重新包装管理规程.docx

评估内容评估结果备注是否涉及变更控制，是否需要开启或已开启变更来评估制修订产生的影响。是否NA其他（如变更号）：是否符合法规及注册标准要求。GMP药典国标ISO其他标准是否NA其他：是否涉及铅印（订做/请购）是否如是，则列出所需铅印的内容是否有记录需设置到电子系统中使用（如：ERP/数据库）是否如是，则列出所涉及的附录是否合并规程是否如是，则列出所涉及的规程是否需要采取其它行动是否NA其他：分发部门价值流原液部科学技术部质量体系其他：价值流制剂部技术支持部质量验证价值流供应部环境健康安全部质量控制价值流质量保证产品放行质量改进项目部规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages1/15规程名称Title产品重新包装管理规程ProductRepackagingManagement规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages2/15规程名称Title产品重新包装管理规程ProductRepackagingManagement目录第一部分正文1.目的第3页2.适用范围第3页3.责任部门（人）第4-5页4.定义和缩略语第5-6页5.物料和设备第6页6.规程第6-12页7.附件第12页8.附录第12页9.参考文件第12-13页10.注意事项第13页第二部分正文附件附件A第14-15页重新包装种类TypesofRepacking适用于AppliesTo不适用于DoesNotApplyTo所有第二次包装操作均发生在成品已经过QP放行或其他同等批次放行流程放行后，和/或该产品已离开原始生产地后，具体内容包括：AllSecondaryPackingOperationsthattakeplaceafterthefinishedproducthasbeenreleasedfollowingQPcertificationorequivalentbatchreleaseprocessand/orhaslefttheoriginalmanufacturingsite,including:外包装材料的变更，添加，替代和/或去除Alteration,addition,substitutionand/orremovalofsecondarypackaging组分（例如：说明书，内盒）Components(Forexample:leaflets,cartons).添加防篡改或防伪标志Additionoftamperevidentorantcounterfeitfeatures.禁止在西林瓶，安瓿瓶，注射器及任何疫苗产品的初次包装上打印或覆盖贴标。任何重新包装发生在成品放行之前和/或离开原始生产地之前，具体内容包括：Printingorover-labelingonvials,ampoules,syringesandanyvaccinesproductprimarypackagingasthisisprohibited.Anyrepacking,whichtakesplacebeforethefinishedproducthasbeenreleasedand/orhaslefttheoriginalmanufacturingsite,Thisincludes:o任何工序涉及内包装材料破坏（或无菌生物制品包装开口/破损）Anyprocessthatinvolvesthebreakingoftheprimarypack(orblisteropening/breachingforsterileandbiologicalproducts).o质量许可情况下，在某一工厂对半成品做进一步处理（贴标或包装）Semi-finishedproductfurtherprocessedbyasite(labelingandpackaging)andforwhichtheactivityiscoveredinQualityAgreement.规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages3/15规程名称Title产品重新包装管理规程ProductRepackagingManagementThetablebelowdetailsthetypesofrepackingtowhichtheprocessdoesordoesnotapply.：产品重新包装管理规程ProductReprocessingandRepackagingManagement1.目的Objective/Purpose1.1明确返工和重新包装的定义DefinitionofReprocessingandRepacking1.2明确返工要求和重新包装操作的管理流程、职责DefineReprocessingrequirementandtheprocessandresponsibilityofRepackaging.2.适用范围Scope2.1重新包装范围见下表1：ThescopeofRepackagingislistedintable1below:2.2TY所有的商业产品均不得进行返工、重新加工；ReprocessingandreworkingisnotallowedforallcommercialproductinTianyuanmanufacturingsite.工艺过程中适用与不适用重新包装的类型详见下表1：商业角色BusinessRole关键职责KeyResponsibilities重新包装发起人RepackingProposer:评估重新包装，确保评估是基于商业，监管，市场及产品质量要求。Toassesstherepackingactivityandensureitisjustifiedbasedoncommercial,regulatory,marketandproductqualityrequirements.:评估报告在重新包装开始前得到批准Toobtainappropriateapprovalfortherepackingbeforeitstarts.:确保重新包装活动是有记录追踪的。Toensurethatrepackingactivityiscapturedinalocaltracker.规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages4/15规程名称Title产品重新包装管理规程ProductRepackagingManagementapprovalsismaintained.由于产品需从一个市场转移到其他市场，重新包装或重新贴标签以符合当地语言要求。Repackingorrelabelingtomeetlocallanguagerequirementsasaresultoftransferofproductformonemarkettoanthermarket初次包装后已放行到市场Packagingofprimaryo产品放行上市之前在原生产地进行的成品重新包装Repackingoffinishedpacksatoriginalpackingsitebeforetheproductisreleasedforsale.o在产品内盒外添加VVM标签AddtheVVMlabelingonthecarton.packsreleasedtothemarket.。3.责任部门（人）Responsibledepartment(person)关键的角色和职责KEYROLESANDRESPONSIBILITIES以下个人和团队有重要的角色和职责来完成重新包装流程。同一个人可能担任不止一个角色，保留必要的独立批准职责ThefollowingindividualsandteamshavekeyrolesandresponsibilitiestofulfillintheRepackingprocess.Thesameindividualmayperformmorethanonerole,providedthenecessaryindependenceofrequired质量部-QualityQAVS:确保重新包装的流程是有效的和健全的，重新包装符合该SMP要求。Toensureeffectiveandrobustprocessesareinplaceandinusetomanagerepacking,inaccordancewiththisSMP.:审阅和批准重新包装申请Toreviewandapproverepackingproposals.:在重新包装开始之前获得适当额外的批准Toobtainappropriateadditionalapprovalsfortherepackingbeforeitstarts.:确保重新包装的设施能满足用途，例如符合要求，文件，设备及人员充足Toensurethatrepackingfacilitiesarefitforpurpose,plywithrequirementsandadequatedocumentation,equipmentandpersonnelareinplace.:确保任何发起的重新包装的法规影响经过评估和记录，否则委托给重新包装者或原始制造地（必要时QS支持）Toensurethatanyregulatoryimplicationsofanyproposedrepackinghavebeenassessedandaddressed.Unlessdelegatedtotherepackerororiginalmanufacturingsite.:批准或拒绝与药品相关的重新包装的要求Toapproveorrejectrepackingrequestsrelatedtomedicinalproducts.放行QA/QPQP/QARelease审阅和批准重新包装申请（二级）Toreviewandapproverepackingproposals.确保所有重新包装的组分是完全受控的Toensureallrepackingcomponentsareadequatelycontrolled.在年度APR中回顾重新包装的批次ToperiodicallyreviewrepackingbatchintheAPRReport.放行重新包装的材料（放行QA）Toreleasecomponentsforrepacking(QARelease)批准或拒绝与药品相关的重新包装的要求（二级）Toapproveorrejectrepackingrequestsrelatedtomedicinalproducts.按照法规要求放行重新包装产品Toreleaserepackedproductswhererequiredbyregulations.仓库管理员WarehouseHandler把所重新检查和重新包装的批号分开存放Segregatephysicallytherecheckandrepackbatchesandindicateintheinventorylogbook.规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages5/15规程名称Title产品重新包装管理规程ProductRepackagingManagement规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages6/15规程名称Title产品重新包装管理规程ProductRepackagingManagement4.定义和缩略语Definitionandabbreviation重新包装：任何内包装材料或者外包装材料的文字的更改,，或去除或替换任何已打印外包装材料，并且操作均发生在成品已按照QP放行或其他同等批次放行流程放行后，和/或该产品已离开原始生产地后。Anyoperationthat:Requiresthealterationoftexttoprimaryorsecondarypackagingand/ortheaddition,removalorexchangeofanyprintedsecondarypackagingmaterial,andtakesplaceafterthefinishedproducthasbeenreleasedfollowingQPcertificationorequivalentbatchreleaseprocessand/orhaslefttheoriginalmanufacturingsite.5.物料和设备MaterialsandequipmentN/A6.规程Procedure6.1重新包装6.1.1重新包装评估（参见附录1）AssessmentofRepacking重新包装申请者必须评估重新包装开始之前所有行动是否合理，要求：TheRepackingProposermustassessifrepackingisjustifiedbeforestartinganyrepackingactivities.Theymust:评估重新包装的理由Evaluatethereason(s)whyrepackingisrequired.由于偏差而需要重新包装时，确认必要的纠正预防措施已经完成Whenrequiredbecauseofadeviation,confirmthatnecessarycorrectiveandpreventativeactions(CAPAs)arecomplete.评估申请的重新包装的商业可行性，需考虑重新包装批次的成本，供应的重要性及再包装产品剩余保质期Evaluatecommercialviabilityofproposedrepacking,takingintoaccounttotalcost,criticalityofsupplyandextentofshelfliferemainingforanyrepackedbatches.定义范围，比如包装需要改变，包装的数目Identifywhatwouldbeinvolved,forexamplechangestobemadetothepack,numberofpackstobeprocessed.评估在什么地方进行重新包装操作，确认以下内容被批准Evaluatewheretherepackingoperationswouldbeconductedandconfirmthatthefollowingareinplaceandapproved:A:供应的技术项目Technicaltermsofsupply.:B:对于第三方，第三方操作现场审计，技术/质量方协议和合同Forthirdparties,Siteauditforproposedactivity,technical/qualityagreementsandcontracts.识别待供应的市场，法规及批次放行的影响Identifymarketstobesupplied,regulatoryandbatchrelease一级评估包括Level1assessmentinclude：二级评估除了上述内容外，还包括：Level2assessmentincludestheseitemsasbelowbesidesthoseinlevel1:1.重新包装的原因，为什么需要重新包装，出错的原因在哪里，是否己有针对这一原因的CAPA。Thereasonwhytherepackisrequiredandwhererequiredasaresultofanerror,andconfirmthatthenecessaryCAPAhavebeenaddressed.。2.对法规和批放行的影响Impactonregulatoryandbatchrelease.3.对产品质量的影响，如冷链条件包装完整性的影1.在哪里进行重新包装.所有涉及产品组分或者打印变化的重新包装必须在浙江天元生物药业有限公司进行。Repacklocation.AlltherepackoperationsrelatedwithcomponentoroverprintingchangingmustbeexecutedinTY,acceptpricelabelsticking.2.如为退货产品，应检查、检验和调查，并有证据证明退货产品质量未收影响，且经质量管理部门根据操作规程评价后，方可考虑将退货重新包装、规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages7/15规程名称Title产品重新包装管理规程ProductRepackagingManagementforanyproposedrepackingoperation.TheymustthensubmittheformtoQualityforapproval.implications.识别任何重新包装操作过程中需要的环境控制，如在非冷藏条件下的储存时间Identifyanyenvironmentalcontrolsrequiredduringrepackingoperations,forexampletimeoutofcoldstore.识别任何与申请的重新包装相关的风险及任何的缓解行动Identifyanyrisksassociatedwithproposedrepackingtogetherwithanymitigationplans.确认防篡改或防伪标志是否会被破坏或者是否需要重新添加Determinewhethertamperevidentoranti-counterfeitfeatureswouldneedtobebroken,orarerequired,andwhethertheymustbereappliedoradded.确认任何额外的测试或抽样的要求Identifyanyadditionaltestingandsamplingrequirements0确认批号的要求SOP.QM.00.04.001.IdentifybatchnumberrequirementsSeeSOP.QM.00.04.00.11确保任何重新包装被当地的法规部门批准（如果需要）。重新包装的申请人必须在重新包装申请单中记录此评估以及重新包装的理由。必须记录清晰，详述重新包装的流程，包括任何重新包装操作的控制要求。然后评估报告须提交给质量进行批准EnsurethatanyrepackingisapprovedbylocalRegulatoryAuthoritiesiflocalregulationsrequireit.Therepackagingproposermustdocumentthisassessmentandrationaleforwhytherepackingisjustifiedinarepackingrequestform.Theymustalsodocumentclear,detailedrepackinginstructionsincludingthecontrolsrequired规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages8/15规程名称Title产品重新包装管理规程ProductRepackagingManagement响、混淆的风险、物料平衡的影响等Impactonproductquality.Suchasimpactoncoldchain,packingintegrity,mix-upandreconciliation.4.对追溯性的影响。哪些需要重新包装，如重新包装则需要做哪些变动，重新包装的数量等Impactontraceability.Whichportionneedtoberecheckedandrepacked,anychangeneedtobedoneifthereisrepacking,andthequantityneedtoberecheckedandrepacked.5.确定防窃起特征是否需要破坏，添加，或重新使用Toconfirmiftemperfeatureneedtobebroken,addedorre-used.6.重新包装的商业可行性，总费用和对供应的影响Impactoncommercialviability,totalcostandcriticalityofsupply.7.重新包装仍沿用以前的批号信息Batchnumberwillnotbechangedforrepacking.8.留样Determineretentionsamples重新发运销售。评价考虑的因素至少应当包括药品的性质、所需的贮存条件、药品的现状、历史，以及发运与退货之间的间隔等因素。不符合贮存和运输要求的退货应当在质量管理部门的监督下予以销毁。对退货质量有怀疑时，不得重新发运。Ifthereturnedgoodsaregoingtoberepacked,theyshouldbechecked,testedandinvestigatedtoprovethatthequalityisnotimpacted.Itshouldbeassessedbyqualitydepartmentbeforereturngoodsbeingrepackedandshippedout.Theassessmentshouldatleastincludestheproductcharacters,storageconditions,thestatusandhistoryoftheproductsandtimebetweenshipmentandreturn.Goodsthatcannotmeetrequirementshouldbedestroyed.Ifthereisanyhesitateonqualityofreturngoods,theyshouldnotbeshippedout.3.文稿变更Artworkchange4.识别重新包装可能引起的其他风险及其缓解措施Identifyanyriskassociatedwiththeproposedrecheckingandrepackingtogetherwithanymitigationplans.Note：本SOP范围之外的情况在实施之前须得到总部机构的批准IncasethereisotherrecheckorrepackcaseoutofthescopeofthisSOP.Approvedbyqualitygroupspriortocommencingrecheckandrepack6.1.2图案文稿及原材料批准ArtworkandMaterialsApproval如果需要重新创建新的图案文稿，则所有的与重新包装组分相关的打印材料和图案文稿必须采用图案文稿控规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages9/15规程名称Title产品重新包装管理规程ProductRepackagingManagement制程序进行批准（SOP.QM.00.02.006）IfthereisarequirementtocreatenewartworkthenallprintedmaterialsandartworkrelatingtorepackingcomponentsmustbeapprovedusingArtworkControlProcess(refertoSOP.QM.00.02.006)6.1.3重新包装批准Repackingapproval质量部必须至少基于以下准则批准或拒绝评估Qualitymustapproveorrejecttheassessmentbaseduponthefollowingcriteriaasaminimum:重新包装不涉及在西林瓶、注射器或疫苗产品上覆盖打印或增加标签Therepackingdoesnotinvolveoverprintingoraddinglabelstovials,syringesoranyvaccinesproducts.任何与重新包装产品相关的纠正预防措施已经完成。重新包装的厂房设施已根据GSK审计要求被批准用于重新包装操作AnyCAPAs,relatingtoproductbeingrepackedarecomplete.Repackingfacilitiesareapprovedforthetypeofrepackingoperationproposed,followingGSKaudit.重新包装的厂房设施相关供应或质量协议和合同的技术条款已准备就绪，以及与重新包装操作的类别TechnicalTermsofSupply/QualityAgreementsandcontractswithrepackingfacilitiesareinplaceandrelatetothetypeofrepackingoperationstobeperformed.法规及批次放行要求能够满足Regulatoryandbatchreleaserequirementsforthemarketcanbemet.与申请的重新包装的操作相关的风险包括环境控制和防篡改标已被充分评估及相应的降低风险的处理措施可接受Risks,includingenvironmentalcontrolsandtamperevidence,associatedwithproposedrepackingoperationshavebeenfullyevaluatedandanycountermeasuresproposedtomitigaterisksareacceptable.批号，包装及包装的组分是匹配的及可追溯的Batchnumber,packandpackcomponentsaresuitableandtraceable.额外的测试和抽样要求是符合重新包装需求、操作和法规要求Additionaltestingandsamplingrequirementsareappropriatefortheproducttype,repackingoperationandmarketregulatoryrequirements.重新包装是否需要额外的质量批准，需考虑以下几点：iftherepackingrequiresadditionalqualityapproval,takingintoaccountthefollowing:正在重新包装的产品Productbeingrepacked.重新包装行动的性质Natureoftherepackingactivity.重新包装的地点（例如GSK工厂或第三方工厂）Wheretherepackingisdone(i.e.GSKsiteorthirdparty活动Activity级别Level组分更换/增加/移除-如说明书，外包装材料第二层包装Exchange/addition/removalofcomponent(s)-leaflets,secondarypacks2增加防篡改和防伪Additionoftamperevidentoranti-counterfeitingfeatures1增加标签：不涉及注册内容Additionoflabelsthatdonotobscure/changeregisteredtext1规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages10/15规程名称Title产品重新包装管理规程ProductRepackagingManagementfacility)以下表格详述了不同的批准要求。如果某种特殊的重新包装行动没有在这个表格列举则采取最高的批准标准Thetablebelowdetailsthedifferentapprovalrequirements.Ifaspecificrepackingactivityisnotlistedinthistable,applythehighestlevelofapproval.Table1Approvallevelsforrepackingactivities使用说明Keytotable1:1-价值流质量保证负责人批准ApprovalbyQAVSLead.2-价值流质量保证负责人和QP批准ApprovalbyQAVSLeadandQP.6.1.4重新包装Repacking重新包装准备Preparingforrepacking质量部必须确保以下用于重新包装的要求达成：Qualitymustensurethatthefollowingisinplaceandusedfortherepackingoperation:适合的受控制区域asuitablecontrolledarea；批准的重新包装程序，包括额外标签或打印信息不会对原始信息产生影响。(如:剂量信息、有效期、批号或其他注册细节)approvedrepackinginstructions,includingwheretoapplyanyadditionallabelsorprintingtonotobscureprimaryinformation(Forexample:dosinginformation,expirydate,batchnumberorotherregistereddetails）；人员培训trainedpersonnel；印刷信息被批准的供应商打印并放行使用，并可以追溯，图案文稿参见SOP.QM.00.02.006componentsgeneratedusingapprovedartworkseeSOP.QM.00.02.006,printedbyanapprovedsupplierreleasedforuse,andfullytraceable；定义合适的/物料平衡定义definedreconciliationlimits,suitablefortheproposedrepacking.实施重新包装Carryingoutrepacking.1必须确保重新包装操作符合相应的程序：Qualitymustensurethattherepackingprocesscomplieswithproceduresapplicabletotherepackingactivities,including:规程编号/版本号Number/VersionSMP.G.00.PR.028/06制/修订部门DepartmentQAVS规程页码PageofPages11/15规程名称Title产品重新包装管理规程ProductRepackagingManagement环境控制，比如移出冷库后最大放置时间（TOR）Specialenvironmentalcontrols,forexamplemaximumtimeoutofcoldstore（TO