摘要
新的《药品管理法》于2019年12月1日起实施,其配套性法律法规文件《药品生产监督管理办法》(2020年版)提出了药品生产企业新建、改建、扩建车间/生产线及药品上市的药品生产质量管理规范(GMP)符合性检查的要求。本文旨在通过梳理相关法律法规,阐述药品GMP符合性检查定义、法律依据、检查分类,同时针对药品GMP符合性检查常态化、关注要点、同步实施检查情形及恢复生产启动药品GMP符合性检查时间等操作层面容易遇到的问题进行梳理总结,为药品GMP符合性检查的施行提供参考意见。
The new Drug Administration Law was implemented on December 1st,2019.Its supporting legal and regulatory document,the Measures for the Supervision and Administration of Drug Production(2020 Edition),puts forward the requirements for the compliance inspection of Drug Production Quality Management Practices(GMP)for the new,reconstructed and expanded workshops/production lines of drug manufacturing enterprises and the listing of drugs.This paper was intended to elaborate the definition,legal basis and inspection classification of GMP compliance inspection by combing the relevant laws and regulations.and summarize the problems in the implementation process,such as normalization of GMP compliance inspection,key points of attention,synchronous implementation of inspection and the time of starting GMP compliance inspection before resuming production.It provided reference opinions for the implementation of GMP compliance inspection.
作者
温雯
朱晓东
熊磊
张军平
张瑜华
李平
WEN Wen;ZHU Xiaodong;XIONG Lei;ZHANG Junping;ZHANG Yuhua;LI Ping(Jiangxi Center for Drug Certification and Evaluation(Jiangxi Center for Medical Device Evaluation),Nanchang Jiangxi 330046,China;Jingdezhen Pharmaceutical Association,Jingdezhen Jiangxi 333000,China)
出处
《药品评价》
CAS
2022年第9期574-576,共3页
Drug Evaluation
基金
2019年江西省药品监督管理局科研项目(2019GL03)。
