GMP现场检查Checklist(ENGLISH)

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1、6.2AddendumB：GMPChecklistforCompliancewithGMPDIRECTORATE:INSPECTORATEandLAWENFORCEMENTROUTINEGMP:APPLICANTWITHOWNMANUFACTURINGPLANTINSPECTOR’SCHECKLISTFORROUTINEGMPINSPECTION6.3AddendumC:CoverletterforGMPinspectionsSUBDIRECTORATE:MEDICINESCONTROLROUTINEGMP:APPLICANTWITHOWNMA

2、NUFACTURINGPLANTINSPECTOR’SCHECKLISTFORRROUTINEGMPINSPECTIONTHISDOCUMENTMAYNOTBEREPRODUCEDFORANYOTHERPURPOSETHANFORTHEUSEBYANINSPECTORTOASSISTDURINGANINSPECTION.ITREMAINSTHEPROPERTYOFTHEINSPECTORATE.NOCOPYMAYBEPROVIDEDTOANYOTHERPERSONWITHOUTTHEPRIORAUTHORISATIONBYTHEHEADOFTH

3、EINSPECTORATE.COMPILEDBYAJVANZYL2EDECEMBER199736Fileno.:TypeofInspection:RoutineGMPCompanyname:Companyaddress:(Postal)Companystreetaddress:Telno.:Faxno.:RESPONSIBELPHARMACIST:QAMANAGERPRUDUCTIONMANAGER:ACTIVITIES:APPLICANT:MANUFACTURER:PACKER:DISTRIBUTOR:LABORATORY:DOSAGEFOR

4、MSHANDLED: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+Tr

5、avel+Inspection+Report)GGvehicleno.:KM:36Fileno.:TypeofInspection:RoutineGMPCompanyname:Companyaddress:(Postal)Companystreetaddress:Telno.:Faxno.:RESPONSIBELPHARMACIST:QAMANAGERPRUDUCTIONMANAGER:ACTIVITIES:APPLICANT:MANUFACTURER:PACKER:DISTRIBUTOR:LABORATORY:DOSAGEFORMSHANDL

6、ED: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+In

7、spection+Report)GGvehicleno.:KM:36OBSERVATIONSA:PLANTWALK-THROUGH1.PREMISESANDEQUIPMENT(general)1.1Layout/designMinimise:riskoferrors,mix-up,cross-contamination,buildupofdustordirt.1.2Permiteffectivecleaning,maintenance1.3SOP:Rodent,insectandpestcontrol.Noinsects,animals(esp

8、eciallyrodents)orbirds,premises1.4Buildingmaintainedingoodorder1.5Wastemate