欧盟药品GDP及药品冷链技术(全)

thecompliancegroupStanO’NeillCPAPE2011年会欧盟药品药品流通法规EURegulationsonDrugDistributionsGuidelinesonGoodDistributionPracticeofMedicinalProductsforHumanUse[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]•Personnel人员•Documentation文件•PremisesandEquipment房屋与设备•DeliveriestoCustomers向客户交付•Returns退货•SelfInspections自检•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•保证足够的产品流转量•Deliverrightproducts交付产品正确无误QualitySystemOperatedbyWholesalersshould批发商的质量系统应–RightAddress发货地址正确–SatisfactoryPeriod发货斯让用户满意•Providetracingsystemforfaultyproducts具备追踪系统，追踪有问题的产品–EffectiveRecallProcedure有效的召回程序QualitySystemOperatedbyWholesalersshould批发商的质量系统•AppointManagementRepresentative-“ResponsiblePerson”-eachdistributioncentre•每个分销中心须指定-“负责人”-即管理代表–Appropriatelyqualified适当的资质–ImplementandmaintainQualitySystem来实施与保持质量系统KeyPersonnel关键人员Appropriateabilityandexperiencetoguaranteeproductsareproperlyhandled有适当的能力与经验来保证产品正确处理Personnel人员Training培训ProvidetrainingforvariousGDPoperations提供不同GDP操作的培训Trainingprogrammes培训计划Maintaintrainingrecords保存培训记录Personnel人员•Procedures程序Writtenproceduresshoulddescribethedifferentoperationswhichmayaffect应当有书面规程来描述不同的操作，它们可能影响：–thequalityoftheproducts产品质量–thedistributionactivity分销活动Proceduresfor有以下规程：-Receiptandcheckingofdeliveries发送产品的接收/检查-Storage储存-Cleaningandmaintenanceofpremises贮存厂房的清洁与维护Documentation文件–ProceduresCont’d程序(续)»Recordingofstorageconditions记录储存条件»Securityonsiteorintransit现场或运送安全»Withdrawalfromsaleablestock从销售仓库撤回»Recordsof-orders记录-定单-returnedproducts-退货»Recallplans召回计划Proceduresforvariousoperationsshouldbeapproved,signedanddatedbytheResponsiblePerson各种规程均应经过负责人的批准，签字与签发日期Documentation文件–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/收货人的名称与地址Documentation文件–RecordsCont’d记录(续)»Transactionsbetween以下交易的记录：(i)ManufacturersandWholesalers制造企业与批发企业(ii)BetweenWholesalers批发企业之间ensuretraceabilityoforigin/destinationproductsi.e.Batchnumberstoidentifysuppliersandthosesuppliedwithmedicinalproducts•能保证产品起点/终点的追踪性，如用批号来识别供应商及其发的药品Documentation文件•Suitableandadequatetoensureproperconservation/distribution适用并足以保证贮存/分销正确无误•Monitoringdevicesshouldbecalibrated监控装置应当进行校准–Receiving接收»Receivingbaysprotectdeliveries有保护收货的区域»Receivingareaseparatefromstorageareas收货区域与储存区域分开»Deliveriesexaminedonreceipt在收货时检查产品•Damage有无损坏•correspondstotheorder与定单是否相符PremisesandEquipment库房设施与设备•Storage储存»Medicinalproductsseparatefromothergoods药品与其它产品分开»Conditionsspecified-protectfromlight,moisture,below25℃规定条件-避光,防潮,低于25℃»Temperaturemonitoringdocumented温度监测有记录»Recordsreviewedregularly定期审核记录»TemperatureMapping.Storageareas/coldrooms温度分布、储存区/冷库PremisesandEquipment库房设施与设备•Ensurealllocationswithinspecifictemperaturerange•保证所有区域都在规定的温度范围内25oC2-8oCPremisesandEquipment库房设施与设备–StorageFacility储存设施»Clean清洁»Freefromlitter,dust,pests无废弃物、灰尘、虫害»Freefromspillageorbreakage没有溢出或损坏»Microcontamination微生物污染»Crosscontamination交叉污染uStockRotation库存流转F“FirstinFirstout”Regularchecks“先进先出”定期检查PremisesandEquipment库房设施与设备uOutofDateorDamagedStock将过期或损坏库存FQuarantine隔离/待检FDestroy销毁PremisesandEquipment库房设施与设备–AuthorisedWholesalers批准的批发商–PersonsauthorisedtosupplyMedicinalProducts经批准可从事药品流通的人员»IMBwilllookrandomlyatcustomerlist爱尔兰药品管理局将在客户清单中随机抽查–SupplyDocument提供的文件应有：»Date日期»NameandPharmaceuticalForm名称与药品剂型»Quantitysupplied供应数量DeliveriestoCustomers向客户发货»Supplierandaddressee供应商以及地址•Nameandaddress名称与地址–ProductShelfLife产品有效期»Productdispatchedmusthaveaminimumdefinedshelfliferemaining所发送的产品必须具有所规定最短有效期DeliveriestoCustomers向客户发货–Transportation运输Ensurethat保证：»Identificationisnotlost不丢失标识»CrossContaminationisavoided避免交叉污染»Productsaresecure产品安全»Breakage&theftareavoided避免损坏与偷窃»Protectedfromunacceptableenvironmentalconditions防止环境条件不符合要求»Temperatureiscontrolledduringtransport在运输中温度受控DeliveriestoCustomers向客户发货–ColdChain冷链Productsrequiringrefrigerationmustbedeliveredin需要冷冻产品必须在下列条件下发运»Refrigeratedtransport冷冻运输»Insulatedboxes绝热箱Validateworstcasesituationduringtransport验证在运输中最坏情况状态Ensureproductdoesnotcomeincontactwithicepacks保证产品不接触冰袋ResponsiblePerson-ensureadequatedeliveryconditionsmaintained负责人-保证保持足够的交付条件DeliveriestoCustomers向客户发货–ControlledDrugs受控药物MaintainSecurityChain保持发货各环节的安全»Separatecontroldrugsindeliveriestofacilitatetransfer受控药品要采用单独发送方式，方便移交»Deliverdirecttopharmacistatthehospitalorretailoutlet直接交到医院或零售店的药剂师DeliveriestoCustomers向客户发货NonDefectiveMedicinalProducts无缺陷药品–SegregationfromSaleableStockuntilchecked–与销售库存相隔离，直到经过检查»Productsingoodcondition-originalunwrappedcontainers产品保持良好状态--容器为原始包装未经开封»Productsstoredunderproperconditions产品在正确条件下储存»Remainingshelflifeacceptable仍有可接受的有效期Returns退货uProductsexaminedandassessedbyauthorised,trainedpersonnel产品由经过批准及培训人员的检测与评估uSpecialstorageconditions-timeelapsedsinceissue特别储存条件-自从发货起的持续时间uMaintainrecordsofreturnedgoods保存退货记录u