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(zhǐnán)[欧盟第92/25/EEC号法令第10款]Ensureproductsareauthorised保证产品经过批准Storageconditionsareobserved(alltimes)关注产品储存条件(任何时候)Preventcontaminationfromotherproducts预防来自其它产品的污染Ensureadequateturnoverofproducts保证足够(zúgòu)的产品流转量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(mǎnyì)Providetracingsystemforfaultyproducts具备追踪系统追踪有问题的产品EffectiveRecallProcedure有效的召回程序AppointManagementRepresentative-“ResponsiblePerson〞-eachdistributioncentre每个分销中心须指定-“负责人〞-即管理代表(dàibiǎo)Appropriatelyqualified适当的资质ImplementandmaintainQualitySystem来施行与保持质量系统KeyPersonnel关键人员Appropriateabilityandexperiencetoguaranteeproductsareproperlyhandled有适当的才能与经历来保证产品正确处理Training培训ProvidetrainingforvariousGDPoperations提供(tígōng)不同GDP操作的培训Trainingprogrammes培训方案Maintaintrainingrecords保存培训记录Procedures程序Writtenproceduresshoulddescribethedifferentoperationswhichmayaffect应当有书面规程来描绘不同的操作它们可能(kěnéng)影响：thequalityoftheproducts产品质量thedistributionactivity分销活动Proceduresfor有以下规程：-Receiptandcheckingofdeliveries发送产品的接收/检查-Storage储存Cleaningandmaintenanceofpremises贮存厂房的清洁与维护ProceduresCont’d程序(续)Recordingofstorageconditions记录储存条件Securityonsiteorintransit现场或运送平安Withdrawalfromsaleablestock从销售仓库撤回Recordsof-orders记录-定单-returnedproducts-退货Recallplans召回方案ProceduresforvariousoperationsshouldbeapprovedsignedanddatedbytheResponsiblePerson各种规程均应经过负责人的批准(pīzhǔn)签字与签发日期Records记录Madewheneachoperationistakingplace每次操作时均应记录Activitiesandeventsaretraceable活动/事件均可追踪Readilyavailable方便查阅Retainedfor5yearsatleast至少保存(bǎocún)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/收货人的名称与地址RecordsCont’d记录(续)Transactionsbetween