验证计划模板.doc

Author's Signature:
授权者署名
Your signature indicates that this document has been prepared in accordance with existing project standards and adequately reflects the tasks and deliverables necessary for validation of the <equipment name>
您的署名表白这份文献的准备符合现行项目的准并且充足反映人物u和可交付使用对<设备名称>验证的必要。

Authored By:
经授权：

Typed/Printed Name, Title
姓名，职称
Signature
署名
Date
日期
Unit
单位

Reviewer's Signature:
审查员署名：

Your signature indicates that, you have reviewed this document and that it accurately and completely reflects the tasks and deliverables necessary for validation of the <equipment name>.
您的署名表白您已经审阅了这份文献，确认它精确并完全的反映任务和可交付使用对<设备名称>验证的必要。

Reviewed By:
经审阅：

Typed/Printed Name, Title
姓名，职称
Signature
署名
Date
日期
Unit
单位

Typed/Printed Name, Title
姓名，职称
Signature
署名
Date
日期
Unit
单位

Typed/Printed Name, Title
姓名，职称
Signature
署名
Date
日期
Unit
单位

Quality Control/Compliance Approver's Signature:
质检/认可署名
Your signature indicates that this document complies with <reference Validation Master Plan, company standards or guidelines>; and that the documentation and information contained herein complies with applicable regulatory, corporate, divisional/departmental requirements, and current Good Manufacturing Practices.
您的署名表白这份文献符合〈证明人验证总计划，公司标准或政策〉，并且在此包含的文献和信息符合可应用的可调整的，共同的以及部门所有的／部门的规定和现行的ＧＭＰ标准。

Approved By:
经核准：

Typed/Printed Name, Title
姓名，职称
Signature
署名
Date
日期
Unit
单位

Typed/Printed Na me, Title
姓名，职称
Signature
署名
Date
日期
Unit
单位

Revision History
修订历史纪录

Revision
修订本
Revision Date
修订日期
Reason for Revision/Change Request
修订/更改规定的因素
Revised By
修订人
0
04-DEC-2023
2023/12/4
Original Release
原始版本
Michael T. Filary
迈克尔
1
16-JAN-2023
2023/1/16
Updated the JETT logo on the cover page.
更新封页面的JETT的标记
Michael T. Filary
迈克尔

TABLE OF CONTENTS
目录
1. Introduction 6
1.1 Purpose 6
1.2 Policy Compliance 6
1.3 Scope of Validation 6
1.4 Objectives 8
1.5 Periodic Review 8
见第五部分有关验证管理和针对该项计划 的回顾、修订过程或指适应公司政策的回顾周期。 9
2. Organizational Structure 9
3.GxP Criticality Assessment 10
3.1GxP Criticality Assessment – Requirements 10
3.2GxP Criticality Assessment – Procedures 11
3.3GxP Criticality Assessment – Current Status 11
4.Validation Strategy 13
4.1Life Cycle 13
4.2Risk Assessment 13
4.3Hardware Categories 13
4.4Software Categories 14
4.5Project Inputs/Outputs for Stages 14
4.6Acceptance Criteria for Stages 15
5.Validation Deliverables 15
5.1Traceability and Linkages 16
5.2Master List of all Validation Products and Supporting Documentation 16
5.3User Requirements Specification (URS) 使用说明书 16
5.4Functional Requirement Specification (FRS) 功能说明书 16
5. 5Configuration Management and Change Control Documentation 17
5.6Vendor Qualification documentation 17
5.7Design Specifications 17
1.6 Testing and Verification Requirements Documentation 18
1.7 System Security 19
1.8 Operational Support 运营支持 20
1.9 Business Continuity Plan 业务连续计划 20
1.10 Disaster Recovery, Backup and Restoration 劫难性恢复，备份及修复 21
1.11 System Acceptance – Final Report 系统接受――终报告 21
1.12 <List any additional validation products required>列出任何其他需要验证的产品 21
2. Acceptance Criteria 可接受标准 21
3. Change Control 变更控制 22
3.1 Pre-Implementation Changes 预执行变更 22
3.2 Post-Implementation Changes 执行后变更 22
4. Standard Operating Procedures SOP 22
4.1 SOP Responsibilities SOP职责 22
4.2 Listing of SOPs SOP列表 23
5. Training 培训 23
6. Documentation Management 资料管理 23
6.1 Document Production 文献产生 23
6.2 Document Review 文献回顾 23
6.3 Document Approval 文献批准 23
6.4 Document Issue 文献发布 24
6.5 Document Changes 文献变更 24
6.6 Document Withdraw 文献撤消 24
6.7 Document Storage 文献保存 24
7. Maintaining the Validated State 验证状态的维护 24
7.1 System Retirement 系统引退 24
8. Validation Activities Timeline 验证执行时间表 25
Appendix A 26
Appendix B 27
Appendix C 30
Appendix D 32
Appendix E 34

(Reminder of Page Intentionally Left Blank)

1. Introduction
绪论
1.1 Purpose
目的
This document, also referred to as the Plan, outlines the planned tasks and expectations for validation of the <equipment name>.
这份文献，也称计划，略述计划的任务和〈设备名称〉的预期验证。
· WHO will be responsible for completion, review, and approval of these tasks.
· 世界卫生组织将负责任务的完毕、审阅和批准。
· WHAT documentation/deliverables will be generated and/or retained as part of the Validation Package(s).
· 什么文献/可交付使用的将会作为验证包的一部分被产生和/或保存。
· HOW this documentation will be produced/created (at a macro level).
· 这份文献将被如何制作/产生（在宏观上）。
1.2 Policy Compliance
遵守政策
This Plan is being written to comply with corporate policy requirements for validation as stated in the <refer to specific Validation Master Plan(s), company policies, company standards, and/or company guidelines >, and the appropriate Appendix of the current revision of GAMP.
这份计划将会遵守在〈涉及特殊验证总计划，公司政策，公司标准和公司指导方针〉和适当性（现行GAMＰ附录）中关于验证的统一规定。
The validation of the <equipment name> system is a cGMP requirement.
《设备名称》的验证系统是现行ＧＭＰ的一个规定。
1.3 Scope of Validation
验证范围
This Validation Plan for the <equipment name> is limited to the unique components and control system that define the equipment. This validation effort will be conducted as a prospective validation.
这份为〈设备名称〉的验证计划仅限于特殊构成和定义设备的控制系统。该项验证成就将会被作为一项预期的验证执行。　
Provide a Brief description of equipment and principal function; Refer to User Requirement Specifications. Provide a description of the research, manufacturing, processing, packaging, holding, or distribution process for which the equipment is planned.
对用户必备使用的说明书中的设备和重要功能的阐述. 对实行计划的设备进行研究、生产、加工、包装、存储、分派过程的说明。
1.3.1 In-Scope
　　　　验证范围　
The scope of validation for the <equipment name> includes all the following that are necessary for the system to operate. <clearly define all boundaries>
（设备名称）验证的范围涉及以下所有的系统运作所必需的内容。（明确界线）
1. Controls system hardware and software
控制系统得硬件和软件
2. Mechanical Hardware
机械的硬件
3. Instrumentation
仪器
4. Process piping
输水管道工艺
5. Utility Systems
通用系统
6. Facility
设施
7. <list all that are appropriate>
其他需要的名单
1.3.2 Out-of-Scope
　　　　　验证范围例外
The scope of validation for the <equipment name> does not include:
（设备名称）验证的范围不涉及：
1. The XYZ system is validated separately.
ＸＹＺ系统单独验证
2. The Data Historian is validated separately.
数据历史单独验证
3. <list all that are appropriate>
其他名单
1.3.3 Related Validation
　　　　相关验证
<Insert a description of any existing or planned validation that is relevant to the validation of this system. The use of prior data may be considered either as reference for test methods or directly replacing tests, if the systems configuration can be shown to be the same now as at the time the data was collected>
插入现有的或计划的与本验证系统有关的验证的描述。假如系统配置和数据采集时是一致的，前期数据的使用可以作为实验方法的参考或直接替代实验，
The related validation that will occur in support of the <equipment name> includes all the following that are necessary for the system to be placed into operation. <clearly define all boundaries>
支持（设备名称）的相关验证在以下情况发生：涉及系统运营必需的几点（清楚的定义分界线）：
1. Process Validation
工艺验证
2. Cleaning Studies
清洁研究

3. Air Classification
风力分级
4. Microbiological Testing
微生物实验
5. Chemical Testing
化学实验
6. Drying Studies
干燥研究
7. Sterilization Studies
无菌研究
8. <list all that are appropriate>
其他名单
1.4 Objectives
　　目的
The objective of this validation plan is to outline the requirements that will demonstrate and document that all components, control system(s) and functionality associated with the <equipment name> are appropriate for cGMP-regulated processes. The qualifications outlined are to be based on < company name> policies and procedures and applicable regulations, guidelines, and accepted industry practices for validation.
该项验证计划的目的是简述一项规定，该规定可以证明所有与设备名称相关的组成、控制系统和功能都是恰当的符合现行ＧＭＰ标准的工艺。资格的综述要基于（公司名称）政策，程序以及可应用的规则、指导方针和公认的工业验证实践。
1.5 Periodic Review
定期回顾
This Plan should be reviewed periodically to ensure compliance and or to determine if a change is required. Some appropriate times to review are:
这份计划应当被定期回顾来保证符合并拟定是否需要更改。一些适当的回顾时间是：
1. Change in Validation Master Plan验证主文献的更改发生时
2. Change in scope occurs验证范围的更改发生时
3. Design change occurs设计更改发生时
4. Prior to IQ and OQ　在进行ＩＱ和ＯＱ之前
5. Completion of IQ and OQ　ＩＱ和ＯＱ完毕时

See section 5 for a description of Validation Management and the process for review and revisions to this plan or refer to the applicable corporate policy review cycle.
见第五部分有关验证管理和针对该项计划 的回顾、修订过程或指适应公司政策的回顾周期。
2. Organizational Structure
组织结构
Specific responsibilities related to the validation of the <equipment name> are outlined in Appendix A. In general, the activities associated with this project, are the responsibility of the following individuals and groups:
与（设备名称）验证相关的具体职责在附录Ａ中概述。大体上，与验证相关的活动项目由以下个人和部门负责：
<The defined role and responsibilities should include at a minimum the individuals listed below - Describe each role and responsibility in a general way as they apply>
拟定个人的任务和责任至少应涉及以下几点，总体根据岗位不同描述每项任务和责任
1. Management level – Responsible for project management and planning, control of project activities/resources/costs, monitoring process, initiating corrective action, ensuring issues/project objectives are correctly addressed/resolved, reporting to senior management, interface to QA to ensure compliance, reviewing and approving validation documentation for the project…
管理层：负责项目管理和计划。方案，活动，资源，成本的控制，监控工艺，
2. Quality Assurance – Responsible for assuring compliance with appropriate
regulatory/business/technical/user community requirements, providing support for the criterion/independent review/approval of deliverables, approving completion of stage/validation status…
质保：负责保证符合适当的调整、商业、技术、用户群规定，支持维护标准、独立审查、可交付的批准、审批完毕阶段和身份验证等。

3. System Owner – Responsible for implementation/management of the system by the business user community, approving completion of stage/validation status…
系统所有者：负责执行和管理系统的用户群，审批完毕阶段和验证身份。
<These role and responsibilities may be defined as appropriate - Describe each role and responsibility in a general way as they apply>
这些任务和责任可以适当的定义：按照他们的分工总体上定义每项任务和责任。
1. Operations – Responsible for providing…
操作：负责提供…
2. Project Level – Responsible for providing…
项目水平：负责提供…
3. Technical and Engineering support – Responsible for providing…
技术和工程支持：负责提供…
4. Validation Specialist – Responsible for providing…
验证专家：负责提供…
5. System Administrator – Responsible for providing…
系统管理：负责提供…
6. Purchasing - Responsible for providing…
采供：负责提供…
7. <List all that are appropriate>
其他名单
3.GxP Criticality Assessment
GxP关键性估计
Detail the GxP criticality assessment information related to the <equipment name>.
This section may reference another source of information covering this topic, such as a system inventory.
详述和（设备名称）有关的 GxP关键性估计信息。
该部分涉及此外一种信息，涉及该主题，例如系统具体目录。
3.1GxP Criticality Assessment – Requirements
GxP 关键性评估——规定
Define the requirements used in the determination of the levels for GxP criticality for the <equipment name>.
The requirements for determination of the levels for GxP criticality may include Direct Impact, Indirect Impact, and No Impact systems.
定义在决定（设备名称）Gxp水平中使用的关键性规定，涉及直接影响，间接影响和无影响系统。
Direct Impact – System or component within a system where the operation, contact, data, control, alarm, or failure will have a direct impact on product quality.
直接影响：系统或系统中的一个组成，对产品质量有直接影响的操作，接触，控制，预警或失败。

Indirect Impact – System or component within a system where the operation, contact, data, control, alarm, or failure will not have a direct impact on product quality. Indirect Impact systems typically support Direct Impact systems, thus indirect impact system may have an affect on the performance or operation of a direct impact system.
间接影响：系统或系统中的一个组成，对产品质量无直接影响的操作，接触，控制，预警或失败。间接影响系统专门支持直接影响系统，因此间接影响系统会对直接影响系统的执行和运作构成影响。

No Impact – System or component within a system where the operation, contact, data, control, alarm, or failure will not have a direct or indirect impact on product quality. No Impact systems will not support Direct Impact systems.
无影响：系统或系统的一个组成，对产品质量不构成直接或间接影响的操作，接触，控制，预警或失败。无影响系统不能支持直接影响系统。
3.2GxP Criticality Assessment – Procedures
GxP关键性评估-程序
Define the procedures used/followed in the assessment of the levels for GxP criticality for the <equipment name>. Develop a documented path that will be followed to determine the levels for GxP criticality for each item associated with the <equipment name>. It may be helpful to develop a decision tree to demonstrate the overview to the process required in determining levels for GxP criticality. Internal procedures may be referenced, if available.
定义使用的程序/（设备名称）的Gxp关键性水平的评估的标准。开发一种具有证明的文献途径，作为（设备名称）GxP关键性水平每一项目的评估标准。创建一个决策树将对在GxP关键性评估中论证工艺的一般观测规定有帮助。假如必要，可以引用国际程序作为参考。

3.3GxP Criticality Assessment – Current Status
GxP关键性评估-现行标准
State the current status of the assessment for the GxP criticality levels for the <equipment name>.
陈述现行（设备名称）的GxP关键性水平评估的规定。

The Direct Impact Systems associated with the <equipment name> include all the following. <Clearly develop supporting rationale>
（设备名称的）直接影响因素涉及以下的所有项。（清楚的规定支持理论）
1. Controls system hardware and software - This has been deemed a direct impact system due to…
控制系统硬件和软件：该项是一个直接影响由于…
2. Mechanical Hardware - This has been deemed a direct impact system due to…
机械硬件：该项是一个直接影响由于…
3. Instrumentation – This has been deemed a direct impact system due to…
仪器：该项是一个直接影响由于…
4. Process piping - This has been deemed a direct impact system due to…
工艺流程：该项是一个直接影响由于…
5. Utility Systems - This has been deemed a direct impact system due to…
效用系统：该项是一个直接影响由于…
6. Facility - This has been deemed a direct impact system due to…
设备：该项是一个直接影响由于…
7. <List all that are appropriate>
其他名单

The Indirect Impact Systems associated with the <equipment name> include all the following. <Clearly develop supporting rationale>
（设备名称的）间接影响因素涉及以下的所有项。（清楚的规定支持原理）

1. Controls system hardware and software - This has been deemed an indirect impact system due to…
控制系统硬件和软件：该项是一个间接影响由于…
2. Mechanical Hardware - This has been deemed an indirect impact system due to…
机械硬件：该项是一个间接影响由于…
3. Instrumentation – This has been deemed an indirect impact system due to…
仪器：该项是一个间接影响由于…
4. Process piping - This has been deemed an indirect impact system due to…
工艺流程：该项是一个间接影响由于…
5. Utility Systems - This has been deemed an indirect impact system due to…
效用系统：该项是一个间接影响由于…
6. Facility - This has been deemed an indirect impact system due to…
设备：该项是一个间接影响由于…
7. <List all that are appropriate>
其他名单

The No Impact Systems associated with the <equipment name> include all the following. <Clearly develop supporting rationale>
（设备名称的）无影响因素涉及以下的所有项。（清楚的规定支持原理）
1. Controls system hardware and software - This has been deemed a no impact system due to…
控制系统硬件和软件：该项是一个无影响系统由于…
2. Mechanical Hardware - This has been deemed a no impact system due to…
机械硬件：该项是一个无影响系统由于…
3. Instrumentation – This has been deemed a no impact system due to…
仪器：该项是一个无影响系统由于…
4. Utility Systems - This has been deemed a no impact syste