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公司名称
验 证 主 计 划 Validation Master Plan VMP
文件编号
File No.
Байду номын сангаас
﹡﹡﹡﹡ ﹡﹡ 共﹡﹡页
﹡﹡Pages in all
版 页
本 数
Version
Page number
修订记录 Revision records 修订版本
Revision
修订日期
Revised Date
修订/更改要求的原因
Reasons for revision / modification
修订者
Reviser
****药业有限公司
***** Pharmaceutical Co., Ltd.
R-SOP***
Page 1 of 32
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公司名称
目录 Content
1 缩略语清单 List of Abbreviations......................................................................................................... 4 2 验证人员与职责....................................................................................................................................... 4 2.1 验证小组成员 Membership of Validation Steering Committee................................................ 4 2.2 职责 Responsibilities..................................................................................................................... 5 3 VMP 概述................................................................................................................................................. 7 3.1 VMP 的目的 The purposes of the VMP...................................................................................... 7 3.3 VMP 的范围..................................................................................................................................... 7 3.3.1 验证计划分类...................................................................................................................... 7 4 验证依据的法规与指南 Regulatory Standards And Guidelines....................................................... 8 5 厂房描述 Project Description............................................................................................................... 8 5.1 厂房地点 Site Location..................................................................................................................8 5.2 厂房设计和布局 Facility Design and Layout.............................................................................. 9 5.2.1 生产区域 Production Suites.............................................................................................. 9 5.2.1.1 固体制剂楼............................................................................................................... 9 5.2.1.2 纯化水制备................................................................................................................ 9 5.2.1.3 空调净化系统和压缩空气........................................................................................ 9 5.2.1.4 仓库.......................................................................................................................... 10 5.2.2 QC....................................................................................................................................... 10 5.2.3 废水处理室........................................................................................................................ 10 5.2.4 危险品库............................................................................................................................ 10 6 产品及工艺概述 Description of Products and Processes.............................................................. 10 6.1 简介 Introduction.........................................................................................................................10 6.2 产品组 Product Groups.............................................................................................................. 10 6.3 工艺 Processes............................................................................................................................ 10 7 确认和验证.............................................................................................................................................10 7.1 确认和验证的目的....................................................................................................................... 10 7.2 何时进行确认和验证.................................................................................................................... 11 7.3 确认和验证的关系........................................................................................................................ 11 7.4 确认和验证分类 Validation Activities........................................................................................ 11 7.5 GMP 影响评估 Impact Assessment.......................................................................................... 12 7.6 风险评估 Risk Assessment........................................................................................................ 12 7.7 验证矩阵 Validation Matrix......................................................................................................... 12 7.8 确认............................................................................................................................................... 12 7.8.1 厂房设计确认.................................................................................................................... 12 7.8.2 设备确认............................................................................................................................ 12 7.8.2.1 用户需求标准（URS）User Requirement Specification (URS).................... 13 7.8.2.2 设计确认（DQ）Design Review/Qualification（DQ）................................... 13 7.8.2.3 工厂验收测试（FAT ）Factory Acceptance Tests.............................................13