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INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR

HUMAN USE

人用药注册技术要求国际协调会议 ICH Harmonised Tripartite Guideline

人用药注册技术要求国际协调会议三方协调后的指南

Quality Risk Management

质量风险管理 Current Step 4 version 现行第四步版本 dated 9 November 2005 2005 年十一月 9日

This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to

the regulatory bodies of the European Union, Japan and USA. 本指南由人用药注册技术要求国际协调会议专家工作组根据人用药注册技术要求国际协调会议程序开发并提交各方的药政部门咨询。根据人用药注册技术要求国际协调会议程序第四步，推荐给欧盟、日本和美国药的政部门采用的最终

文本。

Document History

文件历史

Codification 最初编码 Q9 History 历史 Approval by the Steering Committee under Date Step 2 and release for public consultation. 日期 指导委员会批准第二步文件并发放用于22 March 2005 2005 / 3 /22 公开咨询 Approval by the Steering Committee of 15 June 2005 Post Step 2 correction 2005/ 6 / 15 指导委员会在批准第二步后的订正文件 Approval by the Steering Committee under 9 November Step 4 and recommendation for adoption 2005 to the three ICH regulatory bodies. 2005 / 11 / 9 指导委员会批准第四步文件并推荐 ICH 三方药政部门批准

Current Step 4 version 现行第四步版本 .~

Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2005, this guideline is recommended for adoption to the three regulatory parties to ICH

在 2005 年 11 月 9 日的人用药注册技术要求国际协调会议上，本指南已经通过人用药注册技术要求国际协调会议第四步程序，本指南已经推荐给人用药注册

技术要求国际协调会议三方的药政部门采用。

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TABLE OF CONTENTS

目录

1. INTRODUCTION 简介................................................................................1 2. SCOPE 范围............................................................................2

3. PRINCIPLES OF QUALITY RISK MANAGEMENT 质量风险管理的原则............2

4. GENERAL QUALITY RISK MANAGEMENT PROCESS 常规质量风险管理程序.....2

4.1 Responsibilities 职责.....................................................................................4 4.2 Initiating a Quality Risk Management Process 启动质量风险管理过程.......4 4.3 Risk Assessment 风险评估...................................................................4 4.4 Risk Control风险控制....................................................................5 4.5 Risk Communication风险沟通.....................................................................6 4.6 Risk Review 风险评审..................................................................6 5. RISK MANAGEMENT METHODOLOGY 风险管理方法学 ...................................7

6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS质量风险管理与业界及药政运行整合..................................................8

7. DEFINITIONS 定义.........................................................................9 8. REFERENCES 参考文献.................................................................11 Annex 附录 I: Risk Management Methods and Tools风险管理方法与工具... 12 I.1 Basic Risk Management Facilitation Methods基本风险管理简易方法 ....... 12 I.2 Failure Mode Effects Analysis故障模式效应分析(FMEA)..........................12 I.3 Failure Mode, Effects and Criticality Analysis 故障模式影响与严重性分析(FMECA)....................................................13

I.4 Fault Tree Analysis 故障树分析(FTA)........................................13 I.5 Hazard Analysis and Critical Control Points危害分析关键控制点(HACCP)....................................................................14

I.6 Hazard Operability Analysis 危害及可操作性分析(HAZOP)..................14 I.7 Preliminary Hazard Analysis 预先危险分析(PHA)...................................15