2010年版GMP中制药用水系统检查特点与常见问题的探讨

Discussion of the Characteristics and Problems of Pharmaceutical Water System Inspection Based on GMP in 2010

目的:了解2010年版《药品生产质量管理规范》(GMP)中制药用水系统应予关注的重点,解决企业、特别是新建企业对制药用水系统检查存在的疑惑。方法:比较《中国药典》《美国药典》和《欧洲药典》制药用水质量标准,解析2010年版GMP、2010年版《中国药典》中相关检查内容,讨论制药用水系统GMP检查的特点与发现的主要问题。结果与结论:《中国药典》在制药用水质量标准上与《欧洲药典》基本一致,较《美国药典》则更为详细、严格。在2010年版GMP与2010年版《中国药典》中明确了制药用水质量标准、系统装置的要求与重点关注项、系统管理中质量回顾和偏差控制理念;制药用水系统GMP检查具有全面、严谨、连续的特点,其检查中出现的常见问题包括制药用水系统的设计、施工与后期运行管理。建议企业应注意制药用水系统的细节管理,以利于相关工作的开展。

OBJECTIVE：To provide some references for enterprises,in particular new enterprises,in respect of the inspection of pharmaceutical water system,by discussing about the key points for pharmaceutical water system in Good Manufacturing Practices（GMP） in 2010. METHODS：Pharmaceutical water quality standards of Chinese Pharmacopoeia,U.S. Pharmacopoeia and European Pharmacopoeia were compared. Relevant inspection contents of GMP in 2010 and Chinese Pharmacopoeia 2010 were analyzed. The characteristics and main problems of GMP inspection were discussed. RESULTS CONCLUSIONS：The pharmaceutical water quality standards in Chinese Pharmacopoeia are generally consistent with those in European Pharmacopoeia and more detailed and stricter than those in U.S. Pharmacopeia. GMP 2010 and Chinese Pharmacopoeia 2010 specify pharmaceutical water quality standards,the requirements and key points for system devices,and the concepts of quality review and deviation control in system management. The GMP inspection of the pharmaceutical water system is complete,rigorous and continuous,in which the problems are usually found to be related to the design,construction and final-period operation management of the pharmaceutical water system. Therefore,it is suggested the enterprises should pay attention to the details for the management of the pharmaceutical water system so as to facilitate the performance of relevant work.