验证计划模板.doc

Authors 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 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Reviewers 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 .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 Approvers Signature:质检/认可署名Your signature indicates that this document complies with ; 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004-DEC-20232023/12/4Original Release原始版本Michael T. Filary迈克尔116-JAN-20232023/1/16Updated 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.Introduction61.1Purpose61.2Policy Compliance61.3Scope of Validation61.4Objectives81.5Periodic Review8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。92. Organizational Structure93.GxP Criticality Assessment103.1GxP Criticality Assessment Requirements103.2GxP Criticality Assessment Procedures113.3GxP Criticality Assessment Current Status114.Validation Strategy134.1Life Cycle134.2Risk Assessment134.3Hardware Categories134.4Software Categories144.5Project Inputs/Outputs for Stages144.6Acceptance Criteria for Stages155.Validation Deliverables155.1Traceability and Linkages165.2Master List of all Validation Products and Supporting Documentation165.3User Requirements Specification (URS) 使用说明书165.4Functional Requirement Specification (FRS) 功能说明书165. 5Configuration Management and Change Control Documentation175.6Vendor Qualification documentation175.7Design Specifications171.6Testing and Verification Requirements Documentation181.7System Security191.8Operational Support 运营支持201.9Business Continuity Plan 业务连续计划201.10Disaster Recovery, Backup and Restoration 劫难性恢复，备份及修复211.11System Acceptance Final Report 系统接受终报告211.12列出任何其他需要验证的产品212.Acceptance Criteria 可接受标准213.Change Control 变更控制223.1Pre-Implementation Changes 预执行变更223.2Post-Implementation Changes 执行后变更224.Standard Operating Procedures SOP224.1SOP Responsibilities SOP职责224.2Listing of SOPs SOP列表235.Training 培训236.Documentation Management 资料管理236.1Document Production 文献产生236.2Document Review 文献回顾236.3Document Approval 文献批准236.4Document Issue 文献发布246.5Document Changes 文献变更246.6Document Withdraw 文献撤消246.7Document Storage 文献保存247.Maintaining the Validated State 验证状态的维护247.1System Retirement 系统引退248.Validation Activities Timeline 验证执行时间表25Appendix A26Appendix B27Appendix C30Appendix D32Appendix E34(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 .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 , 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GAM附录）中关于验证的统一规定。The validation of the system is a cGMP requirement. 设备名称的验证系统是现行的一个规定。1.3 Scope of Validation验证范围This Validation Plan for the 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 includes all the following that are necessary for the system to operate. （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. 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 does not include:（设备名称）验证的范围不涉及：1. The XYZ system is validated separately.系统单独验证2. The Data Historian is validated separately.数据历史单独验证3. 其他名单1.3.3 Related Validation相关验证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 includes all the following that are necessary for the system to be placed into operation. 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. 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 are appropriate for cGMP-regulated processes. The qualifications outlined are to be based on 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在进行和之前5. Completion of IQ and OQ和完毕时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 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：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。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. 其他名单3.GxP Criticality AssessmentGxP关键性估计Detail the GxP criticality assessment information related to the . 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 RequirementsGxP 关键性评估规定Define the requirements used in the determination of the levels for GxP criticality for the . 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 ProceduresGxP关键性评估-程序Define the procedures used/followed in the assessment of the levels for GxP criticality for the . Develop a documented path that will be followed to determine the levels for GxP criticality for each item associated with the . 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 StatusGxP关键性评估-现行标准State the current status of the assessment for the GxP criticality levels for the . 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 include all the following. （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. 其他名单The Indirect Impact Systems associated with the include all the following. （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. 其他名单The No Impact Systems associated with the include all the following. （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