药品注册生产现场检查的实施现状分析

Analysis of the Implementation Status of On-site Inspection for Drug Reg istration and Production

本文从药品注册生产现场检查现状的分析入手,明确了检查依据及检查主体,而后以省级药品监督管理局的药品注册生产现场检查项目为例,探讨了检查过程中发现的问题及具体的化解对策,并给出了药品注册生产现场检查工作优化的保障措施,旨在通过药品生产企业、药品监督管理部门双重配合,提高药品注册生产现场检查通过率,从而为高标准、高质量的药品生产提供保障。

The article starts from the analysis of the current situation of drug registration production site inspection,clarifies the inspection basis and inspection subject,and then takes the provincial drug administration's drug registra⁃tion production site inspection project as an example,discusses the problems found in the inspection process and spe⁃cific countermeasures,and gives the guarantee measures for the optimization of the drug registration production site in⁃spection work,to improve the production site inspection rate of drug registration through the dual cooperation of drug manufacturers and drug supervision and management departments,so as to provide a guarantee of high standards and quality drug production.