.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 20052005 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History历史Approval by the Steering Committee under Step 2 and release for public consultation.指导委员会批准第二步文件并发放用于公开咨询Date日期Q922 March 20052005 / 3 /22Approval by the Steering Committee of Post Step 2 correction指导委员会在批准第二步后的订正文件15 June 20052005/ 6 / 15Current Step 4 version现行第四步版本Approval by the Steering Committee under Step 4 and recommendation for adoption to the three ICH regulatory bodies.9 November 20052005 / 11 / 9精品.指导委员会批准第四步文件并推荐 ICH 三方药政部门批准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。精品.TABLE OF CONTENTS目录1. INTRODUCTION 简介.12. SCOPE 范围.23. PRINCIPLES OF QUALITY RISK MANAGEMENT 质量风险管理的原则.24. GENERAL QUALITY RISK MANAGEMENT PROCESS 常规质量风险管理程序.24.1 Responsibilities 职责.44.2 Initiating a Quality Risk Management Process 启动质量风险管理过程.44.3 Risk Assessment 风险评估.44.4 Risk Control风险控制.54.5 Risk Communication风险沟通.64.6 Risk Review 风险评审.65. RISK MANAGEMENT METHODOLOGY 风险管理方法学 .76. 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.87. DEFINITIONS 定义.9精品.8. REFERENCES 参考文献.11Annex 附录 I: Risk Management Methods and Tools风险管理方法与工具. 12I.1 Basic Risk Management Facilitation Methods基本风险管理简易方法 . 12I.2 Failure Mode Effects Analysis故障模式效应分析(FMEA).12I.3 Failure Mode, Effects and Criticality Analysis 故障模式影响与严重性分析(FMECA).13I.4 Fault Tree Analysis 故障树分析(FTA).13I.5 Hazard Analysis and Critical Control Points危害分析关键控制点(HACCP).14I.6 Hazard Operability Analysis 危害及可操作性分析(HAZOP).14I.7 Preliminary Hazard Analysis 预先危险分析(PHA).15I.8 Risk Ranking and Filtering风险排序及过滤 .15I.9 Supporting Statistical Tools辅助性统计工具.16Annex 附录 II: Potential Applications for Quality Risk Management 实施质量风险管理的潜在机会.16II.1 Quality Risk Management as Part of Integrated Quality Management 整合质量管理部分的质量风险管理.16II.2 Quality Risk Management as Part of Regulatory Operations 药政操作部分的质量风险管理.18II.3 Quality Risk Management as Part of development 开发部分的质量风险管理 .19II.4 Quality Risk Management for Facilities, Equipment and Utilities 厂房，设备和公用设施的质量风险管理 .19精品.II.5 Quality Risk Management as Part of Materials Management 物料管理部分的质量风险管理.21II.6 Quality Risk Management as Part of Production 生产部分的质量风险管理.21II.7 Quality Risk Management as Part of Laboratory Control and Stability Studies 实验室控制和稳定性研究部分的质量Quality Risk Management质量风险管理风险管理.22II.8 Quality Risk Management as Part of Packaging and Labelling 包装和标签部分的质量风险管理.22精品.1. INTRODUCTION 导言Risk management principles are effectively utilized in many areas of busi