中美天津史克工厂验证主计划

1、ApprovalandAuthorization批准和授权Completionofthefollowingsignatureblockssignifiesthereviewandapprovalofthisdocument完成以下签字意味着完成了对此文件的回顾和批准Name姓名JobTitle/Role职位/角色Signature签字Date日期TheAuthorissigningtoconfirmthatthisdocumenthasbeenpreparedinaccordancewithanapproveddocumentmanagementprocessthatcontentiscons

2、istentwiththedeliverabledefinitionfoundinthePSOP1432SiteValidationApproach,andthatrelevantinputfromanycontributoryauthorshasbeenincluded.作者的签字证明文件是按照批准的文件管理规程准备的，具中内容符合PSOP1432工厂验证流程对验证文件的定义。并确认相关人员的意见均已包含在文件中后签署文件。MerryXiaoValidationEngineerCompliance&Validationaresigningtoconfirmcompliancewith

3、applicablepharmaceuticalregulatoryagencyrequirementsandCompanystandards.法规和验证的签字确认其符合制药法规组织的要求和公司标准。JessicaHuValidationAssistantManagerBelindaChenQualityHeadSiteDirectorissigningtoconfirmprojectsinsiteandprovidetherequiredresourcesforvalidationactivities.工厂总监的签字是确认工厂需要进行的项目和为工厂验证活动提供需要的资源。ShirleneMG

4、oldsbroughSiteDirectorDistributionList分发清单NoDistributionRequired不需要分发FieldExecutionCopy在执行过程中需要复印件CopyNo复印件编号IssuedTo(Name/Department)交给(姓名/部门)IssuedBy(C&V)由谁生效(法规和验证组)DateofIssue生效日期1231目的Objective22验证的指导方针与规程ValidationPolicesandProcedures23责任Responsibilities44验证的时间表与进展SchedulesandProgress65200

5、7年度完成的验证项目ValidationProjectscompletedin20071962007年度暂停和取消的验证项目ValidationProjectsonholdandcancelledin2007257修订历史RevisionHistory281目的Objective该工厂验证总计划是为了提供一个对中美天津史克制药有限公司的验证工作的综合描述。具体而言，该计划将：ThepurposeoftheSVMPistoprovideacomprehensiveoverviewofallvalidationactivitiesinTSKF.Theplanwillcoverfollowing:1

6、）列出公司在进行验证工作时所必须遵循的指导方针与指南。Listthegoverningpoliciesandproceduresthatmustbefollowedinvalidationactivities.2）确定公司各部门和主要管理人员在验证工作中的主要责任。Definetheresponsibilitiesofkeypersonnelinvalidationactivities.3）列出公司目前主要的验证工作类别以及与其相关的验证主计划。Listthemainvalidationactivitiesinthesiteandthereferencestothevalidationmast

7、erplans.4）描述公司目前正在进行和计划将要进行的验证工作和项目的程序和进展。Describetheexecutionstatusofvalidationactivitiesthatareinprocessorinplan.2验证的指导方针与规程ValidationPolicesandProcedures验证类别ValidationType文件编号DocumentNo文件名称DocumentName验证生命周期TheValidationLifeCycleGQP1204TheValidationLife-Cycle验证生命周期ValidationDocumentation验证义件Valid

8、ationMaintenance验证维护ImpactAssessment影响评估DesignQualification设计确认ValidationReview验证回顾验证生命周期ValidationlifecycleGQMP1008验证生命周期Validationlifecycle清洗验证CleaningValidationGQP6202CleaningValidation清洁验证分析方法与设备验证AnalyticalMethod&EquipmentValidationGQP7113ValidationofAnalyticalEquipmentandAnalyticalMethods分

9、析设备与分析方法的验证计算机系统的验证ComputerValidationGQP1205GQP3202ComputerisedSystemValidation计算机系统验证RegulatedElectronicRecordsandSignatures?法规要求的电子记录和电子签名注释：GQP=GlobalQualityPolicy（葛兰素史克集团）全球质量方针GQMP=GlobalQualityManagementProcess（曷兰素史克集团）全球质量管理规程生产厂关键规程列表如下：Keysiteproceduresarelistedinthetablebelow.文件名称DocumentN

10、ame文件编号SOPNumber工厂验证管理规程SiteValidationApproachPSOP1432生产设施验证规程ManufacturingFacilityValidationSOP1433验证草案和报告的生成GenerationofQualificationProtocolsandReportsSOP1438设计确认程序ValidationProcedureforDesignQualificationSOP1439安装确认程序ValidationProcedureforInstallationQualificationSOP1440运行确认程序ValidationProcedure

11、forOperationalQualificationSOP1441性能确认程序ValidationProcedureforPerformanceQualificationSOP1442计算机验证方法ComputerValidationApproachSOP1443清洁验证CleaningValidationSOP1445维护系统的验证状态MaintainingSystemstheValidatedStatusSOP1446控制系统ControlSystemValidationApproachSOP1447系统影响性评估SystemImpactAssessmentSOP1451分析仪器验证通则

12、AnalyticalEquipmentValidationApproachSOP0832化学检验方法验证规程ChemicalAnalysisMethodValidationApproachSOP08343责任Responsibilities部门/人员Department/Personnel责任Responsibility质量保证部验证组QAValidation负责制订与回顾年度SVMPResponsibleforpreparingandreviewingSVMP负责制订与回顾各项目验证主计划ResponsibleforpreparingandreviewingVMPofeveryproject

13、协调各个验证过程并参与评估待验证项目Co-ordinateallvalidationprocessesand,participatesintheassessmentofprospectiveprojectsforvalidationrequirements.组织与验证相关培训Organizethetrainingforvalidation.对验证主计划、方案及报告进行审核并将已完成的验证文件存档Reviewvalidationmasterplan,validationprotocolsandreports,archivevalidationdocuments.物资管理部Logistic起草仓库

14、相关项目的用户需求标准、方案与报告PreparetheURS,validationprotocolsandreportsforprojectsofwarehouse.进行验证前的评估Systemassessmentbeforevalidation按批准的验证方案执行验证Executevalidationactivitiesfollowingapprovedvalidationprotocol.数据汇总及对在验证过程产生的问题进行调查Datacollectionandprobleminvestigationduringvalidation.工程部EngineeringDepartment起草公用

15、设施与设备的用户需求标准、方案与报告PreparetheURS,validationprotocolsandreportsforfacilitiesandutilities.进行验证前的评估Systemassessmentbeforevalidation按批准的验证方案执行验证Executevalidationactivitiesfollowingapprovedvalidationprotocol.数据汇总及对在验证过程产生的问题进行调查Datacollectionandprobleminvestigationduringvalidation.技术部Technical起草新产品和产品转移的方

16、案与报告Preparevalidationprotocolsandreportsfornewproductsandproductstransfer进行验证前的评估Systemassessmentbeforevalidation按批准的验证方案执行验证Executevalidationactivitiesfollowingapprovedvalidationprotocol.数据汇总及对在验证过程产生的问题进行调查Datacollectionandprobleminvestigationduringvalidation.对工幺验证草案/报告进行批准Approveprocessvalidation

17、protocolandreport价值流ValueStream起草生产设备与工艺的用户需求标准、方案与报告PrepareproductequipmentandprocessURS,validationprotocolsandreports进行验证前的评估Systemassessmentbeforevalidation部门/人员Department/Personnel责任Responsibility按批准的验证方案执行验证Executevalidationactivitiesfollowingapprovedvalidationprotocol.数据汇总及对在验证过程产生的问题进行调查Datac

18、ollectionandprobleminvestigationduringthevalidation.实验室QCLab起草分析仪器及分析方法的用户需求标准、方案与报告PrepareanalyticalequipmentandtestmethodsURS,validationprotocolsandreports进行验证前的评估Systemassessmentbeforevalidation完成在验证过程中涉及的检验并提供及时准确的数据Completethetestinthevalidationactivitiesandprovidetimelyaccuratedata.按批准的验证方案执行验

19、证Executevalidationactivitiesfollowingapprovedvalidationprotocols数据汇总及对在验证过程产生的问题进行调查Datacollectionandprobleminvestigationduringthevalidation.质量保证部QA组确保验证按照批准的方案进行Ensurethevalidationisexecutedaccordingtothevalidationprotocol参与对在验证过程中产生的问题的调查Takepartinprobleminvestigationduringvalidation.质量保证部经理QAHead

20、确保所有的验证活动符合葛兰素史克集团及所涉及市场的法规部门的要求EnsureallthevalidationactivitiescomplywiththeGSKGQPsandsiteprocedures批准SVMP,验证主计划、工艺验证的方案与报告、清洁验证草案和报告、项目cGMP回顾报告、验证总结报告ApproveSVMP,VMP,performancequalificationprotocolandreport,cleaningvalidationprotocolandreport,projectcGMPreviewreport,validationsummaryreport工厂总监Sit

21、eDirectorB批准SVMPApproveSVMP为验证工作提供必要的人力资源及财力资源Providetherequiredresourcesforvalidationactivities4验证的时间表与进展SchedulesandProgress4.1 价值流部门的验证项目ValidationProjectsinValueStreams4.1.1 胶囊价值流CapsuleVS4.1.1.1胶囊价值流新项目CapsuleVSNewprojects项目计划开始与完成日期ScheduledDate项目进程Schedule按计划asper®schedPkegress完推依据&备

22、注Justifications&edCommentsValidationProjects开始日期完成日期20072008成迟StartingEnding678910111212345CompleedostponGlatt流化床更换PLC(系统参考编号203111)GlattfuildbedchangePLC(SystemReferenceNO.203111)2006.112007.10|-X重订时间；大修时间变化Reschedule:Shutdowntimechange芬必得闭口锅验证(系统参考编号203106)FenbidclosepanValidation(SystemRefere

23、nceNO.203106)2007.22007.12卅卜1ill-：力机川花士山匚11；1,：1；'：Lrlrsjririjjr11««,-a",11ljt,°iI,i,i°iu11r411,uxsJ111J11liiii11i-i1"-11，-1i11'jl'l!1|:"ll|l,1|i1r111Frrff1rf|111F11'1!1X自动上料机-芬必得装囊自动上料验证(系统参考编号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重订时间；2007年未启动Reschedule;Notstartedin2007芬必得装囊机提速性能确认(系统参考编号203024-203027)Fenbidfillingmachinespeedupperformance

25、qualification(SystemReferenceNO.203024-203027)2007.42007.12X重订时间；2007年未启动Reschedule;Notstartedin2007MG2装囊机VR系统验证(系统参考编号203123/203124)VRsystemvalidationforMG2capsulefilling(SystemReferenceNO.203123/203124)2007.92007.12I-I-IS-i"«"1ii,1«ii1i-I-X新项目Newproject苏丽丝含量由12%调整至11.5%(Newcont

26、ac)验证(系统参考编号203003)ThecontentofSurleaseadjustsfrom12%to11.5%forNewContacvalidation.(SystemReferenceNO.203003)2005.72007.8X重订时间；优先级改变Reschedule:prioritychange.项目ValidationProjects计划开始与完成日期ScheduledDate项目进程Schedule按计划asper®schedPfeogfess完成Comple推迟edbstpot依据&备注Justifications&edComments开始日期

27、Starting完成日期Ending20072008678910111212345更换成闭口过筛机(系统参考编号203108)Changetoclosedsievingmachine(SystemReferenceNO.203108)2006.112007.6X一胶囊清洁验证(系统参考编号206010)Capsulelinecleaningvalidation(SystemReferenceNO.206010)2006.42007.12XContacND清洁验证（系统参考编号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开(系统参考编号：203135)CombinedispensingandsievingofFenbid(SystemReferenceNO.:203135)2007.62007.8X新项目Newproject根据FenbidPUCC,对芬必得制丸档案进行止f标准化（系统参考编号:204113）：!：!：!：3新项目NewprojectStandardizationtocurrentBRaccording2007.62007.12XtoFenbidPUCC(SystemReferenceNO.:2

29、04113)康合克由口项目为证（系统纶巧编勺1rail203117)ContacNDexportprojectvalidation(SystemReferenceNO.203117)2007.22007.10!X新项目Newproject4.1.1.2胶囊价值流回顾验证CapsuleVSRe-validationprojects项目ValidationProjects计划开始与完成日期ScheduledDate项目进程Schedule按计如schedPergress完成Comple推迟ePfastpon依据&备注Justifications&edComments开始日期Star

30、ting完成日期Ending20072008678910111212345MG37装囊机回顾验证(系统参考编号:203024204027)MG37fillingmachinere-validation2008.12008.3X新项目Newproject(SystemReferenceNO.:203024-203027)MG2转囊机回顾验证(系统参考编号:203016)MG2fillingmachinere-validation(SystemReferenceNO.:203016)2008.32008.6新项目Newproject芬必信ETbooth回顾驳证(系统殄巧编号:204006-2040

31、07)FenbidETboothre-validation(SystemReferenceNO.:204006-204007)2008.12008.3一1新项目Newproject4.1.2 片剂和软膏价值流Tablet&creamVS4.1.2.1 片剂和软膏价值流新项目Tablet&creamVSNewprojects项目ValidationProjects计划开始与完成日期ScheduledDate项目进程Schedule按计划schedPeogres完成rnplo'七推迟tedPostponed依据&备注Justifications&Commen

32、ts开始日期完成日期20StartingEnding072008678r9101112121345片剂价值流气动搅拌桨（系统参-uaa,1.14 :,»<.a <1».！!«：项目延期，重新考编号201040)Gas-motoredstirringdeviceoftabletSolutionpreparation(SystemReference2006.10订完成时间2007.12LI口1J4|>uaa>1.141113IliaEB.I3HIIII.IJIElIu1.JI!I0m *IBU1bia- <*(.bi-XReschedul

33、edforprojectdelayNO.201040)片剂软膏价值流备料间1072、1073室加装Booth（系统参考编号201098）2007.4LI口1JI.II42008.81JU-l,ubm：imX新项目。InstallBoothinVS-TdispensingNewProject.room1072&1073(SystemReferenceNO.201098)anana1,IriiBibii'llraninliiiirnuninramiiGlatt提力机驳证（系统殄巧编勺 ijaj<： :IIIB.«IIBajIBIIXBIBBaKB/201023)/G

34、lattupgradingandcrushingmachineValidation(SystemReferenceNo.201023)2005.12007.12191IEIIIm|I1Ei:iiminui11hiihii1113BillrilBEIIXIBI31IIII!a.ia.K.：1i!iauaaa.lbiaX/«iiamiliiihitanraiaiirii必理通加强片产品转移验证（系统参考编号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/瑞力外包衣参数确认（系统纶巧编号201007）2007.3IkJ*1J1.I41nnwTinnnihiij:,aai«X/Relafencoatingparameters2007.12|,U1!/confirm(SystemReferenceNO.201007)Bkl

36、B,1J1.I4Bkl&,1BJ1.I31111BillmaEIBTEBI31Bl3IBIITBI1.1KJUB1«Z片剂新装素片转移系统（立式筛|1BJ1.I4：1.BIBJ：1.!7/片机+金属检测仪）（系统参考编号/201069)Newde-dusterandmetaldetector(SystemReference2006.92007.11j*i4uaai.1klB,1J1.I4 IBJ!UBBBHBBBUIBI <.!UB!BlX/：1.JUB/NO.201069)项目ValidationProjects计划开始与完成日期ScheduledDate项目进程Sc

37、hedule开始日期完成日期StartingEnding20072008678910111212345软膏生产线从GSKT转移至2006.102008.3IIIij»kSii!1ITSKF(系沆纶专珈it；202015)CreamlinetransferfromGSKTtoTSKF(SystemReferenceNO.202015)II!ijramma!1I,h刀IRrj信版证（余筑纶专编勺206011）200642007121Tabletlinecleaningvalidation(SystemReferenceNO.206011)II!1juB1>秋昌彳目信叔证（余筑纶专编

38、勺206012)Creamlinecleaningvalidation(SystemReference2006.42007.12II!ij1UtLUJINO.206012)I2006.42009.12 1IIH 1IIHii11Bin41U俗故侏田时怛-片刑(余凯殄巧漏号206017(B)206024(B)HoldtimevalidationforsolutionTablet(SystemReferenceNO.206017(B)206024(B)kBU.TRilli111<"!t半成叩保留时间-片剂(系统殄巧编号206017(A)206024(A)Holdtimevalida

39、tionfor2006.42009.12IIIHijI.BIIiI111<"!,1KbulkTablet(SystemReferenceNO.206017(A)206024(A)HijjuBI1,Ima质量警报-压片机验证压片机(系统参考编号：201110,201111,201112)QualityAlert-FETTEvalidation(SystemReferenceNO.:201110,201111,201112)2007.52007.8irii31iiranij按计划asper®scheitedPostponedXXXXX完成推迟新项目。NewProject.

40、4.1.2.2片剂和软膏价值流回顾验证Tablet&creamVSRe-validationprojects项目ValidationProjects依据&备注Justifications&Comments计划开始与完成日期ScheduedDate项目进程Schedulele23jper.,.一忌午多卜一番.推ned,忠依据&备注Justifications&scnecRsasogre表jeiDComplFostp)一开始日期完成日期20072008CommentsStartingEnding678910111212345项目ValidationProje

41、cts计划开始与完成日期ScheduledDate项目进程Scheduleh进!34二1（完FWo榆推ne$o矗依据&备注Justifications&oComments开始日期Starting完成日期20072008Ending67891011121234其它片剂生产设备验证（系统参考编号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新项目Newproject必理通回顾性验证项目（系统参考编号201001）Panadolrevalidationproject（SystemReferenceNO.201001）2007.92007.12arai!.!LBiaIIBM1.1JUBBil1L1：iiBiaiiiiiiiilSiiHiiiliilITIIIVBIIHEIIB11«31:1icibiraaiEBiiEl.X新项目N

43、ewproject赛乐特回顾性验证项目（系统参考编号201008）Seraxotrevalidationproject（SystemReferenceNO.201008）2008.12008.3!IElCl11ClX新项目Newproject瑞力芬回顾性验证项目（系统参考编号201007）Relafenrevalidationproject（SystemReferenceNO.201007）2008.42008.61X新项目Newproject4.1.3胶囊、片剂和软膏的包装线PackagingLineofCapsuleVSandTablet&CreamVS4.1.3.1胶囊、片剂和软

44、膏的包装线新项目PackagingLineofCapsuleVSandTablet&CreamVSNewprojects项目ValidationProjects计划开始与完成日期ScheduledDate项目进程Schedule按计划scfasdpeogres完成sComple推迟:edostpor依据&备注Justifications&Commentsed开始日期Starting完成日期20072008Ending65789101112123451#UHL视觉检测系统验证（系统参考编号203057）1#UHLvisualinspectionsystemValidation（SystemReferenceNo.203057）2005.82007.61JX重订时间：供应商未能按计划到厂安装Reschedule:becauseSuppliercannotinstallequipmentasplan.2#UHL视觉也测系统驳证（系统殄巧编号