药品生产质量管理中变更控制的研究与分析  

Research and Analysis of Change Control in Pharmaceutical Production Quality Management

作　　者：杨敬鹏 张蕾 李武超 宋凯 蔡子洋 颜若曦 YANG Jingpeng;ZHANG Lei;LI Wuchao;SONG Kai;CAI Ziyang;YAN Ruoxi(Center for Food and Drug Inspection of NMPA,Beijing 100076,China;Sichuan Center for Food and Drug Evaluation,Inspection&Monitoring,Sichuan Chengdu 610017,China;Shandong Center for Food and Drug Evaluation&Inspection,Shandong Jinan 250014,China;Shanghai Center for Drug Evaluation and Inspection,Shanghai 201203,China)

机构地区：[1]国家药品监督管理局食品药品审核查验中心,北京100076 [2]四川省食品药品审查评价及安全监测中心,四川成都610017 [3]山东省食品药品审评查验中心,山东济南250014 [4]上海药品审评核查中心,上海201203

出　　处：《中国医药导刊》2025年第1期14-20,共7页Chinese Journal of Medicinal Guide

摘　　要：变更控制作为药品生产质量管理体系的核心组成部分,贯穿于药品全生命周期管理中,对于保障药品的质量、安全性及有效性发挥着重要作用。在快速迭代的制药行业中,变更控制是确保制质量改进不会对产品质量造成不利影响的重要手段,要求制药企业必须对生产过程、生产条件乃至质量管理体系的任何微小变动进行严格的监控、评估与研究。针对当前制药行业在药品生产质量管理变更控制中存在的问题与困惑,本研究在梳理分析国内外药品变更控制政策法规指南系统的基础上,基于具体实践案例,从全面质量管理体系角度分析和阐释了当前行业各类变更控制;同时,系统分析了近几年国内外药品检查中发现的药品生产企业在变更控制中存在的缺陷,总结提炼了变更文件体系的建立、风险评估的准确性、变更分级的合理性、变更方案的制定与执行、变更实施的有效性、变更跟踪的及时性、以及变更申报的规范性等变更控制体系各关键要素的常见问题,并系统梳理了实施变更控制的核心要点和改进建议,旨在为我国制药企业进一步做好变更控制提供参考与借鉴,同时也为高效检查变更控制的相关要点提供参考。Change control,as a core component of the pharmaceutical quality management system(QMS),is integral throughout the drug lifecycle,playing a critical role in ensuring drug quality,safety,and efficacy.In the rapidly evolving pharmaceutical industry,it serves as a vital mechanism to ensure that quality improvements do not adversely affect product quality,requiring manufacturers to rigor-ously monitor,evaluate,and investigate even minor changes to production processes,conditions,or the QMS itself.This study addresses current challenges in pharmaceutical change control by analyzing domestic and international regulatory guidelines and policies,supported by practical case studies,to examine contemporary practices from a comprehensive QMS perspective.It systematically identi-fies deficiencies in change control systems observed during recent inspections,highlighting common issues in documentation frameworks,risk assessment accuracy,change classification,implementation strategies,operational effectiveness,follow-up monitoring,and regula-tory compliance.The study synthesizes key implementation considerations and provides improvement recommendations,offering valuable insights for Chinese pharmaceutical enterprises to enhance their change control systems and for regulators to optimize inspection efficiency.

关 键 词：上市后变更 变更控制 检查缺陷 药品生产 药品生产质量管理 

分 类 号：R95[医药卫生—药学]