欧盟药品流通法规详述.pptx

GuidelinesonGoodDistributionPracticeofMedicinalProductsforHumanUse[Article10EUDir92/25/EEC]人用药品流通质量管理指南[欧盟第92/25/EEC号法令第10款]Ensureproductsareauthorised确保产品经过同意Storageconditionsareobserved(alltimes)关注产品储存条件(任何时候)Preventcontaminationfromotherproducts预防来自其它产品污染Ensureadequateturnoverofproducts确保足够产品流转量Deliverrightproducts交付产品正确无误RightAddress发货地址正确SatisfactoryPeriod发货斯让用户满意Providetracingsystemforfaultyproducts具备追踪系统，追踪有问题产品EffectiveRecallProcedure有效召回程序AppointManagementRepresentative-“ResponsiblePerson”-eachdistributioncentre每个分销中心须指定-“责任人”-即管理代表Appropriatelyqualified适当资质ImplementandmaintainQualitySystem来实施与保持质量系统KeyPersonnel关键人员Appropriateabilityandexperiencetoguaranteeproductsareproperlyhandled有适当能力与经验来确保产品正确处理Training培训ProvidetrainingforvariousGDPoperations提供不一样GDP操作培训Trainingprogrammes培训计划Maintaintrainingrecords保留培训统计Procedures程序Writtenproceduresshoulddescribethedifferentoperationswhichmayaffect应该有书面规程来描述不一样操作，它们可能影响：thequalityoftheproducts产品质量thedistributionactivity分销活动Proceduresfor有以下规程：-Receiptandcheckingofdeliveries发送产品接收/检验-Storage储存Cleaningandmaintenanceofpremises贮存厂房清洁与维护ProceduresCont’d程序(续)Recordingofstorageconditions统计储存条件Securityonsiteorintransit现场或运输安全Withdrawalfromsaleablestock从销售仓库撤回Recordsof-orders统计-定单-returnedproducts-退货Recallplans召回计划Proceduresforvariousoperationsshouldbeapproved,signedanddatedbytheResponsiblePerson各种规程均应经过责任人同意，签字与签发日期Records统计Madewheneachoperationistakingplace每次操作时均应统计Activitiesandeventsaretraceable活动/事件均可追踪Readilyavailable方便查阅Retainedfor5yearsatleast最少保留5年Eachpurchaseandsale每次采购与销售有：Date日期product/quantity产品/数量nameandaddressofsupplier/consignee发货企业/收货人名称与地址RecordsCont’d统计(续)Transactionsbetween以下交易统计：(i)ManufacturersandWholesalers制造企业与批发企业(ii)BetweenWholesalers批发企业之间ensuretraceabilityoforigin/destinationproductsi.e.Batchnumberstoidentifysuppliersandthosesuppliedwithmedicinalproducts能确保产品起点/终点追踪性，如用批号来识别供给商及其发药品Suitableandadequatetoensureproperconservation/distribution适用并足以确保贮存/分销正确无误Monitoringdevicesshouldbecalibrated监控装置应该进行校准Rece