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MHRAGMP2022-08-05LucyWangGMPGMPSoltorisGMPGMPGMPSISQPGMPGoodManufacturingPracticeGMPdataintegrity:anewlookatanoldtopicpart1GMP1DavidChurchward25June2022CompliancemattersDataintegrityisfundamentalinapharmaceuticalqualitysystemwhichensuresthatmedicinesareoftherequiredquality.Arobustdatagovernanceapproachwillensurethatdataiscompleteconsistentandaccurateirrespectiveoftheformatinwhichdataisgeneratedusedorretained.Anincreasedfocusondataintegrityandgovernancesystemshasledtoseriousconsequencesforseveralcompanies.Thisisthefirstofaseriesof3blogswhichwillexploreelementsoforganisationalbehaviorandsystemdesignwhichcanmeanthedifferencebetweendataintegritysuccessandfailure.AnincreasedfocusondataintegrityandgovernancesystemshasledtoseriousconsequencesforseveralcompaniesOneofthetopglobalissuesreportedinthepharmaceuticalmediaoverthepast2yearshasbeendataintegrity.Regulatoryactionsresultingfromdataintegrityfailureshaveledtothewithdrawalofsupplyacrossmultiplemarketsproductrecallandseriousreputationaldamageforthosecompaniesconcerned.Howeverthishottopicisnotanewrequirementasbasicdataintegrityprinciplesarealreadydescribedininternationalgoodmanufacturingpracticeguidance.GMP.Thereisageneralmisconceptionthatdataintegrityfailuresonlyresultfromactsofdeliberatefraud.Yetinthecollectiveexperienceofmycolleaguesandmethemajorityofissuesrelatetobadpracticepoororganisationalbehaviourandweaksystemswhichcreateopportunitiesfordatatobemanipulated.Howeverthereisawayforcompaniestonavigatethetroubledwatersofdataintegritydeficienciesbytakingsomebasicbehaviouralproceduralandtechnicalstepstosignificantlyimprovetheirsystems.Impactoforganisationalculture:isyourcompanybehavingwellTheimpactoforganisationalcultureandseniormanagementbehaviourondatagovernancemustnotbeunderestimated.Indicatorswithrelevancetodatagovernanceprovideameasureoftheworkforcesunderstandingandreportingbehaviourcombinedwiththemanagementsreceptivenesstobadnews.Iserrororsystemfailurereportedasanopportunityforimprovementoristhereamind-setaroundnotwantingtocausetroubleToremovetheincentivetomanipulatere-createoramenddatathemanagerialresponsetobadnewsmustbefairandconsistentandnotbasedonafearofconsequences.Ledfromthetop;empoweredfrombelowOrganisationalcultureisnotjustaddressedbyseniormanagementputtingtherightwordsinamissionstatement.Ihaveseenthatcommunicatingexpectationsclearlytostaffatalllevelsinthecompanyandthenlivingbytheseprinciplesisthekeytosuccess.Leadershipengagementandempowermentofstaffatalllevelsintheorganisationcanthencombinetoidentifyanddeliversystematicdataintegrityimprovementswheregoodpracticebecomesautomatic.ThedatalifecycleWithsupportfromthecorrectorganisationalculturethenextimportantelementofsuccessfuldatagovernanceistounderstandthedatalifecycle.Thiswillenabletheimplementationofasystemwhichisdesignedtoassuretheintegrityofdatathroughoutitslifebeyondthelimitationsofdatareview.Thedatalifecycleconsidersallphasesinthelifeofthedatafrominitialgenerationandrecordingthroughprocessingusearchivingretrievalandwhereappropriatedestruction.Failuretoaddressjustoneelementofthedatalifecyclewillweakentheeffectivenessofthemeasuresimplementedelsewhereinthesystem.EstablishingdatacriticalityandinherentintegrityriskInadditiontostafftrainingandimplementationofdataintegritypoliciesconsiderationshouldbegiventotheorganisationalegproceduresandtechnicalegcomputersystemaccesscontrolsappliedtodifferentareasofthequalitysystem.Thedegreeofeffortandresourceshouldbecommensuratewithdatacriticalityhowitisusedandinherentriskhowitisgenerated.Datawhichrelatestocriticalprocesscontrolbatchreleasedecisionsorlongtermstabilitymayhavesignificantimpacttoproductquality.OtherdatawhileofrelevancetotheoperationofaGMPcompliantfacilitymaybeoflowercriticality.GMPThewayinwhichdataisgeneratedwillinfluencetheinherentdataintegrityrisk.Datamaybegeneratedbyapaper-basedrecordofamanualobservationorintermsofequipmentaspectrumofsimplemachinesegpHmetersandbalancesthroughtocomplexhighly-configurablecomputerisedsystemsegHPLCandERPsystems.Theinherentriskstodataintegritywilldifferdependinguponthedegreetowhichdatageneratedbythesesystemscanbeconfiguredandthereforepotentiallymanipulated.HPLCERPOurinspectoratefindsthatmanufacturerstypicallyfocusdataintegrityandvalidationresourcesonlargeandcomplexcomputerisedsystemswhilepayinglessattentiontoothersystemswithapparentlowercomplexity.WhereassimplemachinesmayonlyrequirecalibrationthedataintegrityriskassociatedwithsystemslinkedtouserconfigurablesoftwareegPLC-linkedproductionequipmentandinfra-red/UVspectrophotometerscanbesignificantespeciallywheretheoutputcanbeinfluencedmodifiedordiscardedbytheuser.Withoutwelldesignedcontrolsitmaybepossibletomanipulatedataorrepeattestingtoachieveadesiredoutcomewithlimitedopportunityofdetection./UVMoredetailedguidanceondataintegrityexpectationswhichbuildsonthebehaviouralissueshasbeenpublishedbyMHRA.Mynextbloginthisserieswilllookatwaysinwhichsystemscanbedesignedtoassuredataqualityandintegrity.MHRA。