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3、iopharmaceutical production based on Good Manufacturing Practice 1 . 2 . . ( ) . KS J 0003, GMP KS Q ISO 9000, 3 KS J 0003 KS Q ISO 9000 . 4 4.1 4.1.1 . 4.1.2 , . 4.2 4.2.1 , , . 4.2.2 . KS J 0016:2010 2 4.3 4.3.1 , , , . 4.3.1.1 4.3.1.2 4.3.1.3 4.3.2 , , , , . 4.3.3 , . 4.3.4 (engineering standard)
4、 . 4.3.5 , , , . HVAC, , , . 4.3.6 , , . 4.3.7 . 4.4 4.4.1 , , . 4.4.2 ( A ). 4.4.2.1 a) b) c) 4.4.2.2 KS J 0016:2010 3 a) b) 4.4.2.3 a) b) 5 5.1 5.1.1 . 5.1.1.1 . a) (, , ) b) 5.1.2 , . 5.2 5.2.1 . 5.2.2 . 5.3 5.3.1 , , , . 5.3.1.1 5.3.1.2 5.3.1.3 5.3.2 , , . KS J 0016:2010 4 5.3.3 , . 5.3.4 , , .
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
