WHO数据与记录管理规范指南征求意见稿

GUIDANCEONGOODDATAANDRECORDMANAGEMENTPRACTICESDRAFTFORCOMMENT\o"WHOGuidanceonGoodDataandRecordManagementPracticescn"CNEN

2015/09

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WorkingdocumentQAS/15.624Shouldyouhaveanycommentsontheattachedtext,pleasesendthesetoDrS.Kopp,GroupLead,MedicinesQualityAssurance,Technologies,StandardsandNorms(kopps@)withacopytoMsMarieGaspard(gaspardm@)by30November2015.MedicinesQualityAssuranceworkingdocumentswillbesentoutelectronicallyonlyandwillalsobeplacedontheMedicineswebsiteforcommentunder“Currentprojects”.Ifyoudonotalreadyreceiveourdraftworkingdocumentspleaseletushaveyouremailaddress(tobonnyw@)andwewilladdittoourelectronicmailinglist.SCHEDULEFORTHEPROPOSEDADOPTIONPROCESSOFDOCUMENTQAS/15.624:GUIDANCEONGOODDATAANDRECORDMANAGEMENTPRACTICESProposalandneedfornewguidancedocumentdiscussedattheinformalconsultationoninspection,goodmanufacturingpracticesandriskmanagementguidanceinmedicines'manufacturing28–30April2014ConceptpaperdraftedandproposalpresentedbyMrI.Thrussell,ExpertInspector,PrequalificationTeam(PQT)-Inspectiontotheforty-ninthmeetingoftheWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations13–17October2014PreparationofdraftdocumentbyMrI.ThrussellinclosecooperationwithcolleaguesfromPQT-Inspectionandadraftinggroup,includingMsM.CahillyandnationalinspectorsOctober2014–June2015Draftdiscussedatconsultationondatamanagement,bioequivalence,goodmanufacturingpracticesandmedicines'inspection29June–1July2015Reviseddraftdocumentpreparedbytheauthors,thedraftinggroup,basedonthefeedbackreceivedduringtheconsultationandthesubsequentWHOworkshopondatamanagementJuly–August2015DocumentsentoutforcommentsSeptember2015CompilationofcommentsreceivedNovember2015SubmissiontofiftiethmeetingoftheWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations12–16October2015Anyfurtheraction,asneededandrecommendedbytheWHOExpertCommitteeonSpecificationsforPharmaceuticalPreparations目录

[隐藏]BACKGROUND1.INTRODUCTIONANDBACKGROUND2.AIMSANDOBJECTIVESOFTHISGUIDANCE3.GLOSSARY4.PRINCIPLES5.QUALITYRISKMANAGEMENTTOENSUREGOODDATAMANAGEMENT6.MANAGEMENTGOVERNANCEANDQUALITYAUDITS7.CONTRACTEDORGANIZATIONS,SUPPLIERS,ANDSERVICEPROVIDERS8.TRAININGINGOODDATAANDRECORDMANAGEMENT9.GOODDOCUMENTATIONPRACTICESAttributable.Legible,traceableandpermanentContemporaneousOriginalAccurate10.DESIGNINGSYSTEMSTOASSUREDATAQUALITYANDRELIABILITY11.MANAGINGDATAANDRECORDSACROSSTHEDATALIFECYCLE12.ADDRESSINGDATARELIABILITYISSUES13.REFERENCESANDFURTHERREADINGBACKGROUNDDuringaninformalconsultationoninspection,goodmanufacturingpracticesandriskmanagementguidanceinmedicines’manufacturingheldbytheWorldHealthOrganization(WHO)inGenevainApril2014aproposalfornewguidanceongooddatamanagementwasdiscussedandrecommendedtobedeveloped.Theparticipantsincludednationalinspectorsandspecialistsinthevariousagendatopics,aswellasstaffofthePrequalificationTeam(PQT)–Inspections.TheWHOExpertCommitteeonSpecificationsforPharmaceuticalsPreparationsreceivedfeedbackfromthisinformalconsultationduringits49thmeetingheldinOctober2014.AconceptpaperwasreceivedfromPQT–Inspectionsforaproposedstructureofanewguidancedocumentwhichwasdiscussedindetail.Theconceptpaperconsolidatedexistingnormativeprinciplesandgavesomeillustrativeexamplesontheirimplementation.IntheAppendixtotheconceptpaperextractsfromexistinggoodpracticesandguidancedocumentswerecombinedtoillustratethecurrentrelevantguidanceonassuringthereliabilityofdataandrelatedGxPmatters.InviewoftheincreasingnumberofobservationsmadeduringinspectionsregardingdatamanagementpracticestheCommitteeendorsedtheproposal.Followingthisendorsement,adraftdocumentwaspreparedbythecolleaguesfromPQT-Inspectionandadraftinggroup,includingnationalinspectors.Thisdraftwasdiscussedataconsultationondatamanagement,bioequivalence,goodmanufacturingpracticesandmedicines'inspectionheld29June–1July2015.Areviseddraftdocumentwassubsequentlypreparedbytheauthors,thedraftinggroup,basedonthefeedbackreceivedduringthisconsultationandthesubsequentWHOworkshopondatamanagement.Collaborationisbeingsortwithotherorganizationstowardsfutureconvergenceinthisarea.Thisfirstdraftispresentedherewithforcomments.1.INTRODUCTIONANDBACKGROUNDMedicinesregulatorysystemsworldwidehavealwaysdependedupontheknowledgeoforganizationsthatdevelop,manufactureandpackage,test,distributeandmonitorpharmaceuticalproducts.Implicitintheassessmentandreviewprocessisatrustbetweentheregulatorandtheregulatedthattheinformationsubmittedindossiersandusedinday-to-daydecision-makingiscomprehensive,completeandreliable.Dataonwhichthesedecisionsarebasedshouldthereforebecompleteaswellasbeingaccurate,legible,contemporaneous,originalandattributable

;commonlyreferredtoas“ALCOA”.ThesebasicALCOAprinciplesandtherelatedgoodpracticeexpectationsthatassuredatareliabilityarenotnew.Muchhigh-andmid-levelnormativeguidancealreadyexists

;however,inrecentyearsthenumberofobservationsmaderegardinggooddatamanagementpracticesduringgoodmanufacturingpractices(GMP),goodclinicalpractice(GCP)andgoodlaboratorypractices(GLP)inspectionshasbeenincreasing.Thereasonsforthisincreasedlevelofhealthauthorityconcernregarding

datareliability

areundoubtedlymultifactorialandincludeincreasedregulatoryawarenessandconcernregardinggapsbetweenindustrychoicesandappropriateandmodern

\o"分类:控制策略"controlstrategies.Contributingfactorsincludefailuresbyorganizationstoapplyrobustsystemsthatinhibitdatarisks,toimprovethedetectionofsituationswheredatareliabilitymaybecompromised,and/ortoinvestigateandaddressrootcauseswhenfailuresdoarise.Forexample,organizationssubjecttomedicalproductgoodpracticerequirementshavebeenusingcomputerizedsystemsformanydecadesbutmanyfailtoadequatelyreviewandmanageoriginalelectronicrecordsandinsteadoftenonlyreviewandmanageincompleteand/orinappropriateprintouts.Theseobservationshighlighttheneedforindustrytomodernizehistorical

\o"分类:控制策略"controlstrategies

andapplymodernquality

\o"分类:风险管理"riskmanagementandsoundscientificprinciplestocurrentbusinessmodels(suchasout-sourcingandglobalization)aswellascurrenttechnologiesinuse(suchas

\o"分类:计算机化系统"computerizedsystems).Examplesofcontrolsthatmayrequiredevelopmentandstrengtheningtoensuregooddatamanagementstrategiesinclude,butarenotlimitedto:aqualityriskmanagementapproachthateffectivelyassurespatientsafetyandproductqualityandvalidityofdatabyensuringthatmanagementalignsexpectationswithactualprocesscapabilities.Managementshouldgoverngooddatamanagementbyfirstsettingrealisticandachievableexpectationsforthetrueandcurrentcapabilitiesofaprocess,method,environment,personnel,technologies,etc.

;managementshouldcontinuouslymonitorprocesscapabilitiesandallocatethenecessaryresourcestoensureandenhanceinfrastructure,asrequired(forexample,tocontinuouslyimproveprocessesandmethods;toensureadequatedesignandmaintenanceofbuildings,facilities,equipmentandsystems;toensureadequatereliablepowerandwater

;toprovidenecessarytrainingforpersonnel;toallocatethenecessaryresourcestotheoversightofcontractsitesandsupplierstoensureadequatequalitystandardsaremet,etc.).Activeengagementbymanagementinthismannerremediatesandreducespressuresandpossiblesourcesoferrorthatmayincrease

\o"分类:数据完整性"dataintegrity

risks;adoptionofaqualityculturewithinthecompanythatencouragespersonneltobetransparentinfailuressothatmanagementhasanaccurateunderstandingofrisksandcanthenprovidethenecessaryresourcestoachieveexpectationsanddataqualitystandards

;mappingofdataprocessesandapplicationofmodernquality

\o"分类:风险管理"riskmanagement

andsoundscientificprinciplesacrossthedatalifecycle

;modernizationoftheunderstandingofallsitepersonnelintheapplicationofgooddocumentationpracticestoensurethattheGxPprinciplesofALCOAareunderstoodandappliedtoelectronicdatainthesamemannerthathashistoricallybeenappliedtopaperrecords;implementationandconfirmationduringvalidationofcomputerizedsystemsthatallnecessarycontrolsforgooddocumentationpracticesforelectronicdataareinplaceandthattheprobabilityoftheoccurrenceoferrorsinthedataisminimized

;trainingofpersonnelwhouse

\o"分类:计算机化系统"computerizedsystems

andreviewelectronicdatainbasicunderstandingofhowcomputerizedsystemsworkandhowtoefficientlyreviewtheelectronicdataandmetadata,suchasaudittrails;definitionandmanagementofappropriaterolesandresponsibilitiesforqualityagreementsandcontractsenteredintobycontractgiversandcontractacceptors,includingtheneedforrisk-basedmonitoringofdatageneratedandmanagedbythecontractacceptoronbehalfofthecontractgiver;modernizationofqualityassuranceinspectiontechniquesandgatheringof

\o"分类:质量量度"qualitymetrics

toefficientlyandeffectivelyidentifyrisksandopportunitiestoimprovedataprocesses.2.AIMSANDOBJECTIVESOFTHISGUIDANCEThisguidanceconsolidatesexistingnormativeprinciplesandgivesfurtherdetailedillustrativeimplementationguidancetobridgethegapsincurrentguidance.Additionally,itgivesguidanceastowhatthesehigh-levelrequirementsmeaninpracticeandwhatshouldbedemonstrablyimplementedtoachievecompliance.Theseguidelineshighlight,andinsomeinstancesclarify,theapplicationofdatamanagementprocedures.ThefocusisonthoseprinciplesthatareimplicitinexistingWHOguidelinesandthatifnotrobustlyimplementedcanimpactondatareliabilityandcompletenessandunderminetherobustnessofdecisionmakingbaseduponthatdata.Illustrativeexamplesareprovidedastohowtheseprinciplesmaybeappliedtocurrenttechnologiesandbusinessmodels.TheseguidelinesdonotdefineallexpectedcontrolsforassuredatareliabilityandthisguidanceshouldbeconsideredinconjunctionwithexistingWHOguidelinesandreferences.3.GLOSSARYALCOA.

Acommonlyusedacronymshortfor“accurate,legible,contemporaneous,originalandattributable.archival.

Archivingistheprocessofprotectingrecordsfromtheabilitytobefurtheralteredordeletedandstoringtheserecordsunderthecontrolofdedicateddatamanagementpersonnelthroughouttherequiredrecordsretentionperiod.audittrail.

Anaudittrailisaprocessthatcapturesdetailssuchasadditions,deletions,oralterationsofinformationinarecord,eitherpaperorelectronic,withoutobscuringorover-writingtheoriginalrecord.Anaudittrailfacilitatesthereconstructionofthehistoryofsucheventsrelatingtotherecordregardlessofitsmedia,includingthe“who,what,whenandwhy”oftheaction.Forexample,inapaperrecord,anaudittrailofachangewouldbedocumentedviaasingle-linecross-outthatallowstheoriginalentrytobelegibleanddocumentstheinitialsofthepersonmakingthechange,thedateofthechangeandthereasonforthechange,asrequiredtosubstantiateandjustifythechange.Whereas,inelectronicrecords,secure,computer-generated,time-stampedaudittrailsatboththesystemandrecordlevelshouldallowforreconstructionofthecourseofeventsrelatingtothecreation,modificationanddeletionofelectronicdata.Computer-generatedaudittrailsshallretaintheoriginalentryanddocumenttheuserID,time/datestampoftheaction,aswellasareasonfortheaction,asrequiredtosubstantiateandjustifytheaction.Computer-generatedaudittrailsmayincludediscreteeventlogs,historyfiles,databasequeriesorreportsorothermechanismsthatdisplayeventsrelatedtothecomputerizedsystem,specificelectronicrecordsorspecificdatacontainedwithintherecord.backup.

Abackupmeansacopyofoneormoreelectronicfilescreatedasanalternativeincasetheoriginaldataorsystemarelostorbecomeunusable(forexample,intheeventofasystemcrashorcorruptionofadisk).Itisimportanttonotethatbackupdiffersfromarchivalinthatback-upcopiesofelectronicrecordsaretypicallyonlytemporarilystoredforthepurposesofdisasterrecoveryandmaybeperiodicallyover-written.Back-upcopiesshouldnotberelieduponasanarchivalputerizedsystem.

A

\o"分类:计算机化系统"computerizedsystem

collectivelycontrolstheperformanceofoneormoreautomatedbusinessprocesses.Itincludescomputerhardware,software,peripheraldevices,networks,personnelanddocumentation,e.g.manualsandstandardoperatingprocedures.data.

Datameansalloriginalrecordsandcertifiedtruecopiesoforiginalrecords,includingsourcedataandmetadataandallsubsequenttransformationsandreportsofthisdata,whicharerecordedatthetimeoftheGxPactivityandallowfullandcompletereconstructionandevaluationoftheGxPactivity.Datashouldbeaccuratelyrecordedbypermanentmeansatthetimeoftheactivity.Datamaybecontainedinpaperrecords(suchasworksheetsandlogbooks),electronicrecordsandaudittrails,photographs,microfilmormicrofiche,audio-orvideo-filesoranyothermediawherebyinformationrelatedtoGxPactivitiesisrecorded.datagovernance.

Thesumtotalofarrangementstoensurethatdata,irrespectiveoftheformatinwhichitisgenerated,arerecorded,processed,retainedandusedtoensureacomplete,consistentandaccuraterecordthroughoutthedatalifecycle.dataintegrity.

\o"分类:数据完整性"Dataintegrity

isthedegreetowhichacollectionofdataiscomplete,consistentandaccuratethroughoutthedatalifecycle.Thecollecteddatashouldbeattributable,legible,contemporaneouslyrecorded,originaloratruecopy,andaccurate.Assuringdataintegrityrequiresappropriatequalityandriskmanagementsystems,includingadherencetosoundscientificprinciplesandgooddocumentationpractices.datalifecycle.

Aplannedapproachtoassessingandmanagingriskstodatainamannercommensuratewithpotentialimpactonpatientsafety,productqualityand/orthereliabilityofthedecisionsmadethroughoutallphasesoftheprocessbywhichdataiscreated,processed,reviewed,analyzedandreported,transferred,storedandretrieved,andcontinuouslymonitoreduntilretired.dynamicrecordformat.

Recordsindynamicformat,suchaselectronicrecords,thatallowsforaninteractiverelationshipbetweentheuserandtherecordcontent.Forexample,electronicrecordsindatabaseformatsallowtheabilitytotrack,trendandquerydata;chromatographyrecordsmaintainedaselectronicrecordsallowtheusertoreprocessthedata,viewhiddenfieldswithproperaccesspermissionsandexpandthebaselinetoviewtheintegrationmoreclearly.fully-electronicapproach.

Theterm“fully-electronicapproach”referstoacomputerizedsystemuseinwhichtheoriginalelectronicrecordsareelectronicallysigned.gooddocumentationpractices.

Inthecontextoftheseguidelines,gooddocumentationpracticesarethosemeasuresthatcollectivelyandindividuallyensuredocumentation,whetherpaperorelectronic,isattributable,legible,traceable,permanent,contemporaneouslyrecorded,originalandaccurate.GxP.

Acronymforthegroupofgoodpracticeguidesgoverningthepreclinical,clinical,manufacturingandpost-marketactivitiesforregulatedpharmaceuticals,biologics,medicaldevices,suchasgoodlaboratorypractices,goodclinicalpractices,goodmanufacturingpracticesandgooddistributionpractices.hybridapproach.

Theterm“hybridapproach”referstotheuseofacomputerizedsysteminwhichthereisacombinationoforiginalelectronicrecordsandpaperrecordsthatcomprisethetotalrecordsetthatshouldbereviewedandretained.Forexample,wherelaboratoryanalystsusecomputerizedinstrumentsystemsthatcreateoriginalelectronicrecordsandthenprintasummaryoftheresults.Personsexecuteahandwrittensignaturetoelectronicrecords,forexample,byhand-signingareviewchecklistthatisthensecurelylinkedtotheelectronicrecordsbeingsigned.Thehybridapproachrequiresasecurelinkbetweenallrecordtypesthroughouttherecordsretentionperiod.qualityriskmanagement.

Asystematicprocessfortheassessment,control,communicationandreviewofriskstothequalityofthedrug(medicinal)productacrosstheproductlifecycle(\o"ICHQ9QualityRiskManagement"ICHQ9).metadata.

Metadataaredataaboutdatathatprovidethecontextualinformationrequiredtounderstandthosedata.Typically,thesearedatathatdescribethestructure,dataelements,interrelationshipsandothercharacteristicsofdata.Theyalsopermitdatatobeattributabletoanindividual.Forexample,inweighingthenumber8ismeaninglesswithoutmetadata,i.e.theunit,mg.Otherexamplesofmetadatamayincludethetime/datestampoftheactivity,theoperatorIDofthepersonwhoperformedtheactivity,theinstrumentIDused,processingparameters,sequencefiles,audittrailsandotherdatarequiredtounderstanddataandreconstructactivities.staticrecordformat.

Astaticrecordformat,suchasapaperorpdfrecord,isonethatisfixedandallowsnoorverylimitedinteractionbetweentheuserandtherecordcontent.Forexample,onceprintedorconvertedtostaticpdfs,chromatographyrecordslosethecapabilitiesofbeingreprocessedorenablingmoredetailedviewingofbaselinesoranyhiddenfields.seniormanagement.

Person(s)whodirectandcontrolacompanyorsiteatthehighestlevelswiththeauthorityandresponsibilitytomobilizeresourceswithinthecompanyorsite(ICHQ10basedinpartonISO9000:2005).truecopy.

Atruecopyisacopyofanoriginalrecordingofdatathathasbeencertifiedtoconfirmitisanexactandcompletecopythatpreservestheentirecontentandmeaningoftheoriginalrecord,includinginthecaseofelectronicdata,allmetadataandtheoriginalrecordformatasappropriate.4.PRINCIPLESGooddataandrecordmanagementarecriticalelementsofthepharmaceuticalqualitysystemandasystematicapproachshouldbeimplementedtoprovideahighlevelofassurancethatacrosstheproductlifecycleallGxPrecordsanddataareaccurate,consistent,trustworthyandreliable.Thedatagovernanceprogrammeshouldincludepoliciesandgovernanceproceduresthataddressthegeneralprincipleslistedbelowforagooddatamanagementprogram.Theseprinciplesareclarifiedwithadditionaldetailinsectionsbelow.Applicabilitytobothpaperandelectronicdata.Therequirementsforgooddataandrecordmanagementthatassurerobustcontrolofdatavalidityapplyequallytopaperandelectronicdata.OrganizationssubjecttoGxPshouldbefullyawarethatrevertingfromautomated/computerizedtomanual/paper-basedsystemsdoesnotinitselfremovetheneedforrobustmanagementcontrols.Applicabilityto

\o"分类:委托方"contractgivers

and

\o"分类:受托方"contractacceptors.Theprinciplesoftheseguidelinesapplytocontractgiversandcontractacceptors.ContractgiversareultimatelyresponsiblefortherobustnessofalldecisionsmadeonthebasisofGxPdata,includingthosethataremadeonthebasisofdataprovidedtothembycontractacceptors.Contractgiversthereforeshouldperformduediligencetoassurethemselvesthatcontractacceptorshaveinplaceappropriateprogrammestoensuretheveracity,completenessandreliabilityofprovideddata.Gooddocumentationpractices

:Toachieverobustdecisionsanddatasetsbasedneedtobereliableandcomplete.Gooddocumentationpractices(GDP)shouldbefollowedinordertoensureallrecords,bothpaperandelectronic,allowthefullreconstructionoftherelatedactivities.Managementgovernance.Toestablisharobustandsustainablegooddatamanagementsystemitisimportantthatseniormanagementensurethatappropriatedatamanagementgovernanceprogrammesareinplace.Elementsofeffectivemanagementgovernanceshouldinclude:applicationofmodernqualityriskmanagementprinciplesandgooddatamanagementprinciplestothecurrentqualitymanagementsystemtointegratethoseelementsthatassurethevalidity,completenessandreliabilityofdata.Forexample,monitoringofrisksandapplicationofappropriatequalitymetricscanhelpmanagementgaintheawarenessnecessaryforgooddecision-makingtoreducedataintegrityrisks;managementshouldensurepersonnelarenotsubjecttocommercial,political,financialandotherorganizationalpressuresorincentivesthatmayadverselyaffectthequalityandintegrityoftheirwork;managementshouldallocateadequatehumanandtechnicalresourcessuchthattheworkload,workhoursandpressuresonthoseresponsiblefordatagenerationandrecordkeepingdonotincreaseerrors;managementshouldalsomakestaffawareoftheimportanceoftheirroleinensuringdataintegrityandtherelationshipoftheseactivitiestoassuringproductqualityandprotectingpatientsafety.Qualityculture.

Management,togetherwiththequalityunit,shouldestablishandmaintainaworkingenvironmentoftenreferredtoasaqualityculturethatminimizestheriskofnon-compliantrecordsanderroneousrecordsanddata.Anessentialelementisthetransparentandopenreportingofdeviations,errors,omissionsandaberrantresultsatalllevelsoftheorganization.Stepsshouldbetakentopreventanddetectandcorrectweaknessesinsystemsandproceduresthatmayleadtodataerrorssoastocontinuallytheimprovescientificrobustnessofdecisionmakingoftheorganization.Qualityriskmanagementandsoundscientificprinciples.

Assuringrobustdecisionmakingrequiresvalidandcompletedata,appropriatequalityand

\o"分类:风险管理"riskmanagement

systems,adherencetosoundscientificandstatisticalprinciples.Forexample,thescientificprincipleofbeinganobjective,unbiasedobserverregardingtheoutcomeofasampleanalysisrequiresthatsuspectresultsbeinvest