who986号报告附录2中英文.doc

World Health Organization WHO Technical Report Series, No. 986, 2014 世界卫生组织技术报告系列，编号986，2014年 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 1 编辑整理:Nancy 2016.03.22 World Health Organization WHO Technical Report Series, No. 986, 2014 世界卫生组织技术报告系列，编号986，2014年 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. Quali?cation and validation 确认和验证 21 5. Complaints 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 2 编辑整理:Nancy 2016.03.22 World Health Organization WHO Technical Report Series, No. 986, 2014 世界卫生组织技术报告系列，编号986，2014年 Follow-up action 跟进措施 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