新版ICH《Q9(R1):质量风险管理》解析  

Interpretation of the New Edition of ICH Q9(R1):Quality Risk Management

作　　者：吴菲 胡菁 高易娥 孙营 胡俊 李茜 WU Fei;HU Jing;GAO Yi-e;SUN Ying;HU Jun;LI Qian(Wuhan Institute of Biological Products Co.,Ltd.;Chengdu Institute of Biological Products Co.,Ltd.)

机构地区：[1]武汉生物制品研究所有限责任公司 [2]成都生物制品研究所有限责任公司

出　　处：《中国食品药品监管》2025年第2期62-69,共8页China Food & Drug Administration Magazine

摘　　要：国际人用药品注册技术协调会(ICH)发布的新版《Q9(R1):质量风险管理》是制药企业实施质量风险管理工作的重要依据,并在多部法规和指南中被提及。本文通过对新版ICH《Q9(R1):质量风险管理》的修订内容进行解析和探讨,以期为制药企业质量风险管理的有效实施提供参考。The International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)released Q9(R1):Quality Risk Management,which serves as a crucial reference for pharmaceutical enterprises in implementing quality risk management and is cited in numerous regulations and guidelines.This article interprets and discusses the revised contents of the new ICH Q9(R1):Quality Risk Management with the aim of providing references for the effective implementation of quality risk management in pharmaceutical enterprises.

关 键 词：质量风险管理 ICHQ9(R1) 解析 探讨 有效实施 

分 类 号：R95[医药卫生—药学]