WHO 986号报告附录2 中英文.pdf

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 3 念和要素 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 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