工廠驗證主計劃模板---中美天津史克

1、Approval and Authorization批準(zhǔn)和授權(quán)Completion of the following signature blocks signifies the review and approval of this document完成以下簽字意味著完成了對此文件的回顧和批準(zhǔn)NameJob Title/RoleSignatureDate日期姓名職位 /角色簽字The Author is signing to confirm that this document has been prepared in accordance with an approved document

2、 management process that content is consistent with the deliverable definition found in the SOPXXXX Site Validation Approach, and that relevant input from any contributory authors has been included.作者的簽字證明文件是按照批準(zhǔn)的文件管理規(guī)程準(zhǔn)備的，其中內(nèi)容符合SOPXXXX工廠驗證流程對驗證文件的定義。并確認相關(guān)人員的意見均已包含在文件中后簽署文件。Validation EngineerCompli

3、ance & Validationare signing to confirm compliance with applicable pharmaceuticalregulatory agency requirements and Company standards.法規(guī)和驗證的簽字確認其符合制藥法規(guī)組織的要求和公司標(biāo)準(zhǔn)。Validation ManagerQuality ManagerSite Directoris signing to confirm projects in site and provide the required resources for validationacti

4、vities.工廠總監(jiān)的簽字是確認工廠需要進行的項目和為工廠驗證活動提供需要的資源。Site DirectorDistribution List分發(fā)清單No Distribution Required不需要分發(fā)Field Execution Copy在執(zhí)行過程中需要復(fù)印件Copy NoIssued To (Name / Department)Issued By (C&V)Date of Issue復(fù)印件編號交給（姓名部門）由誰生效（法規(guī)和驗證組）生效日期123目錄 CONTENT1目的 Objective32驗證的指導(dǎo)方針與規(guī)程Validation Polices and Procedures

5、4;.3責(zé)任 Responsibilities .54驗證的時間表與進展Schedules and Progress .752007年度完成的驗證項目 Validation Projects completed in 2007 .962007年度暫停和取消的驗證項目 Validation Projects on hold and cancelled in 2007.117修訂歷史 Revision History .13;.1 目的 Objective該工廠驗證總計劃是為了提供一個對 XXXX 公司制藥有限公司的驗證工作的綜合描述。具體而言，該計劃將：The purpose of the SV

6、MP is to provide a comprehensive overview of all validation activities in XXXX 公司 . The plan will cover following:1) 列出公司在進行驗證工作時所必須遵循的指導(dǎo)方針與指南。List the governing policies and procedures that must be followed in validation activities.2) 確定公司各部門和主要管理人員在驗證工作中的主要責(zé)任。Define the responsibilities of key per

7、sonnel in validation activities.3) 列出公司目前主要的驗證工作類別以及與其相關(guān)的驗證主計劃。List the main validation activities in the site and the references to the validation master plans.4) 描述公司目前正在進行和計劃將要進行的驗證工作和項目的程序和進展。Describe the execution status of validation activities that are in process or in plan.;.2 驗證的指導(dǎo)方針與規(guī)程 Val

8、idation Polices and Procedures生產(chǎn)廠關(guān)鍵規(guī)程列表如下：Key site procedures are listed in the table below.文件名稱文件編號Document NameSOP Number工廠驗證管理規(guī)程Site Validation Approach分析儀器驗證通則Analytical Equipment Validation Approach化學(xué)檢驗方法驗證規(guī)程Chemical Analysis Method Validation Approach生產(chǎn)設(shè)施驗證規(guī)程Manufacturing Facility Validation驗證

9、草案和報告的生成Generation of Qualification Protocols and Reports設(shè)計確認程序Validation Procedure for Design Qualification安裝確認程序Validation Procedure for Installation Qualification運行確認程序Validation Procedure for Operational Qualification性能確認程序Validation Procedure for Performance Qualification計算機驗證方法Computer Validat

10、ion Approach清潔驗證Cleaning Validation維護系統(tǒng)的驗證狀態(tài)Maintaining Systems the Validated Status控制系統(tǒng)Control System Validation Approach系統(tǒng)影響性評估System Impact Assessment;.3 責(zé)任 Responsibilities部門 /人員Department/Personnel質(zhì)量保證部驗證組QA Validation物資管理部Logistic工程部Engineering Department技術(shù)部Technical價值流Value Stream責(zé)任Responsibi

11、lity負責(zé)制訂與回顧年度SVMPResponsible for preparing and reviewing SVMP負責(zé)制訂與回顧各項目驗證主計劃Responsible for preparing and reviewing VMP of every project協(xié)調(diào)各個驗證過程并參與評估待驗證項目Co-ordinate all validation processes and, participates in the assessment of prospective projects for validation requirements.組織與驗證相關(guān)培訓(xùn)Organize the

12、 training for validation.對驗證主計劃、方案及報告進行審核并將已完成的驗證文件存檔Review validation master plan, validation protocols and reports, archive validation documents.起草倉庫相關(guān)項目的用戶需求標(biāo)準(zhǔn)、方案與報告Prepare the URS, validation protocols and reports for projects of warehouse.進行驗證前的評估System assessment before validation按批準(zhǔn)的驗證方案執(zhí)行驗證E

13、xecute validation activities following approved validation protocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進行調(diào)查Data collection and problem investigation during validation.起草公用設(shè)施與設(shè)備的用戶需求標(biāo)準(zhǔn)、方案與報告Prepare the URS, validation protocols and reports for facilities and utilities.進行驗證前的評估System assessment before validation按批準(zhǔn)的驗證方案

14、執(zhí)行驗證Execute validation activities following approved validation protocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進行調(diào)查Data collection and problem investigation during validation.起草新產(chǎn)品和產(chǎn)品轉(zhuǎn)移的方案與報告Prepare validation protocols and reports for new products and products transfer進行驗證前的評估System assessment before validation按批準(zhǔn)的驗證方案執(zhí)

15、行驗證Execute validation activities following approved validation protocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進行調(diào)查Data collection and problem investigation during validation.對工藝驗證草案 /報告進行批準(zhǔn)Approve process validation protocol and report起草生產(chǎn)設(shè)備與工藝的用戶需求標(biāo)準(zhǔn)、方案與報告Prepare product equipment and process URS, validation protocols a

16、nd reports進行驗證前的評估;.部門 /人員責(zé)任Department/PersonnelResponsibilitySystem assessment before validation按批準(zhǔn)的驗證方案執(zhí)行驗證Execute validation activities following approved validation protocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進行調(diào)查Data collection and problem investigation during the validation.起草分析儀器及分析方法的用戶需求標(biāo)準(zhǔn)、方案與報告Prepare analyt

17、ical equipment and test methodsURS, validationprotocols and reports進行驗證前的評估System assessment before validation實驗室完成在驗證過程中涉及的檢驗并提供及時準(zhǔn)確的數(shù)據(jù)QC LabComplete the test in the validation activities and provide timelyaccurate data.按批準(zhǔn)的驗證方案執(zhí)行驗證Execute validation activities following approved validation protoco

18、ls數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進行調(diào)查Data collection and problem investigation during the validation.確保驗證按照批準(zhǔn)的方案進行質(zhì)量保證部 QA 組Ensure the validation is executed accordingto the validationprotocol參與對在驗證過程中產(chǎn)生的問題的調(diào)查Take part in problem investigation during validation.確保所有的驗證活動符合 XXXX 集團及所涉及市場的法規(guī)部門的要求Ensure all the valid

19、ation activities comply with the and siteprocedures質(zhì)量保證部經(jīng)理批準(zhǔn) SVMP, 驗證主計劃、 工藝驗證的方案與報告、清潔驗證草案和報Head of Quality告、項目 cGMP 回顧報告、驗證總結(jié)報告Approve SVMP, VMP, performance qualification protocol andreport, cleaning validation protocol and report, project cGMP reviewreport ,validation summary report批準(zhǔn) SVMP工廠總監(jiān)Ap

20、prove SVMPSite Director為驗證工作提供必要的人力資源及財力資源Provide the required resources for validation activities;.4驗證的時間表與進展Schedules and Progress4.1某車間的驗證項目Validation Projects in A workshop計劃開始與完成日期項目進程 Schedule按依據(jù) &備注項目Scheduled Date進完推計Justifications &edValidation Projects開始日期完成日期20072008ed遲行劃成schedulProgresPo

21、stponCommentss as perStartingEnding678910 11 1212 3 45Complet2006.112007.10XA2007.22008.12X2007.42007.12XB2007.42007.12XC4.2 某車間回顧驗證 the Re-validation projects for the A workshop計劃開始與完成日期項目進程 Schedule按依據(jù) &備注項目Scheduled Date進完推計JustificationsedValidation Projects開始日期完成日期20072008ed遲行劃成schedulProgres&

22、CommentsStartingEnding678910 11 1212 3 45 s as perPostponComplet;.計劃開始與完成日期項目Scheduled DateValidation Projects開始日期完成日期StartingEnding2007.92007.122008.12008.32008.42008.64.3 物流部新項目Logistics New projects計劃開始與完成日期項目Scheduled DateValidation Projects開始日期完成日期StartingEnding2006.62007.12項目進程 Schedule2007200

23、86789101112123 4項目進程 Schedule200720086789101112123進按完推依據(jù) &備注計Justificationseded遲行劃成schedulProgresPostpon& Comments5 s as perCompletXXX按依據(jù) &備注計完推Justification行 eded遲s &as per劃成Postpon進 CompletscheduleProgressComments4 5X;.計劃開始與完成日期項目進程 Schedule項目Scheduled Date20072008Validation Projects開始日期完成日期Starti

24、ngEnding678910 11 12 1232006.82008.12按依據(jù) &備注計完推Justification行 eded遲s &as per劃成Postpon進 CompletComments4scheduleProgress5X4.4 物流部回顧驗證Logistics Re-validation projects4.5 工程部回顧驗證Engineering Re-validation projects4.6 工程部支持膠囊價值流回顧驗證的項目 Engineering support projects for Capsule VS Re-validation projects 依次

25、羅列出所有部門的驗證項目。5. 相關(guān)部門完成的驗證項目5.1 工程部 2007 年度完成的驗證項目Validation Projects completed in 2007-Engineering計劃開始與完成日期項目進程 Schedule按依據(jù) &備注項目Scheduled Date行完計推Validation Projects開始日期完成日期2007d劃d遲 Justificationsas per成& CommentsStartingEnding進CompletePostponeProgress2006.112007.8X2006.62007.8X5.2 質(zhì)量保證部QA 組 2007 年

26、度完成的驗證項目Validation Projects completed in 2007 - QANA;.5.3 質(zhì)量保證部實驗室2007 年度完成的驗證項目Validation Projects completed in 2007- QC LaboratoriesXXXX 產(chǎn)品軟膏清洗驗證分析方法驗證（系統(tǒng)參考編號 302052 ）Fenbid cream cleaning-validation analytical method validation（ System Reference NO.302052 ）XXXX 產(chǎn)品清洗驗證分析方法驗證（系統(tǒng)參考編號 302058 ）XXXX 產(chǎn)品

27、 ointmentcleaning-validation analytical method validation （ System Reference NO.302058 ）XXXX 產(chǎn)品清洗驗證分析方法驗證（系統(tǒng)參考編號 302054 ）XXXX產(chǎn) 品cleaning-validationanalyticalmethodvalidation（SystemReferenceNO.302054 ）XXXX 產(chǎn)品清洗驗證分析方法驗證（系統(tǒng)參考編號 :302061 ）XXXX產(chǎn) 品cleaning-validationanalyticalmethodvalidation（SystemReferen

28、ceNO.:302061 ）計劃開始與完成日期Scheduled Date開始日期完成日期StartingEnding2006.102007.32007.12007.22006.112007.12007.12007.2項目進程 Schedule2007按依據(jù)行d計完 d推Justifications劃成遲& Commentsas per 進PostponeCompleteProgressXXXX;.6. 2007 年度暫停和取消的驗證項目 Validation Projects on hold and cancelled in 20076.1 某車間計劃開始與完成日期項目進程 Schedule項目Scheduled Date2007Validation Projects開始日期完成日期StartingEnding2006.52007.32007.32007.8按依