中文-USP GDP Mar 2016

MaryG.Foster,PharmDUSPChair,ExpertCommittee,Packaging&DistributionQualityHead,XelliaPharmaceuticals,ClevelandMarch2016Packaging&DistributionExpertCommittee[USPPDEC]GeneralInformationChaptersUpdate:PharmaSupplyChain包装和储运专业委员会标准概要章节更新：药品供应链USPPDECGeneralChapters1079GoodStorage&DistributionPracticesforDrugProducts1083GoodDistributionPractices总则《1079》药品良好的贮存和储运实践《1083》良好的储运实践•2016SupplyChainPlan2016供应链计划Agenda议程ExpertCommittee&ExpertPanelOutcomesCommercial&InvestigationalProduct专业委员会和专家组结果商业和受调查产品32015-2020专家理事会，专业委员会和合作团体DevelopingandupdatingUSPstandardsforpackagingsystemsandtheirmaterialsofconstruction(e.g.,Containers:metal,glass,plastic,elastomericclosuresforinjections)开发和更新USP关于包装系统及其组织材料的标准Revisingpackagingdefinitions(e.g.,CRT);packagingandstoragerequirementsforcompendialarticles重审包装的定义（比如：CRT），包装和储存对于简易材料的要求Creatingandrevisingguidance;examples:编撰和重审指南–Containers容器:Performancetesting–Sterileproductpackaging消毒产品包装:Integrity&evaluation–Goodpackaging&repackagingpractices良好包装和再包装实践–Extractables萃取物–Leachables浸出物–Gooddistributionpractices良好的储运实践Goals包装和储运专家委员会目标USPPackaging&DistributionExpertCommitteeWhatIsGoodDistributionPractice?什么是良好的储运实践（操作）？HowDoesUSPAddValue?USP如何增加价值？Whatdoesgooddistributionpracticemeaninthepharmaindustry?在医药行业，什么是好的储运实践？Whatpart(s)ofthisdefinition/subjectsaddvaluetotheUSPEndUser?在这个主题下，哪一部分是USP可以为最终用户增加的价值？Includesanyactivitiesrelatedtopharmaproducts&associatedmaterialsincluding,包括任何有涉及药品和关联材料的活动，包括：Outsideofthemanufacturingoperation/facility生产设施之外的区域Holding保存–Storageintransportationvehicleorotherareathanmanufacturing/packaging/warehousingfacilityMovement运动过程–Distribution/TransportationprocessesGoodDistributionPracticesGDP良好的储运实践（GDP）LifecycleManagementSubmission&ApprovalPhase3Phase2Phase1Pre-ClinicalDevelopmentGDPTraditionallyGoodPractices(GxP)focusedon:传统的良好实践规范集中在：–GoodLaboratoryPractices(GLP)良好的实验操作（实践）–GoodClinicalPractices(GCP)良好的临床实践–GoodManufacturingPractices(GMP)良好的生产实践GDPpartofGxPstillbeingdevelopedGLPGCPGMPPre-GDPPre-GMPGDPRegulatoryLandscape良好储运实践法规一览GeneralGDPsGIPTCMDCSPortHandling/CustomsOffloadingGeneralLayout/ContructionLoading&ReceivingBaysBuildingCleanlinessGeneralSecurityTemperatureMonitoredStorageAreasProductStabilityProfilesTemperature-ControlledTransportHumidityControlandMonitoringShippingContainers&PackingGeneralLablelingRelabelingPackaging,PrcoessingQualifiedPersonnel,TrainingGoodDocumentationPracticesStockControlSystemsExceptionManagement&ProductCompaintProceduresProductReturn,Recall,Withdraw,ControlandDisposalSerialization&ePedigreeGPSandBulkSecurity,CounterfeitsGS1IdentificationTraceability/StockTrackingArgentinaXXXBrazilXXXXXXXXXMexicoxxxxxxxxAustraliaXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXJapanXXXMalaysiaXXXXXXXXXXXXXXXXXXXXXSingaporeXXXXXXXXXXXXXXXXXSouthAfricaXXXXXXXXXXXXXXXXXPhillipinesXXXXXXXXXXXXXXXXXXXXAustriaXXXXXXXXXXXXXXXXXXXXXXXXXXXXEMAXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXIrelandXXXXXXXXXXXXXXXSwitzerlandXXXXXXXXXXXXXCanadaXXXXXXXXXXXXXXXXXEgyptXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXRomaniaXXXXXXSaudiArabia,SaudiFood&DrugAuthorityXXXXXXUAEXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXXWHOModelrequirementsforthestorageandNewGuidanceforstorageandtransportofDirective2001/83/ECoftheEuropeanInternationalHealthOrganizationsMHRAUpdatedPolicyonReturnsofNon-DefectiveGuidanceonPreventingBreachesintheColdChainDistributionGDPRiskGDPRiskAssessmentStrategyRegulatoryProvisionsforQualityControlledNMANo.30/24.09.2009GCCGuidelinesforStability,PP-SPC-9031,TOPAGTS-6000CircularNo.246-2011Middle-EasternEuropeanRegionMinsterDecreeforWholesalers-CircularIsraelPharmacistRegulations-Circular6StatusofCurrentGDPRegulationsinIsraelNorthAmericanRegionGuidelinesforTemperatureControlofDrugUnitedStatesFDAtoReviseComponentGMPstoBolsterBarCodeTechnologiesforDrugsandStandardsforSecuringDrugSupplyChain...DistributionofTemperatureControlledxRx-360SummaryofIPECGDPGuidetoControlandMonitoringofStoragexxxxxxxxxxxxxxxxEuropeanMedicinesAgency:QPEUGuidelinesonGoodDistributionPracticeofTheIPECGoodDistributionPracticesGuideEurope-GoodDistributionPracticesAuditAustrianGDPRegulationsCzechRepublicGuidelinesforCorrectDistributionofHumanCzechGDPGuidelinesAdoptionandImplementationoftheWorldCentralEuropeanRegionBiologicalPharmaRevisionH15.5.15GuidelinesonGoodDistributionPracticeGuidanceNotesonGoodDistributionGoodWhilesalingPracticeforWholesales,CodeofGoodWholesalingPracticeforIndia(OPPI)ColdChainPharmaeuticalProductsGuidelineonGoodDistributionPracticesforGuidelinesforImportedBiotechnological&InventoryProceduresLAARegionRegulatingtheColdChainofMedicines(LeyResolution-RDCNo.234GDP'sQualitySystemsCountriesRegulationsImportationStorageBuildings/WarehousingTransport,Delivery,StorageLabelingUSPOfficialGeneralChaptersonGDPUSP官方章节中关于良好储运实践的规定1079GoodStorage&DistributionPracticesforDrugProductsPF37(4),2011Official12/1/2012GoodDistributionPractices1197GoodDistributionPracticesforPharmaceuticalExcipientsPF37(6),2011Official05/1/2013Comparisonof1079&1197比较Req