药品批发企业冷链物流设施设备验证的探讨

《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