把握现场检查重点环节 有效提高认证质量  

Grasp the Key Aspects of Site Inspections to Effectively Improve the Quality of Certification

作　　者：林晓明[1] 陈洪忠[1] 冉大强[1] 

机构地区：[1]山东省食品药品监督管理局审评认证中心,济南250013

出　　处：《中国药事》2014年第11期1206-1208,共3页Chinese Pharmaceutical Affairs

摘　　要：目的探讨GSP现场检查重点问题,为有效提高药品GSP认证质量提供参考。方法对新修订药品GSP实施以来的检查情况进行梳理,讨论现场认证检查过程中应把握的重点环节,分析检查报告中易出现的问题。结果与结论应进一步统一检查标准,检查报告的撰写应更加规范,以更好地对药品经营企业实施监管,建立良好的药品市场秩序。Objective To discuss the key issues of GSP site inspection, so as to provide a reference for effective improvement of the quality of GSP certification. Methods Based on the elaboration of inspection situation since the implementation of newly revised medicine GSP, the key aspects in GSP-site certification and inspection process that should be grasped were discussed and some common problems in inspection reports were analyzed. Results and Conclusion It is suggested that inspection criteria should be set up and inspection reports be standardized in order to conduct better supervision over pharmaceutical trading enterprises and establish good medicine market orders.

关 键 词：药品经营质量管理规范 GSP认证 重点环节 认证质量 

分 类 号：R954[医药卫生—药学]