质量风险管理市局培训-11_精品文档.ppt

1、Quality Risk Management质量风险管理质量风险管理Overview Training概要培训概要培训Ronald TangSep.2010Introductions 介绍Learning Objectives 学习目的Background 背景Overview of Directive Purpose/Scope 目的/范围Requirements/Definitions 要求/定义Key Roles and Responsibilities 关键角色和责任Summary 总结Questions&Answers 问答Agenda 流程流程2This training cou

2、rse is an overview of the Quality Risk Management.此培训课程是针对质量风险管理的概要培训。At the conclusion of this module,you will have an understanding of:完成此培训课程你将了解到：完成此培训课程你将了解到：What is Quality Risk Management(QRM)?什么质量风险管理？什么质量风险管理？The BMS Technical Operations systematic approach to Quality Risk Management(QRM)施贵

3、宝技术操作部针对质量风险管理的系统方法施贵宝技术操作部针对质量风险管理的系统方法Key requirements,purpose and scope 关键要求，目的和范围关键要求，目的和范围Key roles and responsibilities 关键角色和责任关键角色和责任The recommended QRM tools for cGMP processes cGMP推荐的质量风险管理工具推荐的质量风险管理工具Learning Objectives 学习目标学习目标3Overview Training:Intended Audience概要培训：受众概要培训：受众Must become

4、 knowledgeable about the Quality Risk Management process 必须对质量风险管理流程熟悉的人May have oversight responsibility for the implementation of the process 可能对质量风险管理的实施负监督责任的人The QRM Overview course is for individuals who 质量风险管理概要培训课程是针对：4Background 背景背景Used in many industries for the past several decades(i.e.I

5、nsurance,IT,Medical Devices,Business).在过去的几十年间已应用于许多行业，例如保险、信息、医疗器械、商务Pharmaceutical industry has lagged behind.制药行业已经落在后面EU GMPs and inspectors have always“expected”risk management to be utilized.欧盟GMP和检察官一直期望风险管理的应用2005 November-ICH Q8&Q9 adopted.2005年11月ICH Q8&Q9 采用2008 February ICH Q9 becomes An

6、nex 20 in EU GMPs and Chapter 1 was revised.2008年2月欧盟GMP的附件20借鉴了ICH Q9并据此修改了第一章2008 June ICH Q10 adopted.2008年6月ICH Q10采用5EU GMPs Chapter 1 欧盟欧盟GMP第一章第一章Quality Risk Management(QRM)is a systematic process for the assessment,control,communication and review of risks to the quality of the medicinal pr

7、oduct.It can be applied both proactively and retrospectively.质量风险管理(QRM)是一个系统化的流程，是对药品的质量风险进行评估，控制，交流并且回顾的过程。它既是前瞻性的也是可回顾的。The quality risk management system should ensure that:质量风险管理系统应该确保：the evaluation of the risk to quality is based on scientific knowledge,experience with the process and ultimat

8、ely links to the protection of the patient 对质量风险的评估是基于科学知识，生产经验，并最终联系到对患者的保护对质量风险的评估是基于科学知识，生产经验，并最终联系到对患者的保护the level of effort,formality and documentation of the quality risk management process is commensurate with the level of risk 质量风险管理流程的程度，格式和文件应与风险的级别相一致质量风险管理流程的程度，格式和文件应与风险的级别相一致Examples of

9、 the processes and applications of quality risk management can be found in Annex 20.质量风险管理的流程和应用实例参见欧盟GMP的附件20.6FDA cGMPs for the 21st Century Desired State FDA cGMP的期望状态的期望状态In response to todays challenges facing pharmaceutical manufacturing and quality,FDA launched its“Pharmaceutical CGMPs for th

10、e 21st Century:A Risk-Based Approach”in August 2002 to:为回应今天的药品生产和质量所面临的挑战，美国FDA在2002年8月推出了“21世纪的制药CGMP：一个基于风险的方法”：Encourage innovation and early adoption of advanced manufacturing technologies PAT/QbD 鼓励创新和先进制造技术的早期采用-性能加速技术/质量源于设计 Facilitate continuous improvement through robust Quality Systems 通过

11、强有力的推动持续改进质量体系 Encourage the use of risk-based and science-based approaches to focus on critical areas.鼓励以风险为本和以科学为基础的方式，重点加强关键领域2004 FDAs“GMPs for the 21st Century”challenges us to use a Risk Based Approach in our operations.2004年FDA的“21世纪GMP”挑战我们在实际操作中采用基于风险的方法7How do we get to Desired State?如何达到期

12、望状态？如何达到期望状态？8ICH Q8,Q9,Q10-Desired State!ICH Q8,Q9,Q10的期望状态的期望状态Quality by Design QbD质量源于设计质量源于设计(ICH Q8)Quality RiskManagement质量风险管理质量风险管理(ICH Q9)Quality Systems 质量系统质量系统(ICH Q10)The Three Musketeers9Key Definitions 关键定义关键定义Detectability 探测度Occurrence 发生率Severity 严重性Risk 风险Residual Risk 残留风险Risk M

13、anagement 风险管理Risk Identification 风险识别10Key Definitions(continued)关键定义关键定义Risk Analysis 风险分析Risk Evaluation 风险估算Risk Control 风险控制Risk Acceptance 风险接受Risk Reduction 风险降低Risk Communication 风险交流Risk Review 风险回顾11Purpose 目的目的To provide a systematic approach to the QRM and examples of the tools for the u

14、se,integration and application of QRM to varying aspects of pharmaceutical quality,including development,manufacturing,distribution,inspection and submission/review processes throughout the lifecycle of the drug product,API,medical devices and biological drug substances.为质量风险管理提供一个系统方法和管理工具应用范例去评估药品

15、质量的各个方面，包括研发，生产，分销，检查和以及药品，API，医疗器械和生物药整个生病周期中的提交/回顾流程。WWQC-1.4.3 QRM 质量风险管理：Provides a structured approach to of QRM across the product lifecycle and within cGMP systems/processes.In-line with the principles outlined in ICH Q9 and ISO 14971.在cGMP系统/流程内，为贯穿于整个药品生命周期的质量风险管理提供一个结构化的工具。与ICH Q9和ISO14971

16、的原则相一致。12This Directive applies to:本指南使用于：本指南使用于：The utilization of QRM when applied to all operations at all BMS Technical Operations facilities and employees engaged in the development,management,manufacture,control and/or distribution throughout the lifecycle of drug product,API,medical devices and biological drug substances(including the use of raw materials,solvents,excipients and packaging components).质量风险管理适用于所有BMS技术操作部，以及所有致力于开发，管理，生产，控制和/或药品/原料药/医疗器械/生物药整个生病周期中的分销（包括使用原料，溶剂，辅料和包装材料）。The