Validation(有效性鉴定.pdf

Process Validation Process Validation 有效性鉴定 有效性鉴定 Quality Assurance - Process Validation Quality Assurance Process Validation July, 2008 ©2000 Procter Gamble ©2000 Procter Gamble About The Course 关于该培训 • Background for the training 背景 – PG QAKE KE6 • Not a Training but a forum 讨论 • Raise question any time 欢迎提问 • Time: 2-3 hrs Quality Assurance - Process Validation Quality Assurance Process Validation July, 2008 ©2000 Procter Gamble ©2000 Procter Gamble Obj ective 学学习习本本课课程程要要求求达达到到的的目目标标 Obj ective 学学习习本本课课程程要要求求达达到到的的目目标标 1.有效性鉴定的基本概念和其重要性 2.有效性鉴定的种类和方法。 3.有效性鉴定系统和主计划 4.编写与执行有效性鉴定协议草案与报告 Quality Assurance - Process Validation Quality Assurance Process Validation July, 2008 ©2000 Procter Gamble ©2000 Procter Gamble What is Validation? 什什么么是是有有效效性性签签定定？？ What is Validation? 什什么么是是有有效效性性签签定定？？ • Validation is establishing documented evidence that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.有效性签定是文件化地 证实一个工艺过程能够持续地生产符合既定 规格或质量要求的产品. Machine Method Machine Method Material Product Material Process Product Process Human Human Quality Assuranc