当前我省新版GMP认证存在问题及对策研究  

Problems and Countermeasures about Current GMP Certification in Fujian Province

作　　者：吴正善[1] 刘晓霞 

机构地区：[1]福建省药品不良反应监测中心,350001 [2]福建省柘荣县食品药品监督管理局,355300

出　　处：《首都医药》2014年第2期8-10,共3页Capital Medicine

摘　　要：目的了解我省药品生产企业新版GMP认证现场检查缺陷项目情况，找出企业实施新版GMP存在主要问题，提出加快推进我省药品生产企业实施GMP的对裳和建议。方法对我省2011年5月～20134-6月认证的16家企业的缺陷项目进行汇总，对主要问题进行分类、归纳。结果与结论应严格执行规定，注重源头设计，加大培训力度，建立专职检查员队伍，妥善处理善后问题，确保新DKGMP得到正确贯彻实施。Object ive Through analysis of defections founding in current GMP certification,and find out the main problems of Pharmaceutical production enterprise in the implementation of current GMP,thcn provide suggestions and countermeasures to accelerate the implementation in our province. Methods The defections of 16 certified enterprises frnm May 2011 to June 2013 were reviewed,the main problems were classified and summarized.Resu Its and Conc I us i on To ensure the correct implementation of the new version of GMP,we should enforce theregulation strictly,emphasize the source oriented design,establish a full-time inspector team,deal with problems arising properly.

关 键 词：新版GMP 认证 问题 对策 

分 类 号：R-012[医药卫生]