附录2 WHO药品GMP指南_中英文_.pdfVIP

Annex 2 WHO good manufacturing practices for pharmaceutical products: main principles 附录2 WHO药品GMP：主要原则 Introduction引言 General considerations总则 Glossary术语 Quality management in the medicines industry: philosophy and essential elements 制药企业的质量管理：GMP 理念和基本元素 1. Pharmaceutical quality system 制药质量体系 Quality risk management 质量风险管理 Product quality review 产品质量回顾 2. Good manufacturing practices for pharmaceutical products 药品GMP 3. Sanitation and hygiene 清洁和卫生 4. Qualification and validation 确认和验证 5. Complaints 投诉 6. Product recalls 产品召回 7. Contract production, analysis and other activities 委托生产、检验和其他活动 General 概述 The contract giver 委托方 The contract accepter 被委托方 The contract 合同 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 Items for self-inspection 自检项目 Self-inspection team 自检团队 Frequency of self-inspection 自检频率 Self-inspection report 自检报告 Follow-up action 后续措施 Quality audit 质量审计 Suppliers’ audits and approval 供应商审计和批准 9. Personnel 人员 General 概述 Key personnel 关键人员 10. Training 培训 11. Personal hygiene 人员卫生 12. Premises 厂房 General 概述 Ancillary areas 辅助区域 Storage areas 仓储区域 Weighing areas 称量区域 Production areas 生产区域 Quality control areas QC 区域 13. Equipment 设备 14. Materials 物料 General 概述 Starting materials 起始物料 Packaging materials 包装材料 Intermediate and bulk products 中间体和成品 Finished products 制剂 Rejected, recovered, reprocessed and reworked materials 不合格、回收、返工和重 加工物料 Recalled products 召回产品 Returned goods 退货 Reagents and culture media 试剂和培养基 Reference standards 标准品 Waste materials 废弃物料 Miscellaneous 其他 15. Documentation 文件 General 概述 Documents required 需要的文件 16. Good practices in production 生产良好规范 General 概述 Prevention of cross-contamination and bacterial contamination during production生产 过程中交叉污染和额细菌污