VMP验证主计划
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Validation Master Plan
第 3 页 共 20 页
1.
Purpose 目的
The Validation Master Plan describes the procedures for the qualification and validation that are to be used for the manufacture of pharmaceutical substances. 验证主计划描述了药品生产相关的确认和验证步骤。
6.1. Qualification Activities 验证内容.................................................................................. 14
6.2. Qualification Documents preparation and Approval 验证文件准备与审批.................... 15 6.3. The Qualification Dossier and Archiving 验证文件夹与归档 ........................................ 16
FAT = Factory Acceptance Test
FAT = 工厂验收测试
Acceptance of an important or critical object at the manufacture’s / supplier’s facility. The FAT documentation can be an integrated part of the commissioning and or qualification.
6.4. Deviation Handling 测试偏差处理 ............................................................................... 16 6.5. Change Control 变更控制 ........................................................................................... 17
5.4. List of Validation Responsibilities 验证负责人列表 ...................................................... 13
6.
Overview of the Plant Qualification 工厂确认概述................................................... 14
logo
文件编码 File Code 文件名称 File Name
验证主计划
Validation Master Plan
第 4 页 共 20 页
design documents have been implemented.
DQ 提供文件证明该厂房和系统的设计适于预定的用途，满足 GMP、URS、FS 及 TS 的要求，且完全执行了设计文件的内 容。
4.
Validation Strategy 验证策略 .................................................................................... 10
4.1. The VMP parts 验证主计划包括的部分 ....................................................................... 10
4.2. The V model 确认/验证策略的 V 模型.......................................................................... 10 4.3. Documentation Standards 验证文件的标准................................................................. 11
5.
Organisation, Responsibilities 组织架构，职责....................................................... 12
5.1. Qualification Team Leader 验证经理........................................................................... 12
2.
Scope 范围................................................................................................................... 3
3.
Abbreviations, Definitions 缩写 ................................................................................. 3
The qualification and validation provides documented evidence that the installations are suitable for the intended purpose and that the stipulated guidelines (especially the GMP requirements) have been fulfilled. 验证和确认提供文件证明，保证安装情况能实现预期的目的且满足预定方针（尤其是 GMP 方面） 的要求。
Reviewed by 审核人：
Date of Review 审核日期：
Approved by 批准人：
Date of approval 批准日期：
Date of Effect 生效日期：
CC: Engineering;QA;QC;PD; Logistics 传阅：工程部；QA；QC；生产部；供应链
Process for executing and approving suggested changes to facilities and/or systems, that could influence the qualification / validation. 一种程序，用于批准对验证和确认产生影响的设施或系统的变 更 A form used process GMP-relevant changes.
6.6. Personnel Training 人员培训 ...................................................................................... 17 6.7. Plant Maintenance 工厂维护 ....................................................................................... 18
5.2. Supervisor of Qualification 验证主管 .......................................................................... 13
5.3. Supervisor of Documentation 文档管理负责人 ............................................................ 13
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File Name 文件名称 File Code 文件编号 Draft 起草部门： Review 审 核： Review 审 核： Review 审 核： Review 审 核： Approval 批 准： State of Control 受控状态
验证主计划 Validation Master Plan
用于记录 GMP 相关变更的记录表格
Report 报告
DQ = Design Qualification DQ = 设计确认
A document containing results is defined as a report.
Examples: Validation Report / DQ Report / OQ Report / Test Report
6.8. Maintenance / Revalidation 维护/再验证 ..................................................................... 18
7.
Validation Schedule 验证进度计划............................................................................ 19
将一份包含结果的文件定义为报告。 例如： 验证报告/DQ 报告/OQ 报告/测试报告
The DQ provides documented evidence that the proposed design for the plant or system is suitable for the foreseen use and conforms to the requirements of GMP and that all requirements in the user requirements specification, the functional specifications, the technical specification and the
第 2 页 共 20 页
Table of contents 目录
1.
Purpose 目的 .............................................................................................................. 3
logo
文件编码 File Code 文件名称 File Name
验证主计划
Validation Master Plan
◆◆◆中英文对照文件，以中文为准◆◆◆ ◆◆◆Bilingual Document, Chinese shall prevail◆◆◆
Validation Master Plan 新厂项目验证主计划
Page 页数
共页
Drafted by 起草人：
Date of Draft 起草日期：
Reviewed by 审核人：
Date of Review 审核日期：
Reviewed by 审核人：
Date of Review 审核日期：
Reviewed by 审核人：
Date of Review 审核日期：
2.
Scopaster Plan is valid for the project qualification or validation of 本验证主计划适用于 与 GMP 相关药品生产的确认和验证。
3.
Abbreviations, Definitions 缩写
8.
Related Documents 相关文件 ................................................................................... 20
logo
文件编码 File Code 文件名称 File Name
验证主计划
SOP = Standard Operating Procedure
SOP = 标准操作规程 Change Management or Change Control 变更管理或变更控制
CR = Change Request CR = 变更申请
Detailed description of a process or procedure. 工艺或步骤的详细描述
第 3 页 共 20 页
1.
Purpose 目的
The Validation Master Plan describes the procedures for the qualification and validation that are to be used for the manufacture of pharmaceutical substances. 验证主计划描述了药品生产相关的确认和验证步骤。
6.1. Qualification Activities 验证内容.................................................................................. 14
6.2. Qualification Documents preparation and Approval 验证文件准备与审批.................... 15 6.3. The Qualification Dossier and Archiving 验证文件夹与归档 ........................................ 16
FAT = Factory Acceptance Test
FAT = 工厂验收测试
Acceptance of an important or critical object at the manufacture’s / supplier’s facility. The FAT documentation can be an integrated part of the commissioning and or qualification.
6.4. Deviation Handling 测试偏差处理 ............................................................................... 16 6.5. Change Control 变更控制 ........................................................................................... 17
5.4. List of Validation Responsibilities 验证负责人列表 ...................................................... 13
6.
Overview of the Plant Qualification 工厂确认概述................................................... 14
logo
文件编码 File Code 文件名称 File Name
验证主计划
Validation Master Plan
第 4 页 共 20 页
design documents have been implemented.
DQ 提供文件证明该厂房和系统的设计适于预定的用途，满足 GMP、URS、FS 及 TS 的要求，且完全执行了设计文件的内 容。
4.
Validation Strategy 验证策略 .................................................................................... 10
4.1. The VMP parts 验证主计划包括的部分 ....................................................................... 10
4.2. The V model 确认/验证策略的 V 模型.......................................................................... 10 4.3. Documentation Standards 验证文件的标准................................................................. 11
5.
Organisation, Responsibilities 组织架构，职责....................................................... 12
5.1. Qualification Team Leader 验证经理........................................................................... 12
2.
Scope 范围................................................................................................................... 3
3.
Abbreviations, Definitions 缩写 ................................................................................. 3
The qualification and validation provides documented evidence that the installations are suitable for the intended purpose and that the stipulated guidelines (especially the GMP requirements) have been fulfilled. 验证和确认提供文件证明，保证安装情况能实现预期的目的且满足预定方针（尤其是 GMP 方面） 的要求。
Reviewed by 审核人：
Date of Review 审核日期：
Approved by 批准人：
Date of approval 批准日期：
Date of Effect 生效日期：
CC: Engineering;QA;QC;PD; Logistics 传阅：工程部；QA；QC；生产部；供应链
Process for executing and approving suggested changes to facilities and/or systems, that could influence the qualification / validation. 一种程序，用于批准对验证和确认产生影响的设施或系统的变 更 A form used process GMP-relevant changes.
6.6. Personnel Training 人员培训 ...................................................................................... 17 6.7. Plant Maintenance 工厂维护 ....................................................................................... 18
5.2. Supervisor of Qualification 验证主管 .......................................................................... 13
5.3. Supervisor of Documentation 文档管理负责人 ............................................................ 13
logo
File Name 文件名称 File Code 文件编号 Draft 起草部门： Review 审 核： Review 审 核： Review 审 核： Review 审 核： Approval 批 准： State of Control 受控状态
验证主计划 Validation Master Plan
用于记录 GMP 相关变更的记录表格
Report 报告
DQ = Design Qualification DQ = 设计确认
A document containing results is defined as a report.
Examples: Validation Report / DQ Report / OQ Report / Test Report
6.8. Maintenance / Revalidation 维护/再验证 ..................................................................... 18
7.
Validation Schedule 验证进度计划............................................................................ 19
将一份包含结果的文件定义为报告。 例如： 验证报告/DQ 报告/OQ 报告/测试报告
The DQ provides documented evidence that the proposed design for the plant or system is suitable for the foreseen use and conforms to the requirements of GMP and that all requirements in the user requirements specification, the functional specifications, the technical specification and the
第 2 页 共 20 页
Table of contents 目录
1.
Purpose 目的 .............................................................................................................. 3
logo
文件编码 File Code 文件名称 File Name
验证主计划
Validation Master Plan
◆◆◆中英文对照文件，以中文为准◆◆◆ ◆◆◆Bilingual Document, Chinese shall prevail◆◆◆
Validation Master Plan 新厂项目验证主计划
Page 页数
共页
Drafted by 起草人：
Date of Draft 起草日期：
Reviewed by 审核人：
Date of Review 审核日期：
Reviewed by 审核人：
Date of Review 审核日期：
Reviewed by 审核人：
Date of Review 审核日期：
2.
Scopaster Plan is valid for the project qualification or validation of 本验证主计划适用于 与 GMP 相关药品生产的确认和验证。
3.
Abbreviations, Definitions 缩写
8.
Related Documents 相关文件 ................................................................................... 20
logo
文件编码 File Code 文件名称 File Name
验证主计划
SOP = Standard Operating Procedure
SOP = 标准操作规程 Change Management or Change Control 变更管理或变更控制
CR = Change Request CR = 变更申请
Detailed description of a process or procedure. 工艺或步骤的详细描述