设备培训

Module10|Slide1of26January2006BasicPrinciplesofGMPEquipment13Module10|Slide2of26January2006EquipmentObjectivesToreviewtherequirementsforequipmentselectiondesignusemaintenanceTodiscussproblemsrelatedtoissuesaroundselecteditemsofequipmentModule10|Slide3of26January2006EquipmentPrincipleEquipmentmustbelocateddesignedconstructedadaptedmaintainedtosuittheoperationstobecarriedout13.1Module10|Slide4of26January2006BasicPrinciplesofGMPWhatdoeslocationdesignconstructionadaptationmaintenancecleaningcalibration…meaninpractice?Module10|Slide5of26January2006EquipmentPrinciplesEquipmentlayoutanddesignmustaim:tominimizerisksoferrortopermiteffectivecleaningandmaintenanceToavoid:cross-contamination,dustanddirtbuild-upanyadverseeffectonthequalityofproductsEquipmentmustbeinstalledto:minimizerisksoferrorminimizerisksofcontamination13.1,13.2Module10|Slide6of26January200613.3,13.4EquipmentPipesFixedpipeworkclearlylabelledindicatecontentsanddirectionofflowServicepipingsanddevicesadequatelymarkednon-interchangeableconnectionsoradaptorsfordangerousgasesandliquidsModule10|Slide7of26January2006BasicPrinciplesofGMPContentsanddirectionofflowindicatede.g.waterlines,equipmentcomponents,air-handlingsystemsModule10|Slide8of26January200613.5EquipmentBalancesandMeasuringEquipmentAppropriaterangeandprecisionavailableInproductionandqualitycontrolCalibratedscheduledbasischecksrecordsmaintainedModule10|Slide9of26January2006EquipmentProductionequipmentAppropriatedesigneasilyandthoroughlycleanedonascheduledbasisproceduresandrecordsNohazardtotheproductscontactpartsofsuitablenon-reactivematerialsnonadditiveandnotabsorptiveDefectiveequipmentremoved,orlabelledtopreventuse13.9,13.10Module10|Slide10of26January200613.11–13.13EquipmentProductionequipmentClosedequipmentusedwhenpossibleOpenequipment,orwhenequipmentopened,precautionstakentopreventcontaminationNon-dedicatedequipmentcleanedaccordingtovalidatedcleaningproceduresbetweendifferentproductsCurrentdrawingsofcriticalequipmentandsupportsystemsmaintainedModule10|Slide11of26January2006BasicPrinciplesofGMPCurrentdrawingsofcriticalequipmentVerifyagainstqualificationprotocolandreport,aswellassupplier'smanualCheckifinaccordancewithdrawing,orchanges(changecontrol)Verifycriticalcomponentsinstalled,e.g.filters,controlandmonitoringdevicesModule10|Slide12of26January2006BasicPrinciplesofGMPWhatarethequestionsyoucanaskaboutthispieceofequipment?Module10|Slide13of26January2006BasicPrinciplesofGMPAndforthisone?Module10|Slide14of26January2006BasicPrinciplesofGMPWhatdotheselabelsindicateforthispieceofequipment?DoyounoticeanyGMPnon-compliance?Module10|Slide15of26January2006BasicPrinciplesofGMPModule10|Slide16of26January2006BasicPrinciplesofGMPWhataresomeofthekeyquestionsyoucanaskabouttheblender?Module10|Slide17of26January2006BasicPrinciplesofGMPTransferofmaterialtothecompressionmachinethroughaclosedsystemispreferredtopreventpossiblecontaminationModule10|Slide18of26January2006BasicPrinciplesofGMPRemembertolookatpunchesanddiesAretherespecificationsforthese?Howaretheycleaned,stored,issuedforuseandreturnedtostorage?Aretheyinagoodconditionandcheckedatregularintervals?Module10|Slide19of26January2006BasicPrinciplesofGMPModule10|Slide20of26January2006BasicPrinciplesofGMPCoatingoftabletsIsqualificationofacoatingmachinenecessary?Ifso,whathastobedone?Whataboutmaintenance?Andcleaningvalidation?Module10|Slide21of26January2006BasicPrinciplesofGMPDon'tforgetthepackaginglines!Module10|Slide22of26January2006EquipmentControllaboratoryequipmentEquipmentandinstrumentssuitablefortheteststobeperformedDefectiveequipmentremovedlabelled13.7,13.10Module10|Slide23of26January200613.6,13.8EquipmentWashing,cleaninganddryingEquipmentusedforwashinganddrying–notthesourceofcontaminationEquipmentdesignshouldpromoteeasycleaningCleaningonscheduledbasis,proceduresandrecordsWashingandcleaningmanualautomated(Cleaninplace(CIP),Steaminplace(SIP))Module10|Slide24of26January2006EquipmentGroupSessionForthegiventypeofequipmentWhatwouldyourconcernsbeinrelationtothemanufactureofproducts,wheninspectingthisparticularpieceofequipment?Whatarethesignsofpoorpracticeincleaning,operationandmaintenance?Module10|Slide25of26January2006BasicPrinciplesofGMPModule10|Slide26of26January2006EquipmentPossibleIssuesPoordesignLackofsafetyPoorqualityfinishesLackofcleaningLackofmaintenanceNousagelogorrecordUseofinappropriateweighingequipmentOpen-planlocationofcompressingmachines