GMP验证过程介绍

• Define product and process characteristics that could be affected by what’s being validated. 说明会受验证内容影响的产品和过程的特征
These requirements include: 这些要求包括：
---Those defined in specifications 质量标准说明的内容 ---Appropriate reference standards, i.e. GMP, ISO, ANSI,
Benefits of Validation 验证的好处
• Quality Benefits 质量方面的好处 • End User Benefits 用户方面的好处 • Business Benefits 商业方面的好处
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Improve Customer Satisfaction / Reduce Cost
验证并不会随验证方案的开始或结束而开始或结束, 它是
持续改进的一个闭合循环活动
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First Step in Validation 验证的第一步
• Establish a Team
建立一个团队
---One of the most important things you can do to
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What Process Require Validation 什么样的过程需要验证
• “ All processes that affect quality must be validated ” “所有影响质量的过程都必须验证。”
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First Step in Validation 验证的第一步
• The team members 团队成员 ---Chemist, Microbiologist, Quality Engineer, Project Engineer, Sterility Assurance Engineer, Production Supervisor, Regulation officer, IT ---化学师, 微生物师, 质量工程师, 无菌保证工程 师, 生产主管, 法规专员, 信息技术人员
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What is Validation
FDA Definition FDA对验证的定义
• Established documented evidence which provide a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes.
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1998版中国GMP
• 第七章的第五十七条至第六十条提出了 “验证“的要求：
1. 验证包括哪些方面， 2. 什么情况下要验证， 3. 验证的实施， 4. 验证的归档。
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SECOND SECTION 第二部分
• What Processes need to be Validated 什么样的过程需要验证？
Types of Processes that required validation 需要验证的过程的类型
• Critical System, e g. Water, air, steam 关键性系统，如水，空气，蒸汽系统等
• Product Manufacturing Processes 产品制造过程 • Product Design Changes 产品设计变更 • New or modified equipment 新的或改良的设备 • Computer Software 计算机软件 • Sterilization 灭菌 • Analytical Test Methods 分析测试方法 • Cleaning Methods 清洁方法
• Sterilization Validation Brief Introduction 灭菌验证简介
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FIRST SECTION 第一部分
• Definitions of Validation 验证的定义 • Significance of a Validation 验证的意义
Begin validation开始验证
End validation 结束验证
Time 时间
Without validation
Begin
没有验证
Production开始生产
Savings 节省 $
Begin
Production 开始生产
With validation 有验证
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THIRD SECTION 第三部分
• Describe an effective Process Validation 描述有效的过程验证
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Validation System Model 验证系统模式
Validation------> 验证
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• Why do we validate? 为什么我们要进行验证？
1. To control the assessment and implementation of equipment and processes, which might impact product safety, quality or efficacy 为了控制那些可能影响产品安全性, 质量或 功效的过程的评估和实施.
High/Mid Risk 高 ／中风险
Low Risk 低风险
Develop Protocol 准备验证 方案
Validation Waiver 验证豁免
Run
Validation 进行验证
Prepare Final Report 准备总结报 告
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Define Requirements 说明要求
• Faster time to market 加快进入市场的步伐
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Regulatory Requirements 法规方面的要求
• Regulatory Agencies require validation:
---US FDA via Drug/Device GMPs
Define Requirements 说明要求
• Design inputs --- To specify each requirements of
product / process, it is including:
设计输入 --- 说明产品或过程的每一项要求，它包 括:
--- Reliability
assure a successful validation is to form a multi-
functional team to oversee the validation activities
---保证验证成功的最重要事情之一是，组建一 个多功能的团队来监督验证活动
源自文库
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2. Fulfill regulatory requirement 满足法规的要求
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Validation Learning Curve 验证学习曲线
Numbers of system errors 系统错误数 量
Begin Process Development 开始过程准备
USP, MDD, etc. 适当的参考标准，如：GMP, ISO, ANSI, USP, MDD 等 ---Additional requirements not covered in specifications and standards 质量标准和参考标准里未包括的附加要求
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---EU CE Mark via the MDD/ISO
---Japan via the GMPs
---Australia via the TGA
法规机构要求验证：
---美国FDA的药品及医疗器械的GMP认证 ---欧洲CE标志的MDD及ISO认证 ---日本的GMP认证
---澳大利亚的TGA认证
• Review what processes need to be validated 检查什么样的过程需要验证
• Describe an effective process validation 描述一个有效的过程验证
• Describe how to manage process validation 描述如何管理过程验证
建立提供高度保证的书面证据，确保特定过程 将持续生产满足既定参数和质量属性的产品。
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What is Validation
ISO Definition ISO对验证的定义
• Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are fulfilled.
Process Operation ------>Re-validation
& Monitoring
再验证
过程操作和监控
Validation Management 验证管理
Validation does not begin or end with the protocol, it is a
continuous improvement process
提高客户满意度/降低成本
• Reduce defects, scrap and rework 减少瑕疵品，废品和返工
• Reduce complaints and field corrective actions 减少投诉和区域纠正措施
• Reduce development time 缩短准备周期
Validation Training
Introduction to Process Validation 过程验证简介
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Course Contents 课程内容
• Explain what validation is and why we do it 验证的定义及进行验证的原因
可靠性
--- Characteristics
特征
--- Physical Requirements
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Validation Following Steps
验证后续步骤
Define
Requirements 说明要求
Approve & File Final Report 批 准并将总结报告 归档
FMEA /
Quality Risk Analysis 失效 模式和影响 分析(FMEA)/ 质量风险分 析
通过测试和提供客观证据，确认达到特定预期用 途的特殊要求是否得到满足。
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What is Validation
Baxter’s Definition 百特公司对验证的定义
• “Confirmation by examination and provision of objective evidence that the particular requirements for a specific intended use are consistently fulfilled.” “通过测试和提供客观证据，确认达到特定预期 用途的特殊要求是否得到持续满足。”