목 차
1. 용어의 정의 ········································································································· 1
2. 시설 및 환경의 관리 ·························································································· 8
2.1. 시설관리 ············································································································ 8
2.2. 자동화장치 등의 관리 ·················································································· 12
2.3. 환경관리 ·········································································································· 13
3. 조직 ······················································································································· 15
3.1. 조직의 구성···································································································· 15
3.2. 제조부서 책임자···························································································· 16
3.3. 품질(보증)부서 책임자 ················································································· 19
3.4. 위원회 ·············································································································· 23
4. 기준서 ··················································································································· 25
4.1. 제품표준서 ······································································································ 26
4.2. 품질관리기준서 ······························································································ 34
4.3. 제조관리기준서 ······························································································ 39
4.4. 제조위생관리기준서 ······················································································ 47
5. 문서 ······················································································································· 53
5.1. 문서의 작성···································································································· 53
5.2. 문서의 관리···································································································· 55
6. 밸리데이션 ·········································································································· 57
6.1. 밸리데이션의 실시대상················································································ 57
6.2. 공정 밸리데이션···························································································· 58
6.3. 시험방법 밸리데이션···················································································· 63
6.4. 세척 밸리데이션···························································································· 64
6.5. 제조지원설비 밸리데이션············································································ 68
6.6. 컴퓨터시스템 밸리데이션············································································ 69
7. 품질관리 ··············································································································· 74
7.1. 시험관리 ·········································································································· 74
7.2. 안정성시험 ······································································································ 82
7.3. 연간 품질평가································································································ 84
8. 제조관리 ··············································································································· 86
8.1. 제조공정관리 ·································································································· 86
8.2. 포장공정관리 ·································································································· 93
8.3. 반품 및 재포장 ······························································································ 96
9. 제조위생관리 ······································································································ 99
9.1. 작업원의 위생································································································ 99
9.2. 작업소의 위생관리······················································································ 100
9.3. 제조설비의 세척·························································································· 102
10. 원자재 및 제품의 관리 ··············································································· 105
10.1. 입고관리······································································································ 105
10.2. 보관관리······································································································ 106
10.3. 원생약의 보관관리 ···················································································· 107
10.4. 출고관리······································································································ 108
11. 불만처리 및 제품회수 ················································································· 110
12. 변경관리 ·········································································································· 112
13. 자율점검 ·········································································································· 114
14. 교육 및 훈련 ·································································································· 116
15. 실태조사 등 ···································································································· 118
15.1. 평가 ················································································································· 118
15.2. 판정 ················································································································· 118
15.4. 기타 ················································································································· 119
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