완제의약품 제조 및 품질관리기준가이던스
목 차
1장 서론 ······················································································································ 6
1. 구성원칙 ··············································································································· 6
2. 구성방법 ··············································································································· 7
2장 완제의약품 제조 및 품질관리기준 ······························································ 9
1. 용어의 정의 ········································································································· 9
1의2. 품질경영 ······································································································· 21
2. 시설 및 환경의 관리 ······················································································· 23
2.1 시설관리 ······································································································· 23
2.2 자동화장치 등의 관리 ··············································································· 39
2.3 환경관리 ······································································································· 42
3. 조직 ····················································································································· 45
3.1 조직의 구성 ································································································· 45
3.2 제조부서 책임자 ························································································· 63
3.3 품질(보증)부서 책임자 ·············································································· 75
3.4 위원회 ········································································································· 125
4. 기준서 ··············································································································· 126
4.1 제품표준서 ································································································· 131
4.2 품질관리기준서 ························································································· 157
4.3 제조관리기준서 ························································································· 182
4.4 제조위생관리기준서 ················································································· 209
5. 문서 ··················································································································· 223
5.1 문서의 작성 ······························································································· 223
5.2 문서의 관리 ······························································································· 230
6. 밸리데이션 ······································································································· 237
6.1 밸리데이션의 대상 ··················································································· 277
6.2 공정 밸리데이션 ······················································································· 244
6.3 시험방법 밸리데이션 ··············································································· 260
6.4 세척 밸리데이션 ······················································································· 262
6.5 제조지원설비 밸리데이션······································································· 275
6.6 컴퓨터시스템 밸리데이션······································································· 276
7. 품질관리 ··········································································································· 279
7.1 시험관리 ····································································································· 279
7.2 안정성 시험 ······························································································· 329
7.3 제품품질평가 ····························································································· 349
8. 제조관리 ··········································································································· 360
8.1 제조공정관리 ····························································································· 360
8.2 포장공정관리 ····························································································· 393
9. 제조위생관리 ··································································································· 434
9.1 작업원의 위생 ··························································································· 434
9.2 작업소의 위생관리 ··················································································· 441
9.3 제조설비의 세척 ······················································································· 448
10. 원자재 및 제품의 관리 ··············································································· 454
10.1 입고관리 ··································································································· 454
10.2 보관관리 ··································································································· 467
10.3 원생약의 보관관리 ················································································· 473
10.4 출고관리 ··································································································· 476
11. 불만처리 및 회수 ························································································· 480
12. 변경관리 ········································································································· 492
13. 자율점검 ········································································································· 499
14. 교육 및 훈련 ································································································· 505
15. 실태조사 등 ··································································································· 510
15.1 평가 ··········································································································· 510
15.2 판정 ··········································································································· 510
15.3 조사관 ······································································································· 511
15.4 기타 ··········································································································· 511
[별첨 1] 의약품 제조소의 시설 ····································································· 513
1. 의약품 등의 제조업 및 수입자의 시설기준령 ········································· 514
2. 의약품 등의 제조업 및 수입자의 시설기준령 시행규칙······················· 537
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