国外供应商审计GMPQuestionnaire.doc

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1、Company:TypeofDocument:QuestionnairePharmaResourcesCOMPANYPROFILESUPPLlER:DATE:2004-06-16ADDRESS:____________________________________PLANTSITETELEPHONE:PLANTSITEFAXNUMBER:MAINOFFICETELEPHONE:)Nameandaddressofparentorganization,ifapplicable___________________________________________________

2、_________________________PlantManager:____________________________________________________QA/QCManager:_________________________________________ProductionManager:__________________________________R&D/TechnicalServices___________________________________________Materialsthatwillbeprovided:Pa

3、ge12Company:TypeofDocument:QuestionnairePharmaResourcesAnswerstoquestions:AsourCompanyissendingthisquestionnairetoallitssuppliers,someofthequestionsmaynotberelevant,inwhichcasepleasemarkthecommentboxwithN/A(notapplicable).No.GENERALYESNOCOMMENTS1.IsthefacilityISOcertified?Ifso,whichstandar

4、dandsincewhen?2.Doyouhaveawrittentrainingprogramforallemployees?DoesthisincludecGMPtraining?Pleaseindicatehowmanyshiftsareatthemanufacturingfacility3.Aretrainingrecordsmaintainedforallemployees?Ifsohowlongarethetrainingrecordskept?4.Doemployeesworkingincertainareasspecialisedtraining(i.e.L

5、aboratories,classifiedareas,packaging)?5.Isthetrainingcompetencybased?6.Arethereproceduresandcontrolsinplacetoensurecross-contaminationdoesnotoccurofmaterialsbeingstoredortransportedinreusablecontainers?7.Aretheenvironmentalconditionsadequateforrawmaterialandfinishedgoodstoensurematerialst

6、ability?8.Arepersonnelsuitablydressedwherealackofsuitableattirecouldadverselyaffecttheproduct?9.Isyourwarehousetemperaturecontrolledandormonitored?10.Dothefacilitiesprovideadequatespacetopreventmixes?11.Aretherecleaningproceduresforthefacilityandacleaningschedule?12.Isthereaninsectandroden

7、tcontrolprogram?DoyouhaveaSOPforpestcontrol?Page12Company:TypeofDocument:QuestionnairePharmaResources1.Areanyofthefollowinghandledatyourplant?:Antibiotics(ifyes,whattype)hormones,steroidscytotoxics,pesticides/insecticides?2.IsthereanHVACsystem?Ifyes,hasitbeenq