制药厂房设备验证培训

如:一个简短的描述:(要论证Fedegari FEOF3 型自动灭菌釜能够在规定时间内对 48盘2毫升装安瓿做到灭菌.)
(A short statement e.g. To demonstrate that the Fedegari FE0F3 Autoclave is capable of terminally sterilising a full load of 48 trays of filled 2ml ampoules)

6
验证的生命周期
验证的生命周期涵盖整个工艺、设备的使 用周期 关键阶段： 客户需求/VMP/FAT/设计/设计确认 起始验证 变更管理（专论） 验证回顾

7
验证的定义Definitions of Validation


根据GMP的各项原则,为证明所有的过程、工 艺、设备、原材料、活动或系统能够确实达到 预期结果而采取行动. 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 GMP欧共体指南 EU Guide To GMP
8
验证的定义Definitions of Validation


验证是通过过程的文件化来提供一定的保证,保证某一 特定的设施或操作能够持续地生产出满足预先规定的 规格标准.验证包含了从设计到最终批准使用的所有活 动. Validation is the documented programme that provides a high degree of assurance that a specified facility or operation will consistently produce a given product meeting a predetermined specification. Validation covers all activities from design to final approval for use GSK 质量系统术语表 GSK Quality System Glossary
18
验证主计划Validation Master Plan







概况/介绍Introduction 目标Objective 方法Approach 范围Scope 基本原理Justification / Rationale 可接受范围Acceptance Criteria 辅助程序Support Programmes 组织结构Organisation / Team structure 时间计划Schedule 附录Appendix
Rreferences to governing policies and procedures.
验证中所涉及标准的参考依据 A reference to the standards followed to ensure that validation is planned,coordinated and performed in a controlled and compliant 应该包括系列的公司政策、指南、SOP和其它相 关文件 a list of company policies and guidelines, SOPs and other reference documents used
21

方法Approach


来自百度文库

明确如何进行验证. A definition of how the validation will be conducted 建立一个将要使用的文件系统 Establishes the document system to be used 描述将要传达的信息或文件 Describes information and documents to be delivered 确定整个验证文件创建各阶段的责任 Defines responsibilities for stages of development of the documentation

建立文件化的证据，该证据能保证某一特定过程/工 艺能够持续地生产符合事先规格标准和质量特征的产 品. Establishing documented evidence which provides a degree of assurance that a specific process will consistently produce a product meeting its predetermined specification and quality attributes. 美国FDA US FDA
19
概况/介绍 Introduction



简要介绍项目所希望的结果 Brief summary of project with expected outcomes 概要性的介绍所要验证的设备/设施 General description of equipment, facility or process to be validated 参照标准文件,设备/设施和工艺的设计方案 Reference to compliance documents to which the equipment, facility or process has been designed
14
Validation Activities 验证工作内容

在项目和VMP水平上工厂验证的总安排 SVMP validatiion activities will generally be provided at a high level by a project or VMP
15
日程安排和进展 Schedules and progress

新厂房验证培训
教案准备:必成制药
讲师: 白坚
1
新厂房验证培训内容
1. 验证主计划和验证生命周期-验证管理 2. 安装确认与运行确认介绍 3. 洁净厂房级别与药品剂型的匹配-空气净化系统介绍与要求 4. 基本概念-客户需求、前期研究、初步风险评估、预算、总体
细节设计、技术指标、供应商选择/采购、完成细 节设计、建造 /FAT/安装、校正、工程试运行、工艺 试运行、项目移交
16
Validation Master Plan (VMP)
验证主计划 (VMP)
17
验证主计划Validation Master Plan



它是验证项目的关键性控制文件 This is the key control document for the validation project 它是一个活的文件,在项目过程当中会变化(版本控制) It is a living document and will change through the project (Version control) 它明确了一个大家认可的责任,进度,测试方法、接受范围 及决策背景. It defines the agreed responsibilities, approach, testing regimes and acceptance criteria and the reasons behind decisions VMP应该尽早制定好. It should be put in place (version 0) as early as practical in the validation programme
5. 新项目管理和验证的切入点 6. 工程试运行和验证文件剖析
2
培训时间安排

09:00-10:45 10:45-10:55 10:55-12:00 13:00-14:50 14:50-15:00 15:00-17:00

验证主计划与验证生命周期 中间休息 安装确认与运行确认介绍,洁净级别与药品 剂型的匹配/相关法规要求剖析 空气净化系统介绍- 简介/构成/确认与验


指导政策和程序的参照Rreferences to governing policies and procedures. 职责范围 Responsibilities 验证工作 Validation activities 日程安排和进展 Schedules and progress
12
指导政策和程序的参照

验证的生命周期 验证定义回顾 工厂验证主计划 验证主计划 验证维护体系
4
验证的定义Definitions of Validation
证明任何规程（或方法）、生产工艺、
设备、物料、活动或系统能达到预期结 果的有文件证明的一系列活动。 -中国GMP定义
5
验证的定义Definitions of Validation
证要点

中间休息 基本概念-客户需求、前期研究、初步风险评估、
预算、总体 细节设计、技术指标、供 应商选择/ 采购、完成细节设计、建造 /FAT/安装、校正、工程试运行、工艺试 运行、项目移交;
新项目管理和验证的切入点,工程试运行和验证文 件剖析
3
主题1：验证主计划和验证生命周期-验证管理


20
目标 Objective


一个简明的对于要完成任务的描述,提供一个 对该验证的完整理解.
A concise statement of the task to be performed to allow a complete understanding of the validation exercise




涵盖从设计到放行可能影响质量的所有操作
Covers all operations impacting on quality from design to release
10
Site Validation Master Plan (VMP)
工厂验证主计划 (VMP)
11
工厂验证主计划 Site Validation Master Plan
9
通常项目Common themes


文件化的证明
Documented evidence


控制度/可信度的示证
Demonstrate control / confidence


事先规定的可接收范围
操作的一致性
Pre-determined acceptance criteria Consistency of operation

13
职责Rresponsibilities


明确在工厂水平上谁负责验证的管理、协调、提供 资源、批准specify who is accountable for managing and coordinating,provision of resource,and approving at a site level SVMP由作者、工厂总监和工厂质量主管批准即可 Typically the signatories to the SVMP will be the author,site director and senior quality excutive



以甘特图或类似方式给出的至少12个月内的验证日程安排a planning schedule should exist in the form of a Gantt chart as a minimum,lists all identified validation activities, at project level,forward 12 month period 版本变更主要因为计划变更 version update chiefly due to the plan change 大变更必须给出原因，可行性判断的解释 Significant change needs to be a clear explanation and justification