1、. ;. . ;. Authors Signature: 授權(quán)者簽名授權(quán)者簽名 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 您的簽名表明這份文件的準(zhǔn)備符合現(xiàn)行項(xiàng)目標(biāo)準(zhǔn)并且充分反映人物 u 和可交付使用對(duì)驗(yàn)證的必 要。 Authored By: 經(jīng)授權(quán)：經(jīng)授權(quán)：

2、Typed/Printed Name, Title 姓名，職稱 Signature 簽名 Date 日期 Unit 單位 Reviewers Signature: 審查員簽名：審查員簽名： 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 . 您的簽名表明您已經(jīng)審閱了這份文件，確認(rèn)它精確并完全的反映任務(wù)和可交付

3、使用對(duì)驗(yàn)證的必 要。 Reviewed By: 經(jīng)審閱：經(jīng)審閱： Typed/Printed Name, Title 姓名，職稱 Signature 簽名 Date 日期 Unit 單位 Typed/Printed Name, Title 姓名，職稱 Signature 簽名 Date 日期 Unit 單位 Typed/Printed Name, Title 姓名，職稱 Signature 簽名 Date 日期 Unit 單位 Quality Control/Compliance Approvers Signature: 質(zhì)檢質(zhì)檢/承認(rèn)簽名承認(rèn)簽名 Your signature indicat

4、es 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. 您的簽名表明這份文件符合證明人驗(yàn)證總計(jì)劃，企業(yè)標(biāo)準(zhǔn)或政策，并且在此包含的文件和信息符合可 應(yīng)用的可調(diào)整的，共同的以及部門所有的部門的要求和現(xiàn)行的標(biāo)準(zhǔn)

5、。 Approved By: 經(jīng)核準(zhǔn)：經(jīng)核準(zhǔn)： . ;. Typed/Printed Name, Title 姓名，職稱 Signature 簽名 Date 日期 Unit 單位 Typed/Printed Na me, Title 姓名，職稱 Signature 簽名 Date 日期 Unit 單位 . ;. Revision History 修訂歷史紀(jì)錄修訂歷史紀(jì)錄 Revision 修訂本修訂本 Revision Date 修訂日期修訂日期 Reason for Revision/Change Request 修訂修訂/更改要求的原因更改要求的原因 Revised By 修訂人修訂人 0

6、04-DEC-2002 2002/12/4 Original Release 原始版本 Michael T. Filary 邁克爾 116-JAN-2003 2003/1/16 Updated the JETT logo on the cover page. 更新封頁面的 JETT 的標(biāo)識(shí) Michael T. Filary 邁克爾 Table of Contents 目錄 1.Introduction 緒論.5 1.1Purpose 目的.5 1.2Policy Compliance 適用的政策 .5 1.3Scope of Validation 驗(yàn)證范圍 .5 1.4Objectives

7、目標(biāo).6 1.5Periodic Review 定期審查 .6 2.Organizational Structure 組織結(jié)構(gòu).7 3.GxP Criticality AssessmentGxP 關(guān)鍵性評(píng)估.7 3.1GxP Criticality Assessment - RequirementsGxP 關(guān)鍵性評(píng)估要求.7 3.2GxP Criticality Assessment - Procedures GxP 關(guān)鍵性評(píng)估程序 8 3.3GxP Criticality Assessment Current StatusGxP 關(guān)鍵性評(píng)估現(xiàn)行標(biāo)準(zhǔn).8 4.Validation Strate

8、gy 驗(yàn)證策略.9 4.1Life Cycle 生命周期.9 4.2Risk Assessment 風(fēng)險(xiǎn)評(píng)估.9 4.3Hardware Categories 硬件分類.9 4.4Software Categories 軟件分類.9 4.5Project Inputs/Outputs for Stages 項(xiàng)目各階段的輸入/輸出.10 4.6Acceptance Criteria for Stages 各階段的接受標(biāo) 10 5.Validation Deliverables.10 5.1 Traceability and Linkages 描述和鏈接 11 5.2Master List of

9、all Validation Products and Supporting Documentation 所有批準(zhǔn)產(chǎn)品和證明文件的總清單 11 5.3User Requirements Specification (URS) 使用說明書.11 5.4Functional Requirement Specification (FRS) 功能說明書.11 5.5Configuration Management and Change Control Documentation 配置管理和變速控制文件 11 . ;. 5.6Vendor Qualification documentation 賣主資格

10、認(rèn)證 11 5.7Design Specifications 設(shè)計(jì)說明.12 5.8 Testing and Verification Requirements Documentation試驗(yàn)和確認(rèn)所需文件 12 5.9System Security系統(tǒng)安全性.13 5.10Operational Support運(yùn)行支持.14 5.11Business Continuity Plan業(yè)務(wù)持續(xù)計(jì)劃.14 5.12Disaster Recovery, Backup and Restoration災(zāi)難性恢復(fù)，備份及修復(fù).14 5.13System Acceptance Final Report系統(tǒng)接

11、受終報(bào)告.14 5.14列出任何其他需要驗(yàn)證的產(chǎn)品.15 6.Acceptance Criteria可接受標(biāo)準(zhǔn).15 7.Change Control變更控制.15 7.1Pre-Implementation Changes預(yù)執(zhí)行變更.15 7.2Post-Implementation Changes執(zhí)行后變更.15 8.Standard Operating Procedures SOP.15 8.1SOP Responsibilities SOP 職責(zé).15 8.2Listing of SOPs SOP 列表.16 9.Training培訓(xùn).16 10.Documentation Manag

12、ement資料管理.16 10.1Document Production文件產(chǎn)生.16 10.2Document Review文件回顧.16 10.3Document Approval文件批準(zhǔn).16 10.4Document Issue文件發(fā)布.16 10.5Document Changes文件變更.17 10.6Document Withdraw文件撤銷.17 10.7Document Storage文件保存.17 11.Maintaining the Validated State驗(yàn)證狀態(tài)的維護(hù).17 11.1System Retirement系統(tǒng)引退.17 12.Validation A

13、ctivities Timeline驗(yàn)證執(zhí)行時(shí)間表.17 Appendix A 附錄 A參與組織參與組織.18 Appendix B 附錄 B縮寫詞，定義縮寫詞，定義.19 Appendix C 附錄 C責(zé)任/時(shí)間.22 Appendix D 附錄 D 可交付的驗(yàn)證.23 Appendix E 附錄 E 參考.24 (Reminder of Page Intentionally Left Blank) . ;. 1. Introduction 緒論 1.1 Purpose 目的 This document, also referred to as the Plan, outlines the

14、planned tasks and expectations for validation of the . 這份文件，也稱計(jì)劃，略述計(jì)劃的任務(wù)和設(shè)備名稱的預(yù)期驗(yàn)證。 WHO will be responsible for completion, review, and approval of these tasks. 世界衛(wèi)生組織將負(fù)責(zé)任務(wù)的完成、審閱和批準(zhǔn)。世界衛(wèi)生組織將負(fù)責(zé)任務(wù)的完成、審閱和批準(zhǔn)。 WHAT documentation/deliverables will be generated and/or retained as part of the Validation Pack

15、age(s). 什么文件/可交付使用的將會(huì)作為驗(yàn)證包的一部分被產(chǎn)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這份文件將被如何制作/產(chǎn)生（在宏觀上）。產(chǎn)生（在宏觀上）。 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

16、 Appendix of the current revision of GAMP. 這份計(jì)劃將會(huì)遵守在涉及特殊驗(yàn)證總計(jì)劃，公司政策，公司標(biāo)準(zhǔn)和公司指導(dǎo)方針和適當(dāng)性（現(xiàn) 行 GAM附錄）中關(guān)于驗(yàn)證的統(tǒng)一要求。 The validation of the system is a cGMP requirement. 設(shè)備名稱的驗(yàn)證系統(tǒng)是現(xiàn)行的一個(gè)要求。 1.3 Scope of Validation 驗(yàn)證范圍 This Validation Plan for the is limited to the unique components and control system that define

17、 the equipment. This validation effort will be conducted as a prospective validation. 這份為設(shè)備名稱的驗(yàn)證計(jì)劃僅限于特殊構(gòu)成和定義設(shè)備的控制系統(tǒng)。該項(xiàng)驗(yàn)證成就將會(huì)被作為 一項(xiàng)預(yù)期的驗(yàn)證執(zhí)行。 Provide a Brief description of equipment and principal function; Refer to User Requirement Specifications. Provide a description of the research, manufacturing,

18、processing, packaging, holding, or distribution process for which the equipment is planned. 對(duì)用戶必備使用的說明書中的設(shè)備和主要功能的闡述. 對(duì)實(shí)施計(jì)劃的設(shè)備進(jìn)行研究、生產(chǎn)、加工、包 裝、存儲(chǔ)、分配過程的說明。 1.3.1 In-Scope 驗(yàn)證范圍 The scope of validation for the includes all the following that are necessary for the system to operate. （設(shè)備名稱）驗(yàn)證的范圍包括以下所有的系統(tǒng)運(yùn)作所

19、必需的內(nèi)容。（明確界限） 1.Controls system hardware and software 控制系統(tǒng)得硬件和軟件 . ;. 2.Mechanical Hardware 機(jī)械的硬件 3.Instrumentation 儀器 4.Process piping 輸水管道工藝 5.Utility Systems 通用系統(tǒng) 6.Facility 設(shè)施 7. 其他需要的名單 1.3.2 Out-of-Scope 驗(yàn)證范圍例外 The scope of validation for the does not include: （設(shè)備名稱）驗(yàn)證的范圍不包括： 1.The XYZ system i

20、s validated separately. 系統(tǒng)單獨(dú)驗(yàn)證 2.The Data Historian is validated separately. 數(shù)據(jù)歷史單獨(dú)驗(yàn)證 3. 其他名單 1.3.3 Related Validation 相關(guān)驗(yàn)證 插入現(xiàn)有的或計(jì)劃的與本驗(yàn)證系統(tǒng)有關(guān)的驗(yàn)證的描述。如果系統(tǒng)配置和數(shù)據(jù)采集時(shí)是一致的，前期 數(shù)據(jù)的使用可以作為試驗(yàn)方法的參考或直接替代試驗(yàn)， The related validation that will occur in support of the includes all the following that are necessary for

21、the system to be placed into operation. 支持（設(shè)備名稱）的相關(guān)驗(yàn)證在以下情況發(fā)生：包括系統(tǒng)運(yùn)行必需的幾點(diǎn)（清晰的定義分界線）： 1.Process Validation 工藝驗(yàn)證 2.Cleaning Studies 清潔研究 . ;. 3.Air Classification 風(fēng)力分級(jí) 4.Microbiological Testing 微生物試驗(yàn) 5.Chemical Testing 化學(xué)試驗(yàn) 6.Drying Studies 干燥研究 7.Sterilization Studies 無菌研究 8. 其他名單 1.4 Objectives 目標(biāo) Th

22、e 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

23、applicable regulations, guidelines, and accepted industry practices for validation. 該項(xiàng)驗(yàn)證計(jì)劃的目標(biāo)是簡(jiǎn)述一項(xiàng)要求，該要求能夠證明所有與設(shè)備名稱相關(guān)的組成、控制系統(tǒng)和功 能都是恰當(dāng)?shù)姆犀F(xiàn)行標(biāo)準(zhǔn)的工藝。資格的綜述要基于（公司名稱）政策，程序以及可應(yīng)用 的規(guī)則、指導(dǎo)方針和公認(rèn)的工業(yè)驗(yàn)證實(shí)踐。 1.5 Periodic Review 定期回顧 This Plan should be reviewed periodically to ensure compliance and or to determine if

24、a change is required. Some appropriate times to review are: 這份計(jì)劃應(yīng)該被定期回顧來保證符合并確定是否需要更改。一些適當(dāng)?shù)幕仡檿r(shí)間是： 1. Change in Validation Master Plan驗(yàn)證主文件的更改發(fā)生時(shí) 2. Change in scope occurs驗(yàn)證范圍的更改發(fā)生時(shí) 3. Design change occurs設(shè)計(jì)更改發(fā)生時(shí) 4. Prior to IQ and OQ 在進(jìn)行和之前 5. Completion of IQ and OQ 和完成時(shí) See section 5 for a descrip

25、tion 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(guān)驗(yàn)證管理和針對(duì)該項(xiàng)計(jì)劃見第五部分有關(guān)驗(yàn)證管理和針對(duì)該項(xiàng)計(jì)劃 的回顧、修訂過程或指適應(yīng)公司政策的回顧周期。的回顧、修訂過程或指適應(yīng)公司政策的回顧周期。 2. Organizational Structure 組織結(jié)構(gòu) . ;. Specific responsibilities related to t

26、he 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: 與（設(shè)備名稱）驗(yàn)證相關(guān)的具體職責(zé)在附錄中概述。大體上，與驗(yàn)證相關(guān)的活動(dòng)項(xiàng)目由以下個(gè)人 和部門負(fù)責(zé)： 確定個(gè)人的任務(wù)和責(zé)任至少應(yīng)包括以下幾點(diǎn)，總體根據(jù)崗位不同描述每項(xiàng)任務(wù)和責(zé)任 1.Management level Responsible for project

27、 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 doc

28、umentation for the project 管理層：負(fù)責(zé)項(xiàng)目管理和計(jì)劃。方案，活動(dòng)，資源，成本的控制，監(jiān)控工藝， 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 s

29、tage/validation status 質(zhì)保：負(fù)責(zé)保證符合適當(dāng)?shù)恼{(diào)整、商業(yè)、技術(shù)、用戶群要求，支持維護(hù)標(biāo)準(zhǔn)、獨(dú)立審查、可交 付的批準(zhǔn)、審批完成階段和身份驗(yàn)證等。 3.System Owner Responsible for implementation/management of the system by the business user community, approving completion of stage/validation status 系統(tǒng)所有者：負(fù)責(zé)執(zhí)行和管理系統(tǒng)的用戶群，審批完成階段和驗(yàn)證身份。 這些任務(wù)和責(zé)任可以適當(dāng)?shù)亩x：按照他們的分工總體上定義每項(xiàng)任務(wù)和

30、責(zé)任。 1.Operations Responsible for providing 操作：負(fù)責(zé)提供 2.Project Level Responsible for providing 項(xiàng)目水平：負(fù)責(zé)提供 3.Technical and Engineering support Responsible for providing 技術(shù)和工程支持：負(fù)責(zé)提供 4.Validation Specialist Responsible for providing 驗(yàn)證專家：負(fù)責(zé)提供 5.System Administrator Responsible for providing 系統(tǒng)管理：負(fù)責(zé)提供 6.P

31、urchasing - Responsible for providing 采供：負(fù)責(zé)提供 7. 其他名單 . ;. 3.GxP Criticality Assessment GxP 關(guān)鍵性估計(jì) 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. 詳述和（設(shè)備名稱）有關(guān)的 GxP 關(guān)鍵性估計(jì)信息。 該部分

32、包括另外一種信息，包括該主題，例如系統(tǒng)詳細(xì)目錄。 3.1GxP Criticality Assessment Requirements GxP 關(guān)鍵性評(píng)估要求 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

33、 systems. 定義在決定（設(shè)備名稱）Gxp水平中使用的關(guān)鍵性要求，包括直接影響，間接影響和無影響系統(tǒng)。 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. 直接影響：系統(tǒng)或系統(tǒng)中的一個(gè)組成，對(duì)產(chǎn)品質(zhì)量有直接影響的操作，接觸，控制，預(yù)警或失敗。 Indirect Impact System or component within

34、 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. 間接影響：系

35、統(tǒng)或系統(tǒng)中的一個(gè)組成，對(duì)產(chǎn)品質(zhì)量無直接影響的操作，接觸，控制，預(yù)警或失敗。 間接影響系統(tǒng)專門支持直接影響系統(tǒng)，因此間接影響系統(tǒng)會(huì)對(duì)直接影響系統(tǒng)的執(zhí)行和運(yùn)作構(gòu) 成影響。 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 Imp

36、act systems. 無影響：系統(tǒng)或系統(tǒng)的一個(gè)組成，對(duì)產(chǎn)品質(zhì)量不構(gòu)成直接或間接影響的操作，接觸，控制，預(yù)警或 失敗。無影響系統(tǒng)不能支持直接影響系統(tǒng)。 3.2GxP Criticality Assessment Procedures GxP 關(guān)鍵性評(píng)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

37、 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. 定義使用的程序/（設(shè)備名稱）的 Gxp 關(guān)鍵性水平的評(píng)估的標(biāo)準(zhǔn)。開發(fā)一種具有證明的文件路徑，作 為（

38、設(shè)備名稱）GxP 關(guān)鍵性水平每一項(xiàng)目的評(píng)估標(biāo)準(zhǔn)。創(chuàng)建一個(gè)決策樹將對(duì)在 GxP 關(guān)鍵性評(píng)估中論 證工藝的一般觀察要求有幫助。如果必要，可以引用國(guó)際程序作為參考。 3.3GxP Criticality Assessment Current Status GxP 關(guān)鍵性評(píng)估-現(xiàn)行標(biāo)準(zhǔn) State the current status of the assessment for the GxP criticality levels for the . 陳述現(xiàn)行（設(shè)備名稱）的 GxP 關(guān)鍵性水平評(píng)估的要求。 . ;. The Direct Impact Systems associated with t

39、he include all the following. （設(shè)備名稱的）直接影響因素包括以下的所有項(xiàng)。（清楚的規(guī)定支持理論） 1.Controls system hardware and software - This has been deemed a direct impact system due to 控制系統(tǒng)硬件和軟件：該項(xiàng)是一個(gè)直接影響由于 2.Mechanical Hardware - This has been deemed a direct impact system due to 機(jī)械硬件：該項(xiàng)是一個(gè)直接影響由于 3.Instrumentation This has be

40、en deemed a direct impact system due to 儀器：該項(xiàng)是一個(gè)直接影響由于 4.Process piping - This has been deemed a direct impact system due to 工藝流程：該項(xiàng)是一個(gè)直接影響由于 5.Utility Systems - This has been deemed a direct impact system due to 效用系統(tǒng)：該項(xiàng)是一個(gè)直接影響由于 6.Facility - This has been deemed a direct impact system due to 設(shè)備：該項(xiàng)是

41、一個(gè)直接影響由于 7. 其他名單 The Indirect Impact Systems associated with the include all the following. （設(shè)備名稱的）間接影響因素包括以下的所有項(xiàng)。（清楚的規(guī)定支持原理） 1.Controls system hardware and software - This has been deemed an indirect impact system due to 控制系統(tǒng)硬件和軟件：該項(xiàng)是一個(gè)間接影響由于 2.Mechanical Hardware - This has been deemed an indirect

42、 impact system due to 機(jī)械硬件：該項(xiàng)是一個(gè)間接影響由于 3.Instrumentation This has been deemed an indirect impact system due to 儀器：該項(xiàng)是一個(gè)間接影響由于 4.Process piping - This has been deemed an indirect impact system due to 工藝流程：該項(xiàng)是一個(gè)間接影響由于 5.Utility Systems - This has been deemed an indirect impact system due to 效用系統(tǒng)：該項(xiàng)是一個(gè)

43、間接影響由于 6.Facility - This has been deemed an indirect impact system due to 設(shè)備：該項(xiàng)是一個(gè)間接影響由于 7. . ;. 其他名單 The No Impact Systems associated with the include all the following. （設(shè)備名稱的）無影響因素包括以下的所有項(xiàng)。（清楚的規(guī)定支持原理） 1.Controls system hardware and software - This has been deemed a no impact system due to 控制系統(tǒng)硬件和

44、軟件：該項(xiàng)是一個(gè)無影響系統(tǒng)由于 2.Mechanical Hardware - This has been deemed a no impact system due to 機(jī)械硬件：該項(xiàng)是一個(gè)無影響系統(tǒng)由于 3.Instrumentation This has been deemed a no impact system due to 儀器：該項(xiàng)是一個(gè)無影響系統(tǒng)由于 4.Utility Systems - This has been deemed a no impact system due to 工藝流程：該項(xiàng)是一個(gè)無影響系統(tǒng)由于 5.Facility - This has been de

45、emed a no impact system due to 設(shè)備：該項(xiàng)是一個(gè)無影響系統(tǒng)由于 6. 其他名單 4.Validation Strategy 驗(yàn)證策略 4.1Life Cycle 生命周期 Define the internal requirements for development, testing, delivery, and support that define the period of time that begins when a system is conceived and ends when the system is no longer available

46、for use. 陳述國(guó)內(nèi)研發(fā)，測(cè)試，運(yùn)輸和維護(hù)的要求，定義驗(yàn)證開始的時(shí)間段（系統(tǒng)存在時(shí)開始），系統(tǒng)結(jié)束 的時(shí)間（系統(tǒng)不可用時(shí)結(jié)束）。 4.2Risk Assessment 風(fēng)險(xiǎn)評(píng)估 State the current status of the assessment for the GxP Risk and Business Risk for the . The process needs to address the following questions: 陳述現(xiàn)行（設(shè)備名稱）的 GxP 關(guān)鍵性水平評(píng)估的風(fēng)險(xiǎn)和商業(yè)風(fēng)險(xiǎn)。該程序必須包括以下問題： Does this automated system require validation? 自動(dòng)化系統(tǒng)需要驗(yàn)證嗎？ How much validation is required