工厂验证主计划模板标准模板标准标准模板中美天津史克.doc
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activities.
工厂总监的签字是确认工厂需要进行的项目和为工厂验证活动提供需要的资源。
Site Director
Distribution List
分发清单
No Distribution Required Field Execution Copy
不需要分发
在执行过程中需要复印件
Copy No复印件编号
The purpose of the SVMP is to provide a comprehensive overview of all validation activities in XXXX公司. The plan will cover following:
1)列出公司在进行验证工作时所必须遵循的指导方针与指南。
安装确认程序
Validation Procedure for Installation Qualification
运行确认程序
Validation Procedure for Operational Qualification
性能确认程序
Validation Procedure for Performance Qualification
Describe the execution status of validation activities that are in process or in plan.
2验证的指导方针与规程Validation Polices and Procedures
生产厂关键规程列表如下：
Key site procedures are listed in the table below.
Prepare product equipment and process URS, validation protocols and reports
进行验证前的评估
部门/人员
责任
Department/Personnel
Responsibility
System assessment before validation
起草公用设施与设备的用户需求标准、方案与报告
Prepare the URS, validation protocols and reports for facilities and utilities.
进行验证前的评估
System assessment before validation
按批准的验证方案执行验证
文件名称
文件编号
Document Name
SOP Number
工厂验证管理规程
Site Validation Approach
分析仪器验证通则
Analytical Equipment Validation Approach
化学检验方法验证规程
Chemical Analysis Method Validation Approach
Job Title/Role
Signature
Date
日期
姓名
职位/角色
签字
The Author is signing to confirm that this document has been prepared in accordance with an approved document management process that content is consistent with the deliverable definition found in the SOPXXXX Site Validation Approach, and that relevant input from any contributory authors has been included.
按批准的验证方案执行验证
Execute validation activities following approved validation protocol.
数据汇总及对在验证过程产生的问题进行调查
3)列出公司目前主要的验证工作类别以及与其相关的验证主计划。
List the main validation activities in the site and the references to the validation master plans.
4)描述公司目前正在进行和计划将要进行的验证工作和项目的程序和进展。
作者的签字证明文件是按照批准的文件管理规程准备的，其中内容符合
SOPXXXX
工厂验证流程对验
证文件的定义。并确认相关人员的意见均已包含在文件中后签署文件。
Validation Engineer
Compliance & Validation are signing to confirm compliance with applicable pharmaceutical regulatory agency requirements and Company standards.
Issued To (Name / Department)
交给（姓名／部门）
Issued By (C&V)
由谁生效（法规和验证组）
Date of Issue
生效日期
1
2
3
目录CONTENT
1目的Objective3
2验证的指导方针与规程Validation Polices and Procedures4
进行验证前的评估
System assessment before validation
按批准的验证方案执行验证
Execute validation activities following approved validation protocol.
数据汇总及对在验证过程产生的问题进行调查
Data collection and problem investigation during validation.
System Impact Assessment
3责任Responsibilities
部门/人员
Department/Personnel
质量保证部验证组
QA Validation
物资管理部
Logistic
工程部
Engineering Department
技术部
Technical
价值流
ValueBiblioteka BaiduStream
3
责任Responsibilities .................................................................................................................
5
4
验证的时间表与进展Schedules and Progress .........................................................................
Approval and Authorization
批准和授权
Completion of the following signature blocks signifies the review and approval of this document
完成以下签字意味着完成了对此文件的回顾和批准
Name
Execute validation activities following approved validation protocol.
数据汇总及对在验证过程产生的问题进行调查
Data collection and problem investigation during validation.
起草新产品和产品转移的方案与报告
10
7
修订历史Revision History .........................................................................................................
13
1目的Objective
该工厂验证总计划是为了提供一个对XXXX公司制药有限公司的验证工作的综合描述。具体而言，该计划将：
List the governing policies and procedures that must be followed in validation activities.
2)确定公司各部门和主要管理人员在验证工作中的主要责任。
Define the responsibilities of key personnel in validation activities.
Prepare validation protocols and reports for new products and products transfer
进行验证前的评估
System assessment before validation
按批准的验证方案执行验证
Execute validation activities following approved validation protocol.
责任
Responsibility
负责制订与回顾年度SVMP
Responsible for preparing and reviewing SVMP
负责制订与回顾各项目验证主计划
Responsible for preparing and reviewing VMP of every project
协调各个验证过程并参与评估待验证项目
7
5
2007
年度完成的验证项目Validation Projects completed in 2007 ..............................................
9
6
2007
年度暂停和取消的验证项目Validation Projects on hold and cancelled in 2007.................
法规和验证的签字确认其符合制药法规组织的要求和公司标准。
Validation Manager
Quality Manager
Site Director
is signing to confirm projects in site and provide the required resources for validation
计算机验证方法
Computer Validation Approach
清洁验证
Cleaning Validation
维护系统的验证状态
Maintaining Systems the Validated Status
控制系统
Control System Validation Approach
系统影响性评估
数据汇总及对在验证过程产生的问题进行调查
Data collection and problem investigation during validation.
对工艺验证草案/报告进行批准
Approve process validation protocol and report
起草生产设备与工艺的用户需求标准、方案与报告
生产设施验证规程
Manufacturing Facility Validation
验证草案和报告的生成
Generation of Qualification Protocols and Reports
设计确认程序
Validation Procedure for Design Qualification
对验证主计划、方案及报告进行审核并将已完成的验证文件存档
Review validation master plan, validation protocols and reports, archive validation documents.
起草仓库相关项目的用户需求标准、方案与报告
Prepare the URS, validation protocols and reports for projects of warehouse.
Co-ordinate all validation processes and, participates in the assessment of prospective projects for validation requirements.
组织与验证相关培训
Organize the training for validation.
工厂总监的签字是确认工厂需要进行的项目和为工厂验证活动提供需要的资源。
Site Director
Distribution List
分发清单
No Distribution Required Field Execution Copy
不需要分发
在执行过程中需要复印件
Copy No复印件编号
The purpose of the SVMP is to provide a comprehensive overview of all validation activities in XXXX公司. The plan will cover following:
1)列出公司在进行验证工作时所必须遵循的指导方针与指南。
安装确认程序
Validation Procedure for Installation Qualification
运行确认程序
Validation Procedure for Operational Qualification
性能确认程序
Validation Procedure for Performance Qualification
Describe the execution status of validation activities that are in process or in plan.
2验证的指导方针与规程Validation Polices and Procedures
生产厂关键规程列表如下：
Key site procedures are listed in the table below.
Prepare product equipment and process URS, validation protocols and reports
进行验证前的评估
部门/人员
责任
Department/Personnel
Responsibility
System assessment before validation
起草公用设施与设备的用户需求标准、方案与报告
Prepare the URS, validation protocols and reports for facilities and utilities.
进行验证前的评估
System assessment before validation
按批准的验证方案执行验证
文件名称
文件编号
Document Name
SOP Number
工厂验证管理规程
Site Validation Approach
分析仪器验证通则
Analytical Equipment Validation Approach
化学检验方法验证规程
Chemical Analysis Method Validation Approach
Job Title/Role
Signature
Date
日期
姓名
职位/角色
签字
The Author is signing to confirm that this document has been prepared in accordance with an approved document management process that content is consistent with the deliverable definition found in the SOPXXXX Site Validation Approach, and that relevant input from any contributory authors has been included.
按批准的验证方案执行验证
Execute validation activities following approved validation protocol.
数据汇总及对在验证过程产生的问题进行调查
3)列出公司目前主要的验证工作类别以及与其相关的验证主计划。
List the main validation activities in the site and the references to the validation master plans.
4)描述公司目前正在进行和计划将要进行的验证工作和项目的程序和进展。
作者的签字证明文件是按照批准的文件管理规程准备的，其中内容符合
SOPXXXX
工厂验证流程对验
证文件的定义。并确认相关人员的意见均已包含在文件中后签署文件。
Validation Engineer
Compliance & Validation are signing to confirm compliance with applicable pharmaceutical regulatory agency requirements and Company standards.
Issued To (Name / Department)
交给（姓名／部门）
Issued By (C&V)
由谁生效（法规和验证组）
Date of Issue
生效日期
1
2
3
目录CONTENT
1目的Objective3
2验证的指导方针与规程Validation Polices and Procedures4
进行验证前的评估
System assessment before validation
按批准的验证方案执行验证
Execute validation activities following approved validation protocol.
数据汇总及对在验证过程产生的问题进行调查
Data collection and problem investigation during validation.
System Impact Assessment
3责任Responsibilities
部门/人员
Department/Personnel
质量保证部验证组
QA Validation
物资管理部
Logistic
工程部
Engineering Department
技术部
Technical
价值流
ValueBiblioteka BaiduStream
3
责任Responsibilities .................................................................................................................
5
4
验证的时间表与进展Schedules and Progress .........................................................................
Approval and Authorization
批准和授权
Completion of the following signature blocks signifies the review and approval of this document
完成以下签字意味着完成了对此文件的回顾和批准
Name
Execute validation activities following approved validation protocol.
数据汇总及对在验证过程产生的问题进行调查
Data collection and problem investigation during validation.
起草新产品和产品转移的方案与报告
10
7
修订历史Revision History .........................................................................................................
13
1目的Objective
该工厂验证总计划是为了提供一个对XXXX公司制药有限公司的验证工作的综合描述。具体而言，该计划将：
List the governing policies and procedures that must be followed in validation activities.
2)确定公司各部门和主要管理人员在验证工作中的主要责任。
Define the responsibilities of key personnel in validation activities.
Prepare validation protocols and reports for new products and products transfer
进行验证前的评估
System assessment before validation
按批准的验证方案执行验证
Execute validation activities following approved validation protocol.
责任
Responsibility
负责制订与回顾年度SVMP
Responsible for preparing and reviewing SVMP
负责制订与回顾各项目验证主计划
Responsible for preparing and reviewing VMP of every project
协调各个验证过程并参与评估待验证项目
7
5
2007
年度完成的验证项目Validation Projects completed in 2007 ..............................................
9
6
2007
年度暂停和取消的验证项目Validation Projects on hold and cancelled in 2007.................
法规和验证的签字确认其符合制药法规组织的要求和公司标准。
Validation Manager
Quality Manager
Site Director
is signing to confirm projects in site and provide the required resources for validation
计算机验证方法
Computer Validation Approach
清洁验证
Cleaning Validation
维护系统的验证状态
Maintaining Systems the Validated Status
控制系统
Control System Validation Approach
系统影响性评估
数据汇总及对在验证过程产生的问题进行调查
Data collection and problem investigation during validation.
对工艺验证草案/报告进行批准
Approve process validation protocol and report
起草生产设备与工艺的用户需求标准、方案与报告
生产设施验证规程
Manufacturing Facility Validation
验证草案和报告的生成
Generation of Qualification Protocols and Reports
设计确认程序
Validation Procedure for Design Qualification
对验证主计划、方案及报告进行审核并将已完成的验证文件存档
Review validation master plan, validation protocols and reports, archive validation documents.
起草仓库相关项目的用户需求标准、方案与报告
Prepare the URS, validation protocols and reports for projects of warehouse.
Co-ordinate all validation processes and, participates in the assessment of prospective projects for validation requirements.
组织与验证相关培训
Organize the training for validation.