摘要
目的通过介绍国际药品监管公约/药品监管合作计划(PIC/S)工厂主文档(SMF)的主要内容,为国内制药企业编写SMF、准备进口国的GMP现场检查提供参考。方法研究PIC/S工厂主文档(SMF)的指导文件及其他有关国家/地区的相关法规规定,明确其法律地位及内容、结构要求。结果与结论工厂主文档(SMF)在被欧盟(EU)及澳大利亚(TGA)GMP等同采用后,成为现场检查所需的重要文件,希望出口医药产品的国内企业引起足够的重视。
Objective To introduce the main contents of Site Master File recommended by PIC/S and provide domestic pharmaceutical manufacturer references on SMF preparation for GMP on-site inspection by competent authorities of import countries/regions. Methods We studied the SMF related g PIC/S and SMF related regulations and guidance from other competent authorities, and tried SMF legal role, content requirement and framework. Results and Conclusion After fully ad uidance from to clarify opted in EU GMP and by TGA, SMF played an important role in international on-site inspection, to which more attention should be paid by domestic pharmaceutical manufacturers with export business.
出处
《中国药事》
CAS
2012年第8期911-914,共4页
Chinese Pharmaceutical Affairs
