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Table of Contents 1. INTRODUCTION 2. SCOPE 3. PRINCIPLES OF QUALITY RISK MANAGEMENT 4. GENERAL QUALITY RISK MANAGEMENT PROCESS 4.1 Responsibilities 4.2 Initiating a Quality Risk Management Process 4.3 Risk Assessment 4.4 Risk Control 4.5 Risk Communication 4.6 Risk Review 5. RISK MANAGEMENT METHODOLOGY 6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND 风险评估 风险控制 风险交流 风险回顾 风险管理方法学 工业及监管与质量风险管理的整合 职责分配 质量风险管理的启动 质量风险管理基本程序 目录 引言 范围 质量风险管理原理 REGULATORY OPERATIONS 7. DEFINITIONS 8. REFERENCES 定义 参考资料 Annex I: Risk Management Methods and 附件 I:风险管理方法及工具 Tools I.1 Basic Risk Management Facilitation I.1 基本风险管理简易方法 Methods I.2 Failure Mode Effects Analysis (FMEA) I.3 Failure Mode, Effects and Criticality Analysis (FMECA) I.4 Fault Tree Analysis (FTA) I.5 Hazard Analysis and Critical Control Points (HACCP) I.6 Hazard Operability Analysis (HAZOP) I.7 Preliminary Hazard Analysis (PHA) I.7 初步危害分析(PHA) I.8 Risk Ranking and Filtering I.8 风险排序及滤除 I.6 危害可操作性分析(HAZOP) I.3 失误模式影响及危险程度分析 (FMECA) I.4 故障树型分析(FTA) I.5 危害分析及关键控制点(HACCP) I.2 失误模式影响分析(FMEA) I.9 Supporting Statistical Tools I.9 辅助统计工具 Annex II: Potential Applications for 附件 II: 质量风险管理潜在应用前景. Quality Risk Management II.1 Quality Risk Management as Part of II.1 综合质量管理中的质量风险管理 Integrated Quality Management II.2 Quality Risk Management as Part of II.2 操作优化中的应用 Regulatory Operations II.3 Quality Risk Management as Part of II.3 研发中的应用 development II.4 Quality Risk Management for II.4 对工具、设备和设施的质量风险管Facilities, Equipment and Utilities 理 II.5 Quality Risk Management as Part of II.5 物料管理中的应用 Materials Management II.6 Quality Risk Management as Part of II.6 生产中的应用 Production II.7 Quality Risk Management as Part of II.7 实验室控制及稳定性研究中的应用 Laboratory Control and Stability Studies II.8 Quality Risk Management as Part of II.8 标签及包装中的应用 Packaging and Labelling 1. INTRODUCTION 引言 Risk management principles are 风险管理原理在商业和政府的许多领域都effectively utilized in many areas of 得到了有效应用，如：金融、保险、职业business and government including finance, insurance, occupational safety, public health, pharmacovigilance, and by agencies 安全、公共卫生、药物监测及相应的监管部门。如今质量风险管理在药企中虽有应用，但范围有限，并没有发挥出它的全部效用。药企已经意识到了质量体系的重要regulating these industries. Although 性，而质量风险管理越来越明显地成为有there are some examples of the use of 效质量体系的重要组分。 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 becoming evident that quality risk management is a valuable component of an effective quality system. It is commonly understood that risk is 根据常规理解，风险被定义为伤害发生的defined as the combination of the 可能性及严重程度。然而，要在不同利益probability of occurrence of harm and 集团之间寻求风险管理应用方面的共同认the severity of that harm. However, 识是相当困难的，因为他们认识到的潜在achieving a shared understanding of the 危害、各危害发生的可能性及严重程度都application of risk management among 不同。药品相关的利益集团很多，如病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. The manufacturing and use of a drug (medicinal) product, including its components, necessarily entail some 药品生产、使用过程，包括药品的成分，都会不可避免地引入一定的风险。质量风险只是其中的一部分。在产品整个生命周人、医疗人员和政府企业，但是质量风险管理的首要目的是保护病人。 degree of risk. The risk to its quality 期中，确保产品的质量，使得药品质量方
企业质量风险管理中英文对照
