【正文】 效的管理過程會將所有因素納入考慮，各因素受關注程度會因風險的特異而各有區(qū)別 。 and ? The level of effort, formality and documentation of the quality risk management process should be mensurate with the level of risk. 質量風險管理的兩條基 本原理是： 1. 評估質量風險應基于科學知識并最終同對病人的保護聯(lián)系起來。有時也允許使用非正式的風險管理程序（用經驗工具或內部程序）。 The purpose of this document is to offer a systematic approach to quality risk management. It serves as a foundation or resource document that is independent of, yet supports, other ICH Quality documents and plements existing quality practices, requirements, standards, and guidelines within the pharmaceutical industry and regulatory environment. It specifically provides guidance on the principles and some of the tools of quality risk management that can enable more 此文件的目的是 提供質量風險管理方面的系統(tǒng)方法 。在產品整個生命周期中，確保產品的質量，使得藥品質量方面的重要性質與臨床研究中的一致 ，做到這些是非常重要的。 然而，要在不同利益集團之間尋求風險管理應用方面的共同認識是相當困難的，因為他們認識到的潛在危害、各危害發(fā)生的可能性及嚴重程度都不同。Contains Nonbinding RemendationsQUALITY RISK MANAGEMENT Q9 工業(yè) 指南 Q9 質量風險管理 美國健康與公眾服務部 食品藥品 監(jiān)督 管理 局（ FDA） 藥品評價與研究中心 （ CDER） 生物評價與研究中心 (CBER) 2022 年 6 月 人用藥物注冊技術要求國際協(xié)調會議（ ICH） Contains Nonbinding Remendations Table of Contents 目錄 1. INTRODUCTION 引言 2. SCOPE 范圍 3. PRINCIPLES OF QUALITY RISK MANAGEMENT 質量風險管理原理 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 質量風險管理基本程序 Responsibilities 職責分配 Initiating a Quality Risk Management Process 質量風險管理的啟動 Risk Assessment 風險評估 Risk Control 風險控制 Risk Communication 風險 交流 Risk Review 風險 回顧 5. RISK MANAGEMENT METHODOLOGY 風險管理方法學 6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 工業(yè)及監(jiān)管與質量風險管理的整合 7. DEFINITIONS 定義 8. REFERENCES 參考資料 Annex I: Risk Management Methods and Tools 附件 I:風險管理方法及工具 Basic Risk Management Facilitation Methods 基本風險管理簡易方法 Failure Mode Effects Analysis (FMEA) 失 誤模 式影響分析 (FMEA) Failure Mode, Effects and Criticality Analysis (FMECA) 失 誤模式影響及危險程度分析 (FMECA) Fault Tree Analysis (FTA) 故障樹型分析 (FTA) Hazard Analysis and Critical Control Points (HACCP) 危害分析及關鍵控制點 (HACCP) Hazard Operability Analysis (HAZOP) 危害可操作性分析 (HAZOP) Preliminary Hazard Analysis (PHA) 初步危害分析 (PHA) Risk Ranking and Filtering 風險排序及濾除 Supporting Statistical Tools 輔助統(tǒng)計工具 Annex II: Potential Applications for Quality Risk Management 附件 II: 質量風 險管理潛在應用前景 . Quality Risk Management as Part of Integrated 綜合質量管理中的質量風險管理 Contains Nonbinding Remendations Quality Management Quality Risk Management as Part of Regulatory Operations 操作優(yōu)化中的應用 Quality Risk Management as Part of development 研發(fā)中的應用 Quality Risk Management for Facilities, Equipment and Utilities 對工具、設備和設施的質量風險管理 Quality Risk Management as Part of Materials Management 物料管理中的應用 Quality Risk Management as Part of Production 生產中的應用 Quality Risk Management as Part of Laboratory Control and Stability Studies 實驗室控制及穩(wěn)定性研究中的應用 Quality Risk Management as Part of Packaging and Labelling 標簽及包裝中的應用 Contains Nonbinding Remendations 1. INTRODUCTION 引言 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. 風險管理原理在商業(yè)和政府的許多領域都得到了有效應用，如：金融、保險、職業(yè)安全、公共衛(wèi)生、藥物監(jiān)測及相應的監(jiān)管部門。 It is monly understood that risk is defined as the bination of the probability of occurrence of harm and the severit