纠正和预防措施在GLP法规实施中的应用  

Application of Corrective and Preventive Action in GLP

作　　者：李旻 马璟 张呈菊 葛元圆 职阳阳 

机构地区：[1]国家上海新药安全评价研究中心,上海201203

出　　处：《中国药事》2015年第6期577-580,共4页Chinese Pharmaceutical Affairs

基　　金："十二五"国家"重大新药创制"专项项目(编号2012ZX09302002;上海市研发公共服务平台项目(编号13DZ2290100)

摘　　要：GLP作为一种质量管理体系,其持续的质量改进已成为永恒的目标。因此,应确保将GLP实际运行过程中发生的问题更好地改正,降低问题发生率和/或减低其发生后的危害程度,甚至于预判可能出现的问题并提前规划,从而尽可能避免其发生。本文介绍一种方法 -纠正和预防措施,简要描述通过七大步骤完成上述目标,使其成为不断改进GLP质量管理体系的有效工具。GLP is a quality management system with an eternal aim of improving quality continuously. Therefore, to achieve this aim, it is necessary to ensure the better correction of problems which take place during the process of GLP running, reduce the incidence and/or decrease the degree of the hazards, and even to forecast problems that might occur so as to avoid them as much as possible. This paper introduces a method, i.e., corrective and preventive action（CAPA）, and briefly describes its seven steps to achieve the above targets, making it an effective tool for continuous improvement of the GLP quality management system.

关 键 词：药品非临床质量管理规范 质量管理体系 纠正和预防措施 风险分析 风险评估 

分 类 号：R95[医药卫生—药学] R994.2