1、1/31Author's Signature:授權者簽名Your signature indicates that this document has been prepared in accordance with existing project standards andadequately reflects the tasks and deliverables necessary for validation of the <equipmentname >您的簽名表明這份文件的準備符合現行項目標準并且充分反映人物u 和可交付使用對<設備名稱 >驗證的必要

2、。Authored By:經授權：Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Reviewer's Signature:審查員簽名：Your signature indicates that, you have reviewed this document and that it accurately and completely reflects the tasksand deliverables necessary for validation of the < equipment name>.<設備名

3、稱 >驗證的必要。您的簽名表明您已經審閱了這份文件，確認它精確并完全的反映任務和可交付使用對Reviewed By:經審閱：Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Quality Control/Compliance Approver's Signature:質檢 /承認簽名Your signature i

4、ndicates 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 Pract

5、ices.您的簽名表明這份文件符合證明人驗證總計劃，企業標準或政策，并且在此包含的文件和信息符合可應用的可調整的，共同的以及部門所有的部門的要求和現行的標準。Approved By:經核準：2/31Typed/Printed Name, TitleSignatureDateUnit姓名，職稱簽名日期單位Typed/Printed Na me, TitleSignatureDateUnit姓名，職稱簽名日期單位3/31Revision History修訂歷史紀錄RevisionRevision DateReason for Revision/Change RequestRevised By修訂本

6、修訂日期修訂 /更改要求的原因修訂人004-DEC-2002Original ReleaseMichael T. Filary2002/12/4原始版本邁克爾116-JAN-2003Updated the JETT logo on the cover page.Michael T. Filary2003/1/16更新封頁面的 JETT 的標識邁克爾Table of Contents目錄1.Introduction 緒論 .171.1Purpose目的 .171.2Policy Compliance 適用的政策 .171.3Scope of Validation 驗證范圍 .171.4Objec

7、tives 目標 .171.5Periodic Review 定期審查 .172.Organizational Structure 組織結構 .173.GxP Criticality AssessmentGxP 關鍵性評估 .173.1GxP Criticality Assessment - RequirementsGxP 關鍵性評估要求 .173.2GxP Criticality Assessment - Procedures GxP 關鍵性評估程序173.3GxP Criticality Assessment Current StatusGxP 關鍵性評估現行標準 .174.Validat

8、ion Strategy 驗證策略 .174.1Life Cycle 生命周期 .174.2Risk Assessment風險評估 .174.3Hardware Categories 硬件分類 .174.4Software Categories 軟件分類 .174.5Project Inputs/Outputs for Stages 項目各階段的輸入 /輸出 .174.6Acceptance Criteria for Stages 各階段的接受標175. Validation Deliverables .175.1 Traceability and Linkages 描述和鏈接175.2Mas

9、ter List of all Validation Products and Supporting Documentation所有批準產品和證明文件的總清單175.3User Requirements Specification (URS) 使用說明書 .175.4Functional Requirement Specification (FRS) 功能說明書 .175.5Configuration Management and Change Control Documentation17配置管理和變速控制文件4/315.6Vendor Qualification documentation

10、 賣主資格認證175.7Design Specifications 設計說明 .175.8 Testing and Verification Requirements Documentation 試驗和確認所需文件175.9System Security 系統安全性 .185.10Operational Support 運行支持 .185.11Business Continuity Plan 業務持續計劃 .195.12Disaster Recovery, Backup and Restoration 災難性恢復，備份及修復 .195.13System Acceptance Final Rep

11、ort 系統接受終報告 .195.14<List any additional validation products required> 列出任何其他需要驗證的產品 .206.Acceptance Criteria 可接受標準 .207.Change Control 變更控制 .207.1Pre-Implementation Changes 預執行變更 .207.2Post-Implementation Changes 執行后變更 .208.Standard Operating ProceduresSOP .208.1SOP Responsibilities SOP 職責 .20

12、8.2Listing of SOPs SOP 列表 .219.Training 培訓 .2110.Documentation Management 資料管理 .2110.1Document Production 文件產生 .2210.2Document Review 文件回顧 .2210.3Document Approval 文件批準 .2210.4Document Issue 文件發布 .2210.5Document Changes文件變更 .2210.6Document Withdraw 文件撤銷 .2210.7Document Storage 文件保存 .2211.Maintaining

13、 the Validated State 驗證狀態的維護 .2311.1System Retirement 系統引退 .2312.Validation Activities Timeline 驗證執行時間表 .23Appendix A 附錄 A 參與組織 .24Appendix B 附錄 B 縮寫詞，定義 .25Appendix C 附錄 C 責任 /時間 .28Appendix D 附錄 D 可交付的驗證 .29Appendix E 附錄 E 參考 .31(Reminder of Page Intentionally Left Blank)5/311.Introduction緒論1.1Pur

14、pose目的This document, also referred to as the Plan, outlines the planned tasks and expectations for validation of the<equipment name >.這份文件，也稱計劃，略述計劃的任務和設備名稱的預期驗證。WHO will be responsible for completion, review, and approval of these tasks.世界衛生組織將負責任務的完成、審閱和批準。WHAT documentation/deliverables wil

15、l be generated and/or retained as part of the Validation Package(s).什么文件 /可交付使用的將會作為驗證包的一部分被產生和/或保留。HOW this documentation will be produced/created (at a macro level).這份文件將被如何制作/產生（在宏觀上）。1.2Policy Compliance遵守政策This Plan is being written to comply with corporate policy requirements for validation as

16、 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.這份計劃將會遵守在涉及特殊驗證總計劃，公司政策，公司標準和公司指導方針和適當性（現行 GAM 附錄）中關于驗證的統一要求。The validation of the < equipment name>

17、 system is a cGMP requirement.設備名稱的驗證系統是現行的一個要求。1.3Scope of Validation驗證范圍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.這份為設備名稱的驗證計劃僅限于特殊構成和定義

18、設備的控制系統。該項驗證成就將會被作為一項預期的驗證執行。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.對用戶必備使用的說明書中的設備和主要功

19、能的闡述 . 對實施計劃的設備進行研究、生產、加工、包裝、存儲、分配過程的說明。In-Scope驗證范圍The scope of validation for the < equipment name> includes all the following that are necessary for the system to operate. <clearly define all boundaries>（設備名稱）驗證的范圍包括以下所有的系統運作所必需的內容。（明確界限）1. Controls system hardware and software控制系統得硬件

20、和軟件6/312. Mechanical Hardware機械的硬件3. Instrumentation儀器4. Process piping輸水管道工藝5. Utility Systems通用系統6. Facility設施7. <list all that are appropriate>其他需要的名單Out-of-Scope驗證范圍例外The scope of validation for the <equipment name> does not include:（設備名稱）驗證的范圍不包括：1. The XYZ system is validated separ

21、ately.系統單獨驗證2. The Data Historian is validated separately.數據歷史單獨驗證3. <list all that are appropriate>其他名單相關驗證<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 met

22、hods or directly replacing tests, if the systems configuration can be shown to be the same now as at the time the data was collected>插入現有的或計劃的與本驗證系統有關的驗證的描述。如果系統配置和數據采集時是一致的，前期數據的使用可以作為試驗方法的參考或直接替代試驗，The related validation that will occur in support of the < necessary for the system to be plac

23、ed into operation. <equipment name> includes all the following that are clearly define all boundaries>支持（設備名稱）的相關驗證在以下情況發生：包括系統運行必需的幾點（清晰的定義分界線）：1. Process Validation工藝驗證2. Cleaning Studies清潔研究7/313. Air Classification風力分級4. Microbiological Testing微生物試驗5. Chemical Testing化學試驗6. Drying Studi

24、es干燥研究7. Sterilization Studies無菌研究8. <list all that are appropriate>其他名單1.4Objectives目標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> ar

25、e 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.該項驗證計劃的目標是簡述一項要求，該要求能夠證明所有與設備名稱相關的組成、控制系統和功能都是恰當的符合現行標準的工藝。資格的綜述要基于（公司名稱）政策，

26、程序以及可應用的規則、指導方針和公認的工業驗證實踐。1.5Periodic Review定期回顧This Plan should be reviewed periodically to ensure compliance and or to determine if a change is required.Some appropriate times to review are:這份計劃應該被定期回顧來保證符合并確定是否需要更改。一些適當的回顧時間是：1. Change in Validation Master Plan驗證主文件的更改發生時2. Change in scope occurs

27、 驗證范圍的更改發生時3. Design change occurs 設計更改發生時4. Prior to IQ and OQ在進行和之前5. Completion of IQ and OQ和完成時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.見第五部分有關驗證管理和針對該項計劃的回顧、修訂過程或指適應公司政

28、策的回顧周期。2. Organizational Structure組織結構8/31Specific responsibilities related to the validation of the<equipment name > are outlined in Appendix A. Ingeneral, the activities associated with this project, are the responsibility of the following individuals and groups:與（設備名稱）驗證相關的具體職責在附錄中概述。大體上，與驗

29、證相關的活動項目由以下個人和部門負責：<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 >確定個人的任務和責任至少應包括以下幾點，總體根據崗位不同描述每項任務和責任1. Management level Responsible for project management and planning, c

30、ontrol of project activities/resources/costs, monitoring process, initiating corrective action, ensuring issues/projectobjectives are correctly addressed/resolved, reporting to senior management, interface to QA to ensurecompliance, reviewing and approving validation documentation for the project管理層

31、：負責項目管理和計劃。方案，活動，資源，成本的控制，監控工藝，2.Quality Assurance Responsible for assuring compliance with appropriateregulatory/business/technical/user community requirements, providing support for the criterion/independentreview/approval of deliverables, approving completion of stage/validation status質保：負責保證符合適當

32、的調整、商業、技術、用戶群要求，支持維護標準、獨立審查、可交付的批準、審批完成階段和身份驗證等。3. System Owner Responsible for implementation/management of the system by the business usercommunity, approving completion of stage/validation status系統所有者：負責執行和管理系統的用戶群，審批完成階段和驗證身份。<These role and responsibilities may be defined as appropriate - De

33、scribe each role and responsibility in a general way as they apply>這些任務和責任可以適當的定義：按照他們的分工總體上定義每項任務和責任。1.Operations Responsible for providing操作：負責提供 2.Project Level Responsible for providing項目水平：負責提供 3.Technical and Engineering support Responsible for providing技術和工程支持：負責提供 4.Validation Specialist

34、Responsible for providing驗證專家：負責提供 5.System Administrator Responsible for providing系統管理：負責提供 6.Purchasing - Responsible for providing采供：負責提供 7. <List all that are appropriate>其他名單3.GxP Criticality AssessmentGxP 關鍵性估計9/31Detail the GxP criticality assessment information related to the<equipm

35、ent name >.This section may reference another source of information covering this topic, such as a system inventory.詳述和（設備名稱）有關的GxP 關鍵性估計信息。該部分包括另外一種信息，包括該主題，例如系統詳細目錄。3.1GxP Criticality AssessmentRequirementsGxP 關鍵性評估要求Define the requirements used in the determination of the levels for GxP critic

36、ality for the <equipment name>.The requirements for determination of the levels for GxP criticality may include Direct Impact, Indirect Impact, and No Impact systems.定義在決定（設備名稱）Gxp 水平中使用的關鍵性要求，包括直接影響，間接影響和無影響系統。Direct Impact System or component within a system where the operation, contact, dat

37、a, control, alarm, or failure will have a direct impact on product quality.直接影響：系統或系統中的一個組成，對產品質量有直接影響的操作，接觸，控制，預警或失敗。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 s

38、ystems typically support Direct Impact systems, thus indirect impact system may have an affect on the performance or operation of a direct impact system.間接影響：系統或系統中的一個組成，對產品質量無直接影響的操作，接觸，控制，預警或失敗。間接影響系統專門支持直接影響系統，因此間接影響系統會對直接影響系統的執行和運作構成影響。No Impact System or component within a system where the oper

39、ation, 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.無影響：系統或系統的一個組成，對產品質量不構成直接或間接影響的操作，接觸，控制，預警或失敗。無影響系統不能支持直接影響系統。3.2GxP Criticality AssessmentProceduresGxP 關鍵性評估 -程序Define the procedu

40、res 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 itemassociated with the < equipment name>. It may be helpful to develop a decision tree to demonstrate the overviewto the process required in determining levels for GxP criticality. Internal procedures may be referenced, ifavailable.定義使用的程序/（設備名稱）的Gxp 關鍵性水平的評估的標準。開發一種具有證明的文件路徑，作為（設備名稱）GxP 關鍵性水平每一項目的評估標準。創