工廠驗(yàn)證主計(jì)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(duì)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(yàn)證流程對(duì)驗(yàn)證文件的定義。并確認(rèn)相關(guān)人員的意見(jiàn)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(yàn)證的簽字確認(rèn)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(rèn)工廠需要進(jìn)行的項(xiàng)目和為工廠驗(yàn)證活動(dòng)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(guò)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(hào)交給（姓名部門）由誰(shuí)生效（法規(guī)和驗(yàn)證組）生效日期123目錄 CONTENT1目的 Objective32驗(yàn)證的指導(dǎo)方針與規(guī)程Validation Polices and Procedures

5、4;.3責(zé)任 Responsibilities .54驗(yàn)證的時(shí)間表與進(jìn)展Schedules and Progress .752007年度完成的驗(yàn)證項(xiàng)目 Validation Projects completed in 2007 .962007年度暫停和取消的驗(yàn)證項(xiàng)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(yàn)證總計(jì)劃是為了提供一個(gè)對(duì) XXXX 公司制藥有限公司的驗(yàn)證工作的綜合描述。具體而言，該計(jì)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(jìn)行驗(yàn)證工作時(shí)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(yàn)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(yàn)證工作類別以及與其相關(guān)的驗(yàn)證主計(jì)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(jìn)行和計(jì)劃將要進(jìn)行的驗(yàn)證工作和項(xiàng)目的程序和進(jìn)展。Describe the execution status of validation activities that are in process or in plan.;.2 驗(yàn)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(hào)Document NameSOP Number工廠驗(yàn)證管理規(guī)程Site Validation Approach分析儀器驗(yàn)證通則Analytical Equipment Validation Approach化學(xué)檢驗(yàn)方法驗(yàn)證規(guī)程Chemical Analysis Method Validation Approach生產(chǎn)設(shè)施驗(yàn)證規(guī)程Manufacturing Facility Validation驗(yàn)證

9、草案和報(bào)告的生成Generation of Qualification Protocols and Reports設(shè)計(jì)確認(rèn)程序Validation Procedure for Design Qualification安裝確認(rèn)程序Validation Procedure for Installation Qualification運(yùn)行確認(rèn)程序Validation Procedure for Operational Qualification性能確認(rèn)程序Validation Procedure for Performance Qualification計(jì)算機(jī)驗(yàn)證方法Computer Validat

10、ion Approach清潔驗(yàn)證Cleaning Validation維護(hù)系統(tǒng)的驗(yàn)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(píng)估System Impact Assessment;.3 責(zé)任 Responsibilities部門 /人員Department/Personnel質(zhì)量保證部驗(yàn)證組QA Validation物資管理部Logistic工程部Engineering Department技術(shù)部Technical價(jià)值流Value Stream責(zé)任Responsibi

11、lity負(fù)責(zé)制訂與回顧年度SVMPResponsible for preparing and reviewing SVMP負(fù)責(zé)制訂與回顧各項(xiàng)目驗(yàn)證主計(jì)劃Responsible for preparing and reviewing VMP of every project協(xié)調(diào)各個(gè)驗(yàn)證過(guò)程并參與評(píng)估待驗(yàn)證項(xiàng)目Co-ordinate all validation processes and, participates in the assessment of prospective projects for validation requirements.組織與驗(yàn)證相關(guān)培訓(xùn)Organize the

12、 training for validation.對(duì)驗(yàn)證主計(jì)劃、方案及報(bào)告進(jìn)行審核并將已完成的驗(yàn)證文件存檔Review validation master plan, validation protocols and reports, archive validation documents.起草倉(cāng)庫(kù)相關(guān)項(xiàng)目的用戶需求標(biāo)準(zhǔn)、方案與報(bào)告Prepare the URS, validation protocols and reports for projects of warehouse.進(jìn)行驗(yàn)證前的評(píng)估System assessment before validation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證E

13、xecute validation activities following approved validation protocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)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(bào)告Prepare the URS, validation protocols and reports for facilities and utilities.進(jìn)行驗(yàn)證前的評(píng)估System assessment before validation按批準(zhǔn)的驗(yàn)證方案

14、執(zhí)行驗(yàn)證Execute validation activities following approved validation protocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)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(bào)告Prepare validation protocols and reports for new products and products transfer進(jìn)行驗(yàn)證前的評(píng)估System assessment before validation按批準(zhǔn)的驗(yàn)證方案執(zhí)

15、行驗(yàn)證Execute validation activities following approved validation protocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)行調(diào)查Data collection and problem investigation during validation.對(duì)工藝驗(yàn)證草案 /報(bào)告進(jìn)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(bào)告Prepare product equipment and process URS, validation protocols a

16、nd reports進(jìn)行驗(yàn)證前的評(píng)估;.部門 /人員責(zé)任Department/PersonnelResponsibilitySystem assessment before validation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證Execute validation activities following approved validation protocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)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(bào)告Prepare analyt

17、ical equipment and test methodsURS, validationprotocols and reports進(jìn)行驗(yàn)證前的評(píng)估System assessment before validation實(shí)驗(yàn)室完成在驗(yàn)證過(guò)程中涉及的檢驗(yàn)并提供及時(shí)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(yàn)證方案執(zhí)行驗(yàn)證Execute validation activities following approved validation protoco

18、ls數(shù)據(jù)匯總及對(duì)在驗(yàn)證過(guò)程產(chǎn)生的問(wèn)題進(jìn)行調(diào)查Data collection and problem investigation during the validation.確保驗(yàn)證按照批準(zhǔn)的方案進(jìn)行質(zhì)量保證部 QA 組Ensure the validation is executed accordingto the validationprotocol參與對(duì)在驗(yàn)證過(guò)程中產(chǎn)生的問(wèn)題的調(diào)查Take part in problem investigation during validation.確保所有的驗(yàn)證活動(dòng)符合 XXXX 集團(tuán)及所涉及市場(chǎng)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(yàn)證主計(jì)劃、 工藝驗(yàn)證的方案與報(bào)告、清潔驗(yàn)證草案和報(bào)Head of Quality告、項(xiàng)目 cGMP 回顧報(bào)告、驗(yàn)證總結(jié)報(bào)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(yàn)證工作提供必要的人力資源及財(cái)力資源Provide the required resources for validation activities;.4驗(yàn)證的時(shí)間表與進(jìn)展Schedules and Progress4.1某車間的驗(yàn)證項(xiàng)目Validation Projects in A workshop計(jì)劃開(kāi)始與完成日期項(xiàng)目進(jìn)程 Schedule按依據(jù) &備注項(xiàng)目Scheduled Date進(jìn)完推計(jì)Justifications &edValidation Projects開(kāi)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(yàn)證 the Re-validation projects for the A workshop計(jì)劃開(kāi)始與完成日期項(xiàng)目進(jìn)程 Schedule按依據(jù) &備注項(xiàng)目Scheduled Date進(jìn)完推計(jì)JustificationsedValidation Projects開(kāi)始日期完成日期20072008ed遲行劃成schedulProgres&

22、CommentsStartingEnding678910 11 1212 3 45 s as perPostponComplet;.計(jì)劃開(kāi)始與完成日期項(xiàng)目Scheduled DateValidation Projects開(kāi)始日期完成日期StartingEnding2007.92007.122008.12008.32008.42008.64.3 物流部新項(xiàng)目Logistics New projects計(jì)劃開(kāi)始與完成日期項(xiàng)目Scheduled DateValidation Projects開(kāi)始日期完成日期StartingEnding2006.62007.12項(xiàng)目進(jìn)程 Schedule2007200

23、86789101112123 4項(xiàng)目進(jìn)程 Schedule200720086789101112123進(jìn)按完推依據(jù) &備注計(jì)Justificationseded遲行劃成schedulProgresPostpon& Comments5 s as perCompletXXX按依據(jù) &備注計(jì)完推Justification行 eded遲s &as per劃成Postpon進(jìn) CompletscheduleProgressComments4 5X;.計(jì)劃開(kāi)始與完成日期項(xiàng)目進(jìn)程 Schedule項(xiàng)目Scheduled Date20072008Validation Projects開(kāi)始日期完成日期Starti

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

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

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

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

28、ceNO.:302061 ）計(jì)劃開(kāi)始與完成日期Scheduled Date開(kāi)始日期完成日期StartingEnding2006.102007.32007.12007.22006.112007.12007.12007.2項(xiàng)目進(jìn)程 Schedule2007按依據(jù)行d計(jì)完 d推Justifications劃成遲& Commentsas per 進(jìn)PostponeCompleteProgressXXXX;.6. 2007 年度暫停和取消的驗(yàn)證項(xiàng)目 Validation Projects on hold and cancelled in 20076.1 某車間計(jì)劃開(kāi)始與完成日期項(xiàng)目進(jìn)程 Schedule項(xiàng)目Scheduled Date2007Validation Projects開(kāi)始日期完成日期StartingEnding2006.52007.32007.32007.8按依