【正文】 Contains Nonbinding RemendationsQUALITY RISK MANAGEMENT Q9 工業(yè) 指南 Q9 質(zhì)量風(fēng)險管理 美國健康與公眾服務(wù)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(shù)要求國際協(xié)調(diào)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(zhì)量風(fēng)險管理原理 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 質(zhì)量風(fēng)險管理基本程序 Responsibilities 職責(zé)分配 Initiating a Quality Risk Management Process 質(zhì)量風(fēng)險管理的啟動 Risk Assessment 風(fēng)險評估 Risk Control 風(fēng)險控制 Risk Communication 風(fēng)險 交流 Risk Review 風(fēng)險 回顧 5. RISK MANAGEMENT METHODOLOGY 風(fēng)險管理方法學(xué) 6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS 工業(yè)及監(jiān)管與質(zhì)量風(fēng)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(fēng)險管理方法及工具 Basic Risk Management Facilitation Methods 基本風(fēng)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(guān)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(fēng)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(zhì)量風(fēng) 險管理潛在應(yīng)用前景 . Quality Risk Management as Part of Integrated 綜合質(zhì)量管理中的質(zhì)量風(fēng)險管理 Contains Nonbinding Remendations Quality Management Quality Risk Management as Part of Regulatory Operations 操作優(yōu)化中的應(yīng)用 Quality Risk Management as Part of development 研發(fā)中的應(yīng)用 Quality Risk Management for Facilities, Equipment and Utilities 對工具、設(shè)備和設(shè)施的質(zhì)量風(fēng)險管理 Quality Risk Management as Part of Materials Management 物料管理中的應(yīng)用 Quality Risk Management as Part of Production 生產(chǎn)中的應(yīng)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(yīng)用 Quality Risk Management as Part of Packaging and Labelling 標(biāo)簽及包裝中的應(yīng)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(fēng)險管理原理在商業(yè)和政府的許多領(lǐng)域都得到了有效應(yīng)用，如：金融、保險、職業(yè)安全、公共衛(wèi)生、藥物監(jiān)測及相應(yīng)的監(jiān)管部門。如今質(zhì)量風(fēng)險管理在藥企中雖有應(yīng)用，但范圍有限，并沒有發(fā)揮出它的全部效用。 藥企已經(jīng)意識到了質(zhì)量體系的重要性，而質(zhì)量風(fēng)險管理越來越明顯地成為有效質(zhì)量體系的重要組分。 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 pharmaceuticals, although there are a variety of stakeholders, including patients and medical practitioners as well as government and industry, the protection of the patient by managing the risk to quality should be considered of prime importance. 根據(jù)常規(guī)理解，風(fēng)險被定義為傷害發(fā)生的可能性及嚴(yán)重程度。 然而，要在不同利益集團之間尋求風(fēng)險管理應(yīng)用方面的共同認(rèn)識是相當(dāng)困難的，因為他們認(rèn)識到的潛在危害、各危害發(fā)生的可能性及嚴(yán)重程度都不同。藥品相關(guān)的利益集團很多，如病人、醫(yī)療人員和政府企業(yè)， 但是質(zhì)量風(fēng)險管理的 首要目的是保護病人。 The manufacturing and use of a drug (medicinal) 藥品生產(chǎn)、使用過程，包括藥品的成分，都會不可避Contains Nonbinding R