过程确认及方法概述

1、整理ppt1整理ppt2整理ppt3整理ppt4整理ppt5整理ppt6整理ppt7整理ppt8整理ppt9整理ppt10整理ppt11整理ppt12整理ppt13整理ppt14整理ppt15Installation 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 specificatio

2、n 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。整理ppt16Operational qualification (OQ)操作鉴定（OQ）Establishing by objective evidence process control limits and action levels which result in product that

3、 meets all predetermined requirements 用客观证据确定能够生产出满足所有预定要求的产品的过程控制极限和行动标准。 整理ppt17Performance qualification (PQ)性能鉴定（PQ）establishing by objective evidence that the process, under anticipated conditions, consistently produces a product which meets all predetermined requirements.用客观证据确定，在预期条件下，过程能连续地产

4、出符合所有预定要求的产品。 整理ppt18整理ppt19整理ppt20整理ppt21整理ppt22整理ppt23过程确认的要素过程确认的要素确认确认安装鉴定安装鉴定操作鉴定操作鉴定性能鉴定性能鉴定开发开发整理ppt24何时确认何时确认A过程输出可验证吗？B验证是充分及成本可接受吗？C验证并控制过程D确认E重新设计产品和/或过程整理ppt25整理ppt26整理ppt27整理ppt28整理ppt29整理ppt30整理ppt31整理ppt32整理ppt33整理ppt34整理ppt35整理ppt36Protocol development方案编制 Process validation protocol

5、s should include the following elements:过程确认方案应该包括如下元素：l Complete description of the process 过程的完整描述 l Identification of the process to be validated 要确认的过程标识 l Select the worst case 选择最差条件（产品）l Identification of device(s) to be manufactured using this process 在这个过程下产出的器械的标识 l Objective and measurabl

6、e criteria for a successful validation 一个成功确认的目标和可测量的标准 l Length and duration of the validation 确认的用时和有效期限 l Shifts, operators, equipment to be used in the process 过程中采用的轮班制、操作人员和设备l Identification of utilities for the process equipment and quality of the utilities 过程设备中使用器具(utilities)的标识和质量l Identi

7、fication of operators and required operator qualification 操作员识别和要求的操作员资格（证） l 整理ppt37Protocol development方案编制 、l Relevant specifications that relate to the product, components, manufacturing materials, etc 产品、元件、生产材料等的相关规格 l Any special controls or conditions to be placed on preceding processes duri

8、ng the validation 在（过程）确认中，对先发生的过程所设置的任何特殊控制或条件 l Process parameters to be monitored, and methods for controlling and monitoring 要监控的过程参数和监控方法 l Product characteristics to be monitored and method for monitoring 监视的产品特性和方法 l Any subjective criteria used to evaluate the product 用来评估产品的主观标准 l Definitio

9、n of what constitutes non-conformance for both measurable and subjective criteria 对于可测量标准和主观标准，定义什么是不合格 l Statistical methods for data collection and analysis 数据收集和分析的统计方法 l Consideration of maintenance and repairs of manufacturing equipment 生产设备保养和修理方面的考虑 l IQ、OQ & PQl Criteria for revalidation

10、 再确认标准 整理ppt38Protocol development方案编制 For all three phases, IQ, OQ, and PQ, based on product/process requirements:对于三个阶段，IQ、OQ和PQ都要基于产品或过程的要求： l Determine what to verify/measure 决定验证或测量什么 l Determine how to verify/measure 决定如何验证或测量 l Determine how many to verify/measure, i.e. statistical significan

11、ce 决定验证或测量多少，如统计量 l Determine when to verify/measure 决定何时验证或测量 l Define acceptance/rejection criteria 规定接受或拒绝的标准 l Define required documentation 规定要求的文件 Remember: protocol must be reviewed and approved before execution 记住，在实施前，方案必须被评审和批准。整理ppt39Protocol development方案编制 Generally, protocol includes 4

12、 sections:一般来讲，方案可分为四大部分：The 1st section: validation overview, including validation scope, process description, background, worst cases, length and duration of the validation, objective etc.第一部分：确认概述部分，包含确认范围，过程描述，背景介绍，最差条件挑选，确认的用时和有效期限，目标 等等；The 2nd section: qualification readiness, including the r

13、equirements for man, machine, material, method, environment, test and label & traceability,PFMEA etc. 第二部分：鉴定准备阶段，包含所有的人、机、料、法、环、测及标志和追溯,PFMEA等要求和准备；The 3rd section: qualification (IQ,OQ&PQ), including qualification plan and deviation disposal etc. 第三部分：鉴定阶段(IQ,OQ&PQ)，包含鉴定计划及偏差处理等；The 4t

14、h section: document requirements，including the input and output documents required by this protocol.第四部分：文件要求，包含本方案所需的文件及输出文件要求。整理ppt40整理ppt41整理ppt42整理ppt43整理ppt44整理ppt45整理ppt46整理ppt47整理ppt48整理ppt49整理ppt50Some time, limits can be gotten herefrom experience and other source in advance 有时，此处可由经验或其他来源预先获得极限。整理ppt51整理ppt52整理ppt53整理ppt54整理ppt55整理ppt56整理ppt57整理ppt58整理ppt59整理ppt60整理ppt61PQ considerations include:PQ应该考虑： Actual product and process parameters and procedures established in OQ OQ阶段的真实产品、过程参数和建立的程序 Acceptability of the product 产品的可接受性 Assurance of