广东省实施药品GMP、GSP认证专家审评制的探讨  

Analysis and Consideration of the Problems in the Expert Review System of GMP and GSP Certification in Guangdong

作　　者：颜红[1] 张建浩[1] 

机构地区：[1]广东省食品药品监督管理局审评认证中心,广州510080

出　　处：《中国药事》2010年第9期847-848,863,共3页Chinese Pharmaceutical Affairs

摘　　要：目的介绍广东省实施药品GMP、GSP认证专家审评制的基本情况和在药品GMP、GSP认证工作过程中实施此制度的意义。方法分析目前在实施专家审评制度过程中存在的问题,就建立健全药品GMP、GSP认证专家审评制度提出几点建议。结果与结论通过健全制度、保持沟通和加强教育等方式,不断完善药品认证专家审评制度,不断规范认证行为,提高药品认证的质量。Objective To introduce situation for the expert review system of GMP and GSP certification in Guangdong,and the significance for the implementation of this system in drug GMP and GSP certification. Methods This paper analyzed the current problems which carry out the expert review system of GMP and GSP certification at present. This paper makes some suggestions on how to construct and strengthen the drug expert review system of GMP and GSP certification. Results and Conclusion Through the sound system,with its means of communication and continuous improvement to strengthen education for the expert review system of GMP and GSP certification to continue to regulate certified behavior,and improve the quality of medicines certification.

关 键 词：药品 认证 专家审评 

分 类 号：R954.2[医药卫生—药学] R95