中美天津史克工廠驗(yàn)證主計(jì)劃

1、ApprovalandAuthorization批準(zhǔn)和授權(quán)Completionofthefollowingsignatureblockssignifiesthereviewandapprovalofthisdocument完成以下簽字意味著完成了對(duì)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(yàn)證流程對(duì)驗(yàn)證文件的定義。并確認(rèn)相關(guān)人員的意見均已包含在文件中后簽署文件。MerryXiaoValidationEngineerCompliance&Validationaresigningtoconfirmcompliancewith

3、applicablepharmaceuticalregulatoryagencyrequirementsandCompanystandards.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)。JessicaHuValidationAssistantManagerBelindaChenQualityHeadSiteDirectorissigningtoconfirmprojectsinsiteandprovidetherequiredresourcesforvalidationactivities.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。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(hào)IssuedTo(Name/Department)交給(姓名/部門)IssuedBy(C&V)由誰生效(法規(guī)和驗(yàn)證組)DateofIssue生效日期1231目的Objective22驗(yàn)證的指導(dǎo)方針與規(guī)程ValidationPolicesandProcedures23責(zé)任Responsibilities44驗(yàn)證的時(shí)間表與進(jìn)展SchedulesandProgress65200

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

6、）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。Listthegoverningpoliciesandproceduresthatmustbefollowedinvalidationactivities.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。Definetheresponsibilitiesofkeypersonnelinvalidationactivities.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。Listthemainvalidationactivitiesinthesiteandthereferencestothevalidationmast

7、erplans.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。Describetheexecutionstatusofvalidationactivitiesthatareinprocessorinplan.2驗(yàn)證的指導(dǎo)方針與規(guī)程ValidationPolicesandProcedures驗(yàn)證類別ValidationType文件編號(hào)DocumentNo文件名稱DocumentName驗(yàn)證生命周期TheValidationLifeCycleGQP1204TheValidationLife-Cycle驗(yàn)證生命周期ValidationDocumentation驗(yàn)證義件Valid

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

9、析設(shè)備與分析方法的驗(yàn)證計(jì)算機(jī)系統(tǒng)的驗(yàn)證ComputerValidationGQP1205GQP3202ComputerisedSystemValidation計(jì)算機(jī)系統(tǒng)驗(yàn)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(hào)SOPNumber工廠驗(yàn)證管理規(guī)程SiteValidationApproachPSOP1432生產(chǎn)設(shè)施驗(yàn)證規(guī)程ManufacturingFacilityValidationSOP1433驗(yàn)證草案和報(bào)告的生成GenerationofQualificationProtocolsandReportsSOP1438設(shè)計(jì)確認(rèn)程序ValidationProcedureforDesignQualificationSOP1439安裝確認(rèn)程序ValidationProcedureforInstallationQualificationSOP1440運(yùn)行確認(rèn)程序ValidationProcedure

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

12、AnalyticalEquipmentValidationApproachSOP0832化學(xué)檢驗(yàn)方法驗(yàn)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(yàn)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(xiàng)目驗(yàn)證主計(jì)劃ResponsibleforpreparingandreviewingVMPofeveryproject

13、協(xié)調(diào)各個(gè)驗(yàn)證過程并參與評(píng)估待驗(yàn)證項(xiàng)目Co-ordinateallvalidationprocessesand,participatesintheassessmentofprospectiveprojectsforvalidationrequirements.組織與驗(yàn)證相關(guān)培訓(xùn)Organizethetrainingforvalidation.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Reviewvalidationmasterplan,validationprotocolsandreports,archivevalidationdocuments.物資管理部Logistic起草倉(cāng)庫(kù)

14、相關(guān)項(xiàng)目的用戶需求標(biāo)準(zhǔn)、方案與報(bào)告PreparetheURS,validationprotocolsandreportsforprojectsofwarehouse.進(jìn)行驗(yàn)證前的評(píng)估Systemassessmentbeforevalidation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)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(bào)告PreparetheURS,validationprotocolsandreportsforfacilitiesandutilities.進(jìn)行驗(yàn)證前的評(píng)估Systemassessmentbeforevalidation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)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(bào)告Preparevalidationprotocolsandreportsfornewproductsandproductstransfer進(jìn)行驗(yàn)證前的評(píng)估Systemassessmentbeforevalidation按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過程產(chǎn)生的問題進(jìn)行調(diào)查Datacollectionandprobleminvestigationduringvalidation.對(duì)工幺驗(yàn)證草案/報(bào)告進(jìn)行批準(zhǔn)Approveprocessvalidation

17、protocolandreport價(jià)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(bào)告PrepareproductequipmentandprocessURS,validationprotocolsandreports進(jìn)行驗(yàn)證前的評(píng)估Systemassessmentbeforevalidation部門/人員Department/Personnel責(zé)任Responsibility按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)證Executevalidationactivitiesfollowingapprovedvalidationprotocol.數(shù)據(jù)匯總及對(duì)在驗(yàn)證過程產(chǎn)生的問題進(jìn)行調(diào)查Datac

18、ollectionandprobleminvestigationduringthevalidation.實(shí)驗(yàn)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(bào)告PrepareanalyticalequipmentandtestmethodsURS,validationprotocolsandreports進(jìn)行驗(yàn)證前的評(píng)估Systemassessmentbeforevalidation完成在驗(yàn)證過程中涉及的檢驗(yàn)并提供及時(shí)準(zhǔn)確的數(shù)據(jù)Completethetestinthevalidationactivitiesandprovidetimelyaccuratedata.按批準(zhǔn)的驗(yàn)證方案執(zhí)行驗(yàn)

19、證Executevalidationactivitiesfollowingapprovedvalidationprotocols數(shù)據(jù)匯總及對(duì)在驗(yàn)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(yàn)證按照批準(zhǔn)的方案進(jìn)行Ensurethevalidationisexecutedaccordingtothevalidationprotocol參與對(duì)在驗(yàn)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(yàn)證活動(dòng)符合葛蘭素史克集團(tuán)及所涉及市場(chǎng)的法規(guī)部門的要求EnsureallthevalidationactivitiescomplywiththeGSKGQPsandsiteprocedures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)告、項(xiàng)目cGMP回顧報(bào)告、驗(yàn)證總結(jié)報(bào)告ApproveSVMP,VMP,performancequalificationprotocolandreport,cleaningvalidationprotocolandreport,projectcGMPreviewreport,validationsummaryreport工廠總監(jiān)Sit

21、eDirectorB批準(zhǔn)SVMPApproveSVMP為驗(yàn)證工作提供必要的人力資源及財(cái)力資源Providetherequiredresourcesforvalidationactivities4驗(yàn)證的時(shí)間表與進(jìn)展SchedulesandProgress4.1 價(jià)值流部門的驗(yàn)證項(xiàng)目ValidationProjectsinValueStreams4.1.1 膠囊價(jià)值流CapsuleVS4.1.1.1膠囊價(jià)值流新項(xiàng)目CapsuleVSNewprojects項(xiàng)目計(jì)劃開始與完成日期ScheduledDate項(xiàng)目進(jìn)程Schedule按計(jì)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(hào)203111)GlattfuildbedchangePLC(SystemReferenceNO.203111)2006.112007.10|-X重訂時(shí)間；大修時(shí)間變化Reschedule:Shutdowntimechange芬必得閉口鍋驗(yàn)證(系統(tǒng)參考編號(hào)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(dòng)上料機(jī)-芬必得裝囊自動(dòng)上料驗(yàn)證(系統(tǒng)參考編號(hào)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(shí)間；2007年未啟動(dòng)Reschedule;Notstartedin2007芬必得裝囊機(jī)提速性能確認(rèn)(系統(tǒng)參考編號(hào)203024-203027)Fenbidfillingmachinespeedupperformance

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

26、ac)驗(yàn)證(系統(tǒng)參考編號(hào)203003)ThecontentofSurleaseadjustsfrom12%to11.5%forNewContacvalidation.(SystemReferenceNO.203003)2005.72007.8X重訂時(shí)間；優(yōu)先級(jí)改變Reschedule:prioritychange.項(xiàng)目ValidationProjects計(jì)劃開始與完成日期ScheduledDate項(xiàng)目進(jìn)程Schedule按計(jì)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(hào)203108)Changetoclosedsievingmachine(SystemReferenceNO.203108)2006.112007.6X一膠囊清潔驗(yàn)證(系統(tǒng)參考編號(hào)206010)Capsulelinecleaningvalidation(SystemReferenceNO.206010)2006.42007.12XContacND清潔驗(yàn)證（系統(tǒng)參考編號(hào)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(hào)：203135)CombinedispensingandsievingofFenbid(SystemReferenceNO.:203135)2007.62007.8X新項(xiàng)目Newproject根據(jù)FenbidPUCC,對(duì)芬必得制丸檔案進(jìn)行止f標(biāo)準(zhǔn)化（系統(tǒng)參考編號(hào):204113）：!：!：!：3新項(xiàng)目NewprojectStandardizationtocurrentBRaccording2007.62007.12XtoFenbidPUCC(SystemReferenceNO.:2

29、04113)康合克由口項(xiàng)目為證（系統(tǒng)綸巧編勺1rail203117)ContacNDexportprojectvalidation(SystemReferenceNO.203117)2007.22007.10!X新項(xiàng)目Newproject4.1.1.2膠囊價(jià)值流回顧驗(yàn)證CapsuleVSRe-validationprojects項(xiàng)目ValidationProjects計(jì)劃開始與完成日期ScheduledDate項(xiàng)目進(jìn)程Schedule按計(jì)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(yàn)證(系統(tǒng)參考編號(hào):203024204027)MG37fillingmachinere-validation2008.12008.3X新項(xiàng)目Newproject(SystemReferenceNO.:203024-203027)MG2轉(zhuǎn)囊機(jī)回顧驗(yàn)證(系統(tǒng)參考編號(hào):203016)MG2fillingmachinere-validation(SystemReferenceNO.:203016)2008.32008.6新項(xiàng)目Newproject芬必信ETbooth回顧駁證(系統(tǒng)殄巧編號(hào):204006-2040

31、07)FenbidETboothre-validation(SystemReferenceNO.:204006-204007)2008.12008.3一1新項(xiàng)目Newproject4.1.2 片劑和軟膏價(jià)值流Tablet&creamVS4.1.2.1 片劑和軟膏價(jià)值流新項(xiàng)目Tablet&creamVSNewprojects項(xiàng)目ValidationProjects計(jì)劃開始與完成日期ScheduledDate項(xiàng)目進(jìn)程Schedule按計(jì)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(jià)值流氣動(dòng)攪拌槳（系統(tǒng)參-uaa,1.14 :,»<.a <1».！!«：項(xiàng)目延期，重新考編號(hào)201040)Gas-motoredstirringdeviceoftabletSolutionpreparation(SystemReference2006.10訂完成時(shí)間2007.12LI口1J4|>uaa>1.141113IliaEB.I3HIIII.IJIElIu1.JI!I0m *IBU1bia- <*(.bi-XReschedul

33、edforprojectdelayNO.201040)片劑軟膏價(jià)值流備料間1072、1073室加裝Booth（系統(tǒng)參考編號(hào)201098）2007.4LI口1JI.II42008.81JU-l,ubm：imX新項(xiàng)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(qiáng)片產(chǎn)品轉(zhuǎn)移驗(yàn)證（系統(tǒng)參考編號(hào)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(hào)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(cè)儀）（系統(tǒng)參考編號(hào)/201069)Newde-dusterandmetaldetector(SystemReference2006.92007.11j*i4uaai.1klB,1J1.I4 IBJ!UBBBHBBBUIBI <.!UB!BlX/：1.JUB/NO.201069)項(xiàng)目ValidationProjects計(jì)劃開始與完成日期ScheduledDate項(xiàng)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(shí)怛-片刑(余凱殄巧漏號(hào)206017(B)206024(B)HoldtimevalidationforsolutionTablet(SystemReferenceNO.206017(B)206024(B)kBU.TRilli111<"!t半成叩保留時(shí)間-片劑(系統(tǒng)殄巧編號(hào)206017(A)206024(A)Holdtimevalida

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

40、4.1.2.2片劑和軟膏價(jià)值流回顧驗(yàn)證Tablet&creamVSRe-validationprojects項(xiàng)目ValidationProjects依據(jù)&備注Justifications&Comments計(jì)劃開始與完成日期ScheduedDate項(xiàng)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(xiàng)目ValidationProje

41、cts計(jì)劃開始與完成日期ScheduledDate項(xiàng)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(yàn)證（系統(tǒng)參考編號(hào)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(xiàng)目Newproject必理通回顧性驗(yàn)證項(xiàng)目（系統(tǒng)參考編號(hào)201001）Panadolrevalidationproject（SystemReferenceNO.201001）2007.92007.12arai!.!LBiaIIBM1.1JUBBil1L1：iiBiaiiiiiiiilSiiHiiiliilITIIIVBIIHEIIB11«31:1icibiraaiEBiiEl.X新項(xiàng)目N

43、ewproject賽樂特回顧性驗(yàn)證項(xiàng)目（系統(tǒng)參考編號(hào)201008）Seraxotrevalidationproject（SystemReferenceNO.201008）2008.12008.3!IElCl11ClX新項(xiàng)目Newproject瑞力芬回顧性驗(yàn)證項(xiàng)目（系統(tǒng)參考編號(hào)201007）Relafenrevalidationproject（SystemReferenceNO.201007）2008.42008.61X新項(xiàng)目Newproject4.1.3膠囊、片劑和軟膏的包裝線PackagingLineofCapsuleVSandTablet&CreamVS4.1.3.1膠囊、片劑和軟

44、膏的包裝線新項(xiàng)目PackagingLineofCapsuleVSandTablet&CreamVSNewprojects項(xiàng)目ValidationProjects計(jì)劃開始與完成日期ScheduledDate項(xiàng)目進(jìn)程Schedule按計(jì)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(cè)系統(tǒng)驗(yàn)證（系統(tǒng)參考編號(hào)203057）1#UHLvisualinspectionsystemValidation（SystemReferenceNo.203057）2005.82007.61JX重訂時(shí)間：供應(yīng)商未能按計(jì)劃到廠安裝Reschedule:becauseSuppliercannotinstallequipmentasplan.2#UHL視覺也測(cè)系統(tǒng)駁證（系統(tǒng)殄巧編號(hào)