药品现场检查十三要戒  

The Thirteen "Dos" and "DON'Ts" for Pharmaceutical On-site Inspection

作　　者：刘渊[1] 毕军[2] 

机构地区：[1]国家食品药品监督管理局药品认证管理中心,北京100061 [2]广东省食品药品监督管理局审评认证中心

出　　处：《中国药事》2011年第5期451-452,472,共3页Chinese Pharmaceutical Affairs

摘　　要：目的规范药品现场检查工作。方法对检查员在药品现场检查中的基本要求进行总结,并归纳为十三要及十三戒。结果与结论为检查员改进检查方法及技巧、规范药品现场检查工作、提高工作质量提供有益借鉴。Objective To regulate the pharmaceutical on-site inspection.Methods This article summarizes the basic requirements for pharmaceutical on-site inspection.The thirteen ＂Dos＂ and ＂DON＇Ts＂ proposed in this article were expected.Results and Conclusion To provide a guideline for inspectors to improve tactics and techniques adopted in inspection,and therefore further regulate and enhance the quality of pharmaceutical on-site inspection.

关 键 词：药品认证 现场检查 要戒 

分 类 号：R954[医药卫生—药学]