WHO TRS1033 附录2 清洁验证考虑要点 中英.pdfVIP

WHO Expert Committee on Specifications for Pharmaceutical Preparations Fifty-fifth report 2021 Annex 2 Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation Annex 2 附录2 Points to consider when including Health-Based Exposure Limits (HBELs) in cleaning validation 清洁验证中包括基于健康的暴露限（HBEL）时的考虑要点 1. Introduction and background 介绍与背景 2. Scope 范围 3. Glossary 术语 4. Historical approach in cleaning validation 清洁验证历史方法 5. New approach using HBELs in cleaning validation 使用HBEL的清洁验证新方法 5.1 Documentation 文件记录 5.2 Equipment 设备 5.3 Cleaning agents 清洁剂 5.4 Sampling 取样 5.5 Cleanability studies 清洁能力研究 5.6 Risk management 风险管理 5.7 Guidance for Health-Based Exposure Limits (HBELs) HBEL设定指南 setting 5.8 Acceptance criteria 可接受标准 5.9 Analytical procedures 分析方法 5.10 Data integrity 数据完整性 5.11 Cleaning validation and cleaning verification 清洁验证与清洁确认 5.12 Visually clean 目视清洁 5.13 Cleaning process capability 清洁工艺能力 5.14 Personnel 人员 5.15 Life cycle 生命周期 References 参考文献 Further reading 扩展阅读 Appendix 1 Using Health-Based Exposure Limits (HBELs) 附录1 使用HBEL评估清洁验证中的 to assess risk in cleaning validation 风险 WHO TRS 1033 附录2 清洁验证包括基于健康的暴露限(