重新包装管理规程完整.docx

1、重新包装管理规程完整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/Versio

2、nSMP.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

3、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：AllSecondaryPackingOperationsthattakeplaceafterthefinishedproducthasbeenreleasedfollowingQPcertificationorequivalentbatchreleasepr

4、ocessand/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

5、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）Anyprocessthatinvolves

6、thebreakingoftheprimarypack(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Pag

7、eofPages3/15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DefineReprocess

8、ingrequirementandtheprocessandresponsibilityofRepackaging.2.适用范围Scope2.1重新包装范围见下表1：ThescopeofRepackagingislistedintable1below:2.2 TY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KeyResponsibiliti

9、es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。Toensurethatrepackingactivityiscaptur

10、edinalocaltracker.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。Repackingorrelabelingtomeetlocallanguagerequirementsasaresultoftransferofproductformonemarketto

11、anthermarket 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

12、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。Toensureeffectiveandrobustprocessesar

13、einplaceandinusetomanagerepacking,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,plywithrequirementsandade

14、quatedocumentation,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Toapproveorrejectrepackingrequestsre

15、latedtomedicinalproducts.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

16、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

17、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

18、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/orhasleftt

19、heoriginalmanufacturingsite.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:6.1.1.1评估重新包装的理由Evaluatethereason(s)whyrepackingisreq

20、uired.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.6.1.1.2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,criticalityofsupplyandextentofshelfl

21、iferemainingforanyrepackedbatches.6.1.1.3定义范围，比如包装需要改变，包装的数目Identifywhatwouldbeinvolved,forexamplechangestobemadetothepack,numberofpackstobeprocessed.6.1.1.4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.6.1.1.5识别待供应的市场，法规及批次放行的影响Identifymarketstobesupplied,regulatoryandbatchrelease