WHO-《研发设施GXP规范》中英文版.pdfVIP

近日，WHO 发布了 Working document QAS/20.865 《研发设施 GxP 规 范》，现将翻译版发给大家，如下： Workingdocument QAS/20.865 November2020 Good practices for research and development facilities 研发设施 GxP 规范 1. Introductionand background 介绍和背景 2. Scope 范围 3. Qualitymanagement 质量管理 4. Qualityrisk management 质量风险管理 5. Sanitationand hygiene 清洁卫生 6. Qualificationand validation 确认与验证 7. Outsourcedactivities 外包活动 8. Self-inspectionand quality audits 自检和质量审计 9. Personnel 人员 10. Training 培训 11. Premises 厂房 12. Equipmentand instruments 设备和仪器 13. Materials 物料 14. Documentation 文件记录 15. Processingand process validation 工艺和工艺验证 16. Qualitycontrol 质量控制 17. Stabilitystudies 稳定性研究 18. Analyticalprocedure development 分析方法开发 19. Transferof technology 技术转移 20. Lifecycle approach 生命周期方法 21. Cleaningprocedure development and cleaning validation 清洁程序开发和清洁验证 Glossary 术语 Abbreviations 缩写 References 参考文献 Further reading 拓展阅读 1. Background 背景 In view of the recent need for the unprecedentedfast development of health products for the treatment of COVID-19 therapies,the World Health Organization (WHO) Prequalification Inspection Services Team(PQT INS) raised the urgency for the development of good manufacturing practice(GMP) text to address the manufacturing of developmental batches, pilot batchesand the sequential stability data that is submitted in product applications(dossiers) for marketing authorization and the prequalification of medicalproducts. 鉴于最近医药产品治疗 COVID-19 的前所未有的快速发展的需要，世界卫生组织 (WHO)预确认检查服务团队 (PQT INS)提出了发展的紧迫性良好生产规范 (GMP)文本 解决发展的生产批次,为上市批准和医药产品预确认而提交的产品申请 (档案)中的 中试批次和序列稳定性数据。 There are currently no regulatory guidelines whichaddress this matter, although the data collecte