1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS J 0003GMP KS J 0003 :2010 2010 12 30 http:/www.kats.go.krKS J 0003:2010 : ( ) ( ) KT&G ( ) : (http:/www.standard.go.kr) ： ：2010 12 30 2010-0689 ： ： ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS J 0003:2010 i ii iii 1 1 2 1 3 .1 4 .1 4.1 GMP (General
2、) .1 4.2 (Production).3 4.3 (Quality).4 ( ) .9 ( ) .11 KS J 0003:2010 ii . . , , . , , . KS J 0003:2010 iii GMP(Good Manufacturing Practice) , . KS J 0003:2010 GMP Good Manufacturing PracticeTerms and definitions 1 GMP(Good Manufacturing Practice) . 2 . . ( ) . KS J 0001, 3 . a) GMP (1000, General)
3、b) (2000, Production) c) (3000, Quality) 4 , KS J 0001 . 1 2 . 2 . 3 . 4 . 4.1 GMP (General) KS J 0003:2010 2 1001 , audit 1002 alert level 1003 , , , , , , , , , , supply agreement 1004 . , , , , , . supplier 1005 , , lot 1006 , sterilization 1007 , , , , , , , , , change control 1008 sanitization
4、1009 FIFO(First In First Out) 1010 FEFO(First Expired First Out) 1011 cleaning 1012 disinfection 1013 (CA) (PA) CAPA(Corrective Action Preventive Action) 1014 . . (corrective action plan) . action plan 1015 , , , , , , , , API manufacturing process KS J 0003:2010 3 1016 . “ (as-built)”, “(at-rest)”
5、“ (operational)” . classified area 1017 . (GMP), (GLP) , , , . clean room 1018 . (organism) . . controlled area 1019 , , quality agreement 1020 SQIPP . , , , , , , , . environmental control parameter 4.2 (Production) 2001 in-process material 2002 (reference standard) (traceable standard) calibration
6、 2003 . , , , . like-for-like 2004 . (MPR：Master Production Record) . Master batch record 2005 intermediate 2006 . . batch 2007 , , design specification KS J 0003:2010 4 2008 1 2 performance calibration 2009 . . system specification 2010 , , . . preventive/plan ned/routine maintenance 2011 reprocess
7、ing 2012 , ( , ) reworking 2013 batch(production) record 2014 , , , , . . commissioning 2015 1 . (IQ) (OQ) . class 1 equipment 2016 2 1 . , . class 2 equipment4.3 (Quality) 3001 ( ) verification 3002 , , , trend analysis 3003 , PV(Process Validation) 3004 OOT(Out Of Tolerance) KS J 0003:2010 5 3005
8、cross-contamination 3006 , , OOS(Out Of Specification) 3007 . . reference standard 3008 . . control 3009 , concurrent validation/ongoing validation 3010 effective date 3011 , , . (state of control) . validation 3012 , , validation master plan 3013 , validation batch 3014 . , , , , . validation proto
9、col 3015 , , . . 1(Level 1) , (qualification) . 2 (Level 2) , . , . 3(Level 3) , , , , . change request level 3016 excipient KS J 0003:2010 6 3017 discrepancy 3018 , DQ(Design Qualification) 3019 , . GMP , , . IQ(Installation Qualification) 3020 , . (specification) . PQ(Performance Qualification) 30
10、21 , , . , , . system suitability 3022 corrective action 3023 test method validation 3024 , , APR(Annual Product Review) 3025 preventive action 3026 , prospective validation 3027 (dosage form) . (, , ) . (placebo) . drug product 3028 . . OQ(Operational Qualification) KS J 0003:2010 7 3029 . , . , .
11、original sample 3030 , , , . . , , , , . (drug substance) . API(Active Pharmaceutical Ingredient) 3031 (API) drug substance 3032 / . , 3 % , 5 % , , . atypical result/OOT(Out Of Trend) 3033 secondary standard 3034 . USP, EP, JP, NF, ANSI . primary standard 3035 . deviation 3036 1 . 1 . in-house refe
12、rence material 3037 , , , . . Revalidation 3038 (OOS) ( ) . QA . , . Retest 3039 . , , , . Dosage form KS J 0003:2010 8 3040 (OOS), (OOT) investigation 3041 , , CSV(Computer System Validation) 3042 1 SQIPP . , HPLC , , pH . class 1 reagent 3043 2 SQIPP . , KCl, pH . class 2 reagent 3044 , . . accept
13、ance criteria 3045 , retrospective validation 3046 SQIPP (Safety)： . (Quality)： (Identity)： ( ) (Purity)： (Potency)： SQIPP(Safety, Quality, Identity, Purity, Potency) KS J 0003:2010 9 ( ) 1001 audit 3016excipient 3001 verification 3017discrepancy 1002 alert level 1008sanitization 3002 trend analysis
14、 1009 FIFO(First In First Out) 1004 supplier 1010 FEFO(First Expired First Out) 1003 supply agreement 3018 DQ(Design Qualification) 3003 PV(Process Validation) 2007design specification 2001 in-process material 3019 IQ(Installation Qualification) 3004 OOT(Out Of Tolerance) 2008performance calibration
15、 2002 calibration 3020 PQ(Performance Qualification) 3005 cross-contamination 1011cleaning 3007 reference standard 1012disinfection 3008 control 3021 system suitability 2003 like-for-like 2009system specification 3009 Concurrent validation/ ongoing validation 1013 CAPA(Corrective Action Preventive A
16、ction) 1005 lot 3022corrective action 2004 master batch record 3023 test method validation 1006 sterilization 1014action plan 2005 intermediate 3024 APR(Annual Product Review) 3010 effective date 2010 preventive/planned/routine maintenance 2006 batch 3025preventive action 3011 validation 3026 prospe
17、ctive validation 3012 validation master plan 3027drug product 3013 validation batch 3028 OQ(Operational Qualification) 3014 validation protocol 3029original sample 1007 change control 3030 API(Active Pharmaceutic al Ingredient) 3015 change request level 3031drug substance KS J 0003:2010 10 / 3032 at
18、ypical result/OOT(Out Of Trend) 2014commissioning 3033 secondary standard 3041 CSV(Computer System Validation) 3034 primary standard 1 3042 class 1 reagent 3035 deviation 1 2015 class 1 equipment 3036 in-house reference material 2 3043 class 2 reagent 2011 reprocessing 2 2016 class 2 equipment 3037
19、revalidation 1017clean room 3038 retest 1018controlled area 2012 reworking 3006 OOS(Out Of Specification) 1015 manufacturing process 1019quality agreement 2013 batch(production) record 3044Acceptance criteria 3039 dosage form 1020 Environmental control parameter 3040 investigation 3045 retrospective validation
