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1、外文翻譯原文ColdChainManagement-AnEssentialComponentoftheGlobalPharmaceuticalSupplyChainMaterialSource:http://www.sensitech.com/PDFS/life_science/Bishara_APR.pdfAuthor:RafikH.Bishara,Ph.DExecutiveSummaryMembersofthepharmaceuticalsupplychainhavevariousglobalregulatory
2、requirementstomeetwhilehandling,storing,anddistributingenvironmentallysensitiveproducts.Theirfocusistoprovidecoldchainmanagementfortemperaturesensitivepharmaceuticalstoensurethatthequalityandefficacyoftheproductwillnotbecompromised.Thisarticlereviewstheincrease
3、dimportanceofpharmaceuticalcoldchainmanagementasaresultofchangingproductportfolios,therequirementsforGoodStorageandDistributionPractices,currentregulatorytrends,qualitymanagement,riskassessmentfactors,andtemperaturemonitoring.Trendsinclude:Responsibilityforcold
4、chainmanagementultimatelyresideswiththemanufacturerIncreasedoversight,management,andcontrolofenvironmentalconditionsacrosstheentiresupplychain(frommanufacturertoconsumer/patient)IncreasedimportanceoftemperaturecontrolandmonitoringtomitigateandidentifyrisksHeigh
5、tenedpriorityofpatientsafetyDuetothepresenceofmultipleuncontrolledvariablesinthedistributionprocess,developinganappropriatetemperatureandhumiditymonitoringprogramisessentialtoprotectthequalityofenvironmental-lysensitivepharmaceuticalproductandensurepatientsafet
6、y.IncreasedImportanceofthePharmaceuticalColdChainOfthegreaterthan$400billionofpharmaceuticalproductssoldworldwidein2003approximately10%or$41billionwerebiopharmaceuticals.From1999to2003thebiopharmaceuticalmarketgrewatanaverageannualcompoundgrowthrateof21%-muchfa
7、sterthantheroughly11%forthetraditionalpharmaceuticalmarket.Giventhatbiopharmaceuticalstendtobetemperaturesensitive,thecoldchainhasbecomeanincreasinglyimportantcomponentoftheoverallpharmaceuticalsupplychain..Theincreasedinvestmentandmanagementfocusonthebiopharma
8、ceuticalmarketisduetoanumberoffactorsincluding:abiopharmaceutical’sabilitytotargetasignificantunmetneed,premiumpricingrelativetootherproducts,andlimitedgenericerosion.Whilei
