
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11 H>KC HCpH blC J)IIOJarp>lJHCHII>I cnCTCMhl (jJOpMC nro'ICC
CIiCTCMbI 11 JO.1I1PYIOWIIC
AHil.1ltTH l leCKue
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4eHb cTaHllapToB, OTHOC5IWI1XC5I K G M p. npJ1BCllCH HH)I(C. Bcc OHJ1 nOll-
roTOBJIeHbI ACJIIHKOM J1 TCXHI1'1CCKJ1MH KOMHTCTaMJ1 no cTaHllapTJ13a-
UHH TK 184 «06ecne4eHHe npOMbIWJIeHHOH 4J1CTOTbI'> H TK 458 (,npo-
H3BOllCTBO I1 KOHTpOJIb Ka4CCTBa JICKapCTBCHHbIX CpCllCTB'>. B OCHOBHOM.

CmaH(Japmbl U npa6UJ1a
505
3TO nepCBOllbI CTaHllapTOB HCO H EH, HO CCTb C06CTBCHHblC pa3pa60T-
KH, Hanpl1MCp:
- rOCT P 52537-2006 npOH3BOllCTBO JICKapCTBCHHbIX CpCllCTB. CJ1-
CTCMa 06CCnC'ICHH5I Ka4CCTBa. 06WHe Tpc60BaHH5I;
- rOCT P 52550-2006 np0J13BOllCTBO JICKapCTBCHHbIX CpCllCTB. Op-
raH J13aUJ10H HO- TCXHOJIOm'leCKa51 1l0KYMeHTaUH5I
- rOCT P 52896-2007 npOH3BOllCTBO JICKapCTBCHHbIX CpCllCTB.
060PYlloBaHJ1C TCXHOJIOm4CCKOC 1lJI5I np0J13BOllCTBa TBepllbIX JIeKap-
CTBCHHbIX <pOpM. 06WHC Tpe60BaHJ151;
- rOCT P 52539-2006 YHcTOTa B0311yxa B JIC4c6HbIX Y4pC)I(1lCHJ151X.
06wI1e Tpc60BaHJ151.
CTaHllapT Ha '1J1CTOry B0311yxa B 60JIbHJ1UaX rOCT P 52539 BbI3BaJI
I1HTcpec 3a py6C)I(OM. ABTOp BbICTynHJI C 1l0KJIallaMH Ha 3TY TCMY BO
MHomx CTpaHax, H HHTCpCC K HCM HC OCJIa6CBacT. ny6JIJ1KaUJ151 06 3TOM
CTaHllapTC OTMC4CHa npCCTH)I(HOH npcMHcH aHfJIl1HCKOro npo<peccJ10-
HaJIbHOro 06WCCTBa (eM. BBCllCHHC K KHHrc).
06UUte CTall,lJ.apTbl no npaBHJlaM GMP
1 rOCT P 52249-2009 npaBJ1J1a npoJ13Bo.aCTBa J1 KOHTpOJUI Ka'leCTBa J1e-
KapCTBeHHblX cpellCTB (GMP EC)
2 rOCT P 52537-2006 np0J13BO.aCTBO J1eKapCTBeHHbIX cpe.aCTB. CJ1CTeMa
06eCne'leHJ1H Ka4eCTBa. 06WJ1e Tpe60BaHI1H
3 rOCT P 52550-2006 npoJ13BO.aCTBO J1eKapcTBeHHbIX cpe.aCTB. OpraHJ13a-
UJ10HHO-TeXH0J10rJ1'1eCKa5I .aOKYMeHTaUJ1H
4 rOCT P 52896-2007 np0J13BO.aCTBO J1eKapcTBeHHbIX Cpe.aCTB. 060py.a0-
BaHHe TeXH0J10fl1'1eCKOe .D,J1H npoJ13BO.aCTBa TBep.ablX J1eKapcTBeHHbIX 4>OpM.
06WI1e Tpe60BaHH5I
5 rOCT P 53699-2009 nepBH4Hble ynaKoB04Hble MaTepJ1aJ1bl .D,J1H J1eKap-
CTBeHHblX Cpe.aCTB. l.{aCTHble Tpe60BaHJ151 no npHMeHeHHIO rOCT P HCO
9001-2008 C Y'leTOM npaBJ1J1 GMP
6 rOCT P EH 12296-2009 EJ10TeXH0J10fl151. 060pYlloBaHJ1e. MeTO.abl KOH-
Tp0J151 34>4>eKTJ1BHOCTJ1 O'lJ1CTKH
CTall,lJ.apTbl no aCernH'IeCKOMY npoH3Bo.nCTBY
I rOCT P I1CO 13408-1-2000 ACel1TJ14eCKOe npOH3Bo.aCTBO Me.aJ1UJ1HCKOH
npo.aYKUJ1H. l.{acTb I. 06WHe Tpe60BaHH5I
2 rOCT P I1CO 13408-2-2007 ACel1TH4eCKOe np0J13Bo.aCTBO Me.aHUJ1HCKOH
npo.aYKUJ1J1. l.{aCTb 2. <DJ1J1bTpaUHH
3 rOCT P I1CO 13408-3-2011 Acel1TH4eCKoe npoJ13Bo.aCTBO MellHUJ1HCKOH
npo.aYKUHH. 4acTb 3. J11104>J1J1113aUI1H
4 rOCT P I1CO 13408-4-2011 Acel1TH4eCKoe np0I13Bo.aCTBO MeJr\1UJ1HCKOH
npo.aYKUHH. 4aCTb 4. 04J1CTKa Ha MeCTe
5 rOCT P "CO 13408-5-2011 ACel1T114eCKOe npoJ13BOllCTBO Melll1UI1HCKOH
npo.aYKUI1H. 4acTb 5. CTepJ1J1113aUJ1H Ha MeCTe
6 rOCT P I1CO 13408-6-2009 ACel1T114eCKOe npoH3Bo.aCTBO Me.aJ1UJ1HCKOM
npo.aYKUHH. l.{aCTb 6. 1-130J1J1PYIOWHe CHCTeMbl

506 a22
CTepH.llH3aLUtH
1 rOCT P I1CO 11138-1-2000 CTepHJ1H3aUHH Me.aHUHHcKOH npo.aYKUHH.
DH0J10rH4eCKJ1e J1H.aJ1KaTOpbI. 4acTb 1. 06lUHe Tpe60BaHI151
2 rOCT P I1CO 11138-2-2000 CTepJ1J1J13aUJ1H Me.aHUI1HCKOH npo.aYKUJ1J1.
DJ10J10rH4eCKJ1e HHnJ1KaTOpbI. 4acTb 2. DH0J10rH4eCKHe I1H.aJ1KaTOpbl .D,J151
CTepJ1J1I13aUI1I1 OKCHnOM 3TJ1J1eHa
3 rOCT P I1CO 11138-3-2000 CTepHJ1H3aUHH Me.aHUJ1HCKoti npo.aYKUHH.
DH0J10rH4eCKJ1e J1H.aHKaTOpbI. 4acTb 3. DH0J10rH4eCKHe J1H.aI1KaTOpbl .D,J1H
CTepHJ1I13aUHJ1 811a)l(HblM TenJ10M
4 rOCT P I1CO 11134-2000 CTepJ1J1113aUJ1H Me.aHUHHcKOH npo.aYKUI1I1.
Tpe60BaHJ1H K BaJlH.aaUJ1J1 H TeKyweMY KOHTpoJ1lO. npOMbIWJ1eHHaH CTepH-
J1J13aUJ151 BJ1a)l(HblM TenJ10M
5 rOCT P I1CO 13683-2000 CTepJ1J1J13aUJ1H Menl1UI1HCKOH npo.aYKUJ1H.
Tpe6oBaHJ1H K BaJlJ1.aaUI1H H TeKyweMY KOHTpOJ1IO. CTepJ1J1H3aUHH 811a)l(-
HblM TenJ10M B Me.aHUJ1HCKI1X Y4pe)l()].eHHHX
6 rOCT P I1CO 11737-1-2000 CTepJ1J1H3aUJ151 Me.aHUJ1HCKOH J13.aeJ1HH.
MHKpo6H0J10fJ14eCKJ1e MeTo.abI. 4aCTb l. OueHKa nonYJ1HUJ1H MHKpoopra-
HH3MOB Ha npo.aYKUHH
7 rOCT P I1CO 11737-2-2003 CTepl1J1J13aUJ1H Me.aJ1UJ1HCKHX J13.aeJ1J1H.
MJ1Kpo6HoJ1orJ1'1ecKHe MeTo.abI. 4aCTb 2. HCnbITaHJ1H Ha CTepJ1JIbHOCTb.
npOBOnl1Mble npH BaJlJ1.aaUI1J1 npoueCCOB CTepJ1J1J13aUJ1J1
8 rOCT P I1CO 11135-2000 Me,D,HUJ1HcKJ1e H3.aeJ1HH. BaJlJ1.D.aUJ1H J1 TeKYWHH
KOHTpoJ1b CTepJ1J1J13aUJ1J1 OKCJ1.aOM 3TJ1J1eHa
9 rOCT P I1CO 14160-2003 CTepJ1J1J13aUJ151 0.aHopa30BblX Me.aI1UHHCKJ1X
J13.aeJ1HH, co.aep)l(aWJ1X MaTepl1aJ1bl )l(HBOTHOro npoJ1CXO)l(1leHJ1R. BaJlH.aa-
UH5I H TeKYWJ1H KOHTpoJ1b CTepJ1J1113aUJ1H C nOMOWblO )I(J1.D,KJ1X CTepJ1J1113Y-
I0111HX BellleCTB
1.JHcTOTa B03.LJYXa B ne<le6HbIX y>lpe)l(,ll.eHHHX
I rOCT P 52539-2006 4J1CTOTa B03)J,yxa B J1e4e6HblX Y4pe)l()].eHJ151X. 06wJ1e
Tpe60BaHJ1H
CTaH,lJ,apTbl no '1HCTbIM nOMeeHHHM
1 rOCT I1CO 14644-1-2002 411cTble nOMeWeHJ1H J1 CB5I3aHHble C HJ1MH
KOHTpOJ1HpyeMble cpe,D,bI. 4acTb I. KnaCCJ14>J1KaUJ1H 4J1CTOTbl B03nyxa
2 rOCT P I1CO 14644-2-2001 4J1CTble nOMeweHHH J1 CBH3aHHble C HHMH
KOHTpOJ1J1pyeMble cpe.abI. 4acTb 2. Tpe60BaHJ151 K KOHTpOJ11O H MOHJ1TOpHH-
ry .D,J1H nO,D,TBep)l(1leHHH nOCT05IHHOro COOTBeTCTBJ151 rOCT P HCO 14644-1
3 rOCT P I1CO 14644-3-2007 4J1CTble nOMeweHJ1H 11 CBH3aHHble C HHMH
KOHTpoJ1HpyeMble cpe.abI. 4acTb 3. MeTo.abl J1CnbITaHHH
4 rOCT P I1CO 14644-4-2002 4J1CTble nOMeweHHH J1 CBH3aHHble C HHMH
KOHTpOJ1HpyeMble cpe.abl. 4aCTb 4. npoeKTHpoBaHHe. cTpOHTeJ1bCTBO H
BBO.a B 3KCnJ1yaTaUHIO
5 rOCT P I1CO 14644-5-2005 411CTble nOMeweHHH 11 CBH3aHHble C HI1MJ1
KOHTpOJ1J1pyeMble cpe.abI. 4acTb 5. 3KCnJ1yaTaul151
6 rOCT P I1CO 14644-6-2010 4HCTbie nOMeweHHH 11 CB5I3aHHble C HI1MH
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7 rOCT P I1CO 14644-7-2007 411cTble nOMeweHHH 11 CBH3aHHble C HHMU

CmaHoapmbl U npa6UJlG
507
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8 rOCT P I1CO 14644-8-2008 4HcTble nOMeweHJ1H Ii CBH3aHHbie C HHMJ1
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rpH3HeHHH B B03.ayxe
9 rOCT I1CO 14698-1-2005 4J1CTble nOMeweHHH H CBH3aHHbIe C HHMH
KOHTpOJ1J1pyeMble Cpe.abI. KOHTpOJ1b 6H03arpH3HeHHH. 4acTb I. 06111He
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10 rOCT I1CO 14698-2-2005 4HcTbie nOMeWeHJ1H H CBH3aHHble C HJ1MH
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06WHe Tpe60BaHHH
12 rOCT P EH 12469-2010 EHOTeXH0J10rHH. TeXHJ14eCKJ1e Tpe60BaHH5I K
60KcaM MHKpo6H0J10rH4eCKOH 6e30naCHOCTJ1
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pOBKa
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1 rOCT P I1CO 8573-1-2005 C)I(aTblH B03.ayX. 4aCTb I. 3arpH3HeHHH H
KJ1aCCbl 4J1CTOTbl
2 rOCT P I1CO 8573-2005 C)I(aTblH B03.ayX. 4acTb 2. MeTO.abl KOHTpOJ1H
co.aep)l(aHHH MaCeJ1 B BHlle a3po30J1eH
3 rOCT I1CO 8573-3-2006 C)I(aTblti B0311YX. 4acTb 3. MeTo.abl KOHTpOJ1H
RIIa)l(HOCTJ1
4 rOCT P I1CO 8573-4-2005 C)I(aTblH B03.ayX. 4acTb 4. MeTO.abl KOHTpOJ1H
co.aep)l(aHJ1H TBep.ablX 4aCTJ1U
5 rOCT I1CO 8573-5-2006 C)I(aTblH B03.ayX. 4acTb 5. MeTo.abl KOHTpOJ1H
co.aep)l(aHJ151 napOB MaCJla H OpraHJ14eCKHX paCTBOpJ1TeJ1eH
6 rOCT P I1CO 8573-6-2005 C)I(aTblH B03.LlYX. 4aCTb 6. MeTO.abI KOHTpOJIH
3arp5l3HeHJ151 ra3aMJ1
7 rOCT P I1CO 8573-7-2005 C)I(aTblH B03.ayx. 4acTb 7. MeTO.a KOHTpOJ1H
3arpH3HeHHH )l(H3HeCnoc06HbIMH MJ1KpOOpraHH3MaMH
8 rOCT P I1CO 8573-8-2007 C)I(aTblH B03.ayX. 4acTb 8. MeTo.abl onpe.ae-
J1eHHH MaCCOBOH KOHueHTpaUHJ1 TBep.abiX 4aCTJ1U
9 rOCT P I1CO 8573-9-2007 C)I(aTblH B03.ayx. 4acTb 9. MeTOllbl onpe.aeJ1e-
HH51 co.aep)l(aHH5I BO.abl B )l(H.aKOH 4>a3e

508
DlG6a 22
BH)J.bl CTaHllapTOB
B HaCT05lIllCe BpCM5I CYWCCTBYIOT CJICllYIOWJ1e BJ111bI CTaHllapTOB:
MeJICoyuapoOuble emauoapmbl:
. CTaHllapTbI HCO (HCO - MC)I(1lYHapOllHa51 OpraH113aUH5I no
CTaHllapTH3aUJ1J1, ISO - International Organization for Standardization);
. CTaHllapTbI EH - CTaHllapTbI EBponcHcKoro COI03a, (CEN -
Comite Europeen de Normalisation);
. CnCUHaJIH3HpOBaHHbIc CTaHllapTbI, HanpJ1MCp, CTaHllapTbI M3K -
MC)I(1lYHapollHoH 3JICKTpOTCXHH4CCKOH KOMI1CCHJ1 (/ EC - International
Electrotechnical Commission).
MeJIC2ocyoapem6euubie emaudapmbl CRr:
. rOCT;
. rOCT I1CO (cTaHllapTbI, npHH5ITbIC np5lMbIM BBCllCHI1CM COOTBCT-
CTBytOWHX cTaHllapTOB HCO).
. rOCT EH (cBponcHcKHc CTaHllapTbI, BBCllCHHbIC B CHr).
Hau,UOUCl.llbUble emauoapmbl Poceuu:
. rOCT P;
. rOCT P HCO (CTaHllapTbI, npHH5ITbIC np5lMbIM BBCllCHHCM COOT-
BCTCTBytOWHX cTaHllapToB HCO);
. rOCT P EH (cBponcHcKHc cTaHllapTbI, BBCllCHHbIe B POCCHH).
Ba)l(Ho, 4T06bI cTaHllapTbI pa3HbIx ypOBHCH COOTBCTCTBOBaJIH llPyr
llPYry, J1 B CJ1CTCMe cTaHllapTH3aUHH HC 6bIJIO npOTJ1BOpC4HH.
PYKOBO)J,CTBa npo«l»eccHOHaJlbHblX o6IllecTB
B Ml1pOBOH npaKTHKC WHpOKO I1CnOJIb3ytOTC5I PYKOBollcTBa 11 pCKO-
MCHllaUHH npo<pcCCl10HaJIbHbIX 06WCCTB, B ncpBYIO O'lCpCllb:
- PYKOBollcTBa (Baselines) ISPE - International Society of Pharma-
ceutical Engineers (MC)I(1lYHapollHoc 06WCCTBO J1H)I(CHepOB <papMaueBTH-
4eCKOH npOMbIWJICHHOCTJ1);
- TCXHJ1'1cCKJ1C OT4CTbl (Technical reports) PDA - Parenteral Drug
Association - ACCOUHaUJ151 no napCHTepaJIbHbIM JICKapCTBeHHbIM cpcll-
CTBaM,
a TaK)I(e OT4eTbI J1 peKOMeHllaUJ1J1 B03 J1 PIC/S.

CmaHoapmbl U npaBUJla
509
,I:(pyme HOpM3THBHbIe )J;OK}'MeHTbI
HaUJ10HaJIbHbIC CTaHllapTbl POCCHJ1 pa3BJ1BaIOTC5I B pYCJIe MC)I(1lYHa-
pOllHbIX Tpc60BaHHH.
HHa4e 06CT0J1T lleJIO C llpyrHMH HOpMaTJ1BHbIMH 1l0KYMeHTaMJ1. npo-
6JlCMa <papMaKOnCJ1 paCCMOTpCHa B rJIaBe 18. Ewc OllHJ1M BJ1110M 1l0KY-
MCHTOB, HcnocpCllCTBCHHO 3aTpamBalOWJ1X np0J13BOllCTBO JICKapCTBeHHbIX
cpellCTB. 51BJI5IIOTC5I CaHJ1TapHO-3nHllCMHOJIOm4eCKJ1e npaBJ1JIa.
B 3TOH 06JIaCTH uapHT nOJIHbIM xaoc. HOpMbI JIH60 6C3HallC)I(HO
YCTapeJIJ1 J1 nepeH311aIOTC5I 1l0KYMCHTbI 50-60-x rollOB pa3pa60TKJ1, JIJ160
roTOBJ1TC5I CMCCb H3 ncpCBOllOB 3apy6c)I(HbIX HOpM H C06CTBCHHbIX npCll-
CTaBJICHJ1H, npOTI1BOpC4aWl1X MHpOBOH npaKTJ1KC J1 JIOrJ1KC Bo06wc.
npHMCpOM 51BJI5IIOTC5I CaHHTapHo-3nHllCMHOJIOrH'-ICCKI1C npaBJ1JIa
en 1.3.2322-08 «oc30nacHocTb pa60TbI C MHKpoopraHH3MaMH Ill-IV
rpynn naTorCHHOCTJ1 (onaCHOCTH) H B036YllHTCJIHMH napa3HTapHbIX 60-
JlC3HCH'). 3TH npaBI1JIa YCTaHaBJIHBalOT KJ1aCCJ1<pJ1KaUJ11O MJ1KpOOpraHH3-
MOB no rpynnaM naToreHHOCTH. LJHCJIO rpynn naTorCHHOCTJ1 paBHO 4C-
TbIpeM, KaK B B03, EBpone H CWA, a HOMcpa rpynn nOCTaBJICHbI B 06-
pamHOM nopRiJKe (Ta6JIHUa 22.1).
Ta6/1uu,a 22.1
KJIacCH<pHKaUJ151 naToreHHbIX MHKpoopraHH3MOB
B POCCJ1H H B OCTaJIbHOM Ml1pC
rpynnbl naToreHHOCTJ1
EBpona, CWA. KaHa.aa, 5InOHJ1H. B03 POCCJ151
I IV
2 III
3 II
4 I
Bo BceM MHpC K rpynnc I OTHCCCHbI MJ1KpOOpraHH3MbI, nOTCHUHaJIb-
HO He 51BJI5IIOWJ1CC5I B036YllJ1TCJI5IMH 3a60JICBaHJ1M 4eJIOBCKa J1 )l(J1 BOTH bIX,
a B POCCJ1H - B036YllJ1TCJIb 4YMbI, OllHOi1 J13 caMbIX onaCHbIX J1H<peKUJ1H.
K rpynnc IV, Ha060pOT, POCCJ1HCKJ1C CaHI1TapHbIe npaBJ1JIa OTHOC5IT HC-
onaCHbIC MI1KpOOpraHH3MbI, a npJ1H5ITa51 B MJ1pC KJIaCCJ1<pHKaUH5I - naTO-
rCHHbIe MHKpoopraHH3MbI, BbI3bIBaIOWJ1C CCpbC3HbIC 3a60JICBaHJ151, npOTI1B
KOTOpbIX 3<p<peKTHBHbIX MCp B 60JIbWHHCTBC CJIY4aCB HC CYWCCTBYCT.
KTO-HJ16Yllb MO)l(CT 06l>51CHHTb, 3a4eM BBellCHa 3Ta nYTaHJ1Ua?
I1JIH 3a 3THM On5lTb CT05lT 1l0KTOpCKHC llHCCepTaUJ1H C «HaUJ10HaJIb-
Hoi1,> cnCUH<pHKOH?
Ll.JI5I POCCHH MHOrJ1e npoeKTbI BbInOJIH5IIOTCH 3apy6e)l(HbIMH <pHpMa-
MH. KOTOpbIC nepeHOC5ITC5I Ha Hawy n04BY BMCCTC C KJ1aCCJ1<pJ1KaUJ1ei1.
3TO y)l(e npHBeJIO K Hepa36cpJ1xe J1 HeHY)l(HbIM 3aTpaTaM. Ho 3TO J1
onaCHO! 3TO BCC paBHO. 4TO aBJ1a1lJ1CneT ' lepbl pa3HblX CTpaH 6YllYT ny-
TaTb nOHHTH5I «Bepx,> J1 «HJ13'>.

510
lG6a 22
06H3aTeJJbHbie Tpe60BaHHH H peKOMeH,lJ.aLl,HH
JICHOCTb B 3TOM Bonpoce - OTnpaBHa51 T04Ka JIl060H CJ1CTeMbI HOp-
MJ1pOBaHJ1H. B CCCP cywecTBOBaJIa lleTKa51 CJ1CTeMa CTaHllapnl3aUJ1J1,
llCHCTBOBaJIJ1 HeCKOJIbKO BJ1110B HOpMaTJ1BHbIX 1l0KYMeHTOB:
- rOCTbl 6bIJIJ1 06513aTeJIbHbIMJ1llJI5I BceH CTpaHbI;
- OTpaCJIeBbIe CTaHllapTbI - OCTbI - 6bIJIJ1 06513aTCJIbHbIMJ1 llJI5I OT-
paCJIJ1 J1 YTBep)l(1laJIJ1Cb CaMJ1MH OTpaCmIMJ1:
- CTaHllapTbI npCllnpH5ITH5I pacnpOCTpaH5IJIHCb Ha lle5lTeJIbHOCTb
npCllnpJ151TH5I H YTBCp)l(1laJIJ1Cb HM caMHM.
Bcc 3TH 1l0KYMCHTbI 6bIJIH 06513aTCJIbHbIMH B npCllCJIaX CBoeH 06JIa-
CTH llCHCTBH5I. CYWCCTBOBaJIH MeTOllH4CCKI1C YKa3aHH5I (MY), PYKOBO-
115lWHC 1l0KYMCHTbI (PLI) H np., HOCHBWJ1C BcnOMOraTCJIbHbIH xapaKTCp.
3TO 6bIJIa pa3YMHa51 CJ1CTCMa. OTpaCJICBbIC Tpc60BaHH5I YTBep)l(1la-
JIHCb OTpaCJICBbIM BCllOMCTBOM, KOTopoe HCCJIO OTBCTCTBCHHOCTb 3a llaH-
HbIH CnCUJ1<pH4CCKJ1H BHll llC5ITCJIbHOCTH. Pa3pa60TKa 6bIJIa npo4Jeccuo-
nOJlbnOU, CIO 3aHHMaJIJ1Cb cneu.UOJlUCmbi. 6e3 HeHY)I(Horo BOBJIC4CHH5I
MHO)l(CCTBa 4J1HOBHJ1KOB, llcnYTaTOB H np.
B 2003 r. BCTynHJI B llCHCTBHC «3aKoH 0 TeXHH4eCKOM pcryJIHpOBa-
HI1H'>. OH nOCTaBHJI BCC C Hor Ha roJIOBY. 3ToT 3aKOH BBCJI HOBbIC Tep-
MHHbI: «TCXHH'leCKOC pcryJIHpOBaHHc» 11 «TCXHH'lCCKHH pcmaMCHT». Bcc
HopMaTHBHbIC 1l0KYMCHTbI 6bIJII1 pa311CJIeHbI Ha llBa BJ111a: TCXHI1'lCCKHC
pemaMCHTbI H HaUHOHaJIbHbIC CTaHllapTbI. OTpaCJICBbIC CTaHllapTbI 6bIJIH
OTMCHeHbI, 3a BCllOMCTBaMJ1 OCTaJIOCb npaBO H311aBaTb TOJIbKO peKOMCH-
llaUHH. C TCX nop 06513aTCJIbHbIC Tpc60BaHJ151 OTHOC5ITC5I TOJIbKO K 6C3-
onaCHOCTH H MOfYT YCTaHaBJIJ1BaTbC5I TOJIbKO meXIlUlieCKUMU peZJlOMen-
mOMU. 3TH Tpc60BaHH5I 1l0JI)I(HbI HOCJ1Tb UC'Iepnbl6QIOUI,uii xapaKTep.
TCXHI1'1CCKHH pCrJIaMCHT npHHI1MaCTC5I <1>CllCpaJIbHbIM 3aKOHOM, nOCTa-
HOBJICHHeM npaBHTCJIbCTBa POCCHHCKOH <1>cllcpaUHH HJIH YKa30M npc-
3HllCHTa POCCHi1cKOH <1>cllcpaUHH.
HJ1KTO He 3a1laJI npOCTOH Bonpoc: a pCaJIbHO JIJ1 3TO? HJ1KTO HC
npellJIO)l(J1JI CllCJIaTb npocToti war: OpraHJ130BaTb llCJIOBYIO Hrpy, onp060-
BaTb pa60TY 3aKOHa Ha npaKTHKC, H3Y4J1Tb B03MO)l(HbIC nJIIOCbI H MJ1HY-
Cbl. 3TO. no MCHbWCH MCpC, cTpaHHo. npJ1 nOCTaHOBKC Ha np0J13BOll-
CTBO JI1060ro. lla)l(C HeCJIO)l(Horo J1311CJIH5I. npOBOllJ1TC5I UCJIa51 nOCJICllOBa-
TCJIbHOCTb HCnbITaHJ1H. EJIarollap51 J1CnbITaHH5IM, Ha npaKTHKc. 3pJ1MO,
BbI5IBJI5IIOTC5I HCllOCTaTKJ1 06wero 3aMbICJIa, KOHCTPYKUJ1J1 J1 TeXHOJIOfJ1J1,
H311CJIJ1C 1l0pa6aTbIBaeTc5I, CHOBa npoBo1l5IT I1cnbITaHJ151 J1, B KOHue KOH-
UOB. n05lBJI5IeTC5I npJ1rollHblH llJI5I HCnOJIb30BaHJ151 npollYKT. C 3aKOHOM.
pcmaMcHTHpYIOWHM nOp5l110K YCTaHOBJICHJ151 Tpc60BaHJ1H 6c30nacHocTH
H KOHTpOJI5I 3a J1X BbInOJIHeHHCM, 3TOro HC np0J130WJIO. 3TO rpy6blH
npoc'IeT, HCllonycTJ1MblH B cepbe3HoM lleJIe.
3aKoH «0 TeXHH'IeCKOM pcryJIHpOnaHJ1H» J1MeeT llBa )YHllaMCHTaJIb-
HblX nopoKa: YXOll B CTOPOHY Henp0<pcCCJ10HaJIJ13Ma J1 nOnbITKa peWJ1Tb

CmaHoapmbl u npafflaa
5/1
BCC MHO)l(CCTBO CneUJ1aJIbHbIX BonpOCOB B OllHOM ueHTpe. PaCCMOTpJ1M
3TO nOllp06HCC.
I. Bcc MHO)l(CCTBO Tpe60BaHJ1H K 6C30naCHOCTI1, 110 MCJIb'laHWJ1X
llCTaJICH, 1l0JI)I(HO paCCMaTpI1BaTbC5I J1 YTBCp)l(1lanC5I Ha BblCWCM ypOBHC
ynpaBJIeHJ151 - B rOCYllapCTBCHHOH llYMC. np0l130WCJI npl1HUl1nl1aJIbHbIH
nOBopOT OT npofjJeccUOHtJ.ilU3.M3 K HeKOMnemeHmHocmu. lla, llenYTaTbI
rOCYllapCTBeHHOH llYMbI a6COJIIOTHO HeKOMneTeHTHbI B TCXHJ1lICCKI1X BO-
npocax. ABTop 3TO BJ111CJI CBOI1MJ1 ma3aMJ1 B <pcBpaJIe 2004 r.. KOflla
3TI1MI1 JIJ1uaMI1 6bIJIa npOBaJICHa cBponCHCKa51 cxeMa pa60TbI no G M P.
Hc J1CKJ1104CHO, 4TO CpClll1 llenYTaTOB CJIY'IaHHO OKa)l(CTC5I KOMne-
TeHTHbIH B llaHHOM Bonpocc 4CJIOBeK. Ho OH 6YllCT B MCHbWI1HCTBC. J1
cro roJIOC HJ1 l lCro HC 3Ha l 1J1T. LIenYTaTbI 3TO nOHI1MalOT 11 npOB01l5lT
MHO)l(CCTBO cOBCwaHJ1H C npJ1maWCHI1CM pa3HbIX JIIOllCH, KOTOpbIC TaK-
)l(C HJ14Cro roJIOCOBaHJ1CM PCWI1Tb He MOryr. PC3YJIbTaT - mraHTCKI1H
pa3MCp 3aTpaT C HYJICBOH nOJIb30H llJI5I llCJIa.
3a4eM llenYTaTY npl1HI1MaTb CnCUl1aJIbHOe TeXHJ1'1eCKOC pCWCHI1C,
Hanpl1MCp, 0 Tpc60BaHI151X K ypOBHIO CTCpI1JIbHOCTI1, KOTopoe 1l0JI)I(HO
6blTb 06513aTCJIbHbIM no OnpCllCJICHJ1IO? LIenYTaT llJI5I 3TOro HC HY)I(CH.
CnCUJ1aJIbHbIC PCWCHJ151 1l0JI)I(HbI npJ1HI1MaTb cnCUJ1aJIJ1CTbl.
Llpyroe lleJ10, lJTO .aOJ1)1(Hbl 6blTb JaaaHbl Tpe6oBaHH51 K npoue.aype
npJ1HHTH5I TaKHX 06H3aTeJ1bHbIX CneUJ1aJ1bHblX peWeHHH. O.aHO J13 Tpe6oBa-
HJ1H - COOTBeTCTBHe HopMaTHBHoro .aOKYMeHTa MUP060MY yp06HIO.
3TO - ueHTpaJIbHa51 3aaa4a. B CCCP OHa peweHa He 6blJ1a J1 He Moma
6blTb peweHa. rocy.aapcTBO YTBep)l(.D,aJlO Tpe60BaHJ1H K npo.aYKUHI1 J1 caMO
onpe.aeJ151J10 nJ1aH npOH3Bo.aCTBa, KOTOpblH H .aOJ1)1(HO 6blJ10 BbmOJ1H5ITb (see
npe.anpJ151TJ1H Haxo.aHJ1HCb B rocy.aapcTBeHHOH c06CTBeHHocm). B 3THX
YCJ10BJ1HX nOnblTKJ1 BBeCTH CTaHllapTbl «MJ1poBOro ypoBHH» 6blJ111 06pelJeHbl
Ha npoBaJ1: CTaH.aapTbl no.aCTpaJ1BaJlJ1Cb no.a B03MO)l(HOCTH npe.anpHHTHH.
B pblHOlJHOH 3KOHOMHKe cHTyaUHH COBceM llpyra5l: rocy.aapCTBO 3a.aaeT
Tpe60BaHHH H HJ1KOI1M 06pa30M He OTBellaeT 3a BbInOJ1HeHHe nJ1aHa npOH3-
BO.aCTBa. npoH3BO.aCTBO - .aeJ10 npe.anpHHHMaTeJ1eH. Te, KOMY y.aaeTCH Bbl-
nOJ1HJ1Tb Tpe6oBaHI1H 11 H3BJ1e'lb npH6blJ1b. OCTalOTCH Ha nJ1aBY.
2. nOJIO)l(CHI1C 3aKOHa 0 TOM, 4TO Tpc60BaHJ151 TCXHJ1lICCKOro pcrJIa-
MCHTa 1l0JI)I(HbI 6bITb UC'IepnbI6alOUMU, 51BJI5ICTC5I npJ1HUl1nJ1aJIbHOH
OWJ16KOH. BbICWI1H opraH roCYllapCTBCHHOH BJIaCTI1 HC TOJIbKO HC 1l0JI)I(CH
YTBep)l(1laTb BCC MHO)l(CCTBO CnCUJ1aJIbHbIX TCXHI14CCKI1X Tpc60BaHI1H, OH
HC MO)l(eT 3TO lleJIaTb 6e3 BpClla llJI5I caMoro llCJIa. npJ14J1HbI llBe:
- npouellypa npJ1H5ITI15I 3aKOHa llJIl1TCJIbHa J1 CJIO)l(Ha;
- B HeH Y'taCTByeT MHO)l(eCTBO JIlOllCH, He I1MeIOWJ1X J1 MaJIeHwcro
npellCTaBJ1eHI1H 0 npellMeTe. B TaKJ1X YCJIOBJ151X YTpaTa CMbICJIa Hel136e)l(Ha.
B CJ1JIY 3TJ1X npJ14J1H np0J130WJIO TO, 4TO 1l0JI)I(HO 6bIJIO np0I130HTJ1:
3aKOH «0 TeXHJ1 l leCKOM perYJIJ1pOB<lHI1I1» He pa60TaeT. LICJIO npJ1H5IJIO
onaCHblH 060POT: OKa3aJIaCb pa3PyweHHoH BCH CJ1CTeMa HRLl.30pa 3a 6e3-
onaCHOCTblO.

512
/'.;W6a 22
nepBbIMI1 3a611JIJ1 TpeBory CTpOI1TeJIJ1. B PC3YJIbTaTe B 2010 r. pac-
nOp5l)l(eHJ1CM npaBI1TCJIbCTBa P<1> OT 21 J1IOHH 2010 NQ 1047-p «06
YTBep)l(1leHl111 nCpe'lH5I HaUJ10HaJIbHbIX cTaHllapToB J1 CBOllOB npaBI1JI (4a-
eTCH TaKJ1X cTaHllapToB J1 CBOllOB npaBI1JI), B pe3YJIbTaTe npJ1MeHeHI151
KOTOpbIX Ha 06513aTCJIbHOH OCHOBC 06CCne4J1BaeTC5I C06JIIOllCHI1C Tpe60-
BaHI1H <1>CllCPaJIbHOro 3aKOHa «TeXHI14eCKJ1H pCrJIaMCHT 0 6e30nacHocTI1
311aHI1H H coopY)l(eHJ1H'> npl1.Ll.aHa 06513aTCJIbHa51 CJ1JIa BOCbMI1 rOCTaM 11
P5l11Y CHJ1noB.
B CTpOI1TCJIbCTBC BCC BcpHYJIaCb «Ha Kpym CB05l'>, CTaHllapTbI 11
CHl1nbI (CTpOJ1TCJIbHbIC HOpMbl 11 npaBHJIa) CTaJIl1 CHOBa 06maTCJIbHbI-
MJ1, nYCTb no OrpaHJ14CHHOMY CnJ1CKY J1 B cTapblx pCllaKUI151X (CCTb
rOCT 1973 r.). «Pc<p0pMaTOpbI,) 3a6bIJIH, a B03MO)l(HO, H HC 3HaJIl1, 4TO
)l(J13Hb l111eT Bnepell 11 CTaHllapTbI HallO nepI1011J14eCKI1 ncpCCMaTpJ1BaTb.
B nOCJICllHI1C llCC5ITb JICT YKopCHHJIaCb OnaCHa51 npaKTJ1Ka B pa3pa-
60TKC HOpMaTJ1BHbIX 1l0KYMeHTOB. 3TO Hcnpo<pcCCI10HaJIJ13M 11 KYJIyap-
HOCTb. 3aKpbITOCTb pa3pa60TKH. HepeampOBaHJ1C aBTopOB 1l0KYMCHTOB
Ha 3aMC4aHI151 cnCUl1aJIJ1CTOB.
HopMaTHBHbIC 1l0KYMCHTbI 1l0JI)I(HbI 6bITb:
- ncpCllOBbIMJ1;
- npo<pcCCJ10HaJIbHbIMH;
- npouccc 06cY)l(1leHJ151 I1X 1l0JI)I(eH 6bITb OTKpbITbIM.
fiC3 3TOro JII06bIe pa3roBopbI 0 npoucccc, 3a60Tc 0 JI101l5lX, MOllCp-
HI13aUl111 3KOHOMJ1KH - nYCTa51 TpaTa BpCMCHH.

513
fJlasa 23
OPfAHII3All,1I11, PAEOTAIOllllIE B 06JIACTII GMP
Hap5l11Y C EBponcHcKoH KOMHCCJ1eH. FDA CWA H npaBHTeJIb-
CTBCHHbIMH OpraHaMJ1 pa3HbIx cTpaH B 06JIaCTH GMP aKTHBHO pa60TaCT
PM MC)I(1lYHapOllHbIX opraHH3aUJ1H.
ICU
MC)I(1lYHapOllHa51 KOH<pCPCHUJ151 no rapMOHH3aUJ1J1 TCXHJ1'1CCKJ1X Tpe-
60BaHJ1H K JIeKapCTBeHHbIM CpCllCTBaM 1lJI5I 4CJIOBeKa (The International
Conference on Harmonisation - ICH) 6bIJIa OCHOBaHa B 1990 r. OHa 06'b-
CllJ1H5ICT Ha1l30pHbIC opraHbI H npCllCTaBJ1TCJICH <papMaueBTH4ccKOH
npOMbIWlICHHOCTI1 EBponbI, CWA J1 5InoHHJ1 1lJI5I 06CY)I(1lCHI151 HaY4HbIx
11 TCXHWICCKI1X acnCKTOB, CB5I3aHHbIX C pcmCTpaUI1CH JICKapCTBcHHbIX
CpCllCTB.
K HaCT05lWCMY BpCMCHI1 BbmycTHJIa p5l11 PYKOBOllCTB, B 4aCTHOCTH,
no aHaJIHTH4CCKHM MCTOllaM, CHCTCMaM Ka4eCTBa, aHaJIJ13Y pJ1CKOB
( www.ich.org).
ISPE
MC)I(1lYHapOllHOc HH)I(CHCpHoe <papMaUCBTJ1'ICCKOC 06WCCTBO (Interna-
tional Society for Pharmaceutical Engineering - ISPE) 6bIJIO 06pa30BaHo B
1980 r. no HHHUHaTHBC HH)I(CHCpOB CCBCpHOH AMcpJ1KJ1 C ueJIbIO pacnpo-
CTpaHCHH5I npaKTH4ecKoro onbITa, HOBbIX pa3pa60ToK J1 I1H<pOpMHpOBaHJ151
CneUJ1aJIHCTOB 06 H3MeHeHH5IX B 3aKOHOllaTCJIbCTBe H HopMaTHBHblX 1l0KY-
MeHTax. LIe5ITCJIbHOCTb ero B KOpOTKJ1H ncpHOll BpCMCHH npH06peJIa MC)I(-
llYHapollHbIH MacwTa6. 06WCCTBO OCHOBaHO Ha J1H1lJ1BJ11lYaJIbHOM 4JICH-
CTBe. B HaCT05IWCC BpeM5I B ISPE BX01l5lT 22 TbIC. 4CJIOBeK J13 90 CTpaH MH-
pa (www.ispe.org).
OCHOBHbIC HanpaBJICHH5I llC5ITCJIbHOCTH:
- pa3pa60TKa PYKOBOllCTB (Baselines), KOTOpbIC OXBaTbIBaIOT p5l11 oc-
HOBHbIX HanpaBJICHHH (npoM3BollCTBO aKTHBHbIX <papMaUCBTJ14eCKMX
cy6cTaHuHH, TBCPllbIX <POPM. CTCpJ1JIbHbIX JICKapCTBeHHbIX CpCllCTB, nOll-
roTOBKY BOllbI H napa H IIp.);
- pa3pa60TKa llpymx PYKOBOllCTB;
- M311aHJ1C )l(ypHaJIa «Pharmaceutical Engineering» C nepJ1011H4HO-
CTblO OllJ1H pa3 B llBa MCC5Iua, KOTOpbIH pacnpOCTpaH5IeTC5I TOJIbKO cpc-
llJ1 'IJIeHOB ISPE.
- H311aHHe ra3CTbl ISPEAK (OCTpoYMHoe C04CTaHJ1C H3 <<I speak,> -
«51 roBOplO'>, J1 HaHMeHOBaHH5I 06wecTBa - ISPE);
- npoBOllHT KOH<pepeHUHH J1 ceMHHapbl, B TOM llJ1CJIe no CeTJ1 J1HTepHeT.

5/4
£W6a 23
YJICHbI ISPE I1MelOT 1l0CTyn K MaTCpl1aJIaM I SPE B 3JICKTpOHHOH
<pOpMC (K )l(ypHaJIY 11 ra3eTe 6eCnJIaTHo. K PYKOBOllCTBaM J1 YlaCTI1IO B
KOH<pepeHUJ151X J1 CeMI1HapaX - no CHJ1)1(eHHbIM Tapl1<paM).
ISPE I1MeCT OTllCJIeHJ151 BO MHOfJ1X CTpaHax MJ1pa.
PDA
Accoul1aUJ151 no napCHTCpaJIbHbIM JICKapCTBCHHbIM CpCllCTBaM (Par-
enteral Drug Association - PDA) 6bIJIa OCHOBaHa B CiliA B 1946 r. Ec llC-
51TeJIbHOCTb 6bICTpO BbIWJIa 3a paMKI1 CTpaHbI 11 npl106pcJIa MC)I(1lYHa-
pOllHbIH xapaKTCp nOllllCBI130M:
«CoeduHflfl /IIodeu, HaYKY u HOpMamU6Hb/e aKmb/».
AccouJ1auJ151 pacnpOCTpaH5ICT HaY'lHYIO, TCXHI14CCKYIO 11 HOpMaTI1B-
HYIO J1H<p0pMaUJ1IO, npOBOlll1T 06Y4eHI1e J1 06MCH OnbITOM 1lJI5I cncUl1a-
JII1CTOB <papMaUCBTJ14eCKOH J1 6J10<papMaUCBTI14eCKOH npOMbIWJICHHOCTI1.
061>CllJ1H5ICT 60JICC 9500 lJJICHOB (www.pda.org).
OCHOBHbIC 3analJl1:
- pacnpOCTpaH5ITb ncpCllOBbIC 3HaHI151 B CBOCH 06JIaCTI1;
- npOBOlll1Tb BCCMl1pHbIC <POPYMbI HaY4HoH 06WCCTBCHHOCTI1, 0<pJ1-
Ul1aJIbHbIX (Ha1l30pHbIX) opraHOB 11 cnCUl1aJIl1CTOB npCllnpJ151TJ1H;
- cnoc06cTBoBaTb pa3BI1TI11O 11 I1CnbITaHJ151M HOBbIX TCXHOJIOfJ1H;
- OpraHI130BbIBaTb 06Y4eHI1e B MC)I(1lYHapOllHOM MacwTa6c 11 B
Y4c6HOM 11 I1CCJICllOBaTCJIbCKOM I1HCTI1Tyre PDA (Training and Research
Institute - TRI);
- cnoc06cTBoBaTb npo<pcCCJ10HaJIbHOMY POCTY CBOJ1X 4JICHOB;
- 06CCnC'II1BaTb I1H<p0pMaUI1CH 11 BJIJ151Tb Ha npoucccbI rJI06aJIbHOH
rapMOHI13aUI1J1.
PDA 11311aCT )l(YPHaJI «Journal of Pharmaceutical Science and Technol-
ogy», KOTOpbIH ny6JII1KYCT TCKYWI1C HOBOCTI1.
PDA pa3pa6aTbIBacT TCXHJ14CCKI1C OT4CTbI - «Technical reports», KO-
TopbIe 51BJI5IIOTC5I UCHHbIMI1 PYKOBOllCTBaMJ1 no BbInOJIHCHJ11O Tpc60Ba-
HJ1H FDA J111PyrJ1X opraHoB.
PHSS
HaY4Hoc 06WCCTBO B 06JIaCTJ1 <papMaUI1I1 11 311paBooXpaHCHI151 Be-
JII1K06pl1TaHI111 - «The Pharmaceutical and Healthcare Sciences Society»
(PHSS) 6bIJIO OCHOBaHO B 1981 r. Ero lle5lTCJIbHOCTb HanpaBJICHa Ha pa3-
BJ1TJ1C I1CCJIellOBaHI1H, pa3pa60ToK, np0l13BOllCTBa 11 KOHTpOJI5I JICKap-
CTBeHHblX cpellCTB 11 MCllJ1UJ1HCKJ1X 11311CJIJ1H. LJJICHbI 06weCTBa aKTJ1BHO
pa60TalOT B 06JIaCTI1 GMP, GCP, GLP, BX01l5lT B pa60411c rpynnbl no
3TJ1M 1l0KYMeHTaM H 3aHI1MalOT aKTI1BHYIO n0311UJ11O (www.phss.co.uk).
06wecTBo J1311aeT )l(ypHaJI «The European Journal of Parenteral and
Pharmaceutical Sciences» - «EBponeHcKJ1H )l(ypHaJI napCHTepaJIbHblX J1
<papMaUeBTI14CCKI1X HaYK'). J1 pa3pa6aTbIBaeT TeXHJ14eCKJ1e OT'IeTbl no aK-
TYaJIbHbIM HanpaBJ1eHJ151M pa3BI1TJ1H np0J13BOllCTBa JIeKapCTBeHHblx
cpellCTB.

OpzaHu3au,uu, pa6ommolll,ue 6 o6J/acmu GMP
515
PIC, PIC/S
OpraHH3aUJ151 PIC (Pharmaceutical Inspection Convention) - KOH-
BCHUI151 no J1HCnCKHlpoBaHHIO <papMaUCBTJ14eCKJ1X npellnpJ151TJ1H - 6bIJIa
C0311aHa B 1970 r. C UCJIbIO B3aHMHoro npH3HaHJ151 PC3YJIbTaTOB pa60TbI
HHCnCKUJ1H CTpaH-4JIeHOB PIC H 06MeHa OT'ICTaMH 0 npOBellCHHJ1 TaKJ1X
J1HCnCKUJ1H. ncpBOHa4aJIbHO B cc COCTaB BOWJIJ1 ABCTpH5I, LIaHH5I, <1>HH-
JI5IHllJ151, HCJIaHllH5I, J1HXTCHWTCHH, HopBcm5l, nopTyraJIJ151, WBeUH5I.
ill BCHuapJ151 H BCJIHK06pHTaHH5I.
OTnpaBHoti T04KOti B pa60Tc PIC 6bIJIO npH3HaHJ1C 3KBJ1BaJICHTHO-
CTH HaUHOHaJIbHbIX J1HCneKUHH CTpaH-4JICHOB PIC. 3TO CbIrpaJIO Ba)l(-
HYIO pOJIb B ynpoweHJ1H 3KcnOpTHO-J1MnOpTHbIX onepauHti H YCTpaHC-
HHI1 6apbcpoB B TOprOBJIe.
3aTcM J1HTCpeC K BCTynJICHHIO B PIC np05lBJ1JIH CTpaHbI BocTo'-lHOH
EBponbI H llpymx pemOHOB, HC BX01l5lWHX B EBponcHcKHH COI03. B
CB5I3H C 3THM B 1995 r. 6bIJIa C0311aHa opraHH3aUH5I Pharmaceutical In-
spection Co-operation Scheme (PICjS) - CxcMa KOOnCpaUJ1J1 <papMaucB-
TH4CCKHX J1HCnCKUHH (www.picscheme.org).
3alla4cH KOHBCHUHJ1 51BJI5ICTC5I nOBbIWCHHC KBaJIH<pHKauHH J1HCnCK-
TOpOB, HX 06Y4cHHe, OKa3aHJ1C nOMOWH CTpaHaM, roTOB5IWHMC5I K BHCll-
pCHHIO GMP, H pa3pa60TKa MCTOllH4CCKI1X 1l0KYMCHTOB. B PIC/S BX01l5lT
BCC CTpaHbI EBponbI 11 MHOfl1C CTpaHbI MHpa, B TOM 'lI1CJIC CWA, AB-
CTpaJIH5I 11 YKpaHHa.
B HIOHC 2003 r. COCT05lJIaCb nCpBa51 nOC311Ka lleJICraUHJ1 POCCI1I1 OT
MJ1H311paBa P<1> Ha KOH<pCpCHUHIO PIC/S B EpaTJ1CJIaBC (WHnKoB B. r.
11 <1>cllOTOB A. E.). EbIJIH HaMC4CHbI MCpOnpH5ITJ151 no nOllroToBKe Poc-
CJ111 K BCTynJICHHIO PI CIS. B 2004 r. 3Ta pa60Ta 6bIJIa npCKpaWCHa.
Ec Hc06xOllJ1MO B0306HOBHTb H BOHTH B c006WCCTBO CTpaH, pa60-
TalOWHX no GMP.
R3 Nordic
AccouJ1auH5I no KOHTpOJIIO 3arp5l3HeHJ1H CKaHllHHaBcKHx CTpaH R3-
Nordic (LIaHJ151, Hopsem5l, <1>J1HJI5IHllJ151 J1 WseUJ151) OCHOBaHa B 1969 r.
npOBOllHT C)I(CrollHbIC KOH<pcpeHUJ1J1, H311aCT )l(YPHaJI «Renhets Teknik» -
«TexHoJIorH5I 4 HCTOTbI'>, ee 4JIeHbI aKTHBHO pa60TalOT no aKTYaJIbHbIM
HanpaBJlCHH5IM pa3BHTH5I npaBJ1JI G M P.
Pa60TbI ll-pa ECpJ1T PCHHMIOJIJICp (Bcrit Rcinmilllcr) H npo<p. E.
J1IOHrKBHCTa (B. Ljungqvist) no 3<P<PCKTHBHOCTJ1 OllC)I(1lbI 1lJI5I 4HCTbIX
nOMCWCHJ1H, paCnpellCJICHHIO nOTOKOB B0311yxa B 4J1CTbIX 30Hax H llPY-
rJ1M np06JlCMaM WHpOKO H3BCCTHbI B MHpe.
ASTM
B nOCJICllHJ1C rollbl B 06JIaCTJ1 G M P Ha4aJIO aKTJ1BHYIO pa60TY
AMepHKaHcKoe 06weCTBO no J1CnbITaHJ151M H MaTepJ1aJIaM - American
Society for Testing and Materials (ASTM). 3TO 06wecTBo 6blJIO OCHOBa-
HO B 1898 r. J1H)I(eHCpaMJ1-XJ1MJ1KaMH, nOCnlBJ1BWJ1MJ1 3all<l'IY 6e311c-

516
D1G6a 23
<pCKTHOro J13roTOBJICHJ151 )l(eJIC3HOllOP0)l(HbIX pClIbCOB no 6JI113KOH K
GMP l111eOJI0fJ1J1.
K HaCT05lweMY BpeMCHI1 06wecTBo 51BJI5ICTC5I Me)l(llYHapollHoH op-
raHI13aUJ1CH J1 pa3pa60TaJIO OKOJIO 12000 CTaHllapTOB ASTM, B TOM
4J1CJIe nOJIY411BWI1H J13BCCTHOCTb CTaHllapT ASTM E2500 «Standard
Guide for Specification, Design and Verification of Pharmaceutical and Bi-
ophannaceutical Manufacturing Systems and Equipment». KOTOpbIH pac-
CMOTpCH B maBC 9.
B pa60Te ASTM npl1HI1MalOT Y4aCTJ1C 60JIee 30 TbIC5I4 BellYWJ1X
cnCUJ1aJIJ1CTOB J1 PYKOBOllJ1TCJICH J13 135 CTpaH MJ1pa (www.astm.org).
B03 - BCeMHpHaB opraHH3aIJ,IDI 3.LJ.paBOOXpaHeHHH
OCHOBHOH 3aila4CH 51BJI5IeTC5I peWCHI1C np06JIeM 311paBOOXpaHCHJ151 J1
oxpaHbI 3110pOBb51 B MC)I(1lYHapOllHOM MacwTa6c. LJJICHaMI1 B03 51BJI5IIOT-
C5I 193 rOCYllapCTBa-4JICHbl.
B03 6bIJIa OCHOBaHa B 1948 r. KaK CnCUI1aJIH3HpOBaHHOC Y'lpC)I(1lC-
Hl1e OOH. WTa6-KBapTl1pa HaXOllI1TC5I B )KeHcBc. WBCHUapJ151.
npl10pHTCTHbIMI1 HanpaBJICHH5IMH pa60TbI 51 BJI5IIOTC5I:
- oxpaHa H YKpenJICHI1C 3110pOBb51 HaCCJICHI151;
- oxpaHa oKpalOwcH CpCllbI;
- 60pb6a C I1H<pCKUHOHHbIMI1 11 napa3HTapHbIMJ1 60JIC3H5IMH;
- oxpaHa H YKpCnJIeHHC nCI1XI14ecKoro 3110pOBb5l:
- 3a60Ta 0 3110pOBbC MaTCpl1 H pC6eHKa;
- I1H<popMaUI10HHa51 pa60Ta;
- HaY4HbIC I1CCJICllOBaHH5I KOHCYJIbTaUl111 H np.
PaCWJ1pCHHa51 nporpaMMa HaY4HbIX MCllHUHHCKI1X I1CCJICllOBaHHH;
B03 (World Health Organization - WHO) BbInycn1J1a 60JIbWOC KO-
JIH4CCTBO 1l0KYMCHTOB (TCXHH4CCKI1X OT4CTOB J1 lIP.), KaCaIOWI1XC5I pa3-
HbIX CTOpOH pa3pa60TKJ1, J1CnbITaHHH. np0l13BOllCTBa J1 06paWCHI151 JIe-
KapCTBCHHbIX CpCllCTB (www.who.int).
ACI1HKOM
AccouJ1aul151 J1H)I(CHCpOB no KOHTpOJIIO MI1Kp03arp5l3HCHJ1H
(ACHHKOM) OCHOBaHa B 1991 r. KaK HC3aBI1CI1MOC HCKOMMep4CCKOC
06l>ellI1HCHJ1C npo<pcCCJ10HaJIOB. pa60TalOwI1x B 06JIaCTJ1 4J1CTbIX TeXHO-
JIOfJ1H B pa3HbIX 06JIaCT5IX npI1MeHeHJ151 (www.asincom.injo).
HanpaBJICHI151 lle5lTCJIbHOCTI1:
- pa3pa60TKa CTaHllapTOB (nollroTOBJIeHO 60JICC 50 HaUJ10HaJIbHbIX
CTaHllapTOB, K HaJ160JIee BCCOMbIM OTHOC5ITC5I rOCT P 52249 - npaBJ1JIa
GMP, CTaHllapT Ha 411CTOTY B0311yxa B 60JIbHI1uaX rOCT P 52239, CTaH-
llapTbl I1CO Ha 4J1CTbIe nOMeweHJ151, J1311aHHbIC Ha PYCCKOM 513bIKC);
- J1311aTeJIbCKa51 pa60Ta ()I(YPHaJI «TeXHOJI0fJ151 'IJ1CTOTbI», KHJ1rJ1);
- nOBbIWeHl1e KBaJIJ1<pI1KaUJ111 cneUJ1aJIJ1CTOB;
- Me)l(1lYHapOllHa51 pa60Ta (KoH<pepeHUHI1, CeMI1Hapbl. BbICTaBKJ1).

5/7
3AKJIIOQEHI1E
HaM HHbI npaBJ1JIa GMP. Ho :noro MaJIO.
Hc06xOllHMO BOCCTaHOBJIeHJ1C OTC'ICCTBCHHOH npOMbIWJIeHHOCTJ1 B
UCJIOM, Ha HOBOH, COBpCMCHHOH OCHOBC. Ll.JI5I 3TOro HY)I(HO CllCJIaTb He-
CKOJIbKO 51CHbIX warOB:
I. BBCCTI1, HaKoHcu, npaBJ1JIa GMP B Ka4eCTBC 06513aTCJIbHoro
HopMaTHBHoro npaBoBoro aKTa. 3TOT 1l0KYMCHT 1l0JI)I(eH 6bITb I111CHTJ14-
HbIM npH3HaHHbIM MC)I(1lYHapollHblM npaBJ1JIaM.
2. BBecTI1 EBponci1cKYIO <1>apMaKonclO H BCCb COnYTCTBYIOWJ1H
KOMnJICKC 1l0KYMCHTOB, Ha ncpBoM 3Tanc B Ka4CCTBC peKoMeHllauHH, a
3aTeM Ha 06513aTCJIbHOH OCHOBe.
3. BoccTaHoBHTb B CTpaHC npOH3BOllCTBO aKTJ1BHbIX <papMaUeBTJ1-
'1eCKI1X cy6cTaHUJ1H B COOTBCTCTBHH C GMP. BepHYTb POCCI1H CTaTYC
cTpaHbI-3KcnopTcpa cy6cTaHuHH. npHBCCTH npOH3BOllCTBO BcnOMora-
TCJIbHbIX BcweCTB B COOTBCTCTBHC C GMP.
4. C0311aTb npOH3BOllCTBa nepBH4HbIX ynaKoB04HbIX MaTCpJ1aJIOB
no COBpeMCHHbIM Tpc60BaHH5IM, B ncpBYIO 04CpCllb <pJ1aKOHOB H aMnYJI.
5. C0311aTb MaTCpJ1aJIbHO-TCXHH4CCKYIO 6a3Y npoH3BollcTBa JICKap-
CTBCHHbIX CpCllCTB no G M P - npOMbIWJICHHOCTb, BbmycKaIOWYIO co-
BpcMeHHoc 060PYlloBaHJ1C J1 TCXHOJIOrH4CCKHe CJ1CTeMbI - CTCpHJIH3aTO-
pbI, Ta6JICTnpCCCbI H T. 11.
npHopHTeT np0J13BOllCTBa CpCllCTB np0J13BOllCTBa ncpCll npOH3BOll-
CTBOM roTOBOH npOllYKl.{HH - a36YKa 3KOHOMI1KI1 1lJI5I pa3BI1TOH CTpaHbl.
6. C0311aTb HHcneKUHIO Ha COOTBCTCTBHe Tpc60BaHH5IM G M P no
06pa3UY FDA CWA. 3TO - maBHOC YCJIOBHC. Y4HTbIBa51 npOJ1CX01l5l-
WYIO B cTpaHc npHBaTJ13aUJ1IO B H31l30pHOH c<pcpc, HaM rp03HT onac-
HOCTb ncpella411 <PYHKUHH J1HCnCKTHpOBaHH5I B 4aCTHbIC PYKH.
LIonYCTJ1Tb 3TOro HCJIb351.
7. nCpCHTI1 K aKTHBHoH pa60Tc Ha Me)l(1lYHapOllHOM ypOBHC, B351B
Ha ce651 HHHUHaTHBY pa3pa60TKJ1 p5I1la KJ11O'IeBbIX HOpMaTI1BHbIX 1l0KY-
MCHTOB. Hc BCC H3 TOro, 4TO YTBCp)l(1laCTC5I B 3an31lHOM MJ1pC, cnoc06-
CTBYCT 6e30naCHOCTJ1 H 3<P<PCKTHBHOCTH JIeKapCTBeHHbIx cpellcTB.
B nOCJICllHJ1e llCC5ITb JICT B MJ1pC HapacTaeT TCHllCHUJ151 nOllMCHbI
pa60Tbl no cywecTBY J1MJ111)l(eM pa60TbI - MCTOllaMJ1 aHaJIJ13a pJ1CKOB,
MCHell)l(MeHTa 11 np. B J1HTepeCax '1aCTHbIX <pJ1PM-KOHcYJIbTaHToB.

518
20 JICT Ha3all HaMJ1 6bIJIa nOCTaBJIeHa 3alla4a np5lMoro BBClleHJ1H
B POCCJ1J1 npaBJ1JI GMP EC.
3TO O'leHb 60JIbWOH CPOK. no COBpCMCHHbIM McpKaM.
TpaH3J1cTOp 6blJ1 J1306peTeH B 194H r.. a '-Iepe3 20 J1eT, B 1968 r.
MHp, B TOM 4HCJ1e Hawa CTpaHa, pacnOJ1araJl MOWHOH 3J1eKTpOHHOH
npOMbllliJleHHOCTblO. B 1948 r. MaJ10 KTO 3HaJ1, 4TO TaKoe TenJ10B03bl H
3J1eKTpOB03W, a '1epe3 .aBa.auaTb J1eT npaKTH4eCKJ1 BCH ceTb )l(eJ1e3HWX
.nopor nepeWJ1a Ha 3J1eKTpJ14eCKYIO J1 TenJ10B03HYIO THry. OCTaBJ1B napo-
B03W B 06J1aCTI1 I1CTOpl1J1.
nepBblH COBeTCKJ1H TenJ10B03 KOHCTPYKUHJ1 J1eHI1HrpallCKoro npo-
4>eccopa 51KoBa Mo.necTOBJ14a raKKeJ151 Ha I1CnbITaHJ1HX, npoxo.a51 C no-
e3.aOM 4epe3 OllHY H3 CTaHUJ1H. BbI3BaJ1 WOK Y .ne)l(ypHoro no CTaHUHI1.
TOT .aOKJ1a.ablBaJI PYKOBO.aCTBY: npOCJ1e.aoBaJ1 COCTaB, a J10KOMOTHBa HeT
HJ1 B roJ10Be, HH B xBocTe!
To 6blJ10 .nPyroe BpeM5I.
JIOKOMOTJ1B 6blJ1, npJ1'1eM cOBpeMeHHblH 11 B roJ10Be COCTaBa.
llpo6/1eMbi GMP 6 POCCUU Hem
ECTb np06JICMa opraHH3aUHH H ynpaBJICHH5I 3KOHOMJ1KOH, MOllCp-
HH3aUl1H npOMbIWJICHHOCTH 11 C0311aHI151 04CHb MHororo JaHOBO.
MbI BCC 3HaCM. '1TO llCHCTBYIOWI1H 4HHOBHWIHH annapaT CllCJIaTb
3TO He cnoc06cH. OH 1l0JI)I(CH 6bITb 3aMCHCH B nOJIHOM COCTaBC. 6C3
3TOro roBOpHTb 0 GMP H, B006wc, 0 '-ICM-TO pa3YMHoM - nycTa51 TpaTa
BpeMeHJ1. 3aHJ1MaTbC5I CCpbC3HbIM llCJIOM 1l0JI)I(HbI npo<pcccHOHaJIbI.
Bcc. 4TO 311CCb CKa3aHO - npaBlla. npH'-ICM pCaJIH3yeMa51 B HC
04CHb 60JIbWJ1C CpOKJ1. Ho 1lJI5I 3TOro HY)l(HO OllHO - 51CHa51 nOJIHTHKa H
I1CnOJIHHTCJIbHbIH annapaT, cnoc06HbIH PCWI1Tb nOCTaBJlCHHbIC 3aila4H.

519
npHJImKeHHe 1
nepeBO.a C aHfJlHHcKOro H3bIKa
5pIOCCeJ1b.
SANCO/C8/AM/sl/ares(201 0) 1064603
EudraLex
The Rules Governing Medicinal Products in the European Union
3aKoHOllaTeJ1bCTBO EC no J1eKapCTBeHHbIM cpe.aCTBaM
Volume 4
Good Manufacturing Practice
Medicinal Products for Human and Veterinary Use
TOM 4
npaBJ1J1a np0J13BOllCTBa JIeKapCTBeHHblX cpellCTB
llJ151 4eJIOBeKa J1 )l(J1BOTHbIX
Explanatory Notes on the preparation of a Site Master File
PeKOMeH,lJ,au,HH no COCTaBJIeHHIO
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flpUJIO:NCeHue 4
541
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MOJICem ee c03iJamb. HYJlCHO npUJlaUJamb «3HalOUJ,UX» JllOiJeii, «omopble HanUUJym
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HO HanHcaHHblX nYTaHO H nJ1Oxo. nJ10XOH nepeBO.a ewe 60J1ee ycyry611J1 .aeJ1o.
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HO no.aMeH5IeT OCHOBHble nOHHTHH.
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npe.anpH5ITH5IX.
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CKoro 03Ha ' taeT «)I(e M'IY)l(H Ha» ).

542
flpUJ/OJICeHUe 4
rOCT P "CO 9001-2008 HOpMaJlbHblH PYCCKHH 113blK
MeHeJJ)KMeHT Ka'leCTBa 06eCne'leHHe Ka'leCTBa
4.2.3 YnpaBJIeHHe II,OKYMemaUHeH CJle11yeT Onpe11eJlHTb nopHllOK 06paweHHH 110-
LloKYMeHTbI CHCTeMbI MeHeIDKMeHTa Ka'-le- KYMeHTOB (paJpa60TKH, COmaCOBaHHH, YfBep-
CTBa 110Jl)l(HbI 6bITb ynpaBJlHeMbIMH. 3anH- )I()1eHHH, BHeceHHH H3MeHeHHH H oTMeHbI).
CH, npe11CTaBJIHIOWHe co60H CneumlJlbHbIH Tpe60BaHHH K OT'IeTHbIM 110KYMeHTaM 11aHbl
BH11110KYMeHTOB, 110Jl)l(HbI 6bITb ynpaBJIH- B 4.2.4.
eMblMH COrJlaCHO lpe60BaHHHM 4.2.4.
4.2.4 YnpaBJleHHe 3anHCIIMH Bell,eHHe OT'IeTHbIX II,OK)'MeHToB
3anHcH, YCTaHOBJIeHHble llJIH npe11CTaB- CJle11Ycr O<pOPMJ1HTb OT'-IeTHble 110KYMeHTbI
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HHII H pa3pa6oTKH TaUHH 110J1)1(Ha 6bITb npe11CTaBJ1eHa B 06"beMe
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UOB.

flpUJ/OJICeHUe 4
543
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3.aeCb napa311Tbl He MeHee OnaCHbI. OHJ1 OTBJleKalOT np0I13Bo.aCTBeHHJ1KOB OT
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PeaJIJ13aUHH JaTeJ1 4>opMaJlJ130BaTb pa60TY no 06eCne4eHJ11O Ka4eCTBa B
BJ1.ae HCO 9000 OKa3aJIaCb Hey.aa4HoH.

544
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TOro B03.ayxa. KOHTpoJ1H KalJeCTBa. TeXH0J10rH4eCKOe 060py.aoBaHHe H T..a. Ka)l(-
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MeHTOB MO)l(eT Bb13blBaTbCH .aeCHTKaMH npHlJHH.
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1l0J1)l(eH pa60TaTb. 3a.aa4a nOJ1b30BaTCJIH - npaBJ1J1bHO ero 3KcnnyarnpoBaTb.
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npUJ10JlCeHUe 5
545
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n.5.3 HAZOP
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Mepbl MOryr 6bITb npJ1MeHeHbl K K3)I(.D,0MY pJ1CKY.
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Compilation of Community Procedures on Inspections and
Exchange of Information. European Medicines Agency
5 July 201] EMAjINS/GMP/459921/2010 Rev 13
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U.S. Food and Drug Administration
Center for Drug Evaluation and Research
Office of Compliance
Office of Manufacturing and Product Quality
Division of International Drug Quality
White Oak, Building 51, Room 4234
\0903 New Hampshire Ave
Silver Spring, MD 20993
Tel: (30 I) 796-3206
Fax: (301) 847-8741
Email:
CYBa)l(eHJ1eM.
(HMH)
Acting Director
Office of Manufacturing and Product Quality
Office of Compliance
Center for Drug Evaluation and Research

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ISBN 978-5-9903456-1-4