GAMP Good Practice Guide for Validation of Laboratory Computerized Systems文档格式.docx
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GAMP Good Practice Guide for Validation of Laboratory Computerized Systems文档格式.docx
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ThishaschangednowwiththepublicationoftheGoodAutomatedManufacturingPractice(GAMP)Forum'
sGoodPracticeGuide(GPG)onValidationofLaboratoryComputerizedSystems.1However,thispublicationneedstobecomparedandcontrastedwiththeAAPSpublicationonQualificationofAnalyticalInstruments(AIQ).2Bothpublicationshavebeenwrittenbyacombinationofrepresentativesfromthepharmaceuticalindustry,regulators,equipmentvendorsandconsultants.
Thiswillbeatwo-partdiscussionoftheguideandwhereweshouldgotocoveradequatelybothequipmentqualificationandvalidationofchromatography-basedlaboratorysystems.
OverviewoftheGuide
Publishedin2005,thestatedaimoftheGPGistodeveloparationalapproachforcomputerizedsystemvalidationinthelaboratoryandprovideguidanceforstrategicandtacticalissuesinthearea.Section5oftheGPGalsonotesthat"
...thefocusshouldbeontherisktodataintegrityandtherisktobusinesscontinuity.TheGuideassumesthatthesetwofactorsareofequalimportance."
1
TheGPGnotesthatcompaniesneedtoestablishtheirownpoliciesandproceduresbasedontheirownriskmanagementapproaches.Ofinterest,theinsidepageoftheGPGstatesthatifcompaniesmanagetheirlaboratorysystemswiththeprinciplesintheguidethereisnoguaranteethattheywillpassaninspection—thereforecaveatemptor!
Table1:
ContentsoftheGAMPGPGonvalidationoflaboratorysystems.
TheguideconsistsofanumberofchaptersandappendicesasshowninTable1.Asyoucansee,theorderofsomeofthechaptersisalittlestrange.Forexample,whyisthevalidationplanwrittensolateinalifecycleorwhyisthechapterontrainingofpersonnelpositionedafterthevalidationreporthasbeenwritten?
However,atleastthemaincomputervalidationsubjectsarecoveredinthewholelifecycleincludingsystemretirement.TheGPGalsocrossreferencesthemainGAMPversion4publicationforanumberoftopicareasforfurtherinformationwhereappropriate.3
OnemajorcriticismisthattheninereferencescitedinAppendix5areveryselectiveand,therefore,theGPGignoressomekeypublicationsinthisareasuchas:
∙Furmanetal.onthedebateofholistic(orsystem)versusmodularvalidationorqualificationofcomputerizedequipment.4ThispaperwaswrittenbythreeFDApersonnelaboutthevalidationofcomputerizedchromatographicequipment;
ignoringitisnotanoptionasitprovidesascientificrationaleforthistwo-levelapproach.
∙PDATechnicalReport18onvalidationofcomputer-relatedsystemsthatcontainsamorespecificcomputervalidationdefinitionthantheFDAprocessvalidationdefinitionquotedinSection3.1oftheGPG.5,6
∙AAPSAnalyticalInstrumentQualificationwhitepaperpublishedin2004,whichwastheoutcomeofajointFDA-AAPSconferencefrom2003.2
Ignoringthesepapersbiasestheapproachthatthisguidehastakenandisafatalflawasweshalldiscusslaterinthisarticle.
Overall,theproblemwiththisGPGisthatyouhavetocherrypickthegoodbitsfromthebad.Aswithanyperformanceappraisalsystem,let'
sstartwiththegoodnewsfirstandworkourwaydownhillafterwards.
TheGoodNews
Figure1:
Systemdevelopmentandsystemimplementationlifecycles(adaptedfromtheGAMPlaboratoryGPG).
ThebestpartsoftheGAMPlaboratorysystemGPGarethelifecyclemodelsforbothdevelopmentandimplementationofcomputerizedlaboratorysystems.1ThewritersoftheguidearetobecongratulatedforproducinglifecyclemodelsfordevelopmentandimplementationthatreflectcomputerizedsystemsratherthanmanufacturingandprocessequipmentpresentedintheoriginalGAMPguide.3ThelatterVmodellifecycleistotallyinappropriateforcomputerizedandlaboratorysystemsasitbearslittlecomparisonwithreality.TheproblemwiththeGAMPVmodelwasthatimmediatelyafterprogrammingthesystemitundergoesinstallationqualification(IQ).Unit,moduleandintegrationorsystemtestingisconvenientlyforgotten,ignoredtotallyorimpliedratherthanexplicitlystated.ThetwomodelsillustratedinthelaboratoryGPGareshowninFigure1.Theleft-handsideshowsthesystemdevelopmentlifecycle(SDLC)thatisintendedformorecomplexsystemsandtheright-handsidewhichshowsthesystemimplementationlifecycle(SILC)forsimplersystems.
Thisreflectsthefactthatwecanpurchaseasystem,installitandthenoperateitasshownontheright-handofFigure1.Thevastmajorityofequipmentandsystemsinourlaboratoriesaresimilartothis,butconsiderthequestion:
hastheSILCoversimplifiedtheimplementationprocessforallspectroscopyandotherlaboratorycomputersystems?
TheargumentfortheSILC:
FormostcomputerizedchromatographsandCDSinapost-Part11world,youwillneedtoaddusertypesanduserstothesystemthatwillneedtobedocumentedforregulatoryreasons,forexample,authorizedusersandaccesslevelsrequiredbybothpredicaterulesand21CFR11.However,afterdoingthisforsimplersystems,suchasanintegrator,wecangointotheperformancequalificationstage;
thisisnotmentionedspecificallyintheSILC.
TheargumentagainsttheSILC:
Thesoftwareusedinsomelaboratorycomputerizedsystemsmayneedtobeconfigured—thisisatermforeitherselectinganoptioninthesoftwaretoalteritsfunctionwithinlimitssetbythevendor.Thiscanbeassimpleasselectingwhichfunctionwillbeusedfromtwoorthreeoptionsor,inmorecomplexsystemssuchasalaboratoryinformationmanagementsystem(LIMS),usingalanguagetosetupalaboratoryprocedureormethod.Thisfactorisnotaccommodatedspecificallyineitherofthelifecyclemodels.However,regardlessoftheapproachtaken,thesystemconfigurationmustbedocumentedpartlyforyourbusinesstoallowreconfigurationofthesystemincaseofdisasterbutalsoforperformingthevalidation.
Figure2:
Modifiedsystemimplementationlifecycleoptionsandmacrodevelopment.
Inmyview,theconceptoftheSILCisgoodbutthescopeandextentofitcanbetakenfurtherthantheLaboratoryGPGsuggests.Furthermore,itcanalsobealignedwiththeexistingsoftwarecategoriescontainedinAppendixM4ofthecurrentGAMPGuide.3Therationaleisthatmanylaboratorysystemsareconfiguredratherthancustomized;
thereforeweneedmoreflexibilitythanthesimpleSILCpresentedintheLaboratoryGPG.ThisiswheretheGAMPsoftwarecategories,outlinedinVersion4AppendixM4,comeinandwheretheLaboratoryGPGmakescomputervalidationmorecomplexthanitneedstobe.
Figure2ismyattempttotaketheSILCprinciplesfurtherthantheGPGandalignthemwiththeexistingGAMPsoftwarecategories.Auserrequirements'
specificationistheentrypointforallvariationsillustratedinFigure2,theexitfromthisfigureistheroutetothequalificationandconfigurationofthesystem.ThedefinitionsofthedifferenttypesofGAMPsoftwareare
∙GAMP3software:
Thisiscommercialoff-the-shelfsoftware(COTS).TheSILCforthistypeofsoftwareisshownontheright-handsideofFigure2Inessence,thisisamodificationoftheGPGimplementationcyclewherethedocumentationofsecurity,accesscontrolandanyothersmallsoftwareconfigurationsforruntimeoperationaresubstitutedforthedesignqualification.
∙GAMP4software:
Thisisconfigurablecommercialoff-the-shelfsoftware(configurableCOTS).Oncethesoftwarefunctionshavebeenunderstood,anapplicationconfigurationspecificationcanbewrittenthatwillstatewhatfunctionsinthesoftwarewillbeused,turnedon,turnedofformodified.AfterthesoftwarehasbeeninstalledandundergonetheIQandoperationalqualification(OQ)hasbeenperformed,thenthesoftwarecanbeconfiguredaccordingtotheconfigurationspecificationdocuments.
∙GAMP5software:
Althoughthisisusuallyauniqueandcustomapplication.However,inthecontextofCDSsoftware,thisistypicallyacustomcalculation,amacroorcustomprogramthatiswrittentoperformaspecificfunction.ThereforebothGAMP4andGAMP5softwarecanexistinthesamesystemandtheGAMP5aspectsaretypicallyanadditiontothenormalfunctionalityofthesoftwareratherthanasubstitute.
Therefore,thelifecyclesforaCDSinthiscategorywillbetheGAMP4software(centralflowinFigure2)plustheadditionalstepsforGAMP5macrosorcalculations(picturedontheleft-handsideofthesamediagram).Here,thereneedstobeaspecificationforthemacro(nameplusversionnumber),thecalculationortheprogrammingorrecordingofthemacro.Againstthiswillbeformaltestingtoensurethatthefunctionalityworksasspecified.Oncethishasbeenperformed,thenthemacroisinstalledwiththeapplicationanditistestedundertheperformancequalification(PQ)phaseofvalidationasanintegralpartoftheoverallsystem.
TheBadNews
Here,inmyview,iswheretheGPGcreatesproblems
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