课件下载--质量风险管理在制药业的应用.pptVIP

Page # Overview Training - WWQC-1.4.3 Overview Training: Intended Audience概要培训：受众 Must become 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 Background 背景 Used in many industries for the past several decades (i.e. Insurance, 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 GMP’s 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 Annex 20 in EU GMP’s 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 EU GMP’s Chapter 1 欧盟GMP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 product. 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 ultimately 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 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 Examples of 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. FDA cGMPs for the 21st Century – Desired State FDA cGMP的期望状态 In response to today’s challenges facing pharmaceutical manufacturing and quality, FDA launched its “Pharmaceutical CGMPs for the 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”