GSP藥品經(jīng)營質(zhì)量管理規(guī)范GSP藥品經(jīng)營質(zhì)量治理規(guī)范第一章總則為了加強(qiáng)藥品經(jīng)營質(zhì)量治理，保障人民用藥的安全和有效性，根據(jù)《中華人民共和國藥品管理法》等相關(guān)法律法規(guī)，制定了本規(guī)范。藥品經(jīng)營企業(yè)應(yīng)該在藥品的采購、儲運(yùn)和銷售等環(huán)節(jié)實(shí)施質(zhì)量治理，建立包括組織結(jié)構(gòu)、職責(zé)制度、過程治理和設(shè)施設(shè)備等方面的質(zhì)量體系，并使之有效運(yùn)行。第三條規(guī)定本規(guī)范是藥品經(jīng)營質(zhì)量治理的基本準(zhǔn)則，適用于在中華人民共和國境內(nèi)經(jīng)營藥品的專營或兼營企業(yè)。第二章藥品批發(fā)的質(zhì)量治理第一節(jié)治理職責(zé)企業(yè)的主要負(fù)責(zé)人應(yīng)該保證企業(yè)遵守國家有關(guān)法律、法規(guī)及本規(guī)范，對企業(yè)經(jīng)營藥品的質(zhì)量負(fù)領(lǐng)導(dǎo)責(zé)任。企業(yè)應(yīng)該建立以主要負(fù)責(zé)人為首的質(zhì)量領(lǐng)導(dǎo)組織，其主要職責(zé)是建立企業(yè)的質(zhì)量體系，實(shí)施企業(yè)質(zhì)量方針，并保證企業(yè)質(zhì)量治理工作人員行使職權(quán)。企業(yè)應(yīng)當(dāng)設(shè)置專門的質(zhì)量治理機(jī)構(gòu)，行使質(zhì)量治理職能，在企業(yè)內(nèi)部對藥品質(zhì)量具有裁決權(quán)。企業(yè)應(yīng)當(dāng)設(shè)置與經(jīng)營規(guī)模相適應(yīng)的藥品檢驗(yàn)部門和驗(yàn)收、養(yǎng)護(hù)等組織。藥品檢驗(yàn)部門和驗(yàn)收組織應(yīng)隸屬于質(zhì)量治理機(jī)構(gòu)。企業(yè)應(yīng)根據(jù)有關(guān)法律、法規(guī)及本規(guī)范，結(jié)合企業(yè)實(shí)際制定質(zhì)量治理制度，并定期檢查和考核制度執(zhí)行情況。企業(yè)應(yīng)定期對本規(guī)范實(shí)施情況進(jìn)行內(nèi)部評審，確保規(guī)范的實(shí)施。第二節(jié)人員與培訓(xùn)企業(yè)的主要負(fù)責(zé)人應(yīng)該具有專業(yè)技術(shù)職稱，熟悉國家有關(guān)藥品管理的法律、法規(guī)、規(guī)章和所經(jīng)營藥品的知識。企業(yè)負(fù)責(zé)人中應(yīng)該有具有藥學(xué)專業(yè)技術(shù)職稱的人員，負(fù)責(zé)質(zhì)量治理工作。企業(yè)質(zhì)量治理機(jī)構(gòu)的負(fù)責(zé)人應(yīng)該是執(zhí)業(yè)藥師或具有相應(yīng)的藥學(xué)專業(yè)技術(shù)職稱，并能堅(jiān)持原則、有實(shí)踐經(jīng)驗(yàn)，可以獨(dú)立解決經(jīng)營過程中的質(zhì)量咨詢問題。藥品檢驗(yàn)部門的負(fù)責(zé)人應(yīng)該具有相應(yīng)的藥學(xué)專業(yè)技術(shù)職稱。從事質(zhì)量治理和檢驗(yàn)工作的人員應(yīng)該具有藥學(xué)或相關(guān)專業(yè)的學(xué)歷，或者具有藥學(xué)專業(yè)技術(shù)職稱，經(jīng)過專業(yè)培訓(xùn)并考核合格后持證上崗。從事驗(yàn)收、養(yǎng)護(hù)、計(jì)量、保管等工作的人員應(yīng)該具有相應(yīng)的學(xué)歷或一定的文化程度，經(jīng)過相關(guān)培訓(xùn)并考核合格后持證上崗。在國家有關(guān)準(zhǔn)入規(guī)定崗位工作的人員，需要通過職業(yè)技能鑒定并取得職業(yè)資格證書后方可上崗。Article16:Enterprisesshouldorganizehealthcheck-upsforpersonnelwhohavedirectcontactwithdrugseveryyearandestablishhealthrecords.Patientswithmentalillness,infectiousdiseases,orotherdiseasesthatmaycontaminatedrugsshouldbetransferredfrompositionswithdirectcontactwithdrugs.Article17:Enterprisesshouldregularlyprovideeducationortrainingondruglaws,regulations,rules,professionalskills,drugknowledge,andprofessionalethicsforallpersonnelandestablishrecords.Section3:FacilitiesandEquipmentArticle18:Enterprisesshouldhavebusinesspremisesandauxiliaryofficebuildingsthatareappropriatefortheiroperatingscale.Thebusinesspremisesshouldbebrightandclean.Article19:Thereshouldbewarehousesthatareappropriatefortheoperatingscale.Thewarehouseareashouldhaveaflatground,nostandingwaterorweeds,nosourcesofpollution,and:(1)Thedrugstoragearea,auxiliaryoperationarea,andofficeandlivingareashouldbeseparatedbyacertaindistanceorhaveisolationmeasures,andtheroofoftheloadingandunloadingoperationareashouldbecovered.(2)Thereshouldbesuitablewarehousesfordrugclassificationandstoragethatmeettherequirementsfordrugstorage.Thewalls,ceilings,andfloorsofthewarehouseshouldbesmoothandflat,andthedoorsandwindowsshouldbetightlystructured.(3)Thewarehouseareashouldhavefireprotectionandsafetyfacilitiesthatmeettherequiredstandards.Article20:Thewarehouseshouldbedividedintospecialplacessuchastheinspectionwaitingwarehouse(area),qualifiedproductwarehouse(area),shippingwarehouse(area),unqualifiedproductwarehouse(area),andreturnwarehouse(area).FortheoperationofChineseherbalmedicinepieces,aspecialwarehouse(area)forweighingandpackagingshouldalsobeestablished.Alloftheabovewarehouses(areas)shouldhaveclearsigns.Article21:Thewarehouseshouldhavethefollowingfacilitiesandequipment:(1)Equipmentthatkeepsacertaindistancebetweendrugsandtheground.(2)Equipmentforavoidinglight,ventilation,anddrainage.(3)Equipmentfortestingandadjustingtemperatureandhumidity.(4)Equipmentfordust,moisture,mold,pollutionprevention,aswellaspest,rat,andbirdprevention.(5)Lightingequipmentthatmeetstherequirementsforsafeuseofelectricity.(6)Workplacesandstorageplacesforpackagingmaterialsthataresuitableforunpackingandpackingandequipment.Article22:Specialwarehousesforstoringnarcotics,classIpsychotropicdrugs,medicaltoxicdrugs,andradioactivedrugsshouldhavecorrespondingsecuritymeasures.Article23:Thereshouldbedruginspectiondepartmentsthatareappropriatefortheenterprise'sscaleandscope,equippedwithcorrespondinginspectioninstrumentsandequipment.FortheoperationofChineseherbalmedicinesandChineseherbalmedicinepieces,aChineseherbalmedicinespecimenroom(cabinet)shouldbeestablished.Article24:Thereshouldbeacceptanceandmaintenanceroomsthatareappropriatefortheenterprise'sscale,meethygienerequirements,andequippedwithnecessaryacceptanceandmaintenancetoolsandequipment.Article25:Regularinspections,repairs,maintenance,andrecord-keepingshouldbeconductedforallfacilitiesandequipmentused.Article26:ThereshouldbeaspecializedplacethatmeetstherequirementsforthepackagingofChineseherbalmedicinepieces,andtheareaandequipmentshouldbeappropriateforthepackagingrequirements.Section4:PurchasingArticle27:Enterprisesshouldprioritizequalitywhenselectingdrugsandsupplierconditionsandestablishpurchasingproceduresthatensurethedrugspurchasedmeetqualityrequirements.Article28:Thepurchaseddrugsshouldmeetthefollowingapproximateconditions:(1)Drugsproducedoroperatedbylegalenterprises.(2)Drugsthathavestatutoryqualitystandards.保持環(huán)境整潔、無污染物，定期清潔、消毒；定期檢查藥品的保質(zhì)期和有效