GAMP-Good-Practice-Guide-for-Validation-of-Laborat

1GAMPGoodPracticeGuideforValidationofLaboratoryComputerizedSystems,Part1Guidancetohelpvalidationofcomputerizedsystemsusedwithinregulatedlaboratoriesisalwayswelcomebutisitalwayshelpful?Inthefirstpart,IpresentanoverviewoftheGuide,differentapproachtolifecyclevalidationandsystemclassification.OverthepastyearsIhavenotspokeninanygreatdetailaboutguidancedocumentsoncomputervalidationforchromatographicsystemsandchromatographydatasystems(CDS)butconcentratedonaspecifictopicfromtheregulationsthemselves.Thisisbecausemostguidancehasconcentratedlargelyoncomputerizedmanufacturingandcorporatesystems,ratherthanlaboratorysystems.ThishaschangednowwiththepublicationoftheGoodAutomatedManufacturingPractice(GAMP)Forum'sGoodPracticeGuide(GPG)onValidationofLaboratoryComputerizedSystems.1However,thispublicationneedstobecomparedandcontrastedwiththeAAPSpublicationonQualificationofAnalyticalInstruments(AIQ).2Bothpublicationshavebeenwrittenbyacombinationofrepresentativesfromthepharmaceuticalindustry,regulators,equipmentvendorsandconsultants.Thiswillbeatwo-partdiscussionoftheguideandwhereweshouldgotocoveradequatelybothequipmentqualificationandvalidationofchromatography-basedlaboratorysystems.OverviewoftheGuidePublishedin2005,thestatedaimoftheGPGistodeveloparationalapproachforcomputerizedsystemvalidationinthelaboratoryandprovideguidanceforstrategicandtacticalissuesinthearea.Section5oftheGPGalsonotesthat...thefocusshouldbeontherisktodataintegrityandtherisktobusinesscontinuity.TheGuideassumesthatthesetwofactorsareofequalimportance.1TheGPGnotesthatcompaniesneedtoestablishtheirownpoliciesandproceduresbasedontheirownriskmanagementapproaches.Ofinterest,theinsidepageoftheGPGstatesthatifcompaniesmanagetheirlaboratorysystemswiththeprinciplesintheguidethereisnoguaranteethattheywillpassaninspection—thereforecaveatemptor!TheguideconsistsofanumberofchaptersandappendicesasshowninTable1.Asyoucansee,theorderofsomeofthechaptersisalittlestrange.Forexample,whyisthevalidationplanwrittensolateinalifecycleorwhyisthechapterontrainingofpersonnelpositionedafterthevalidationreporthasbeenwritten?However,atleastthemaincomputervalidationsubjectsarecoveredinthewholelifecycleincludingsystemretirement.TheGPGalsocrossreferencesthemainGAMPversion4publicationforanumberoftopicareasforfurtherinformationwhereappropriate.3OnemajorcriticismisthattheninereferencescitedinAppendix5areveryselectiveand,therefore,theGPGignoressomekeypublicationsinthisareasuchas:Table1:ContentsoftheGAMPGPGonvalidationoflaboratorysystems.2Furmanetal.onthedebateofholistic(orsystem)versusmodularvalidationorqualificationofcomputerizedequipment.4ThispaperwaswrittenbythreeFDApersonnelaboutthevalidationofcomputerizedchromatographicequipment;ignoringitisnotanoptionasitprovidesascientificrationaleforthistwo-levelapproach.PDATechnicalReport18onvalidationofcomputer-relatedsystemsthatcontainsamorespecificcomputervalidationdefinitionthantheFDAprocessvalidationdefinitionquotedinSection3.1oftheGPG.5,6AAPSAnalyticalInstrumentQualificationwhitepaperpublishedin2004,whichwastheoutcomeofajointFDA-AAPSconferencefrom2003.2Ignoringthesepapersbiasestheapproachthatthisguidehastakenandisafatalflawasweshalldiscusslaterinthisarticle.Overall,theproblemwiththisGPGisthatyouhavetocherrypickthegoodbitsfromthebad.Aswithanyperformanceappraisalsystem,let'sstartwiththegoodnewsfirstandworkourwaydownhillafterwards.TheGoodNewsThebestpartsoftheGAMPlaboratorysystemGPGarethelifecyclemodelsforbothdevelopmentandimplementationofcomputerizedlaboratorysystems.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.Figure1:Systemdevelopmentandsystemimplementa