摘要
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.
出处
《中国药房》
CAS
CSCD
北大核心
2005年第10期730-731,共2页
China Pharmacy
关键词
药品生产质量管理规范
国际标准化组织
中药材生产质量管理规范
整合
Good Manufacturing Practice
International Organization for Standardization
Good Agricultural Practices
Integration
