过程确认及方法概述资料.ppt

Process Validation Approach Overview过程确认及方法概述 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 Validation 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 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 Validation (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 requirements. 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 1987…Global Harmonization Task Force released: Quality Management Systems-Process Validation Guidance 1987年…医疗器械全球协调行动组织发布：质量管理体系-过程确认指导 1987…FDA release: Guideline on General Principles of Process Validation 1987年…发布FDA：过程确认