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1、Thestorybehindthestory!Thestorybehindthestory!WhatthePDATechnicalReport39isallWhatthePDATechnicalReport39isallabout.about.SarMishraSupplyPartnershipSiteWyethApril11’2007NEPDAMeetingPresentationOverviewPresentationOverviewòColdChainOverviewòWhywasacoldchainguidanceneeded?òKeyconceptsint
2、heTR39guidanceòTheTR39developmentprocessòColdChainrelatedregulatoryobservationsòDetaileddiscussionofTR39òContinuousMonitoring&ImprovementòConclusionTR39Presentation,S.Mishra,11April2007NEPDAColdChainOverviewColdChainOverviewòWhatiscoldchain?òWhydocompaniesneedcoldchainmanagement?òWhata
3、retheregulatoryexpectationsregardingcoldchainandcompanyresponsibility?TR39Presentation,S.Mishra,11April2007NEPDATheTransportationEnvironmentTheTransportationEnvironment““InIn--TransitTransit””CustomereCustomsSegtorgaaaagrretooStSAirportTR39Presentation,S.Mishra,11April2007NEPDAWhatisCo
4、ldChain?WhatisColdChain?òThesequenceoftransportationeventsfromthemanufactureoftheFormulatedBulkmaterial,throughtheFinalPackagedproductintheenduser’spossessionthatmaintaintemperaturesensitiveproductswithinapprovedtemperaturespecifications.òMaintainingtemperaturecontrolduringthesetranspo
5、rtationeventsensuresthatproductquality,safety,efficacyandstabilityaremaintained.TR39Presentation,S.Mishra,11April2007NEPDAWhydocompaniesneedtoWhydocompaniesneedtomanagetheircoldchain?managetheircoldchain?òProductname=companynameintransit–reputation,responsibility,liability.òMaintainpro
6、ductqualityuntilpatientuse–“endofchain”,customercompliance.òIncreasecompliance–Reducein-transitproductdeviations,complaints,recalls&tampering.òReducedinventorypressures.òReducecycletimepressures.òAlladdsup!–manageTIME&MONEY.TR39Presentation,S.Mishra,11April2007NEPDAWhatistheregulatoryW
7、hatistheregulatoryexpectationregardingcoldchain?expectationregardingcoldchain?òBiopharmproductgrowthexplodes.òStability:–tosupportexcursions.òQualification:–seasonalshippingconfiguration–loadsizeòMonitoring:–shippingtemperaturestoensurequality.òPartnering:–withsuppliers(components&di
