KS J 0014-2010 Bioindustry-Preparation of standard operating procedure and its application for bioindustrial process《生物产业 工程的标准作业程序制定及实施》.pdf
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2、4.2 SOP 3 4.3 SOP .4 4.4 SOP 5 5 .5 A( ) SOP 6 A.1 .6 A.2 SOP 6 B( ) SOP 7 B.1 (purpose) .8 B.2 (scope) .8 B.3 (reference documents).8 B.4 (definitions) .8 B.5 (responsivilities)8 B.6 (procedure) .8 B.7 11 KS J 0014:2010 ii . KS J 0014: 2005 . . , , . , , . KS J 0014:2010 iii 2005 KS J 0014 . . . ,
3、. KS J 0014:2010 Bioindustry Preparation of standard operating procedure and its application for bioindustrial process 1 . . 2 . . ( ) . KS A 0001, KS J 0001, 3 . KS J 0001 . 3.1 GMP (Good Manufacturing Practice)1) . 2) , . 3.2 SOP (Standard Operating Procedure) GMP . , SOP , SOP 1) 1969 (WHO) GMP ,
4、 , , GMP . GMP . 2) , , , , .KS J 0014:2010 2 . 3.3 QA (QA: Quality Assurance) , QA GMP . QA (QA ) . 3.4 QC (QC: Quality Control) , QC . QC (QC ) , QC , . 3.5 . . 3.6 GMP GMP . 4 SOP 4.1 4.1.1 1 : (SOP No.) (Rev. No.) (Change control No.) (Prepared by) (Checked by) (Reviewed by) ( ) (Reviewed by) (Q
5、C ) (Reviewed by) (QA ) (Approved by) (GMP ) SOP . QA SOP (SOP No.) . KS J 0014:2010 3 SOP . Rev. 0 . QA (Change control No.) . , QA (effective date) . SOP ( , Rev. 0) . SOP . . 4.1.2 SOP 2 SOP (log sheet) Rev.0 . . Rev.1 1 . Rev. 4.1.3 SOP SOP . a) b) c) d) e) f) g) h) 4.2 SOP 4.2.1 . . 4.2.2 SOP .
6、 . 4.2.3 SOP SOP , SOP . KS J 0014:2010 4 4.2.4 . SOP . 4.2.5 SOP . QA SOP . , . 4.2.6 a) SOP , . , 3 , . b) SOP . c) , SOP . d) SOP , QC . 4.2.7 SOP . 4.2.8 , SOP , , (diagram) . 4.3 SOP 4.3.1 a) 4.1.3 . . . b) SOP (5W1H: , , , , , ) . c) SOP . d) SOP SOP . e) SOP . 4.3.2 SOP (4.2.6 ) . a) KS J 001
7、4:2010 5 b) , c) d) e) f) , g) h) 4.4 SOP QA SOP SOP (SOP No.) . 5 , . 3 SOP SOP /SOP (log book)/ QA QA / / KS J 0014:2010 6 A ( ) SOP A.1 SOP , . . A.2 SOP SOP ( ) ( ) ( ) SOP SOP No. Rev. No. ( SOP .) : ( ) ( ) : ( ) ( ) / ( ) C/C No. GMP : ( ) ( ) A4(210 mm297 mm) KS J 0014:2010 7 B ( ) SOP Stand
8、ard Operating Procedure (SOP No.) . . . (Rev. No.) Rev. . . (Change control No.) . 5 1. 2/5 2. 2/5 3. 2/5 4. 2/5 5. 2/5 6. 2/5 7. 4/5 (Prepared by) (Checked by) (Reviewed by) ( ) (Reviewed by) (QC ) (Reviewed by) (QA (Approved by) (GMP ) Rev. 0 . . 2 Rev. 1 . . 1 KS (SOP No.) . . . (Rev. No.) Rev. .
9、 . (Change control No.) . 2/5 KS J 0014:2010 8 . a) . b) . c) , , , . d) . e) . B.1 (purpose) . B.2 (scope) . B.3 (reference documents) B.3.1 P&ID B.3.2 CIP SOP B.4 (definitions) B.4.1 CIP(Cleaning In Place) B.4.2 P&ID(Piping And Instrumentation Diagram) B.5 (responsivilities) B.5.1 , ( , ) . B.5.2
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