KS J 0021-2010 Packaging and labelling system policy in biopharmaceutical production based on Good Manufacturing Practice《为生物医药的生产设施GMP采取的包装及贴标签系统政策》.pdf

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1、 KSKSKSKS KSKSKSK KSKSKS KSKSK KSKS KSK KS KS J 0021 GMP KS J 0021 :2010 2010 12 30 http:/www.kats.go.krKS J 0021:2010 : ( ) ( ) KT&G ( ) : (http:/www.standard.go.kr) : :2010 12 30 2010-0689 : : ( 02-509-7294) (http:/www.kats.go.kr). 10 5 , . KS J 0021:2010 i . . , , . , , . KS J 0021:2010 ii , , .

2、KS J 0021:2010 GMP Packaging and labelling system policy in biopharmaceutical production based on Good Manufacturing Practice 1 , . . 2 . . ( ) . KS J 0003, GMP 3 KS J 0003 . 4 4.1 4.1.1 ( ) . 4.2 4.2.1 . 4.2.2 ( ) , . 4.2.3 , . KS J 0021:2010 2 4.2.4 , . 4.2.5 , . 4.3 4.3.1 , , , , . : : : : , 4.3.

3、2 . 4.3.3 , . 4.3.4 . 4.4 4.4.1 , , , . ( A ). a) 1) 2) 3) 4) 5) b) 1) 2) 3) 4) 5) 6) 7) 8) 9) c) 1) KS J 0021:2010 3 2) 3) d) 1) 2) , 3) , 4) () 5) KS J 0021:2010 4 A () A.1 . . . . . . () . , . A.2 . , () . . . . . . . . . . , A.3 ( ) . . KS J 0021:2010 5 . , . . . A.3 . . , . , (, , ) . SOP . , S

4、OP . . , A.4 ( ) . A.4 . , ( ) . . SOP . , . () . , SOP . . GMP 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS J 0021 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Packaging and labelling system policy in biopharmaceutical production based on Good Manufacturing Practice ICS 03.120.10 Korean Agency for Technology and Standards http:/www.kats.go.kr

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