WHO 指南： 不同方法——包括 HBEL——建立清洁验证的残留限度以确定共用设施生产污染.pdfVIP

WHO 指南：不同方法——包括HBEL——建立清洁验证的残留限度以确定共用设施生产污染风险的考量 Working document QAS/20.849 工作文件QAS/20.849 May 2020 二零二零年五月 DRAFT WORKING DOCUMENT FOR COMMENTS: 工作文件草案: Points to consider on the different approaches – including HBEL – to establish carryover limits in cleaning validation for identification of contamination risks when manufacturing in shared facilities 不同方法——包括HBEL——建立清洁验证的残留 限度以确定共用设施生产污染风险的考量 1. Introduction and background 介绍及背景 2. Scope 范围 3. Glossary 术语 4. Traditional approach 传统方法 5. New approaches 新的方法 References 参考资料 WHO 清洁验证指南-2020 1 / 16 GMP 办公室翻译组 WHO 指南：不同方法——包括HBEL——建立清洁验证的残留限度以确定共用设施生产污染风险的考量 1. Introduction and background 介绍及背景 The World Health Organization (WHO) has published the guideline entitled Good Manufacturing Practices for pharmaceutical products: main principles in the WHO Technical Report Series, No. 986, Annex 2, 2014 (1). WHO 于 2014 年 TRS 986 附录 2 发布了题为 “药品 GMP ：主则”的指南。 The WHO Supplementary guidelines on good manufacturing practice: validation were published in 2006 and were supported by seven appendices. In 2019, the WHO Good manufacturing practices: guidelines on validation (2) were updated and republished. Some of the seven appendices were also individually updated between 2013 and 2019: WHO 的 “GMP 补充指南：验证”于 2006 年发布，有 7 个附录作为支持文件。 2019 年， WHO 的 “GMP ：验证指南”进行了更新并重新发布。 7 个附录中有几个分别于 2013 年和 2019 年进行了更新。 • Appendix 1. Validation of heating, ventilation and air conditioning systems (3). • 附录1 HVAC 系统的验证(3) • Appendix 2. Validation of water systems for pharmaceutical use (4). • 附录2 制药用水