山东2008年验证总计划-山东瑞博德制药有限公司

TRIPARDUSVALIDATIONMASTERPLAN/瑞博德验证主计划VD01001PagePAGE35ofNUMPAGES352008年1月18日980SHANDONGTRIPARDUSPHARMACEUTICALSCO.,LTD.山东瑞博德制药有限公司VALIDATIONDOCUMENT验证文件ValidationMasterPlanfortheFirstPhase2008年验证总计划DocumentNo./文件编号：VD01001IssueNo./版本号：1IssueDate/颁发日期：2007年Writtenby/起草人:TonyLiu/刘福堂ValidationManager/验证经理Signed/签名:Date/日期:年月日Authorizedby/授权人:RayYu/于瑞清TechnicalDirector/技术总监Signed/签名:Date/日期:年月日

Documentcheck/审核Auditedby审核人Title职位Signature签名Date日期JaneChang/常鸿雁ProductionDirector/生产总监ProductionManager/生产经理TonyLiu/刘福堂QAManager/QA经理RockyZhao/赵岩EquipmentManager/设备经理AnnaSong/宋晓燕QCManager/QC经理EngineeringManager/维修经理StorageManager/仓库经理LongBao/包龙CommercialDirector/商务总监DistributionQAValidationarchive(Completedoriginal)QA验证档案（完整的原件）TechnicalDirector(Copy)技术总监（复印件）EngineeringManager(Copy)维修经理（复印件）QCManager(Copy)QC经理（复印件）ProductionManager(Copy)生产经理（复印件）QAManager(Copy)QA经理（复印件）PackingManager(Copy)包装经理（复印件）ValidationManager(Copy)验证经理（复印件）CommercialManager(Copy)商务经理（复印件）ProductionDirector(Copy)生产总监（复印件）

TableofContent/目录1 Purpose/目的 62 Summary/概述 62.1 Companyintroductionandsummaryoffiststageproject/公司及一期工程项目概述 62.2 Scope/验证范围 62.3 ValidationPolicy/验证方针 63 ValidationOrganizationalChartandPersonnelResponsibilities/验证组织结构及人员职责 73.1 OrganizationalChart/组织结构图 73.2 ValidationCommittee/验证委员会 73.3 Validation/QualificationTeam/验证小组 73.4 Responsibilities/职责： 73.4.1 ResponsibilitiesofValidationCommittee/验证委员会职责 73.4.2 ResponsibilitiesofValidationTeam/验证小组职责： 83.4.3 AllDepartmentalManagers/所有部门经理职责 93.5 Training/验证培训 94 TheWritingandApprovalofValidationPlan,ProtocolandReport/验证计划、方案、报告的起草审批程序 95 Documentation/文件 95.1 Content/文件范围 95.1.1 ValidationPlan/验证计划 95.1.2 ValidationProtocol/验证方案 105.1.3 ValidationReport/验证报告 105.1.4 ValidationCertificate/验证证书 105.2 Format/文件格式 105.3 ValidationDocumentnumbering/验证文件的编号 125.4 Validation/QualificationArchiving验证/确认归档 126 ValidationImplementation/验证实施 126.1 SafetyandHealth/安全与健康 126.2 ValidationClassificationandApplicableScope/本次验证所用到的验证分类与适用范围 126.2.1 ProspectiveValidation/前验证 126.2.2 ConcurrentValidation/同步验证 136.2.3 Revalidation/再验证 136.3 ValidationImplementation/验证的实施 146.4 ValidationProjectCollection/本次验证的项目汇总 146.4.1 AnalyticalMethodsValidation/分析方法学 146.4.2 Facilities/设施 146.4.3 Instrumentsandequipments/仪器设备 156.4.4 Process/工艺 156.4.5 EquipmentCleaning/设备清洁 166.4.6 Computerizedsystem/计算机化系统 176.5 Schedule/本次验证的时间计划安排 176.5.1 FirstPhase/第一阶段 176.5.2 Secondphase/第二阶段 186.5.3 Thirdphase/第三阶段 196.5.4 Fourthphase第四阶段 207 ValidationMethodandAcceptanceCriteria/验证方法和可接受标准 207.1 URS/用户需求标准 207.2 Analyticalmethodsvalidation/分析方法学验证 217.3 FacilitiesValidation/厂房设施、仓库设施的验证 217.3.1 DesignQualification/设计确认 217.3.2 InstallationQualification/安装确认 227.3.3 OperationalQualification/运行确认 227.4 ValidationofCleanRoomsandAir-conditioningSystem/洁净车间、空调系统的验证 227.4.1 DesignQualification/设计确认 237.4.2 InstallationQualification/安装确认 237.4.3 OperationalQualification运行确认 247.4.4 PerformanceQualification/性能确认 257.5 Purifiedwatersystemvalidation/纯化水系统验证 257.5.1 DesignQualification/设计确认 257.5.2 InstallationQualification/安装确认 267.5.3 OperationalQualification/运行确认: 267.5.4 PerformanceQualification/性能确认 277.6 Compressedairsystemvalidation/压缩空气系统验证 287.6.1 DesignQualification/设计确认 287.6.2 InstallationQualification/安装确认 287.6.3 OperationalQualification/运行确认 297.6.4 PerformanceQualification/性能确认 297.7 Instrumentsandequipmentsvalidations/仪器设备验证 297.7.1 DesignQualification/设计确认 297.7.2 InstallationQualification/安装确认 307.7.3 OperationalQualification/运行确认 307.7.4 PerformanceQualification/性能确认 317.8 Equipmentcleaningvalidation/设备清洁验证 327.8.1 Establishmentofcleaningprocedure/建立清洁规程 327.8.3 Validationofsamplingmethod/验证取样方法 327.8.4 ConfirmationofChemicalResidue/确定化学残留量 327.8.5 Confirmationofmicrobesresidue/确定微生物残留量 337.8.6 ExpiryDateofCleanedEquipment/确定清洁设备的存放有效期 337.9 ProcessValidation/生产工艺验证 337.9.1 Preconditions/验证先决条件 337.9.2 ValidationMethod/验证方法 337.10 ValidationofComputerizedSystem/计算机化系统验证 347.10.1 Hardware/硬件 347.10.2 OperationalSystem/操作系统 347.10.3 Firmware/生产或支持设备使用的固件 347.10.4 Commercialsystem/商业化系统 347.10.5 Configurablesoftwarepackage/可配置软件包 348 Deviationsandchangecontrol/偏差处理及变更控制 349 HistoryofChange/文件变更及历史 3510 References/参引 3511 Annex/附录 35

Purpose/目的ThisValidationMasterPlan(VMP)describestheValidationandQualificationactivitiesthatwillbeundertakenatTripardusPharmaceuticalsLtd.atfirstphasebeforestart-up.Itsummarizesthecompany’sValidationintentions,philosophy,policy,project,plan,andapproachandacceptancecriteria.本验证总计划（VMP）描述了瑞博德制药有限公司新建的一期工程在启用前应该进行的验证和确认活动，概括地阐述验证目的、原则、方针、项目、计划、方法和可接受标准等。Summary/概述Companyintroductionandsummaryoffiststageproject/公司及一期工程项目概述ShandongTripardusPharmaceuticalCo.,Ltd.islocatedinJinanExportProcessingZone,andtheconstructionstartin2006.TripardusundertakesmanufacturingofproductsandNutritional/Vitaminproductsonacontractualbasis.Theannualoutputoftabletwillbe***aftercompletion.Thewarehouseis***m2andthegranulationplantis***m2瑞博德制药有限公司一期工程位于山东济南出口贸易加工区，于2006年开始建设，本工厂根据与客户的合同，从事药品及营养维生素产品的加工。项目建成后，将达到年产量****的片剂生产量，有仓储系统***平方米，制粒生产车间***，……。Scope/验证范围Thisplanistobefollowedforthevalidationofplant,purifiedproject,facilities,HVAC,purifiedwatersystem,compressedairsystem,productionequipment,computerizedsystem,process,cleaningprocedures,etc.ThevalidationwillprovethattheplantmeetsGMPrequirementsandissuitableformedicineproduction.验证包括本次建设的厂房、净化工程、仓储设施、HVAC系统、纯化水系统、压缩空气系统、生产设备、计算机化系统、加工工艺、清洁程序等，本次验证后，本次建设的项目应符合GMP要求可以生产药品。ValidationPolicy/验证方针Inordertoproducetheproductofrightquality,safetyandefficacyandultimatelyprotectionofpatients,thevalidationmustconformtocGMPandcustomerrequirements..Aplannedapproachisthereforerequiredinordertoprogresstheworkinastructuredandcontrolledmanner.EnsurethevalidationisbasedontheriskassessmentandcGMP-relatedcriticalequipment,process,cleaning,facilities,computerizedsystemandsupportivesystemhavebeenvalidated.TheriskassessmentiscarriedoutwithprotocolestablishmentsimultaneouslybyValidationTeam.ThescopeandextentofValidationactivitiesforanindividualproject,basedontheconclusionsandrecommendationsintheGMPRiskAnalysis,andapprovedbyValidationCommitteeaswellasQAManager.为使瑞博德能生产出合格、安全和有效的产品，最终能保证用户的健康。验证应符合cGMP和客户的验证要求，验证工作应有计划、有组织、有控制的进行，确保验证建立在风险评估的基础上，确保与cGMP相关的、有主要作用的关键设备、工艺、清洗、设施、计算机系统和支持系统都进行验证。风险分析由验证小组成员负责在制定验证方案时进行，根据GMP风险分析的结果和建议确定的单个项目的验证内容和范围，由包括QA经理在内的验证委员会在审核验证方案时批准。

ValidationOrganizationalChartandPersonnelResponsibilities/验证组织结构及人员职责OrganizationalChart/组织结构图ValidationCommittee/验证委员会ValidationCommittee/验证委员会ValidationManager验证经理验证小组（1）ValidationTeam(1)验证小组（2）ValidationTeam(2)验证小组（3）ValidationTeam(3)验证小组（4）ValidationTeam(4)验证小组（…）ValidationTeam(…)ValidationCommittee/验证委员会TechnicalDirectorisresponsibleforthewholevalidationactivities;ValidationManagerisresponsibleforco-coordinating.TheValidationCommitteeiscompromisedofTechnicalDirector,ValidationManager,ProductionDirector,EHSManager,CommercialManager,QAManager,QCManager,ProductionManager,WarehouseManager,EquipmentManager,EngineeringManager,andMaintenanceManager.瑞博德的验证总负责人为技术总监，组织协调人为验证经理，由技术总监、验证经理、生产总监、环境安全健康总监、商务总监、QA经理、QC经理、生产经理、仓库经理、设备经理、维修经理组成验证委员会。Validation/QualificationTeam/验证小组AValidation/Qualificationteamisassembledtoguidetheindividualprojectsthroughtocompletion.TheteamshouldbemultidisciplinaryandwillbecomprisedofpersonnelwithskillstoassistthesatisfactorycompletionofValidationandQualificationactivities,andtheTeamLeadershouldbethepeoplewhoisfamiliarwiththevalidationprojectandisappointedbyValidationManager.TheteammembersareappointedbyTeamLeaderatthetimeofprotocoldraft.验证小组是为完成每个项目验证工作而成立的工作小组，该小组应是多学科的，组长由熟悉本项目验证要求的人员担任，小组成员掌握的技术能协助验证和确认工作的圆满完成。组长一般由验证经理根据实际情况指定，小组成员由验证组长在起草验证方案时根据要求指定。Responsibilities/职责：ResponsibilitiesofValidationCommittee/验证委员会职责Personnel人员Responsiblefor:职责TripardusPharmaceuticalsSeniorManagement瑞博德高层EnsuringthatsufficientcommitmentandresourcesareavailabletorelevantdepartmentstoachievetheaimsoftheprojectssetoutintheVMPandincompliancewithcGMP.确保为相关部门提供足够的义务和资源，以达到VMP中规定的验证目标，并符合GMP要求。ValidationManager验证经理Toco-ordinatevalidationandqualificationprojects,drafttheVMP,ensuretheValidationTeamcompletingthevalidation,andestablishvalidationarchive.协调验证和确认工作，起草验证总计划，督促各验证小组按照计划和方案完成验证，建立验证档案。TechnicalDirector技术总监ToapprovetheValidationPlan,ValidationProtocolandValidationReport批准验证计划、验证方案、验证报告。OthermembersintheValidationCommittee验证委员会其他成员EnsuringthatproductsaremanufacturedusingValidatedEquipment,Facilities,Processes,TestMethodandSystemsTochecktheValidationPlan,ProtocolandReport.确保正式生产使用的设施、设备、工艺、检验方法和系统经过验证。审核验证计划、方案和报告。QAManagerQA经理EnsuringthatallValidation&QualificationactivitiesarecompletedandauthorizedaccordingtoQAacceptablestandardsandincompliancewithcGMP.ToissuetheValidationCertificateforthequalifiedvalidationprojectbyreferringtotheapprovedValidationReport.ChecktheValidationPlan,ProtocolandReport.确保按照QA合格标准及GMP要求完成所有的验证和确认。根据批准的验证报告发放验证合格证书。审核验证计划、方案和报告。ResponsibilitiesofValidationTeam/验证小组职责：Personnel/人员Responsibilities/职责TeamLeader验证组长TodrafttheValidationProtocolandReport,organizetheindividualvalidationactivities,arrangethevalidationarchive,organizethetrainingandensuretheTeamMembercankeeptherecordindetailaccordingtotheprotocolrequirements.起草验证方案、组织项目的具体验证、督促验证小组成员按照验证方案的要求做好验证记录、起草验证报告、整理验证档案，组织相关的验证培训。MembersofValidationTeam验证小组成员Tocarryoutthevalidationactivities,makerecord,reporttheincident,andassistdraftingthevalidationprotocolandreport.按照方案实施验证、并做好记录、例外情况及时汇报和记录、协助起草验证方案和报告。AllDepartmentalManagers/所有部门经理职责CompletionofValidation/Qualificationprojectsrelatingtotheirareas.完成与其区域相关的验证/确认工作。Training/验证培训AppropriatetrainingmustbegiventofacilitatethesatisfactoryperformanceofValidationandQualificationactivities,includingtheValidationPlan,ValidationProtocolandrequiredskills.Thetrainingshouldfollowtherequirementsspecifiedin“TrainingManagement”验证过程中，验证计划、验证方案以及验证中应该掌握的技能应该进行培训，培训应遵循《培训管理办法》。TheWritingandApprovalofValidationPlan,ProtocolandReport/验证计划、方案、报告的起草审批程序TheValidationPlaniswrittenbyValidationManager,ValidationProtocolandValidationReportarewrittenbyValidationTeamMember.验证计划由验证经理起草，验证方案和报告由验证小组组织起草。ThedocumentsarecheckedbyallmembersofValidationCommittee.以上文件的审核由验证委员会全体成员审核。TheValidationPlan,ProtocolandReportareapprovedbyTechnicalDirector.所有验证计划、方案、报告均由技术总监批准。TheValidationCertificateisissuedbyQAManagerbyreferringtotheValidationReportwhichwillstatetheapprovedproject.验证报告显示验证符合要求的验证项目由QA经理发放验证证书。Documentation/文件Content/文件范围ThedocumentationiscompromisedofValidationPlan,ValidationProtocol,ValidationReportandValidationCertificate文件包括验证计划、方案、报告、证书ValidationPlan/验证计划ItconsistsofValidationMasterPlan,IndividualValidationPlanandAnnualValidationPlan,whichdescribetheplanandrequirementsforindividualorannualvalidationactivities.AValidationPlangenerallyincludestheprojectsummary,validationscope,regulatoryandstatutoryrequirements,validatedproject,validationorganizationalchart,acceptancecriteria,documentationrequirementsandschedule,etc.包括验证总计划、分项的或年度的验证计划，是对某个项目或者某个年度的验证工作的规划和要求。一般包括：项目概述、验证的范围、所遵循的法规标准，被验证的厂房设施、系统、生产工艺，验证的组织机构，验证合格的标准，验证文件管理要求，验证大体进度计划等内容。ValidationProtocol/验证方案Itisawrittenprotocolstatinghowtovalidateandspecifyingtheacceptancecriteria.TheValidationProtocolgenerallyincludesthreemainparts:thevalidationprojectsummarywhichdescribesthespecificcontentstobecheckedcalibratedandtested;theacceptancecriteriaandvalidationmethodforcriticalpoints;andrecord,i.e.checkandtestresultsandevaluation.一个阐述如何进行验证并确定验证合格标准的书面方案。通常由三大部份组成：一是验证项目概述，阐述需要检查、校正及试验的具体内容；二是对需要验证的关键点设定可接受标准和验证方法，即检查及试验达到什么要求以及如何检查的方法；三是记录格式，即检查及试验应记录的内容、结果及评估意见。ValidationReport/验证报告Itisawrittendocumentforreviewandevaluationofvalidationresults,missoutanddeviations.Thecontentsthatareidenticalwiththatintheprotocolmaynotberepeatedbutmustbereferredto.对验证方案及已完成验证试验的结果、漏项及发生的偏差等进行回顾、审核并做出评估的说明文件，与方案的内容一致的可以不重复方案内容，仅写明与对应的方案相同即可。ValidationCertificate/验证证书TheValidationCertificateisissuedbyQAprovingthevalidatedprojectisqualifiedandmaintainedinValidationFile.TheCertificateshouldindicatethenumbersofvalidationprotocolandreport,andtheapplicablescope.由QA部门颁发一个证书，以证明对某个项目通过验证，存放于项目的档案中。验证证书应包括验证方案和验证报告的编号，以及可以该项目可以使用的范围。Format/文件格式Theprotocolandreportshalltypicallyinclude,butnotbelimitedto,thefollowing:-方案和报告一般应包括，但不限于以下内容：1Documenttitle,referenceandversionnumber,theprotocolnumbershouldbeincludedinthereport文件题目、文件编号及版本号，报告中应有对应的方案编号2TableofContents,numberofdocumentpages,e.g.,“PageXofY”目录、文件页码，如：第X页共Y页3Documentpersonnelendorsementforwriting,reviewandauthorization.文件签字，包括起草、审核和授权4Documentdistribution文件分发的对象5Summaryofvalidationproject验证项目的基本情况概述6Summaryofindividualcriticalvalidationproject,acceptancecriteriaandvalidationmethod.每个关键验证项目的简述，确认及合格标准，验证方法7Schedule验证实施的时间计划安排8Referencestootherrelevantdocumentsapplicabletotheproject(e.g.,SOP’s,guidancedocumentsetc.)适用于本项目的其它相关文件的参引（如SOP、指导文件等）9Deviationsfromtheprotocol,includingthetreatmentandrecord.偏差的处理方案，报告中应有每个偏差的处理情况总结与记录。10Validationreport,thesummaryofeachvalidationprojectincludingtheconclusions,confirmationandsuggestions.报告是对每一个验证关键点的总结，包括结论、确认和建议。11Documentchangehistory/Reasonforupdate文件变更历史/修订原因12Attachmentsorappendices,e.g.containingrawdataandothersupportiveinformation,etc.Adequatecross-referenceshallbemadeinthedocumentationtoinformationthatisnotpossibletostoreinthedocumentappendices附录，如包括的原始数据及其它支持性信息等。无法存放在文件附录中的文件，要有足够的参引。Apro-formaprotocol/reportmaybeusedforthesimpleproject.Forthisformat,thetestdataisfilleddirectlyontotheprotocol,whereuponthecompletedprotocolbecomesthereport.ThisVMPmaybeusedasamodeltemplatedocumentonwhichtobaseValidationProtocolsandReports.对一些特别简单的验证项目，可使用一个形式方案/报告。对此，直接将检测数据填在方案中，填写完整的方案，由此形成报告。本VMP可以作为一个模版文件，建立验证方案和报告。ValidationRecord/验证记录：Itisusedforrecordingtheresultsofexperiment,calibrationandtestduringthevalidationprocess.Theformatcancopyfromdailyusedrecordorbespecificallydesignedintheprotocol.Therecordcanbeputintheappendixorintheprotocolaccordingto5.2.2.验证记录是在验证过程中的实验、校验以及检查的记录，格式可以是日常的记录格式，也可以是在方案中为了此验证而专门设计的记录格式，具体的记录格式可以在附录中，也可以按照5.2.2在方案。ValidationCertificate/验证证书：TheCertificateisinA4sizeandincludesthevalidationprojectname,validationprotocolnumber,validationreportnumber,authorizersignature,etc.验证证书的格式为一张A4纸制作的证书，应该有验证项目的名称、验证方案编号、验证报告编号、授权人签字等。ValidationDocumentnumbering/验证文件的编号ThedocumentnumberisassignedbyValidationManagerinaccordancewithSOP“DocumentClassificationandNumbering”.验证文件的编号按照SOP《文件的分类和编号》由验证经理指定。Validation/QualificationArchiving验证/确认归档AlldocumentationshouldbemanagedbyValidationTeamLeaderafterthecompletionandshallbestoredinasecurelocationbyQADocumentControllerandavailableforauditreview.TheProtocol&Validation/QualificationReportshouldbearchivedforaminimumof15years.ValidationManagerisresponsibleforestablishingthevalidationdocumentationindex.Therecordshouldbemaintainedwithvalidationreportastheappendix.所有文件都应该在验证结束后，由验证小组组长负责整理，将所有验证文件的原件交负责存档的QA存放在一个安全的地方，可随时进行审核，方案和验证/确认报告必须至少存放15年，验证经理应建立并保存所有验证档案的索引。验证过程的记录作为验证报告的附属档案与验证报告一起保存。ValidationImplementation/验证实施SafetyandHealth/安全与健康NoValidationorQualificationactivitiesshouldbecarriedoutpriortosafetychecksonequipmentbeingcarriedout.Thesechecksmustbedocumentedandsatisfactory.AllappropriateCompanyHealth&SafetyprecautionsandpoliciesmustbefollowedwhencarryingoutValidationorQualificationwork.对设备安全检查之前，不能进行验证或确认。这些检查必须归档，并且检查合格。验证或确认时，必须遵循相应的公司安全和健康预防措施及原则。ValidationClassificationandApplicableScope/本次验证所用到的验证分类与适用范围ProspectiveValidation/前验证Validationconductedpriortotheformaluseofprocess,procedure,system,equipmentormaterials,etc.inaccordancewiththepre-establishedprotocol.Thepurposeofprospectivevalidationistotestifyandconfirmthereproducibilityandreliabilityofaprocessorprocedure,whichwillrequirecomparativelyadequateandcompletedesignanddevelopmentinformationfortheequipment,productorprocess.Theprospectivevalidationisappliedforthenewproduct,equipmentandprocess.Thesuccessofprospectivevalidationistheessentialelementforthetransferenceofnewprocessorequipmentfromresearchandtrialstagetoroutineproduction.Theapprovedprocessandequipmentsaretheinitialconditionsforstartingtheroutineproduction.Prospectivevalidationisappliedforallthefacilities,equipments,testmethod,computerizedsystem,cleaningmethodspecifiedinthisVMP.指一项工艺、过程、系统、设备或材料等在正式投入使用前进行的，按照预定验证方案进行的验证。前验证是考察并确认工艺或过程的重现性和可靠性，一般需要有比较充份和完整的设备、产品和工艺的设计开发资料。引入新产品、新设备以及新的生产工艺时应用前验证的方式，前验证的成功是实现新工艺、新设备从研究、试车阶段向生产阶段转移的必要条件，工艺或设备是交付常规生产的起点。适用于本次验证总计划中所有的设施、设备、检验方法、计算机化系统、清洁方法的验证。ConcurrentValidation/同步验证Validationconductedsimultaneouslywiththeprocessoperation,i.e.aseriesofactivitiescarriedoutwhendataobtainedfromtheprocessrunning,toprovethataprocessmeettheexpectedrequirements.Theconcurrentvalidationisinfactthetrialproductionunderspecialmonitoringconditionstoobtainthequalifiedproductandvalidationresultsatonetime,i.e.theevidenceofprocessreproducibilityandreliability,thuswillprovethecontrolofprocessconformtothedesignedspecifications.ConcurrentvalidationisappliedtotheprocessvalidationspecifiedinthisVMP.AlltheproductshavebeenmanufacturedinCPLformanyyears;theprocessisstableanddirectlytransferredtoTripardus.指生产中在某项工艺运行的同时进行的验证，即从工艺实际运行过程中获得的数据作为验证文件的依据，以证明某项工艺达到预定要求的一系列活动。同步验证实际上是特殊监控条件下的试生产，于此既可获得合格产品又可得到验证结果，即“工艺的重现性及可靠性”的证据，从而证实工艺条件的控制达到预计要求。适用于本次验证总计划中的工艺验证，因为本次计划投产的所有产品均为CPL多年生产的产品，产品工艺稳定，并将原工艺的技术交接给了tripardus。Revalidation/再验证Validationconductedforaprocess,procedure,system,equipmentormaterialafteraperiodoftimeofvalidationanduse,toprovethatthevalidatedstatusisnotchanged.Revalidationisrequiredforcriticalprocess,facilities,equipments,andwheneverthereischangeandregulatoryorstatutoryrequirements.AnyprojectscannotbeusedforroutineproductionuntilthecompletionofallvalidatedcontentsspecifiedintheVMP.TherevalidationresultedfromchangeshouldbecarriedoutinaccordancewithSOP“ChangeControl”.TheperiodicalrevalidationisraisedintheannualVMP.指一项工艺、过程、系统、设备或材料等经过验证并在使用一个阶段以后进行的，旨在证实已验证状态没有发生漂移而进行的验证。关键工艺、设施、设备需要进行定期再验证，发生变更的部分需要进行再验证，法规要求强制执行的再验证。本次验证总计划中的每项验证报告中应该包括再验证的周期，因本次验证无再验证的内容，就不再说明再验证的方法。本次验证总计划中的验证内容全部完成后，本次建设项目可投入生产，如果有因为变更发生的再验证，按照《变更控制程序》执行，周期性的再验证在下年度的验证总计划中提出。ValidationImplementation/验证的实施TheValidationTeamshouldbeorganizedandwritethevalidationprotocolaccordingtoVMPandSOP“ValidationOrganizationandImplementation”ThevalidationactivitiesshouldbecarriedoutbyValidationTeamaftertheapproval.ThereportshouldbeformedandthecertificatewillbeissuedbyQAManager.ThedocumentationshouldbehandedovertoQAforfiling.按照《验证的组织实施程序》和本计划，成立验证小组，起草验证方案，验证方案经批准后，由验证小组实施，结束后形成验证报告，经审核合格的验证项目由QA经理发放验证证书，验证小组将所有验证文件整理交QA归档。ValidationProjectCollection/本次验证的项目汇总AnalyticalMethodsValidation/分析方法学QCManagerisresponsiblefortheanalyticalmethodsvalidation,includingtheanalyticalmethodsfromCPLandnewadoptedone本部分验证由QC经理负责，包括CPL向TRIPARDUS进行技术转移中涉及的分析方法和新采用的分析方法。Facilities/设施TheIQoffacilitiesshouldconformtothedesignedoutputrequirementsatthefirstphasespecifiedinthisVMP.TheURSshouldbestatedandtheP&IDsmustbereviewedpriortotheIQprotocolwriting.EquipmentManagerisresponsibleforthefacilitiesvalidation.Thespecificequipmentstobevalidatedasfollows:设施的设计确认均应符合本验证总计划中一期工程项目的设计产量要求，在制定每个设施的设计验证方案时应先写明URS，对施工的竣工图纸进行审核。本部分验证由设备经理赵岩负责，具体需要验证的设备如下：No./编号Name/名称Quantity/数量Facilities/厂房设施1套Warehouse/仓储区域1Cleanrooms/洁净车间1HVACsystem/HVAC系统5Purifiedwatersystem/纯化水系统1Compressedairsystem/压缩空气系统Instrumentsandequipments/仪器设备QCManagerisresponsibleforthetestinstrumentsvalidation;EquipmentManagerisresponsiblefortheotherequipments.本部门中的检验设备由QC经理宋晓燕负责，其他设备由设备经理赵岩负责。No.编号Name名称Quantity数量Responsiblepeople负责人HPLC/高效液相1套AnnaSong/宋晓燕Autoclave/高压灭菌柜1AnnaSong/宋晓燕UV/紫外分光光度计1AnnaSong/宋晓燕IR/红外5AnnaSong/宋晓燕CleanBench/净化操作台1AnnaSong/宋晓燕BiologicalSafetyCabinet生物安全柜AnnaSong/宋晓燕TabletPressMachine/压片机RockyZhao/赵岩GranulationMachine/制粒机RockyZhao/赵岩Dryer/干燥器RockyZhao/赵岩CoatingMachine/包衣机RockyZhao/赵岩Mixer/混合器RockyZhao/赵岩Oven/烘箱RockyZhao/赵岩Process/工艺ProductionDirectorisresponsiblefortheprocessvalidation.本部分的验证由生产总监常鸿彦负责。具体项目如下：No.编号Name/名称ITAMINC60mgCHEWABLETABLETST2842维C咀嚼片（60mg）FOLICACIDTABLETSRTA60T2848叶酸片VCZINCTABLETSRTA65T2850锌片VITAMINBCOMPLEXTABLETS(RTA67)T2851复合VB片VITAMINC500mgCHEWABLETABLETS(RTA69)T2843VC咀嚼片（500mg）MULTIVITAMIN&IRONTABLETST2838多维铁片MULTIVITAMINTABLETS(RTA57)T2837多维片A-ZMULTIVITAMIN&MINERALSVEGA-Z完全多维片EquipmentCleaning/设备清洁ProductionDirectorisresponsible