【正文】 Contains Nonbinding RemendationsQUALITY RISK MANAGEMENT Q9 工業(yè) 指南 Q9 質(zhì)量風(fēng)險(xiǎn)管理 美國(guó)健康與公眾服務(wù)部 食品藥品 監(jiān)督 管理 局（ FDA） 藥品評(píng)價(jià)與研究中心 （ CDER） 生物評(píng)價(jià)與研究中心 (CBER) 2022 年 6 月 人用藥物注冊(cè)技術(shù)要求國(guó)際協(xié)調(diào)會(huì)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(xiǎn)管理原理 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 質(zhì)量風(fēng)險(xiǎn)管理基本程序 Responsibilities 職責(zé)分配 Initiating a Quality Risk Management Process 質(zhì)量風(fēng)險(xiǎn)管理的啟動(dòng) Risk Assessment 風(fēng)險(xiǎn)評(píng)估 Risk Control 風(fēng)險(xiǎn)控制 Risk Communication 風(fēng)險(xiǎn) 交流 Risk Review 風(fēng)險(xiǎn) 回顧 5. RISK MANAGEMENT METHODOLOGY 風(fēng)險(xiǎn)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(xiǎn)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(xiǎn)管理方法及工具 Basic Risk Management Facilitation Methods 基本風(fēng)險(xiǎn)管理簡(jiǎn)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(xiǎn)程度分析 (FMECA) Fault Tree Analysis (FTA) 故障樹(shù)型分析 (FTA) Hazard Analysis and Critical Control Points (HACCP) 危害分析及關(guān)鍵控制點(diǎn) (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(xiǎn)排序及濾除 Supporting Statistical Tools 輔助統(tǒng)計(jì)工具 Annex II: Potential Applications for Quality Risk Management 附件 II: 質(zhì)量風(fēng) 險(xiǎn)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(xiǎn)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(duì)工具、設(shè)備和設(shè)施的質(zhì)量風(fēng)險(xiǎn)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(shí)驗(yàn)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(xiǎn)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(xiǎn)、職業(yè)安全、公共衛(wèi)生、藥物監(jiān)測(cè)及相應(yīng)的監(jiān)管部門。如今質(zhì)量風(fēng)險(xiǎn)管理在藥企中雖有應(yīng)用，但范圍有限，并沒(méi)有發(fā)揮出它的全部效用。 藥企已經(jīng)意識(shí)到了質(zhì)量體系的重要性，而質(zhì)量風(fēng)險(xiǎn)管理越來(lái)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(xiǎn)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(tuán)之間尋求風(fēng)險(xiǎn)管理應(yīng)用方面的共同認(rèn)識(shí)是相當(dāng)困難的，因?yàn)樗麄冋J(rèn)識(shí)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(tuán)很多，如病人、醫(yī)療人員和政府企業(yè)， 但是質(zhì)量風(fēng)險(xiǎn)管理的 首要目的是保護(hù)病人。 The manufacturing and use of a drug (medicinal) 藥品生產(chǎn)、使用過(guò)程，包括藥品的成分，都會(huì)不可避Contains Nonbinding R