1、Author's Signature: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 <equipment name>您的簽名表明這份文件的準(zhǔn)備符合現(xiàn)行項目標(biāo)準(zhǔn)并且充分反映人物u和可交付使用對<設(shè)備名稱>驗證的必要。Aut

2、hored By:經(jīng)授權(quán)：Typed/Printed Name, Title姓名，職稱Signature簽名Date日期Unit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 tasks and deliverables necessary for validation of the <equipment name>.您的簽名表明您已經(jīng)審閱

3、了這份文件，確認它精確并完全的反映任務(wù)和可交付使用對<設(shè)備名稱>驗證的必要。Reviewed By: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 Approver's Signature:質(zhì)檢/承認簽名Your signature indicat

4、es 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.您的簽

5、名表明這份文件符合證明人驗證總計劃，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)。Approved By: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Revision修訂本Revision Date修訂日期Reason for Revision/Change Request修訂/更改要求的原因Revised By修訂

6、人004-DEC-20022002/12/4Original Release原始版本Michael T. Filary邁克爾116-JAN-20032003/1/16Updated the JETT logo on the cover page.更新封頁面的JETT的標(biāo)識Michael T. Filary邁克爾TABLE OF CONTENTS目錄1.Introduction緒論51.1Purpose目的51.2Policy Compliance適用的政策51.3Scope of Validation驗證范圍 51.4Objectives目標(biāo)61.5Periodic Review定期審查62.

7、Organizational Structure組織結(jié)構(gòu)73.GxP Criticality AssessmentGxP關(guān)鍵性評估73.1GxP Criticality Assessment - RequirementsGxP關(guān)鍵性評估要求73.2GxP Criticality Assessment - Procedures GxP關(guān)鍵性評估程序 83.3GxP Criticality Assessment Current StatusGxP關(guān)鍵性評估現(xiàn)行標(biāo)準(zhǔn)84.Validation Strategy 驗證策略94.1Life Cycle生命周期94.2Risk Assessment風(fēng)險評估

8、94.3Hardware Categories硬件分類94.4Software Categories軟件分類94.5Project Inputs/Outputs for Stages項目各階段的輸入/輸出104.6Acceptance Criteria for Stages各階段的接受標(biāo) 105.Validation Deliverables105.1Traceability and Linkages描述和鏈接 115.2Master List of all Validation Products and Supporting Documentation所有批準(zhǔn)產(chǎn)品和證明文件的總清單 115.

9、3User Requirements Specification (URS) 使用說明書115.4Functional Requirement Specification (FRS) 功能說明書115.5Configuration Management and Change Control Documentation 配置管理和變速控制文件 115.6Vendor Qualification documentation賣主資格認證 115.7Design Specifications設(shè)計說明125.8Testing and Verification Requirements Documenta

10、tion試驗和確認所需文件125.9System Security系統(tǒng)安全性135.10Operational Support運行支持145.11Business Continuity Plan業(yè)務(wù)持續(xù)計劃145.12Disaster Recovery, Backup and Restoration災(zāi)難性恢復(fù)，備份及修復(fù)145.13System Acceptance Final Report系統(tǒng)接受終報告145.14<List any additional validation products required>列出任何其他需要驗證的產(chǎn)品156.Acceptance Criter

11、ia可接受標(biāo)準(zhǔn)157.Change Control變更控制157.1Pre-Implementation Changes預(yù)執(zhí)行變更157.2Post-Implementation Changes執(zhí)行后變更158.Standard Operating Procedures SOP158.1SOP Responsibilities SOP職責(zé)158.2Listing of SOPs SOP列表169.Training培訓(xùn)1610.Documentation Management資料管理1610.1Document Production文件產(chǎn)生1610.2Document Review文件回顧161

12、0.3Document Approval文件批準(zhǔn)1610.4Document Issue文件發(fā)布1610.5Document Changes文件變更1710.6Document Withdraw文件撤銷1710.7Document Storage文件保存1711.Maintaining the Validated State驗證狀態(tài)的維護1711.1System Retirement系統(tǒng)引退1712.Validation Activities Timeline驗證執(zhí)行時間表17Appendix A附錄A參與組織18Appendix B附錄B縮寫詞，定義19Appendix C附錄C責(zé)任/時間2

13、2Appendix D附錄D可交付的驗證23Appendix 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 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(wù)和設(shè)備名稱的預(yù)期驗證。· WHO will be respon

14、sible for completion, review, and approval of these tasks.· 世界衛(wèi)生組織將負責(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 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(chǎn)生和/或保留。· HOW this documentation will be produced/created (at a macro

15、 level).· 這份文件將被如何制作/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 <refer to specific Validation Master Plan(s), company policies, company standards, and/or company guidelines >, and the appropriat

16、e 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(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)于驗證的統(tǒng)一要求。The validation of the <equipment name> system is a cGMP requirement. 設(shè)備名稱的驗證系統(tǒng)是現(xiàn)行的一個要求。1.3 Scope of Validation驗證范圍This Validation Plan for the <equipment name> is limited to the unique c

17、omponents and control system that define the equipment. This validation effort will be conducted as a prospective validation.這份為設(shè)備名稱的驗證計劃僅限于特殊構(gòu)成和定義設(shè)備的控制系統(tǒng)。該項驗證成就將會被作為一項預(yù)期的驗證執(zhí)行。Provide a Brief description of equipment and principal function; Refer to User Requirement Specifications. Provide a descrip

18、tion 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(shè)備和主要功能的闡述. 對實施計劃的設(shè)備進行研究、生產(chǎn)、加工、包裝、存儲、分配過程的說明。1.3.1 In-Scope驗證范圍The scope of validation for the <equipment name> includes all the following that are neces

19、sary for the system to operate. <clearly define all boundaries>（設(shè)備名稱）驗證的范圍包括以下所有的系統(tǒng)運作所必需的內(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. <list all that are appropriate>其

20、他需要的名單1.3.2 Out-of-Scope驗證范圍例外The scope of validation for the <equipment name> does not include:（設(shè)備名稱）驗證的范圍不包括：1. The XYZ system is validated separately.系統(tǒng)單獨驗證2. The Data Historian is validated separately.數(shù)據(jù)歷史單獨驗證3. <list all that are appropriate>其他名單1.3.3 Related Validation相關(guān)驗證<Inser

21、t 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

22、collected>插入現(xiàn)有的或計劃的與本驗證系統(tǒng)有關(guān)的驗證的描述。如果系統(tǒng)配置和數(shù)據(jù)采集時是一致的，前期數(shù)據(jù)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 <equipment name> includes all the following that are necessary for the system to be placed into operation. <clearly define all boundaries>支持（設(shè)備名稱）的相關(guān)驗證

23、在以下情況發(fā)生：包括系統(tǒng)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3. Air Classification風(fēng)力分級4. Microbiological Testing微生物試驗5. Chemical Testing化學(xué)試驗6. Drying Studies干燥研究7. Sterilization Studies無菌研究8. <list all that are appropriate>其他名單1.4 Objectives目標(biāo)The objective of this validation p

24、lan 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 pr

25、ocedures and applicable regulations, guidelines, and accepted industry practices for validation.該項驗證計劃的目標(biāo)是簡述一項要求，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)方針和公認的工業(yè)驗證實踐。1.5 Periodic Review定期回顧This Plan should be reviewed periodically to ensure compliance and or to determ

26、ine if a change is required. Some appropriate times to review are:這份計劃應(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間是：1. Change in Validation Master Plan驗證主文件的更改發(fā)生時2. Change in scope occurs驗證范圍的更改發(fā)生時3. Design change occurs設(shè)計更改發(fā)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 descripti

27、on 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)驗證管理和針對該項計劃 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 the validation of the <equipment name> are out

28、lined 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）驗證相關(guān)的具體職責(zé)在附錄中概述。大體上，與驗證相關(guān)的活動項目由以下個人和部門負責(zé)：<The defined role and responsibilities should include at a minimum the individuals listed below - Describe e

29、ach role and responsibility in a general way as they apply>確定個人的任務(wù)和責(zé)任至少應(yīng)包括以下幾點，總體根據(jù)崗位不同描述每項任務(wù)和責(zé)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

30、are correctly addressed/resolved, reporting to senior management, interface to QA to ensure compliance, reviewing and approving validation documentation for the project管理層：負責(zé)項目管理和計劃。方案，活動，資源，成本的控制，監(jiān)控工藝，2. Quality Assurance Responsible for assuring compliance with appropriate regulatory/business/tech

31、nical/user community requirements, providing support for the criterion/independent review/approval of deliverables, approving completion of stage/validation status質(zhì)保：負責(zé)保證符合適當(dāng)?shù)恼{(diào)整、商業(yè)、技術(shù)、用戶群要求，支持維護標(biāo)準(zhǔn)、獨立審查、可交付的批準(zhǔn)、審批完成階段和身份驗證等。3. System Owner Responsible for implementation/management of the system by the

32、 business user community, approving completion of stage/validation status系統(tǒng)所有者：負責(zé)執(zhí)行和管理系統(tǒng)的用戶群，審批完成階段和驗證身份。<These role and responsibilities may be defined as appropriate - Describe each role and responsibility in a general way as they apply>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任務(wù)和責(zé)任。1. Operations Respon

33、sible for providing操作：負責(zé)提供2. Project Level Responsible for providing項目水平：負責(zé)提供3. Technical and Engineering support Responsible for providing技術(shù)和工程支持：負責(zé)提供4. Validation Specialist Responsible for providing驗證專家：負責(zé)提供5. System Administrator Responsible for providing系統(tǒng)管理：負責(zé)提供6. Purchasing - Responsible for

34、providing采供：負責(zé)提供7. <List all that are appropriate>其他名單3.GxP Criticality AssessmentGxP關(guān)鍵性估計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.詳述和（設(shè)備名稱）有

35、關(guān)的 GxP關(guān)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(tǒng)詳細目錄。 3.1GxP Criticality Assessment RequirementsGxP 關(guān)鍵性評估要求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 I

36、mpact, Indirect Impact, and No Impact 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)中的一個組成，對產(chǎn)品質(zhì)量有直接影響的操作，接觸，控制，預(yù)警或失敗。Indirect

37、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

38、of a direct impact system.間接影響：系統(tǒng)或系統(tǒng)中的一個組成，對產(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)會對直接影響系統(tǒng)的執(zhí)行和運作構(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 system

39、s will not support Direct Impact systems.無影響：系統(tǒng)或系統(tǒng)的一個組成，對產(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 ProceduresGxP關(guān)鍵性評估-程序Define the procedures used/followed in the assessment of the levels for GxP criticality for the <equipment name>. Develop a documented path

40、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 reference

41、d, if available.定義使用的程序/（設(shè)備名稱）的Gxp關(guān)鍵性水平的評估的標(biāo)準(zhǔn)。開發(fā)一種具有證明的文件路徑，作為（設(shè)備名稱）GxP關(guān)鍵性水平每一項目的評估標(biāo)準(zhǔn)。創(chuàng)建一個決策樹將對在GxP關(guān)鍵性評估中論證工藝的一般觀察要求有幫助。如果必要，可以引用國際程序作為參考。3.3GxP Criticality Assessment Current StatusGxP關(guān)鍵性評估-現(xiàn)行標(biāo)準(zhǔn)State the current status of the assessment for the GxP criticality levels for the <equipment name>.

42、 陳述現(xiàn)行（設(shè)備名稱）的GxP關(guān)鍵性水平評估的要求。The Direct Impact Systems associated with the <equipment name> include all the following. <Clearly develop supporting rationale>（設(shè)備名稱的）直接影響因素包括以下的所有項。（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

43、件：該項是一個直接影響由于2. Mechanical Hardware - This has been deemed a direct impact system due to機械硬件：該項是一個直接影響由于3. Instrumentation This has been deemed a direct impact system due to儀器：該項是一個直接影響由于4. Process piping - This has been deemed a direct impact system due to工藝流程：該項是一個直接影響由于5. Utility Systems - This h

44、as been deemed a direct impact system due to效用系統(tǒng)：該項是一個直接影響由于6. Facility - This has been deemed a direct impact system due to設(shè)備：該項是一個直接影響由于7. <List all that are appropriate>其他名單The Indirect Impact Systems associated with the <equipment name> include all the following. <Clearly develop

45、supporting rationale>（設(shè)備名稱的）間接影響因素包括以下的所有項。（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：該項是一個間接影響由于2. Mechanical Hardware - This has been deemed an indirect impact system due to機械硬件：該項是一個間接影響由于3. Instrumentation This has been

46、 deemed an indirect impact system due to儀器：該項是一個間接影響由于4. Process piping - This has been deemed an indirect impact system due to工藝流程：該項是一個間接影響由于5. Utility Systems - This has been deemed an indirect impact system due to效用系統(tǒng)：該項是一個間接影響由于6. Facility - This has been deemed an indirect impact system due to

47、設(shè)備：該項是一個間接影響由于7. <List all that are appropriate>其他名單The No Impact Systems associated with the <equipment name> include all the following. <Clearly develop supporting rationale>（設(shè)備名稱的）無影響因素包括以下的所有項。（清楚的規(guī)定支持原理） 1. Controls system hardware and software - This has been deemed a no impa

48、ct system due to控制系統(tǒng)硬件和軟件：該項是一個無影響系統(tǒng)由于2. Mechanical Hardware - This has been deemed a no impact system due to機械硬件：該項是一個無影響系統(tǒng)由于3. Instrumentation This has been deemed a no impact system due to儀器：該項是一個無影響系統(tǒng)由于4. Utility Systems - This has been deemed a no impact system due to工藝流程：該項是一個無影響系統(tǒng)由于5. Facilit

49、y - This has been deemed a no impact system due to設(shè)備：該項是一個無影響系統(tǒng)由于6. <List all that are appropriate>其他名單4.Validation Strategy驗證策略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 conceive

50、d and ends when the system is no longer available for use.陳述國內(nèi)研發(fā)，測試，運輸和維護的要求，定義驗證開始的時間段（系統(tǒng)存在時開始），系統(tǒng)結(jié)束的時間（系統(tǒng)不可用時結(jié)束）。4.2Risk Assessment風(fēng)險評估State the current status of the assessment for the GxP Risk and Business Risk for the <equipment name>. The process needs to address the following questions:

51、陳述現(xiàn)行（設(shè)備名稱）的GxP關(guān)鍵性水平評估的風(fēng)險和商業(yè)風(fēng)險。該程序必須包括以下問題：· Does this automated system require validation?· 自動化系統(tǒng)需要驗證嗎？· How much validation is required for this system?· 該系統(tǒng)要求多少驗證？· What aspects of the system or process are critical to product and patient safety?· 系統(tǒng)的哪個方面或工藝對產(chǎn)品和患者安全性是

52、關(guān)鍵性因素？· What aspects of the system or process are critical to business?· 系統(tǒng)的哪個方面或工藝過程對商業(yè)是關(guān)鍵性因素?4.3Hardware Categories硬件分類Define the categories of the hardware associated with the <equipment name>. 定義(設(shè)備名稱)的硬件種類Hardware components of a system can be analyzed and categorized into one o

53、f the following GAMP defined categories:硬件系統(tǒng)組成可以按照以下GAMP詳述的分類方法進行分析和歸類：· Hardware Category 1 Standard Hardware Components· 硬件分類1: 標(biāo)準(zhǔn)硬件組成 · Hardware Category 2 Custom Built Hardware Components· 硬件分類2：定制的硬件組成4.4Software Categories軟件分類Define the categories of the software associated

54、 with the <equipment name>. 定義(設(shè)備名稱)的軟件種類Software components of a system can be analyzed and categorized into one of the following GAMP defined categories:軟件系統(tǒng)組成可以按照以下GAMP詳述的分類方法進行分析和歸類：· Software Category 1 Operating Systems· 軟件分類1：運行系統(tǒng)· Software Category 2 Firmware· 軟件分類2

55、：固件（軟件硬件相結(jié)合）· Software Category 3 Standard Software Packages· 軟件分類3：標(biāo)準(zhǔn)軟件包· Software Category 4 Configurable Software Packages· 軟件分類4：結(jié)構(gòu)軟件包· Software Category 5 Custom Software· 軟件分類5：定制軟件4.5Project Inputs/Outputs for Stages項目各階段的輸入/輸出Define the project input and outputs for each sta