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大小:1.26 MB
页数:3页
时间:2019-02-25
《药品批发企业冷链物流设施设备验证的探讨》由会员上传分享,免费在线阅读,更多相关内容在工程资料-天天文库。
1、·药业专论·药品批发企业冷链物流设施设备验证的探讨*陈悦(浙江丰元医药有限公司,杭州310009)中图分类号R955文献标志码C文章编号1001-0408(2013)21-1921-03DOI10.6039/j.issn.1001-0408.2013.21.01摘要目的:为确保药品冷链完整,质量可控提供参考。方法:依据相关药事法规和冷链物流技术规范性文件的要求,对药品批发企业冷链物流设施设备及相关设备的类型、验证的现状和步骤、应该注意的问题进行分析,并提出建议。结果与结论:药品批发企业冷链物流设施设备
2、有冷藏库、专用冷藏车等;目前我国尚未制定、出台药品冷链物流管理的国家标准,对设施设备性能验证的要求尚属探索阶段;步骤为先要确定验证的原则,然后制订验证方案,再实施验证,总结验证结论,最后出具验证报告;应注意的问题有:需要进行周期性再验证、及时进行设施设备的计量检定或校准、制订运输操作规程等;建议健全制度、更新管理理念,并拟定切实可行的验证方案。关键词药品批发企业;冷链;物流设施设备;验证;质量可控InvestigationofCold-chainLogisticsFacilitiesandEquipm
3、entsVerificationinMedicineWholesaleEnterpriseCHENYue(ZhejiangFengyuanMedicineCo.,Ltd.,Hangzhou310009,China)ABSTRACTOBJECTIVE:Toprovidereferenceforthecompletemedicinecold-chainandqualitycontrol.METHODS:Thecold-chainlogisticsfacilitiesandrelatedequipments
4、ofmedicinewholesaleenterprisewereanalyzedinrespectsoftype,situationandstepsofverification,attentionsaccordingtorelevantpharmaceuticallawsandrequirementsandcold-chainlogisticstechnologi-calnormativedocuments.Somesuggestionswereputforward.RESULTS&CONCLUSI
5、ONS:Thecold-chainlogisticsfacilitiesandequipmentsofmedicinewholesaleenterpriseincludecoldstores,specialrefrigeratorcarandsoon;atpresent,noneofnation-alstandardofmedicinecold-chainlogisticsmanagementhasbeenestablishedandissued,andtheperformanceverificati
6、onoffacili-tiesandequipmentsstillinanexploratorystage;thestepsofverificationwereasfollows:principleconfirmation,theformulationofverificationplan,theimplementationofverificationplan,summaryofverificationconclusion,preparationofverificationreport;thematte
7、rsneedingattentionincludeperiodicalre-verificationisnecessary,metrologicalverificationandcalibrationoffacilitiesandequipmentsshouldbecarriedouttimely,andtheoperationregulationoftransportationshouldbedeveloped,etc.;itissuggestedtoimprovethesystem,renewma
8、nagementconceptanddevelopfeasibleverificationplan.KEYWORDSMedicinewholesaleenterprise;Cold-chain;Logisticsfacilitiesandequipments;Verification;Qualitycontrol药品冷链物流指药品生产企业、经营企业(批发、零售)、储存、运输的温度监测、储运设施设备提出了较为详细的要求[1];物流企业和使用单位采用专用设施
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