【正文】 Document History First Codification History Date New Codification November 2021 Q9 Approval by the Steering Committee under Step 2and release for public consultation. 22 March 2021 Q9 Q9 Approval by the Steering Committee of Post Step 2correction 15 June 2021 Q9 Current Step 4 version Q9 Approval by the Steering Committee under Step 4 and remendation for adoption to the three ICH regulatory bodies. 9 November 2021 Q9 QUALITY RISK MANAGEMENT 質量風險管理 ICH Harmonised Tripartite Guideline ICH三方 協(xié)調 指南 Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2021, this guideline is remended for adoption to the three regulatory parties to ICH TABLE OF CONTENTS 目 錄 1. INTRODUCTION 介紹 ......................................................................................1 2. SCOPE 范圍 ........................................................................................................2 3. PRINCIPLES OF QUALITY RISK ....2 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 一般質量風險管理的過程 ………………………………………………………………………………………… 2 ..........................................................................................................3 Initiating a Quality Risk Management Process..啟動質量風險管理過程 .......................3 Risk ..............................................................................................3 Risk .....................................................................................................4 Risk .......................................................................................5 Risk ......................................................................................................5 5. RISK MANAGEMENT METHODOLOGY風險管理方法 ...................................5 6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS將質量風險管理融入到工業(yè)和法規(guī)操作中 .........................................................................................................................6 7. .............................................................................................7 8. ....................................................................................9 Annex I: Risk Management Methods and Tools. 附錄 I：風險管理方法和工具 .......................................................................................11 Basic Risk Management Facilitation .........................11 Failure Mode Effects Analysis (FMEA)失敗模式效果分析（ FMEA） ............................11 Failure Mode, Effects and Criticality Analysis (FMECA) 失敗模式、效果及危害程度分析（ FMECA） ...........................................................................11 Fault Tree Analysis (FTA).故障樹形圖分析（ FTA） ............................................................12 Hazard Analysis and Critical Control Points (HACCP) 危險分析和關鍵控制點（ HACCP） .................................................................................12 Hazard Operability Analysis (HAZOP) 危險可操作性分析（ HAZOP） ..........................13 Preliminary Hazard Analysis (PHA) 事先危險分析（ PHA） ...............................................13 Risk Ranking and Filtering 風險分 級與過濾 ....................................................................13 Supporting Statistical Tools輔助統(tǒng)計工具 ............................................................................14 Annex II: Potential Applications for Quality Risk Management 附 錄 II：質量風險管理的應用 ....................................................................................................15 Quality Risk Management as Part of Integrated Quality Management 綜合 質量管理的 質量風險管理 ………………………………… . ..........................................15 Quality Risk Management as Part of Regulatory Operations 法規(guī)操作 的 質量風險管理 …………………………… ........................................................16 Quality Risk Management as Part of development 研發(fā)的 質量風險管理 .........................................................................................................16 Quality Risk Management for Facilities, Equipment and Utilities 設施、設備與公用工程的質量風險管理 ………………………………… ..............................17 Quality Risk Management as Part of Materials Management 物料 管理的質量風險管理 …………………………………………… .....................................18 Quality Risk Management as Part of Production 生產(chǎn)的質量風險管理 ………………………………… ..........................................................19 Quality Risk Management as Part of Laboratory Control and Stability Studies 實驗室控制盒穩(wěn)定性研究的質量風險管理 ……………………………………………… ..........19 Quality Risk Management as Part of Packaging and Labelling 包裝與貼簽的質量風險管理 …………………………………………… .....................................19 QUALITY RISK MANAGEMENT 質量風險管理 1. INTRODUCTION 介紹 Risk management principles are effectively utilized in many areas of business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies regulating these industries. Although there are some examples of the use of quality risk management in the pharmaceutical industry today, they are limited and do not represent the full contributions that risk management has to offer. In addition, the importance of quality systems has been recognized in the pharmaceutical industry and it is being evident that quality risk management is a valuable ponent of an effective quality system. It is monly understood that risk is defined as the bination of the probability of occurrence of harm and the severity of that harm. However, achieving a shared understanding of the application of risk management among diverse stakeholders is difficult because each stakeholder might perceive different potential harms, place a different probability on each harm occurring and attribute different severities to each harm. In relation to pharmac