ValidationMaster Plans Vs Project Validation Plans
验证主计划和项目验证计划
As with all validation life-cycledocuments, a validation master plan is a formal document produced by thepharmaceutical manufacturer. The plan should require that all validation documentationis under a strict document control procedure with issue and revision ofdocuments controlled by means of an approval tables, identifying the name,signature, date, and level of authority of the signatory.
与所有验证生命周期文件一样，验证主计划（VMP）是一个生产商编写的正式文件。该计划要求所有验证文件是在一个严格的文件控制流程里面，该文件的发布和修订由一个审批表控制，确定名称、签名、日期和签字人的权限级别。
A validation master plan should describethe purpose and level of the plan and must be consistent with establishedpolicies and the GMP risk and criticality analysis. The document must beapproved and state the period after which the plan is to be reviewed.
验证主计划应描述计划的目的和水平，必须符合既定的政策和GMP风险及危害性分析。该文件必须经过批准，并声明回顾该计划的周期。
Computer systems that are identified asrequiring validation must be included in the site validation master plan. Avalidation master plan is typically used as a high-level plan for the site orprocesses and systems that make up the facility GMP operations. The plan shouldoutline the scope of the validation program, controls to be adopted and howactivities are to be conducted, documented, reviewed, approved and reported.Target completion dates should be included for validation work in each area.
计算机系统被确定为需要验证的必须包括在工厂验证主计划中。验证主计划通常是用作构成设施GMP操作的工厂或流程和系统的高级计划。该计划应列出验证程序的范围，所采取的控制，以及如何执行、记录、审核、批准和报告这些活动。每个领域的验证工作应有计划完成日期。
It should address and identifyprocedures for:
应该列出和确定下列程序：
Validation strategy (including reference to the respective regulations)
验证策略（包括参考相关法规）
Structure, reference/naming conventions
结构，参考/命名规范
Location of validation documentation
验证文件位置
Description of the facility, products, operations, process equipment
设施，产品，操作，工艺设备的描述
Computer system register
计算机系统目录
Validation evaluation and rationale
验证评估和理由
Validation program priorities
验证项目的优先级
Justification for non-validated systems
非验证系统的论证
Validation organisation/responsibilities
验证组织/责任
Validation training
验证培训
Ongoing evaluation, periodic review intervals
持续的评估，定期回顾的时间间隔
Use of validation project plans
验证项目计划的使用
Support programs and procedures
支持的程序和规程
Reference documents and definitions
参考文件和定义
The plan should be reviewed annually (asa minimum) to ensure and record that it is current and that progress is beingmade against the plan.
该计划应每年回顾（至少）保证和记录它是最新的和与时俱进的。
Validation Master Plans Vs Project Validation Plans
验证主计划和项目验证计划
The project validation plan is forindividual projects (including equipment) or systems and is derived from thevalidation master plan. The project validation plan should be closely linked tothe overall project and quality plan.
项目验证计划（VP）是对单个项目（包括设备）或系统而言的，并且它来自验证主计划。项目验证计划应紧扣项目总体和质量计划。
The validation plan should put forward areasoned, logical case that completion of the defined activities will besufficient to deliver the documented evidence that will provide a high degreeof assurance that a computer system will consistently meet its predeterminedspecifications.
验证计划应提出一个合理的、合逻辑的示例描述定义的活动完成将提供计算机系统始终满足其预定的规格的高水平保证。
A project – or system-specificvalidation plan should address the following in sufficient detail to form thebasis for reporting the validation program:
一个项目–或系统的特定验证计划应该包括以下详细的内容以构成报告验证程序的基本面：
Description of process/environment
工艺/环境描述
Quality related critical parameters
质量相关的关键参数
Purpose and objectives of the system
系统的用途和目标
Major benefits of the system
系统的主要优点
Special requirements
特殊要求
Specific training needs
具体的培训需求
System operating strategy
系统的运行策略
Related GMP compliance/regulations
相关GMP法规
Physical and logical boundaries
物理和逻辑的边界
System GMP risk assessment
系统的GMP风险评估
System validation rationale
系统的验证原理
Life-cycle documentation
生命周期的文件
Assumptions and prerequisites
前提和先决条件
Limitations and exclusions
限度和拒绝域
Quality-related critical parameters/data
质量相关的关键参数/数据
Standard operating procedures
标准操作规程
System requirement specification
系统需求规范
Supplier and system history
供应商和系统的历史
Vendor evaluations and audits
供应商评估和审计
System design, development, build
系统的设计、开发、构建
Software review
软件审核
Qualifications (DQ, IQ, OQ and PQ)
确认（DQ，IQ，OQ和PQ）
Qualification and validation reports
确认和验证报告
Ongoing evaluation
持续评价
Problem reporting/resolution
问题报告/解决
Operational plans
运行计划
Validation file
验证文件
Internal audits
内部审核
Support programs/procedures
支持的程序/规程
Reference documents
参考文献
Authorities/responsibilities
部门/责任
Resource plan and target end dates
资源计划和计划完成日期
Live Document
动态文件
The project plan is a live document thatshould be reviewed against each life-cycle step and any other validationmilestones (as a minimum). Any changes to the plan should be identified on arevision history section within the document. The plan should be retained inthe validation file and should be easily accessible.
项目计划是一个动态文件，应当进行对生命周期每个阶段和任何其他验证的时间表（至少）审查。该计划的任何变化都应该包含在文件的修订历史部分。该计划应保留在验证档案中并应方便获取。
The Team
团队
For each system validation project thevalidation team must be identified and would typically consist of designatedpersonnel (normally identified by job function at this stage) that will beresponsible for the provision, review, and approval of all validation documentsand implementation of the qualification testing.
每个系统验证项目验证团队必须确定，通常由指定人员（通常由这个阶段的工作职能确定），将负责准备、审核、批准所有验证文件和实施确认测试。
As applicable, the project engineeringcontractor and the system supplier/integrator can expect to participate on theproject validation team at the appropriate time. The purchasing/contractsgroups may also be involved and play a key role in administering contractualvalidation activities and documentation.
如适用，工程承包商和系统供应商/集成商可以在适当的时间参与项目团队中。采购/合同组也可以参与并在管理合约的验证活动和文件中发挥关键作用。
Computer System
计算机系统
In the case of a computer system appliedto a live manufacturing process and integral with plant equipment and thisprocess itself, the project validation plan should specify the relationship ofthe computer system qualification activities and documentation with that of thecorresponding plant equipment qualification and process validation. Indeed, thequalification activities and documentation of these elements of a computerisedoperation are sometimes combined.
在一个计算机系统应用于现场生产工艺并与该设备及其工艺成一体时，项目验证计划应详细说明计算机系统确认活动和文件与相应的设备确认和工艺验证之间的关系。事实上，计算机操作的这些要素的确认活动和文件证明经常合并。
Execution of the project validation planwill provide control and full documentation of the validation.
项目验证计划的执行将提供验证的控制和完整的文件证明。
Annual validation plan
年度验证计划
Besides, there may be annual validationplan(avp) that includes validation validation projects needed to be done thisyear and related schedule. This document may also be included in validationmaster plan or separate.
除此之外，还有年度验证计划（AVP），它列举了本年度需要完成的验证项目清单和时间计划表。这份文件可以包含在验证主计划（VMP）中，也可以单独编写。
ValidationMaster Plans Vs Project Validation Plans
验证主计划和项目验证计划
As with all validation life-cycledocuments, a validation master plan is a formal document produced by thepharmaceutical manufacturer. The plan should require that all validation documentationis under a strict document control procedure with issue and revision ofdocuments controlled by means of an approval tables, identifying the name,signature, date, and level of authority of the signatory.
与所有验证生命周期文件一样，验证主计划（VMP）是一个生产商编写的正式文件。该计划要求所有验证文件是在一个严格的文件控制流程里面，该文件的发布和修订由一个审批表控制，确定名称、签名、日期和签字人的权限级别。
A validation master plan should describethe purpose and level of the plan and must be consistent with establishedpolicies and the GMP risk and criticality analysis. The document must beapproved and state the period after which the plan is to be reviewed.
验证主计划应描述计划的目的和水平，必须符合既定的政策和GMP风险及危害性分析。该文件必须经过批准，并声明回顾该计划的周期。
Computer systems that are identified asrequiring validation must be included in the site validation master plan. Avalidation master plan is typically used as a high-level plan for the site orprocesses and systems that make up the facility GMP operations. The plan shouldoutline the scope of the validation program, controls to be adopted and howactivities are to be conducted, documented, reviewed, approved and reported.Target completion dates should be included for validation work in each area.
计算机系统被确定为需要验证的必须包括在工厂验证主计划中。验证主计划通常是用作构成设施GMP操作的工厂或流程和系统的高级计划。该计划应列出验证程序的范围，所采取的控制，以及如何执行、记录、审核、批准和报告这些活动。每个领域的验证工作应有计划完成日期。
It should address and identifyprocedures for:
应该列出和确定下列程序：
Validation strategy (including reference to the respective regulations)
验证策略（包括参考相关法规）
Structure, reference/naming conventions
结构，参考/命名规范
Location of validation documentation
验证文件位置
Description of the facility, products, operations, process equipment
设施，产品，操作，工艺设备的描述
Computer system register
计算机系统目录
Validation evaluation and rationale
验证评估和理由
Validation program priorities
验证项目的优先级
Justification for non-validated systems
非验证系统的论证
Validation organisation/responsibilities
验证组织/责任
Validation training
验证培训
Ongoing evaluation, periodic review intervals
持续的评估，定期回顾的时间间隔
Use of validation project plans
验证项目计划的使用
Support programs and procedures
支持的程序和规程
Reference documents and definitions
参考文件和定义
The plan should be reviewed annually (asa minimum) to ensure and record that it is current and that progress is beingmade against the plan.
该计划应每年回顾（至少）保证和记录它是最新的和与时俱进的。
Validation Master Plans Vs Project Validation Plans
验证主计划和项目验证计划
The project validation plan is forindividual projects (including equipment) or systems and is derived from thevalidation master plan. The project validation plan should be closely linked tothe overall project and quality plan.
项目验证计划（VP）是对单个项目（包括设备）或系统而言的，并且它来自验证主计划。项目验证计划应紧扣项目总体和质量计划。
The validation plan should put forward areasoned, logical case that completion of the defined activities will besufficient to deliver the documented evidence that will provide a high degreeof assurance that a computer system will consistently meet its predeterminedspecifications.
验证计划应提出一个合理的、合逻辑的示例描述定义的活动完成将提供计算机系统始终满足其预定的规格的高水平保证。
A project – or system-specificvalidation plan should address the following in sufficient detail to form thebasis for reporting the validation program:
一个项目–或系统的特定验证计划应该包括以下详细的内容以构成报告验证程序的基本面：
Description of process/environment
工艺/环境描述
Quality related critical parameters
质量相关的关键参数
Purpose and objectives of the system
系统的用途和目标
Major benefits of the system
系统的主要优点
Special requirements
特殊要求
Specific training needs
具体的培训需求
System operating strategy
系统的运行策略
Related GMP compliance/regulations
相关GMP法规
Physical and logical boundaries
物理和逻辑的边界
System GMP risk assessment
系统的GMP风险评估
System validation rationale
系统的验证原理
Life-cycle documentation
生命周期的文件
Assumptions and prerequisites
前提和先决条件
Limitations and exclusions
限度和拒绝域
Quality-related critical parameters/data
质量相关的关键参数/数据
Standard operating procedures
标准操作规程
System requirement specification
系统需求规范
Supplier and system history
供应商和系统的历史
Vendor evaluations and audits
供应商评估和审计
System design, development, build
系统的设计、开发、构建
Software review
软件审核
Qualifications (DQ, IQ, OQ and PQ)
确认（DQ，IQ，OQ和PQ）
Qualification and validation reports
确认和验证报告
Ongoing evaluation
持续评价
Problem reporting/resolution
问题报告/解决
Operational plans
运行计划
Validation file
验证文件
Internal audits
内部审核
Support programs/procedures
支持的程序/规程
Reference documents
参考文献
Authorities/responsibilities
部门/责任
Resource plan and target end dates
资源计划和计划完成日期
Live Document
动态文件
The project plan is a live document thatshould be reviewed against each life-cycle step and any other validationmilestones (as a minimum). Any changes to the plan should be identified on arevision history section within the document. The plan should be retained inthe validation file and should be easily accessible.
项目计划是一个动态文件，应当进行对生命周期每个阶段和任何其他验证的时间表（至少）审查。该计划的任何变化都应该包含在文件的修订历史部分。该计划应保留在验证档案中并应方便获取。
The Team
团队
For each system validation project thevalidation team must be identified and would typically consist of designatedpersonnel (normally identified by job function at this stage) that will beresponsible for the provision, review, and approval of all validation documentsand implementation of the qualification testing.
每个系统验证项目验证团队必须确定，通常由指定人员（通常由这个阶段的工作职能确定），将负责准备、审核、批准所有验证文件和实施确认测试。
As applicable, the project engineeringcontractor and the system supplier/integrator can expect to participate on theproject validation team at the appropriate time. The purchasing/contractsgroups may also be involved and play a key role in administering contractualvalidation activities and documentation.
如适用，工程承包商和系统供应商/集成商可以在适当的时间参与项目团队中。采购/合同组也可以参与并在管理合约的验证活动和文件中发挥关键作用。
Computer System
计算机系统
In the case of a computer system appliedto a live manufacturing process and integral with plant equipment and thisprocess itself, the project validation plan should specify the relationship ofthe computer system qualification activities and documentation with that of thecorresponding plant equipment qualification and process validation. Indeed, thequalification activities and documentation of these elements of a computerisedoperation are sometimes combined.
在一个计算机系统应用于现场生产工艺并与该设备及其工艺成一体时，项目验证计划应详细说明计算机系统确认活动和文件与相应的设备确认和工艺验证之间的关系。事实上，计算机操作的这些要素的确认活动和文件证明经常合并。
Execution of the project validation planwill provide control and full documentation of the validation.
项目验证计划的执行将提供验证的控制和完整的文件证明。
Annual validation plan
年度验证计划
Besides, there may be annual validationplan(avp) that includes validation validation projects needed to be done thisyear and related schedule. This document may also be included in validationmaster plan or separate.
除此之外，还有年度验证计划（AVP），它列举了本年度需要完成的验证项目清单和时间计划表。这份文件可以包含在验证主计划（VMP）中，也可以单独编写。