药品生产现场检查工作中物料系统常见问题分析及检查策略思考  

Analysis of Common Problems in Material System during on-site Inspection of Drug Production and Consideration of Inspection Strategies

作　　者：招伟汉 张庆芬 江映珠 庞精聪 Zhao Weihan;Zhang Qingfen;Jiang Yingzhu;Pang Jingcong Qingfen(Center for Evaluation and Certification,Guangdong Drug Administration,Guangzhou 510080,China)

机构地区：[1]广东省药品监督管理局审评认证中心,广东广州510080

出　　处：《广东化工》2021年第16期120-121,共2页Guangdong Chemical Industry

基　　金：广东省药品监督管理局科技创新项目(2019ZDZ01)。

摘　　要：目的:为提高药品检查员对药品生产现场检查工作中对物料系统检查要求的认识,开拓检查思路,用相互联系的视觉制定检查策略提供参考。方法:对2019~2020年广东省药品现场检查工作中物料系统涉及的问题和检查经验进行梳理,整理出物料系统检查的主要内容、常见缺陷问题,并对检查策略开展研究。结果与结论:药品质量基于物料的质量,形成于药品生产的全过程。物料是药品生产质量管理过程中始终贯彻的一条线索,抓住这一线索将有利于对生产企业质量水平的评价。在药品生产现场检查工作中,在执行好规范明确要求的检查内容外,更应主动发掘不同体系间的有机联系,制定出具有突破性的检查策略。Objective: In order to improve the understanding of drug inspectors on the inspection requirements of the material system in the on-site inspection of drug production, open up inspection ideas, and provide reference for formulating inspection strategies with interconnected vision. Method: To sort out the problems and inspection experience involved in the material system in the drug on-site inspection work in Guangdong Province from 2019 to 2020, compare the requirements of drug GMP, sort out the main content of the material system inspection, common defects, and conduct research on inspection strategies. Results and conclusions: The material system is a set of clues implemented in the process of drug production quality management. Grasping the relationship between this set of clues and other elements will greatly benefit the evaluation of the quality assurance level of the manufacturer. In the on-site inspection of drug production, in addition to implementing the inspection content required by the specifications, it is also necessary to actively think, explore the organic connections between different systems, and formulate breakthrough inspection strategies.

关 键 词：药品生产现场检查 物料 分析 检查 策略 

分 类 号：TQ[化学工程]