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1、Process Validation & Approach Overview 过程确认及方法概述,Wally Wang Paragon Medical Device Changzhou 王新化 派瑞格医疗器械（常州）有限公司,Agenda/Topics 日程 / 主题,What is Process Validation? 什么是过程确认？ Brief history of validation 确认的简要历史 Who concerns about validation? 谁关心确认？ Expectations 期望 Definitions/Compliance 定义 / 符合性 Valida
2、tion Economics 确认的经济意义 Examples of Warning Letters 警告信的案例 Elements of Process Validation 过程确认的要素 When to Validate 何时确认 Validation Master Plans 确认主计划 What is Required to Be Outstanding in Process Validation? 确认中需要强调什么？ Steps to Validation of a Process 过程确认的步骤 Protocol development 方案编制 IQ 安装鉴定 OQ 操作鉴定
3、 PQ 性能鉴定 The Final Report 最终报告 Revalidation 再确认 Monitoring 监控,Why Are we discuss this? 为什么我们要讨论？,Validation may be new 也许确认对你来说是一个全新的概念 You need a refresher 你需要更新知识 You have specific questions 你有一些具体的问题 You may be under a 483 (or worse, a warning letter!) 也许你已经收到了483（或更糟，警告信！）,What is Process Valida
4、tion (FDA)? 什么是过程确认(FDA)？,Process validation is establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics 过程确认就是建立一套能证明特定的过程可以以高度的信心持续地生产出满足预定规格和质量特性的产品的书
5、面证据。 Guidelines on General Principle of Process Validation, GMP Manual, May 1987 过程确认总原则指导， 1987年5月，GMP手册，,What is Process Validation (GHTF)? 什么是过程确认(GHTF)?,Process validation: establishing by objective evidence that a process consistently produces a result or product meeting its predetermined requi
6、rements. 过程确认：有客观证据支持，即过程将连续地产出符合预定要求的结果或产品。 2004 GHTF,History of Validation 确认的简要历史,Before 1978.no FDA regulations 1978年之前.没有FDA法规 Current GMP became law in 1978 目前的GMP是在1978年成为法规的 1987Global Harmonization Task Force released: Quality Management SystemsProcess Validation Guidance 1987年医疗器械全球协调行动组织发
7、布：质量管理体系-过程确认指导 1987FDA release: Guideline on General Principles of Process Validation 1987年发布FDA：过程确认总原则指导 1999Global Harmonization Task Force update: Quality Management SystemsProcess Validation Guidance 1999年医疗器械全球协调行动组织更新了：质量管理体系-过程确认指导 2004Global Harmonization Task Force update: Quality Managem
8、ent SystemsProcess Validation Guidance 2004年医疗器械全球协调行动组织更新了：质量管理体系-过程确认指导,Who concerns about validation? 谁关心确认？,Medical device manufacturing and quality management regulatory 医疗器械生产质量管理规范 FDA Preamble FDA导言 ISO13485：2003；YY0287：2003 21 CFR 820FDA Regulation 21 CFR 820FDA法规 Global Harmonization Task
9、Force 全球医疗器械协调行动组织 Company who hopes to consistently produce a product meeting its predetermined specifications and quality characteristics 希望能持续地生产出满足预定规格和质量特性的产品的公司,The Expectation 期望,One of the principles on which the quality systems regulation is based is that all processes require some degree o
10、f qualification, verification, or validation, and manufacturers should not rely solely on inspection and testing to ensure processes are adequate for their intended use. 质量体系法规建立的基本原则之一是：所有的过程都要求进行一定程度的认证、验证、或确认，制造商不应该仅仅依靠检验和测试来确保其过程能充分地满足其预期要求。 Preamble #41, pg. 52612,Does Your Company Need to Do P
11、rocess Validation? 你们公司需要做过程确认吗？,Yes, if you are producing a medical device (it is the law!) 是的，如果你们生产医疗器械，需要做过程确认（这是法规要求！） What are classes of medical devices? 医疗器械的类别 Class I 一类 Class II 二类 Class III 三类,Does Your Company Need to Do Process Validation? 你们公司需要做过程确认吗？,Are any classes of medical devic
12、es exempt? 哪个类别的医疗器械不需要做过程确认？ No! Unless specifically stated in Medical Device Exemptions 510(k) and GMP Requirements 没有！除非医疗器械豁免510(k) 和GMP要求中有特别声明。 http:/www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpcd/315.c fm,Definitions 定义,Understanding definitions is important in making sure we all are on the
13、 same page especially when it comes to talking with the FDA. 理解定义对于确保我们有相同的理解是非常重要，尤其当我们与FDA讨论时。 Your definition of how a term is interpreted is not as important as knowing how the FDA interprets it! 对于一个条款的解释，你个人的解释没有了解FDA的解释重要。,Objective Evidence 客观证据,Objective evidence is information that can be
14、proved true, based on facts through observation, measurement, test or other means. 客观证据是可以通过观察、测量、测试或其他方法被证实为真实的信息。 ISO 8402 2.19 As the old saying goes, “If you didnt document it, you didnt do it!” 正如老话所说“如果你没有做记录，就等于你什么也没做”。,Verification 验证,Confirmation by examination and provision of objective ev
15、idence that specified requirements have been fulfilled. 通过检查并提供客观证据来证实已经满足特定的要求。 820.3 (aa),Process Validation Protocol 过程确认方案,A document stating how validation will be conducted, including test parameters, product characteristics, manufacturing equipment, and decision points on what constitutes acc
16、eptable test results. 说明如何实施确认的文件，包含了测试参数、产品特性、生产设备和由什么构成可接受测试结果的判断要点。 2004 GHTF Sometimes validation requires you start with the acceptance criteria and work backwards. 有时候，过程确认要求你首先从确定接受标准开始，逆向实施确认。,Installation qualification (IQ) 安装鉴定（IQ）,Establishing by objective evidence that all key aspects of the process equipment and ancillary system installation adhere to the manufacturers approved specification and that the recommendations of the supplier of the equipment are suitably considered. 用客观证据来支持证明，所安装的过程设备和辅助系统的关键安装方面，能满足制造商已批准的技术规范，且供应商的建议也被恰当的考虑了。 2004 GHTF,
