中美天津史克工廠驗證主計劃

1、ApprovalandAuthorization批準(zhǔn)和授權(quán)Completionofthefollowingsignatureblockssignifiesthereviewandapprovalofthisdocument完成以下簽字意味著完成了對此文件的回顧和批準(zhǔn)Name姓名JobTitle/Role職位/角色Signature簽字Date日期TheAuthorissigningtoconfirmthatthisdocumenthasbeenpreparedinaccordancewithanapproveddocumentmanagementprocessthatcontentiscons

2、istentwiththedeliverabledefinitionfoundinthePSOP1432SiteValidationApproach,andthatrelevantinputfromanycontributoryauthorshasbeenincluded.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，具中內(nèi)容符合PSOP1432工廠驗證流程對驗證文件的定義。并確認(rèn)相關(guān)人員的意見均已包含在文件中后簽署文件。MerryXiaoValidationEngineerCompliance&Validationaresigningtoconfirmcompliancewith

3、applicablepharmaceuticalregulatoryagencyrequirementsandCompanystandards.法規(guī)和驗證的簽字確認(rèn)其符合制藥法規(guī)組織的要求和公司標(biāo)準(zhǔn)。JessicaHuValidationAssistantManagerBelindaChenQualityHeadSiteDirectorissigningtoconfirmprojectsinsiteandprovidetherequiredresourcesforvalidationactivities.工廠總監(jiān)的簽字是確認(rèn)工廠需要進(jìn)行的項目和為工廠驗證活動提供需要的資源。ShirleneMG

4、oldsbroughSiteDirectorDistributionList分發(fā)清單NoDistributionRequired不需要分發(fā)FieldExecutionCopy在執(zhí)行過程中需要復(fù)印件CopyNo復(fù)印件編號IssuedTo(Name/Department)交給(姓名/部門)IssuedBy(C&V)由誰生效(法規(guī)和驗證組)DateofIssue生效日期1231目的Objective22驗證的指導(dǎo)方針與規(guī)程ValidationPolicesandProcedures23責(zé)任Responsibilities44驗證的時間表與進(jìn)展SchedulesandProgress65200

5、7年度完成的驗證項目ValidationProjectscompletedin20071962007年度暫停和取消的驗證項目ValidationProjectsonholdandcancelledin2007257修訂歷史RevisionHistory281目的Objective該工廠驗證總計劃是為了提供一個對中美天津史克制藥有限公司的驗證工作的綜合描述。具體而言，該計劃將：ThepurposeoftheSVMPistoprovideacomprehensiveoverviewofallvalidationactivitiesinTSKF.Theplanwillcoverfollowing:1

6、）列出公司在進(jìn)行驗證工作時所必須遵循的指導(dǎo)方針與指南。Listthegoverningpoliciesandproceduresthatmustbefollowedinvalidationactivities.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。Definetheresponsibilitiesofkeypersonnelinvalidationactivities.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。Listthemainvalidationactivitiesinthesiteandthereferencestothevalidationmast

7、erplans.4）描述公司目前正在進(jìn)行和計劃將要進(jìn)行的驗證工作和項目的程序和進(jìn)展。Describetheexecutionstatusofvalidationactivitiesthatareinprocessorinplan.2驗證的指導(dǎo)方針與規(guī)程ValidationPolicesandProcedures驗證類別ValidationType文件編號DocumentNo文件名稱DocumentName驗證生命周期TheValidationLifeCycleGQP1204TheValidationLife-Cycle驗證生命周期ValidationDocumentation驗證義件Valid

8、ationMaintenance驗證維護(hù)ImpactAssessment影響評估DesignQualification設(shè)計確認(rèn)ValidationReview驗證回顧驗證生命周期ValidationlifecycleGQMP1008驗證生命周期Validationlifecycle清洗驗證CleaningValidationGQP6202CleaningValidation清潔驗證分析方法與設(shè)備驗證AnalyticalMethod&EquipmentValidationGQP7113ValidationofAnalyticalEquipmentandAnalyticalMethods分

9、析設(shè)備與分析方法的驗證計算機(jī)系統(tǒng)的驗證ComputerValidationGQP1205GQP3202ComputerisedSystemValidation計算機(jī)系統(tǒng)驗證RegulatedElectronicRecordsandSignatures?法規(guī)要求的電子記錄和電子簽名注釋：GQP=GlobalQualityPolicy（葛蘭素史克集團(tuán)）全球質(zhì)量方針GQMP=GlobalQualityManagementProcess（曷蘭素史克集團(tuán)）全球質(zhì)量管理規(guī)程生產(chǎn)廠關(guān)鍵規(guī)程列表如下：Keysiteproceduresarelistedinthetablebelow.文件名稱DocumentN

10、ame文件編號SOPNumber工廠驗證管理規(guī)程SiteValidationApproachPSOP1432生產(chǎn)設(shè)施驗證規(guī)程ManufacturingFacilityValidationSOP1433驗證草案和報告的生成GenerationofQualificationProtocolsandReportsSOP1438設(shè)計確認(rèn)程序ValidationProcedureforDesignQualificationSOP1439安裝確認(rèn)程序ValidationProcedureforInstallationQualificationSOP1440運行確認(rèn)程序ValidationProcedure

11、forOperationalQualificationSOP1441性能確認(rèn)程序ValidationProcedureforPerformanceQualificationSOP1442計算機(jī)驗證方法ComputerValidationApproachSOP1443清潔驗證CleaningValidationSOP1445維護(hù)系統(tǒng)的驗證狀態(tài)MaintainingSystemstheValidatedStatusSOP1446控制系統(tǒng)ControlSystemValidationApproachSOP1447系統(tǒng)影響性評估SystemImpactAssessmentSOP1451分析儀器驗證通則

12、AnalyticalEquipmentValidationApproachSOP0832化學(xué)檢驗方法驗證規(guī)程ChemicalAnalysisMethodValidationApproachSOP08343責(zé)任Responsibilities部門/人員Department/Personnel責(zé)任Responsibility質(zhì)量保證部驗證組QAValidation負(fù)責(zé)制訂與回顧年度SVMPResponsibleforpreparingandreviewingSVMP負(fù)責(zé)制訂與回顧各項目驗證主計劃ResponsibleforpreparingandreviewingVMPofeveryproject

13、協(xié)調(diào)各個驗證過程并參與評估待驗證項目Co-ordinateallvalidationprocessesand,participatesintheassessmentofprospectiveprojectsforvalidationrequirements.組織與驗證相關(guān)培訓(xùn)Organizethetrainingforvalidation.對驗證主計劃、方案及報告進(jìn)行審核并將已完成的驗證文件存檔Reviewvalidationmasterplan,validationprotocolsandreports,archivevalidationdocuments.物資管理部Logistic起草倉庫

14、相關(guān)項目的用戶需求標(biāo)準(zhǔn)、方案與報告PreparetheURS,validationprotocolsandreportsforprojectsofwarehouse.進(jìn)行驗證前的評估Systemassessmentbeforevalidation按批準(zhǔn)的驗證方案執(zhí)行驗證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進(jìn)行調(diào)查Datacollectionandprobleminvestigationduringvalidation.工程部EngineeringDepartment起草公用

15、設(shè)施與設(shè)備的用戶需求標(biāo)準(zhǔn)、方案與報告PreparetheURS,validationprotocolsandreportsforfacilitiesandutilities.進(jìn)行驗證前的評估Systemassessmentbeforevalidation按批準(zhǔn)的驗證方案執(zhí)行驗證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進(jìn)行調(diào)查Datacollectionandprobleminvestigationduringvalidation.技術(shù)部Technical起草新產(chǎn)品和產(chǎn)品轉(zhuǎn)移的方

16、案與報告Preparevalidationprotocolsandreportsfornewproductsandproductstransfer進(jìn)行驗證前的評估Systemassessmentbeforevalidation按批準(zhǔn)的驗證方案執(zhí)行驗證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進(jìn)行調(diào)查Datacollectionandprobleminvestigationduringvalidation.對工幺驗證草案/報告進(jìn)行批準(zhǔn)Approveprocessvalidation

17、protocolandreport價值流ValueStream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PrepareproductequipmentandprocessURS,validationprotocolsandreports進(jìn)行驗證前的評估Systemassessmentbeforevalidation部門/人員Department/Personnel責(zé)任Responsibility按批準(zhǔn)的驗證方案執(zhí)行驗證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進(jìn)行調(diào)查Datac

18、ollectionandprobleminvestigationduringthevalidation.實驗室QCLab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PrepareanalyticalequipmentandtestmethodsURS,validationprotocolsandreports進(jìn)行驗證前的評估Systemassessmentbeforevalidation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)Completethetestinthevalidationactivitiesandprovidetimelyaccuratedata.按批準(zhǔn)的驗證方案執(zhí)行驗

19、證Executevalidationactivitiesfollowingapprovedvalidationprotocols數(shù)據(jù)匯總及對在驗證過程產(chǎn)生的問題進(jìn)行調(diào)查Datacollectionandprobleminvestigationduringthevalidation.質(zhì)量保證部QA組確保驗證按照批準(zhǔn)的方案進(jìn)行Ensurethevalidationisexecutedaccordingtothevalidationprotocol參與對在驗證過程中產(chǎn)生的問題的調(diào)查Takepartinprobleminvestigationduringvalidation.質(zhì)量保證部經(jīng)理QAHead

20、確保所有的驗證活動符合葛蘭素史克集團(tuán)及所涉及市場的法規(guī)部門的要求EnsureallthevalidationactivitiescomplywiththeGSKGQPsandsiteprocedures批準(zhǔn)SVMP,驗證主計劃、工藝驗證的方案與報告、清潔驗證草案和報告、項目cGMP回顧報告、驗證總結(jié)報告ApproveSVMP,VMP,performancequalificationprotocolandreport,cleaningvalidationprotocolandreport,projectcGMPreviewreport,validationsummaryreport工廠總監(jiān)Sit

21、eDirectorB批準(zhǔn)SVMPApproveSVMP為驗證工作提供必要的人力資源及財力資源Providetherequiredresourcesforvalidationactivities4驗證的時間表與進(jìn)展SchedulesandProgress4.1 價值流部門的驗證項目ValidationProjectsinValueStreams4.1.1 膠囊價值流CapsuleVS4.1.1.1膠囊價值流新項目CapsuleVSNewprojects項目計劃開始與完成日期ScheduledDate項目進(jìn)程Schedule按計劃asper®schedPkegress完推依據(jù)&備

22、注Justifications&edCommentsValidationProjects開始日期完成日期20072008成遲StartingEnding678910111212345CompleedostponGlatt流化床更換PLC(系統(tǒng)參考編號203111)GlattfuildbedchangePLC(SystemReferenceNO.203111)2006.112007.10|-X重訂時間；大修時間變化Reschedule:Shutdowntimechange芬必得閉口鍋驗證(系統(tǒng)參考編號203106)FenbidclosepanValidation(SystemRefere

23、nceNO.203106)2007.22007.12卅卜1ill-：力機(jī)川花士山匚11；1,：1；'：Lrlrsjririjjr11««,-a",11ljt,°iI,i,i°iu11r411,uxsJ111J11liiii11i-i1"-11，-1i11'jl'l!1|:"ll|l,1|i1r111Frrff1rf|111F11'1!1X自動上料機(jī)-芬必得裝囊自動上料驗證(系統(tǒng)參考編號203037)AutomaticloadingmachineusedforFenbidcapsulefilli

24、ngValidation(SystemReferenceNO.203037)2007.42007.12IL"!,""IffIa1,1I1II1,b-hl1I1JJI31I1E1LJ1I13i1iJ111444.1KJ11111)TITI-I,111-ii-»1j"jI1'1II1I*III-1liII-s|nIIIIX重訂時間；2007年未啟動Reschedule;Notstartedin2007芬必得裝囊機(jī)提速性能確認(rèn)(系統(tǒng)參考編號203024-203027)Fenbidfillingmachinespeedupperformance

25、qualification(SystemReferenceNO.203024-203027)2007.42007.12X重訂時間；2007年未啟動Reschedule;Notstartedin2007MG2裝囊機(jī)VR系統(tǒng)驗證(系統(tǒng)參考編號203123/203124)VRsystemvalidationforMG2capsulefilling(SystemReferenceNO.203123/203124)2007.92007.12I-I-IS-i"«"1ii,1«ii1i-I-X新項目Newproject蘇麗絲含量由12%調(diào)整至11.5%(Newcont

26、ac)驗證(系統(tǒng)參考編號203003)ThecontentofSurleaseadjustsfrom12%to11.5%forNewContacvalidation.(SystemReferenceNO.203003)2005.72007.8X重訂時間；優(yōu)先級改變Reschedule:prioritychange.項目ValidationProjects計劃開始與完成日期ScheduledDate項目進(jìn)程Schedule按計劃asper®schedPfeogfess完成Comple推遲edbstpot依據(jù)&備注Justifications&edComments開始日期

27、Starting完成日期Ending20072008678910111212345更換成閉口過篩機(jī)(系統(tǒng)參考編號203108)Changetoclosedsievingmachine(SystemReferenceNO.203108)2006.112007.6X一膠囊清潔驗證(系統(tǒng)參考編號206010)Capsulelinecleaningvalidation(SystemReferenceNO.206010)2006.42007.12XContacND清潔驗證（系統(tǒng)參考編號11cmiiari13Ell206033)ContacNDCleaningvalidation(SystemRefere

28、nceNO.206033)2007.52008.6J1BianiIX分必彳可制也苗科予何定物予日勺J開(系統(tǒng)參考編號：203135)CombinedispensingandsievingofFenbid(SystemReferenceNO.:203135)2007.62007.8X新項目Newproject根據(jù)FenbidPUCC,對芬必得制丸檔案進(jìn)行止f標(biāo)準(zhǔn)化（系統(tǒng)參考編號:204113）：!：!：!：3新項目NewprojectStandardizationtocurrentBRaccording2007.62007.12XtoFenbidPUCC(SystemReferenceNO.:2

29、04113)康合克由口項目為證（系統(tǒng)綸巧編勺1rail203117)ContacNDexportprojectvalidation(SystemReferenceNO.203117)2007.22007.10!X新項目Newproject4.1.1.2膠囊價值流回顧驗證CapsuleVSRe-validationprojects項目ValidationProjects計劃開始與完成日期ScheduledDate項目進(jìn)程Schedule按計如schedPergress完成Comple推遲ePfastpon依據(jù)&備注Justifications&edComments開始日期Star

30、ting完成日期Ending20072008678910111212345MG37裝囊機(jī)回顧驗證(系統(tǒng)參考編號:203024204027)MG37fillingmachinere-validation2008.12008.3X新項目Newproject(SystemReferenceNO.:203024-203027)MG2轉(zhuǎn)囊機(jī)回顧驗證(系統(tǒng)參考編號:203016)MG2fillingmachinere-validation(SystemReferenceNO.:203016)2008.32008.6新項目Newproject芬必信ETbooth回顧駁證(系統(tǒng)殄巧編號:204006-2040

31、07)FenbidETboothre-validation(SystemReferenceNO.:204006-204007)2008.12008.3一1新項目Newproject4.1.2 片劑和軟膏價值流Tablet&creamVS4.1.2.1 片劑和軟膏價值流新項目Tablet&creamVSNewprojects項目ValidationProjects計劃開始與完成日期ScheduledDate項目進(jìn)程Schedule按計劃schedPeogres完成rnplo'七推遲tedPostponed依據(jù)&備注Justifications&Commen

32、ts開始日期完成日期20StartingEnding072008678r9101112121345片劑價值流氣動攪拌槳（系統(tǒng)參-uaa,1.14 :,»<.a <1».！!«：項目延期，重新考編號201040)Gas-motoredstirringdeviceoftabletSolutionpreparation(SystemReference2006.10訂完成時間2007.12LI口1J4|>uaa>1.141113IliaEB.I3HIIII.IJIElIu1.JI!I0m *IBU1bia- <*(.bi-XReschedul

33、edforprojectdelayNO.201040)片劑軟膏價值流備料間1072、1073室加裝Booth（系統(tǒng)參考編號201098）2007.4LI口1JI.II42008.81JU-l,ubm：imX新項目。InstallBoothinVS-TdispensingNewProject.room1072&1073(SystemReferenceNO.201098)anana1,IriiBibii'llraninliiiirnuninramiiGlatt提力機(jī)駁證（系統(tǒng)殄巧編勺 ijaj<： :IIIB.«IIBajIBIIXBIBBaKB/201023)/G

34、lattupgradingandcrushingmachineValidation(SystemReferenceNo.201023)2005.12007.12191IEIIIm|I1Ei:iiminui11hiihii1113BillrilBEIIXIBI31IIII!a.ia.K.：1i!iauaaa.lbiaX/«iiamiliiihitanraiaiirii必理通加強片產(chǎn)品轉(zhuǎn)移驗證（系統(tǒng)參考編號205005）PanadolextraProductTransfer2006.2ITHiiaEiii'EaiiraiaaEliiraii!1,iajamKH|h1hhBh200

35、712 IBJUBBBBBBJUIIBlIB IBJ-JUB!Bl«：aiJbi1111al>»>>X/./validation(SystemReference域皋.鬻,小|H|h|h|Bill/NO.205005)ii3Baia"EiaaaEiiiiTaiitbiism/瑞力外包衣參數(shù)確認(rèn)（系統(tǒng)綸巧編號201007）2007.3IkJ*1J1.I41nnwTinnnihiij:,aai«X/Relafencoatingparameters2007.12|,U1!/confirm(SystemReferenceNO.201007)Bkl

36、B,1J1.I4Bkl&,1BJ1.I31111BillmaEIBTEBI31Bl3IBIITBI1.1KJUB1«Z片劑新裝素片轉(zhuǎn)移系統(tǒng)（立式篩|1BJ1.I4：1.BIBJ：1.!7/片機(jī)+金屬檢測儀）（系統(tǒng)參考編號/201069)Newde-dusterandmetaldetector(SystemReference2006.92007.11j*i4uaai.1klB,1J1.I4 IBJ!UBBBHBBBUIBI <.!UB!BlX/：1.JUB/NO.201069)項目ValidationProjects計劃開始與完成日期ScheduledDate項目進(jìn)程Sc

37、hedule開始日期完成日期StartingEnding20072008678910111212345軟膏生產(chǎn)線從GSKT轉(zhuǎn)移至2006.102008.3IIIij»kSii!1ITSKF(系沆綸專珈it；202015)CreamlinetransferfromGSKTtoTSKF(SystemReferenceNO.202015)II!ijramma!1I,h刀IRrj信版證（余筑綸專編勺206011）200642007121Tabletlinecleaningvalidation(SystemReferenceNO.206011)II!1juB1>秋昌彳目信叔證（余筑綸專編

38、勺206012)Creamlinecleaningvalidation(SystemReference2006.42007.12II!ij1UtLUJINO.206012)I2006.42009.12 1IIH 1IIHii11Bin41U俗故侏田時怛-片刑(余凱殄巧漏號206017(B)206024(B)HoldtimevalidationforsolutionTablet(SystemReferenceNO.206017(B)206024(B)kBU.TRilli111<"!t半成叩保留時間-片劑(系統(tǒng)殄巧編號206017(A)206024(A)Holdtimevalida

39、tionfor2006.42009.12IIIHijI.BIIiI111<"!,1KbulkTablet(SystemReferenceNO.206017(A)206024(A)HijjuBI1,Ima質(zhì)量警報-壓片機(jī)驗證壓片機(jī)(系統(tǒng)參考編號：201110,201111,201112)QualityAlert-FETTEvalidation(SystemReferenceNO.:201110,201111,201112)2007.52007.8irii31iiranij按計劃asper®scheitedPostponedXXXXX完成推遲新項目。NewProject.

40、4.1.2.2片劑和軟膏價值流回顧驗證Tablet&creamVSRe-validationprojects項目ValidationProjects依據(jù)&備注Justifications&Comments計劃開始與完成日期ScheduedDate項目進(jìn)程Schedulele23jper.,.一忌午多卜一番.推ned,忠依據(jù)&備注Justifications&scnecRsasogre表jeiDComplFostp)一開始日期完成日期20072008CommentsStartingEnding678910111212345項目ValidationProje

41、cts計劃開始與完成日期ScheduledDate項目進(jìn)程Scheduleh進(jìn)!34二1（完FWo榆推ne$o矗依據(jù)&備注Justifications&oComments開始日期Starting完成日期20072008Ending67891011121234其它片劑生產(chǎn)設(shè)備驗證（系統(tǒng)參考編號201097）Tabletmanufacturingequipmentsvalidation（SystemReferenceNO.201097）2007.9J2007.12Fanraiiiinwiiaq!ITIIVBIIHEIIB'I1iicaia11.1JUBBil 1.BrB.U

42、IBJ-1IBaM 11.1.1II £iakBB.14 Iilianlia1>1aIiriITUISBIIHEIIB'IIBIlEII3ii-ranaeiitanaeiX新項目Newproject必理通回顧性驗證項目（系統(tǒng)參考編號201001）Panadolrevalidationproject（SystemReferenceNO.201001）2007.92007.12arai!.!LBiaIIBM1.1JUBBil1L1：iiBiaiiiiiiiilSiiHiiiliilITIIIVBIIHEIIB11«31:1icibiraaiEBiiEl.X新項目N

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44、膏的包裝線新項目PackagingLineofCapsuleVSandTablet&CreamVSNewprojects項目ValidationProjects計劃開始與完成日期ScheduledDate項目進(jìn)程Schedule按計劃scfasdpeogres完成sComple推遲:edostpor依據(jù)&備注Justifications&Commentsed開始日期Starting完成日期20072008Ending65789101112123451#UHL視覺檢測系統(tǒng)驗證（系統(tǒng)參考編號203057）1#UHLvisualinspectionsystemValidation（SystemReferenceNo.203057）2005.82007.61JX重訂時間：供應(yīng)商未能按計劃到廠安裝Reschedule:becauseSuppliercannotinstallequipmentasplan.2#UHL視覺也測系統(tǒng)駁證（系統(tǒng)殄巧編號