新形势下关于开展药品GMP符合性检查的思考  

Reflections on GMP Compliance Inspections under the New Situation

作　　者：曹鸿雁 张杰 赵杰 柴发永 柏建学 周勇 CAO Hong-yan;ZHANG Jie;ZHAO Jie;CHAI Fa-yong;BAI Jian-xue;ZHOU Yong(Shandong Center for Food and Drug Evaluation and Inspection)

机构地区：[1]山东省食品药品审评查验中心

出　　处：《中国食品药品监管》2024年第7期114-121,共8页China Food & Drug Administration Magazine

摘　　要：《药品管理法》《药品生产监督管理办法》等法律法规修订实施后,提出了药品生产质量管理规范(GMP)符合性检查的概念。以山东省为例,依企业申请开展的药品GMP符合性检查涉及改扩建生产线、场地变更、委托生产等,申报检查情形复杂多样。同时,药品上市许可持有人或药品生产企业还需要接受许可检查、注册核查和上市后监督检查等,部分企业出现频繁接受检查的情况,为相关企业及检查资源带来新的挑战。本文着重梳理和分析了药品GMP符合性检查依据的法律法规政策,以及山东省药品检查剂型或种类、检查情形、检查需求问卷调研情况等,并结合检查实际,依法并基于风险管理原则,探索性地提出关于开展药品GMP符合性检查的思考。After the revision and implementation of the Drug Administration Law and the Drug Production Supervision and Management Rules,the concept of good manufacturing practice(GMP)compliance inspection was proposed.Taking Shandong Province as an example,GMP inspections applied by enterprises include renovation and expansion of production lines,site changes,commissioned production,etc.In addition,marketing authorization holders or drug manufacturing enterprises also undergo licensing inspections,registration checks,and post-market inspections.Frequent inspections pose new challenges to enterprises and inspection resources.This article focuses on laws,regulations and policies that form the basis of GMP inspections,as well as the dosage forms or types,inspection situations,and inspection demands displayed in a questionnaire survey conducted for Shandong enterprises.Combining actual inspections with principles of risk-based management,this paper explores opinions and suggestions for conducting GMP compliance inspections.

关 键 词：药品生产质量管理规范 符合性检查 检查情形 风险管理 

分 类 号：R95[医药卫生—药学]