验证生命周期

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验证Validation =
文件证明所需验证的系统达到预期的标准 ＋一致性 Documented demonstration of expected Quality + Consistency
Garfield Wang
Refresh GMP training for Engineering
03/03/2010
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GQP1204-验证生命周期 Validation Life Cycle
周期性的方法－结构化的，文件化的 Life Cycle Approach－structured, documented process
不No
回顾和参与 Review and participate
项目暂停 Project Suspended
评估 Validation impact review
项目管理 Project Management
决定DECISION
文件DOCUMENT
项目组任务 PROJECT TEAM
验证行为 VALIDATION ACTIVITIES
为什么会这样Ask WHY??
Garfield Wang
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03/03/2010
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那么为什么要验证 So Why Validate?
畅所欲言Brainstorming
Garfield Wang
Refresh GMP training for Engineering
验证生命周期 Validation Life Cycle
验证回顾报告VRR
常规使用Go/routine use
用户使用要求 URS
DQ 设计标准
DS
PQ
动态Dynamic OQ 静态Static IQ
验证总结报告VSR
SOPs 培训Training
建立Build/buy
Garfield Wang
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• 验证包括所有的操作过程，从设计到最终使用 Validation covers all activities from design through to final approval for use.
Garfield Wang
03/03/2010
Refresh GMP training for Engineering
开始验证 Initial Validation
变更管理 Change Management
验证回顾 Validation Review
Garfield Wang
Refresh GMP training for Engineering
03/03/2010
13
GQP1204-验证生命周期 Validation Life Cycle
•验证在很多方面已成为我们工厂负面的强制性任务 “Validation is becoming, in many ways, a negative force within our site”.
•验证更多的是带有官僚色彩，而非科学化的操作过程 “It is evolving into a bureaucratic exercise rather than a scientific one”
Garfield Wang
03/03/2010
Refresh GMP training for Engineering
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为什么NERI3 的验证过程没有价值-一切正常 Why no value for the NERI3 sensor validation?－ everything is OK
但是But： 市场上收到投诉Complaints received from the market QA中控－不稳定QA in process control-unstable
法规从未解释说验证就是3次连续验证，但是已经成为一种习惯的思维模式 Authorities never explain that the validation is 3 consistence tests, but it’s become conventional pattern.
Garfield Wang
验证必须包括Validation must be performed on all:
• 设备Facilities • 电脑Computers • 工艺Processes • 系统Systems
对质量有影响的任何体系 that have been identified as having a potential impact on product quality
03/03/2010
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第1阶段Stage 1-开始Initiation
开始 Project Initiation
商业需要 BUSINESS NEED
解释KEY
行动ACTION
工厂批准 Site Approval t
Progress
是Yes
用户要求摘要 Higher level User Requirements Brief
03/03/2010
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第1阶段包括Activities during stage 1:
• 形成项目组Project team assembling
• 用户要求纲要－高水平Higher level URB
• 主验证计划－高水平Higher level VMP
• 认证计划Qualification planning - 详细的文件Detailed documentation - 进程时间The schedule - 资源和物料要求The resource and materials requirement
验证是通过文件证明所需验证的系统达到预期的标准 Validation is the establishment of documented evidence that a system does what it is supposed to do.
Garfield Wang
Refresh GMP training for Engineering
Garfield Wang
Refresh GMP training for Engineering
03/03/2010
8
定义Definitions-WHO
•是积累和评估数据的过程，从工艺开发到常规的生产过程，保证整个生 产过程－包括设备，建筑，人员和物料能够一致的、连续性的达到其预 期的结果 The collection and evaluation of data, beginning at the process development stage and continuing through the production phase, which ensures that the manufacturing processes - including equipment, buildings, personnel and materials - are capable of achieving the intended results on a consistent and continuous basis.
03/03/2010
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定义Definitions-EU
•是一种证明符合GMP规范要求，任何的操作规 范，工艺，设备，物料，行为或系统都能达到其预 期的结果的操作 Action of proving, in accordance with the principles of GMP, that any procedure, process, equipment, material, activity or system actually leads to the expected results
项目组 Project Team
第二阶段 To stage 2
认证 Qualification?
是Yes
主验证计划 Higher level Validation Master Plan
不No
不需要 No Qualification required
Garfield Wang
Refresh GMP training for Engineering
Garfield Wang
Refresh GMP training for Engineering
03/03/2010
14
验证生命周期Validation Life Cycle
Garfield Wang
Refresh GMP training for Engineering
03/03/2010
15
03/03/2010
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定义Definitions-GSK QMS Glossary
• 文件证明设备，实验室，计算机，工艺或系统能够一致的、连续性的达 到其预期的标准 A documented process that provides a high degree of assurance that a facility, laboratory, computer, process or system will consistently and reproducibly produce product, or perform to a predetermined specification.
Refresh GMP training for Engineering
3
关于验证的一些说法Some Quotes...
•那些负责验证的人员需要回答很多问题：“验证为什么会延迟？”，” 为什么会出现这个问题？”，“为什么要花多余的钱？” “Those responsible ...(for validation)...have much to answer for in terms of confusion, delays and unnecessary cost”.
Garfield Wang
03/03/2010
Refresh GMP training for Engineering
4
验证需要Validation WILL involve…
• 时间People’s time • 资源Resources • 生产过程/产品放行时间延迟
Possible delays in production/product release • 文件Documentation • 准备SOP Available SOPs
03/03/2010
Refresh GMP training for Engineering
2
目的Objective
• 了解验证过程 Have a command of the validation activities
• 学习过去经验Learn from past
Garfield Wang
03/03/2010
验证生命周期 Validation Life Cycle
13/04/2006
Refresh GMP training for Engineering
目录Content
验证介绍Validation Introduction 验证生命周期Validation life cycle 总结Summary
Garfield Wang
• 变更控制Change control management
Garfield Wang
Refresh GMP training for Engineering
03/03/2010
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风险评估过程概述
Risk Assessment Processห้องสมุดไป่ตู้Overview
系统水平上影响评估 SLIA (system)
10
共同点Common Themes
• 正式的，文件证明Formal, documented evidence • 受控、自信Demonstration of control / confidence • 预设定的可接受标准Pre-determined acceptance criteria • 操作的一致性Consistency of operation • 包括所有影响质量的操作 Covers all operations impacting on quality