期刊文献+

广东省实施药品GMP、GSP认证专家审评制的探讨 被引量:2

Analysis and Consideration of the Problems in the Expert Review System of GMP and GSP Certification in Guangdong
下载PDF
导出
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.
作者 颜红 张建浩
出处 《中国药事》 CAS 2010年第9期847-848,863,共3页 Chinese Pharmaceutical Affairs
关键词 药品 认证 专家审评 drug certification expert review
  • 相关文献

参考文献14

二级参考文献37

  • 1杜晶晶,胡廷熹.浅谈FDA以风险为基础的药品生产检查方法及启示[J].中国药事,2007,21(3):210-213. 被引量:14
  • 2MPA. Aboul MPA [EB/OL]. [2008-03-17]. http:// www. lakemedelsverket. se/Tpl/Startpage_ 395. aspx.
  • 3GMP发展和分类[EB/OL]. [2008-03-17]. http: //www. cfiin. com/news/echo. php? id=3562.
  • 4ICH. ICH-Q7 [EB/OL]. [2008-03-17]. http: //www. cepa. com.
  • 5药品生产质量管理规范[S].国家药品监督管理局令第9号.1998.
  • 6药品不良反应报告和监测管理办法[S].国家食品药品监督管理局令第7号,2004.
  • 7国家食品药品监督管理局.关于印发《药品GMP认证检查评定标准》的通知[Z].国食药监安[2007]648号.2007.
  • 8FDA.联邦食品、药品和化妆品法的修正案[EB/OL].[2008-03-16].http://www.fda.gov.
  • 9FDA. Current Good manufactuying practice [EB/OL]. [2008-03-17]. http.. //www. fda. gov/cder/dmpq.
  • 10FDA. Current Good manufactuying practice [EB/OL] . [2008-03-17] . http: //www. fda. gov/cder/dmpq.

共引文献66

同被引文献4

引证文献2

二级引证文献2

相关作者

内容加载中请稍等...

相关机构

内容加载中请稍等...

相关主题

内容加载中请稍等...

浏览历史

内容加载中请稍等...
;
使用帮助 返回顶部