KS J 0016-2010 Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice《为生物医药的生产设施GMP采取的设备及机械装置系统政策》.pdf

《KS J 0016-2010 Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice《为生物医药的生产设施GMP采取的设备及机械装置系统政策》.pdf》由会员分享，可在线阅读，更多相关《KS J 0016-2010 Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice《为生物医药的生产设施GMP采取的设备及机械装置系统政策》.pdf（20页珍藏版）》请在麦多课文档分享上搜索。

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5、5.3.5 , . 5.3.6 . 5.4 5.4.1 , , , , , . 5.4.2 ( B ). 5.4.2.1 a) b) c) 5.4.2.2 a) b) c) d) 5.4.2.3 a) b) c) 5.4.2.4 a) b) 5.4.2.5 a) b) 5.4.2.6 KS J 0016:2010 5 a) b) / c) ( ) 6 6.1 6.1.1 . 6.1.1.1 . a) b) c) d) e) f) g) h) 6.1.2 , . 6.1.3 , . 6.2 6.2.1 , , . 6.2.2 . 6.2.3 , , . 6.2.4 , / . 6.3 6.3.1

6、 , , , . 6.3.1.1 KS J 0016:2010 6 6.3.1.2 6.3.1.3 6.3.2 , , . 6.3.3 , (compressed gases), HVAC , . 6.3.4 , . 6.3.5 . 6.3.6 ( ) , (action limit) (alert limit) . 6.3.7 . 6.3.8 . 6.4 6.4.1 , , . 6.4.2 ( C ). 6.4.2.1 a) b) 6.4.2.2 a) b) ( ) c) 6.4.2.3 a) b) ( ) KS J 0016:2010 7 A () A.1 A.1.1 . A.1.2 (U

7、ser Requirement Specification：URS) . A.1.3 . A.1.4 . A.1.5 . A.1.6 , . A.1.7 (commissioning) . A.1.8 . , , . A.1.9 . A.1.10 . A.2 A.2.1 (Inst allation Qualification：IQ) . A.2.2 (Operational Qualification： OQ) . KS J 0016:2010 8 A.2.3 . A.2.4 . A.2.5 , . A.3 A.3.1 . A.3.2 / .A.3.3 . A.3.4 . A.3.5 . K

8、S J 0016:2010 9 B () B.1 B.1.1 . B.1.2 . B.1.3 , . B.1.4 , . B.1.5 , , . B.1.6 , . B.2 B.2.1 , . B.2.2 . B.2.3 . B.2.4 (：, ) . B.2.5 . B.2.6 , . B.2.7 , . KS J 0016:2010 10 B.2.8 , . B.2.9 . B.2.10 , , , / . B.2.11 / . B.3 B.3.1 . B.3.2 . B.3.3 . B.3.4 . B.3.5 , . B.4 B.4.1 . B.4.2 , , . B.4.3 ( ) .

9、 , . B.4.4 . B.5 B.5.1 . KS J 0016:2010 11 B.5.2 , . B.5.3 ( ) . B.5.4 , . B.5.5 , . B.5.6 , . B.6 B.6.1 . B.6.2 . B.6.3 . B.6.4 . B.6.5 , . B.6.6 . B.6.7 . KS J 0016:2010 12 C () C.1 C.1.1 ( ) , . C.1.2 . C.1.3 . C.2 C.2.1 ( ) , . C.2.2 . C.2.3 . C.2.4 . C.2.5 . C.3 C.3.1 . C.3.2 , . C.3.3 . C.3.4

10、, . C.3.5 . GMP 153787 1 92 3(13) (02)26240114 (02)262401489 http:/ KS J 0016 :2010 KSKSKS SKSKS KSKS SKS KS SKS KSKS SKSKS KSKSKS Facility and equipment system policy in biopharmaceutical production based on Good Manufacturing Practice ICS 03.120.00 Korean Agency for Technology and Standards http:/www.kats.go.kr