WHO GMP 937 清洁验证 附录3.pdfVIP

WHO-937-Appendix 3 Cleaning validation 附录3 清洁验证 1. Principle 原则 2. Scope 范围 3. General 概述 4. Cleaning validation protocols and reports 清洁验证方案和清洁验证 报告 4.1 Cleaning validation protocols 清洁验证方案 4.2 Cleaning validation reports 清洁验证报告 5. Personnel 人员 6. Equipment 设备 7. Detergents 清洗剂 8. Microbiology 微生物学 9. Sampling 取样 9.1 General 概述 9.2 Direct surface sampling (direct method) 表面直接取样（直接方法） 9.3 Rinse samples (indirect method) 冲洗取样 （间接方法） 9.4 Batch placebo method 批对照方法 10. Analytical methods 分析方法 11. Establishing acceptable limits 确定验收限度 第 1 页 共 34 页 1. Principle 原则 1.1 The objectives of good manufacturing practices (GMP) include the prevention of possible contamination and cross-contamination of pharmaceutical starting materials and products. GMP的目标包括了对药品起始物料和产品可能发生的污染和交叉 污染进行预防。 1.2 Pharmaceutical products can be contaminated by a variety of substances such as contaminants associated with microbes, previous products (both active pharmaceutical ingredients (API) and excipient residues), residues of cleaning agents, airborne materials, such as dust and particulate matter, lubricants and ancillary material, such as disinfectants, and decomposition residues from: 许多物质都可能对药品造成污染，如微生物污染物、前个产品（包 括活性药物成分API和辅料残留物）、清洗剂残留、空气物质如粉 尘和颗粒物、润滑油和辅助材料如消毒剂、以及以下情况的分解 产物： — product residue breakdown occasioned by, e.g. the use of strong acids and alkalis during the cleaning process; and 如在清洁过程中使用强酸强碱引起的产品残留分解；和 — breakdown products of the detergents, acids and alkalis that may be used as part of the cleaning process. 可能用于清洁过程的洗涤剂、酸碱等的分解产物。 1.3 Adequate cleaning procedures p