Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles
附录2 世界卫生组织（WHO）药品GMP主要原理
目录
Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 世界卫生组织药品GMP主要原理 (1)
Introduction 介绍 (5)
General considerations 总则 (7)
Glossary 术语表 (7)
Quality management in the medicines industry: philosophy and essential elements3 药业的质量管理：理念和要素3 (13)
1.Pharmaceutical quality system药品质量系统 (15)
Quality risk management 质量风险管理 (18)
Product quality review产品质量回顾 (18)
2.Good manufacturing practices for pharmaceutical products 药品生产质量管理规范 (19)
3.Sanitation and hygiene清洁和卫生 (21)
4.Qualification and validation确认和验证 (21)
plaints 投诉 (22)
6.Product recalls 产品召回 (23)
7.Contract production and analysis 委托生产和分析 (24)
General 概述 (24)
The contract giver 委托方 (25)
The contract acceptor 受托方 (25)
The contract 合同 (26)
8.Self-inspection, quality audits and supplier’s audits and approval 自检、质量审计、供应商审计和批
准27
Items for self-inspection 自检项目 (27)
Self-inspection team 自检团队 (28)
Frequency of self-inspection 自检频率 (28)
Self-inspection report 自检报告 (28)
Quality audit 质量审计 (28)
Suppliers’ audits and approval 供应商审计和批准 (28)
9.Personnel 人员 (29)
General 概述 (29)
Key personnel 关键人员 (29)
10.Training 培训 (34)
11.Personal hygiene 个人卫生 (34)
12.Premises 厂房 (35)
General 概述 (35)
Ancillary areas 辅助区域 (36)
Storage areas 仓储区域 (37)
Weighing areas 称量区域 (38)
Production areas 生产区域 (38)
Quality control areas 质量控制区域 (39)
13.Equipment 设备 (40)
14.Materials 物料 (41)
General 概述 (41)
Starting materials 原辅料 (41)
Packaging materials 包装材料 (43)
Intermediate and bulk products 中间产品和待包装品 (43)
Finished products 成品 (44)
Rejected, recovered, reprocessed and reworked materials 拒绝的、回收的、重新加工的和返工的物料 (44)
Recalled products 召回产品 (44)
Returned goods 退回货物 (44)
Reagents and culture media 试剂和培养基 (45)
Reference standards 标准品 (45)
Miscellaneous 其他 (46)
15.Documentation 文件 (46)
General 概述 (47)
Documents required 所需文件 (48)
16.Good practices in production 生产质量管理规范 (57)
General 概述 (57)
Prevention of cross-contamination and bacterial contamination during production 在生产过程中避免交叉污染和细菌污染 (58)
Processing operations 生产操作 (60)
Packaging operations 包装操作 (61)
17. Good practices in quality control 质量控制管理规范 (62)
Control of starting materials and intermediate, bulk and finished products 原辅料、中间产品、待包装品和成品的控制 (64)
Test requirements 检验要求 (65)
Batch record review 批记录审核 (67)
Stability studies 稳定性试验 (68)
References 参考资料 (68)
