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ID:453730
大小:60.00 KB
页数:8页
时间:2017-08-04
《全球医药供应链的基础——冷链物流【外文翻译】》由会员上传分享,免费在线阅读,更多相关内容在学术论文-天天文库。
1、外文翻译原文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
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