GMP现场检查Checklist(ENGLISH)

16.2AddendumB：GMPChecklistforCompliancewithGMPDIRECTORATE:INSPECTORATEandLAWENFORCEMENTINSPECTOR’SCHECKLISTFORROUTINEGMPINSPECTION6.3AddendumC:CoverletterforGMPinspectionsSUBDIRECTORATE:MEDICINESCONTROLINSPECTOR’SCHECKLISTFORRROUTINEGMPINSPECTIONTHISDOCUMENTMAYNOTBEREPRODUCEDFORANYOTHERPURPOSETHANFORTHEUSEBYANINSPECTORTOASSISTDURINGANINSPECTION.ITREMAINSTHEPROPERTYOFTHEINSPECTORATE.NOCOPYMAYBEPROVIDEDTOANYOTHERPERSONWITHOUTTHEPRIORAUTHORISATIONBYTHEHEADOFTHEINSPECTORATE.COMPILEDBYAJVANZYL2EDECEMBER1997ROUTINEGMP:APPLICANTWITHOWNMANUFACTURINGPLANTROUTINEGMP:APPLICANTWITHOWNMANUFACTURINGPLANT2Fileno.:TypeofInspection:RoutineGMPCompanyname:Companyaddress:(Postal)Companystreetaddress:Telno.:Faxno.:RESPONSIBELPHARMACIST:QAMANAGERPRUDUCTIONMANAGER:ACTIVITIES:APPLICANT:MANUFACTURER:PACKER:DISTRIBUTOR:LABORATORY:DOSAGEFORMSHANDLED:CAPSULES:LIQUIDS:S.V.P:AEROSOLS:LOZENGES:OTHER(SPECIFY):TABLETS:POWDERS:L.V.P:SUPPOSITORIES:CREAM/OINTMENTS:TYPE:CYTOTOXICS:HORMONES:PENICILLINS:BIOLOGICALS:OTHER:HOMEOPATHIC:CEPHALOSPORINS:DENTAL:VETERINARY:StaffMember:Dateofcontact:Timeinvolvement:(Preparation+Travel+Inspection+Report)GGvehicleno.:KM:3Fileno.:TypeofInspection:RoutineGMPCompanyname:Companyaddress:(Postal)Companystreetaddress:Telno.:Faxno.:RESPONSIBELPHARMACIST:QAMANAGERPRUDUCTIONMANAGER:ACTIVITIES:APPLICANT:MANUFACTURER:PACKER:DISTRIBUTOR:LABORATORY:DOSAGEFORMSHANDLED:CAPSULES:LIQUIDS:S.V.P:AEROSOLS:LOZENGES:OTHER(SPECIFY):TABLETS:POWDERS:L.V.P:SUPPOSITORIES:CREAM/OINTMENTS:TYPE:CYTOTOXICS:HORMONES:PENICILLINS:BIOLOGICALS:OTHER:HOMEOPATHIC:CEPHALOSPORINS:DENTAL:VETERINARY:StaffMember:Dateofcontact:Timeinvolvement:(Preparation+Travel+Inspection+Report)GGvehicleno.:KM:4OBSERVATIONSA:PLANTWALK-THROUGH1.PREMISESANDEQUIPMENT(general)1.1Layout/designMinimise:riskoferrors,mix-up,cross-contamination,buildupofdustordirt.1.2Permiteffectivecleaning,maintenance1.3SOP:Rodent,insectandpestcontrol.Noinsects,animals(especiallyrodents)orbirds,premises1.4Buildingmaintainedingoodorder1.5Wastematerialscontinuallyremoved,checkdustbins,labels,products1.6SOPforsanitationwithschedules,methods,materialsandequipmentavailable,cleaninganddisinfectionon-goingonaregularbasisandincludechangerooms,washrooms,toiletsandcanteen1.7Adequatelightingandvenitilation,filters,gauges,dustcontrolled,humidity,pressureandtemperatures,(filtrationofoutsideairandairreturnedtotheatmospheretheminimumrequirement).1.8Environmentalconditionsmonitoredregularlyandrecorded.1.9Productionareas-logicalflow,sufficientspace1.10Productionofpotentproductsinseparatefacilities(penicillins,biologicals,certainantibiotics,certainhormonesandcertaincytotoxicsindedicatedfacillities)1.11Technicalpoisons,(pesticidesandherbicides)notinpremisesusedforthemanufactureofmedicinalproducts.51.12Workingandin-processstoragespacesufficient.1.13Dustextractionandcollectionwheredustisgenerated.1.14Drainshavetrappedgullies1.15Pipes,fittingsandtheotherservicesdonotcreateplacesdifficulttoclean1.16Fixedpipeworklabeledtoindicatethecontentsanddirectionofflow.1.17Floors,wallsandceilings:materialsthatfacilitatecleaning1.18Storageareas:ensuregoodstorageconditions(clean,dry,temperature)1.19Specialstorageareaforflammablegoods/coldrooms/lowhumidityrooms.Monitoredandequippedwithalarmstoalertincaseoffailure.2.CHANGEROOMS2.1Restrooms,smokingareasandRefreshmentroomsseparatefromOtherareas2.2Washingandtoileteasilyaccessibleandappropriateforthenumberofusers.2.3ToiletsnotdirectlycommunicatewithProductionorstorageareas,cleanandwellventilated2.4Soap,towels,toiletpaper,(showerswherenecessary)2.5Noforeignmaterial(labels,medicine)3.RECEIVALAREA3.1Acceptanceanddispatchbaysprotectmaterials/productsfromtheweather.3.2Eachcontainer/groupingofcontainercleaned,examinedforappropriatelabeling(includingname,batchnumber,expirydate,supplier)damageandcontamination,containerscomparedwithorderdocumentandinvoice63.3In-housenomenclaturelist3.4Approvedsupplierslist(RegAffairs)3.5SOP’savailable:control,purchasing,receipt,storage,handlingandissuingofrawmaterials,packagingmaterialcomponents,intermediateandfinishedproducts.3.6Allmaterialshandledandstoredinamannertopreventcontamination,deteriorationandintermixing.3.7Onlytakenintostockifallrelevantdocumentation(eg.DeliverynoteandCOA)accompanied.3.8MaterialssubjecttoQCquarantinedandithheldfromuse,untiltestedandreleasedbyqualitycontrol.3.9Statusclear,appropriatelylabeledmanuallyorvalidatedcomputersystems.3.10Purchase,handlingandcontrolofprimaryandprintedpackagingmaterials.3.11Receiptofstartingmaterial,andPPMrecorded,(GRV),include:dateofreceipt,nameofmaterial,supplier,supplier’sbatchnumber,totalquantityandnumberofcontainers,ARnumberassigned.4WAREHOUSES4.1Ifnotcomputercontrolled-separatedemarcatedareas,preferablyphysicallyseparatedfor:sampling,quarantine,rawmaterials,packagingmaterial,intermediateandfinishedproducts,rejected,recalledandreturnedgoods.4.2Accessrestricted,safeandsecureconditions.4.3Quarantined,approvedorrejectedgoodssegregatedbyPhysicallysegregatedareas7ClearandeasilydistinguishableStatuslabel