关于2004年后我国GMP认证工作的探讨

Discussion of GMP Certification in Pharmaceutical Enterprise after 2004 in China

目的:探讨2004年后我国开展《药品生产质量管理规范》(GMP)认证工作的方向。方法:阐述我国GMP认证的发展历程及现状,总结现阶段面临的问题,提出解决问题的建议。结果与结论:我国2004年后的GMP认证,应整合好GMP与国际标准化组织系列标准、与药品相关领域、与《中药材生产质量管理规范》等的关系,尤其应根据我国制药企业自身的特点,设计合理的GMP认证方案。

OBJECTIVE:To predict the trend of Good Manufacturing Practice(G MP)certification in China after2004.METHODS:The development and the current situation of GMP certification were summarized,the problems as well as the suggestions were put forward.RESULTS&CONCLUSIONS:GMP certification after2004should be integrated with Interˉnational Organization for Standardization(ISO),the domain correlated drug and'Good Agricultural Practices'(GAP),it should be design rational project of GMP certification on the basis of specificity of enterprises in China.