基于ICH指导原则的药用辅料元素杂质风险管理与评估  

Risk Management and Assessment of Elemental Impurities for Pharmaceutical Excipients Based on ICH Guidelines

作　　者：王粟明 宋郁 陈蕾[3] WANG Suming;SONG Yu;CHEN Lei(Ashland(China)Holdings Co.,Ltd.,Shanghai 200233,China;Merck Chemicals(Shanghai)Co.,Ltd.,Shanghai 200126,China;Chinese Pharmacopoeia Commission,Beijing 100061,China)

机构地区：[1]亚什兰(中国)投资有限公司,上海200233 [2]默克化工技术(上海)有限公司,上海200126 [3]国家药典委员会,北京100061

出　　处：《药学进展》2025年第2期91-99,共9页Progress in Pharmaceutical Sciences

基　　金：国家药典委员会课题(No.2020Y12)。

摘　　要：评估药用辅料的元素杂质是控制药品安全的重要一环。基于国际人用药品注册技术协调会(ICH)发布的指导原则和质量风险管理的理念,采用ICH Q3D元素杂质指导原则对药用辅料元素杂质进行有效风险评估的方法,可用于药用辅料和药品研发及生产实践。通过药用辅料中元素杂质的来源及其对药品安全性的影响研究,提出系统性的风险管理流程,包括风险评估、风险控制、风险沟通和风险回顾4个关键步骤。引用具体案例分析药用辅料元素杂质风险评估的实际操作方法,展望相关风险管理工具的应用前景和药用辅料质量管理的持续改进。The evaluation of elemental impurities in pharmaceutical excipients is a critical part of drug safety control.Based on the guidelines from the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use(ICH)and the quality risk management principles,an effective method for the risk assessment of elemental impurities in pharmaceutical excipients can be established using the ICH Q3D Elemental Impurities Guidelines.This approach is applicable to both the research and development and manufacturing of pharmaceutical excipients and drugs.This paper proposes a comprehensive risk management framework,which encompasses risk assessment,risk control,risk communication,and periodic risk review,by investigating the sources of elemental impurities in pharmaceutical excipients and their potential impact on drug safety.Through specific case studies,this paper reviews the practical methodologies for conducting risk assessment of elemental impurities in pharmaceutical excipients,with a prospect of the application of relevant risk management tools and the continuous improvement of the quality management of pharmaceutical excipients.

关 键 词：国际人用药品注册技术协调会 元素杂质 药用辅料 风险评估 风险管理 

分 类 号：R944[医药卫生—药剂学]