WHO GMP-937清洁验证（附录3-4）.docx

第 第 PAGE 11 页 共 34 页 WHO-937-Appendix 3 Cleaning validation 附录3 清洁验证 Principle 原则 Scope 范围 General 概述 Cleaning validation protocols and reports 清洁验证方案和清洁验证报告 Cleaning validation protocols 清洁验证方案 Cleaning validation reports 清洁验证报告 Personnel 人员 Equipment 设备 Detergents 清洗剂 Microbiology 微生物学 Sampling 取样 General 概述 Direct surface sampling (direct method) 表面直接取样（直接方法） Rinse samples (indirect method) 冲洗取样（间接方法） Batch placebo method 批对照方法 Analytical methods 分析方法 Establishing acceptable limits 确定验收限度 Principle 原则 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。 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。 Adequate cleaning procedures play an important role in preventing contamination and cross-contamination. Validation of cleaning methods provides documented evidence that an approved cleaning procedure will provide clean equipment, suitable for its intended use. 恰当的清洁程序能有效预防污染和交叉污染。清洁方法的验证可以作为书面证据，证明已批准的清洁程序将提供符合自身用途的洁净设备。 The objective of cleaning validation is to prove that the equipment is consistently cleaned of product, detergent and microbial residues to an acceptable level, to prevent possible contamination and cross