发布时间 : 星期日 文章ICH-Q9质量风险管理更新完毕开始阅读7a1f14d511a6f524ccbff121dd36a32d7275c793
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE
人用药注册技术要求国际协调会议 ICH Harmonised Tripartite Guideline
人用药注册技术要求国际协调会议三方协调后的指南
Quality Risk Management
质量风险管理 Current Step 4 version 现行第四步版本 dated 9 November 2005 2005 年十一月 9日
This Guideline has been developed by the appropriate ICH Expert Working Group and has been subject to consultation by the regulatory parties, in accordance with the ICH Process. At Step 4 of the Process the final draft is recommended for adoption to
the regulatory bodies of the European Union, Japan and USA.
本指南由人用药注册技术要求国际协调会议专家工作组根据人用药注册技术要求国际协调会议程序开发并提交各方的药政部门咨询。根据人用药注册技术要求国际协调会议程序第四步，推荐给欧盟、日本和美国药的政部门采用的最终
文本。
Document History
文件历史 CodificatioHistory Approval by the Steering Committee under Date n Step 2 and release for public consultation. 历史 日期 最初编码 指导委员会批准第二步文件并发放用于Q9 22 March 2005 公开咨询 2005 / 3 /22 Approval by the Steering Committee of 15 June 2005 Post Step 2 correction 2005/ 6 / 15 指导委员会在批准第二步后的订正文件 Current Approval by the Steering Committee under 9 November Step 4 Step 4 and recommendation for adoption to 2005 version the three ICH regulatory bodies. 2005 / 11 / 9 现行第四指导委员会批准第四步文件并推荐 ICH 步版本 三方药政部门批准
Having reached Step 4 of the ICH Process at the ICH Steering Committee meeting on 9 November 2005, this guideline is recommended for adoption to the three regulatory parties to ICH
在 2005 年 11 月 9 日的人用药注册技术要求国际协调会议上，本指南已经通过人用药注册技术要求国际协调会议第四步程序，本指南已经推荐给人用药注册
技术要求国际协调会议三方的药政部门采用。
TABLE OF CONTENTS
目录
1. INTRODUCTION 简介................................................................................1 2. SCOPE 范围............................................................................2
3. PRINCIPLES OF QUALITY RISK MANAGEMENT 质量风险管理的原则............2
4. GENERAL QUALITY RISK MANAGEMENT PROCESS 常规质量风险管理程序.....2
4.1 Responsibilities 职责.....................................................................................4 4.2 Initiating a Quality Risk Management Process 启动质量风险管理过程.......4 4.3 Risk Assessment 风险评估...................................................................4 4.4 Risk Control风险控制....................................................................5
4.5 Risk Communication风险沟通.....................................................................6 4.6 Risk Review 风险评审..................................................................6 5. RISK MANAGEMENT METHODOLOGY 风险管理方法学 ...................................7
6. INTEGRATION OF QUALITY RISK MANAGEMENT INTO INDUSTRY AND REGULATORY OPERATIONS质量风险管理与业界及药政运行整合..................................................8
7. DEFINITIONS 定义.........................................................................9 8. REFERENCES 参考文献.................................................................11
Annex 附录 I: Risk Management Methods and Tools风险管理方法与工具... 12 I.1 Basic Risk Management Facilitation Methods基本风险管理简易方法 ....... 12 I.2 Failure Mode Effects Analysis故障模式效应分析(FMEA)..........................12 I.3 Failure Mode, Effects and Criticality Analysis 故障模式影响与严重性分析(FMECA)....................................................13
I.4 Fault Tree Analysis 故障树分析(FTA)........................................13 I.5 Hazard Analysis and Critical Control Points危害分析关键控制点(HACCP)....................................................................14
I.6 Hazard Operability Analysis 危害及可操作性分析(HAZOP)..................14 I.7 Preliminary Hazard Analysis 预先危险分析(PHA)...................................15 I.8 Risk Ranking and Filtering风险排序及过滤 ........................15
I.9 Supporting Statistical Tools辅助性统计工具............................................16 Annex 附录 II: Potential Applications for Quality Risk Management 实施质量风险管理的潜在机会.......................................16
II.1 Quality Risk Management as Part of Integrated Quality Management 整合质量管理部分的质量风险管理....................16
II.2 Quality Risk Management as Part of Regulatory Operations 药政操作部分的质量风险管理...........................................18
II.3 Quality Risk Management as Part of development 开发部分的质量风险管理 ..................................................................19
II.4 Quality Risk Management for Facilities, Equipment and Utilities 厂房，设备和公用设施的质量风险管理 ..................19
II.5 Quality Risk Management as Part of Materials Management 物料管理部分的质量风险管理..........................................21
II.6 Quality Risk Management as Part of Production 生产部分的质量风险管理......................................................................21
II.7 Quality Risk Management as Part of Laboratory Control and Stability Studies 实验室控制和稳定性研究部分的质量
Quality Risk Management质量风险管理风险管理....................................22
II.8 Quality Risk Management as Part of Packaging and Labelling 包装和标签部分的质量风险管理...................................22
1. INTRODUCTION 导言
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 becoming evident that quality risk management is a valuable component of an effective quality system.
风险管理原则被有效地应用于许多商业和政府的领域，包括金融、保险、职业安全、公共健康、药物预警，以及这些行业的主管部门。如今，尽管在制药行业也有一些运用质量风险管理的例子，但其非常有限，且没有体现出风险管理能提供的全部贡献。另外，制药行业已经认识到质量体系的重要性，而且，质量风险管理对一个有效的质量体系来说，是一个有价值的组成部分这一点越来越明显。
It is commonly understood that risk is defined as the combination 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.
通常将风险理解为，风险是由伤害发生的概率及伤害严重性结合而成。然而，在不同的风险涉众中达成对风险管理应用共识仍是困难的，因为每个风险涉众可能感觉到不同的潜在伤害，对每个所发生的伤害设置不同的概率以及伤害不同的严重性属性。对于药品来说，尽管有多种的风险涉众，包括患者、医疗从业人员，以及政府和业界，运用质量风险管理都应该以保护病人为基本出发点。
The manufacturing and use of a drug (medicinal) product, including its components, necessarily entail some degree of risk. The risk to its quality is just one component of the overall risk. It is important to understand that product quality should be
maintained throughout the product lifecycle such that the attributes that are important to the quality of the drug (medicinal) product remain consistent with those used in the clinical studies. An effective quality risk management approach can further ensure the high quality of the drug (medicinal) product to the patient by providing a proactive means to identify and control potential quality issues during development and manufacturing. Additionally, use of quality risk management can improve the
decision making if a quality problem arises. Effective quality risk management can facilitate better and more informed decisions, can provide regulators with greater assurance of a company’s ability to deal with potential risks and can beneficially affect the extent and level of direct regulatory oversight.
药物(医疗)产品制造和使用，包括它的组份，必然要承担一定程度的风险。其质量风险仅是全部风险中的一个。重要的是要了解到，产品质量应当贯穿产品的生命周期，这个属性对于药物(医疗)产品保持与临床研究时一致是非常重要的。通过前瞻意义上辨识与控制在研发与制造中的潜在质量问题，一个有效的