CAPA预防纠偏措施(cGMP培训系列)-课件

CorrectiveActionandPreventiveAction(CAPA)预防纠偏措施

GMPTrainingModule4WhatissaidincGMPbook?Sec.211.192Productionrecordreview.Alldrugproductproductionandcontrolrecords,includingthoseforpackagingandlabeling,shallbereviewedandapprovedbythequalitycontrolunittodeterminecompliancewithallestablished,approvedwrittenproceduresbeforeabatchisreleasedordistributed.Anyunexplaineddiscrepancy(includingapercentageoftheoreticalyieldexceedingthemaximumorminimumpercentagesestablishedinmasterproductionandcontrolrecords)orthefailureofabatchoranyofitscomponentstomeetanyofitsspecificationsshallbethoroughlyinvestigated,whetherornotthebatchhasalreadybeendistributed.Theinvestigationshallextendtootherbatchesofthesamedrugproductandotherdrugproductsthatmayhavebeenassociatedwiththespecificfailureordiscrepancy.Awrittenrecordoftheinvestigationshallbemadeandshallincludetheconclusionsandfollowup.产品记录复查所有药品生产和控制记录，包括包装和标签记录，须按全部已制订通过的程序复查和认可。此复查和认可应在该批药品发放或销售前完成。一些不可解释性差异（包括超过在主要生产和控制记录中制订的最大或最小百分数的理论产量的百分数）或一批或任何一个成份不符合其规格中任一项，则应作彻底调查，不管这批药品是否已销售。这种调查应提高扩展到该同一药品的其他批号和与此具体的不合格或差异相联系的其它药品。调查应写成文字记录，包括结论和继续跟踪。4WhatarethesymptomsofaneffectiveCAPAsystem?

好的预防纠偏系统有那些特征？

AreductioninqualityissuesAreductionintheseverityofissuesMorepreventiveactionsovertimeMoreconsistentproducts/processesImprovedcustomersatisfactionBetterbusinessresults5WhatarethesymptomsofalessthaneffectiveCAPAsystem?

不好的预防纠偏系统有那些特征？

RecurringissuesInabilityto“manage”themanysourcesofqualitydatatounderstandearlytrendsandissuesMorereactionthanpreventionResources($$$)arespenton“handling”failureratherthanlearningfromitandpreventing“moreofthesame”FieldissuesWhatareFDAenforcementsonCAPA?

FDA对不称职的CAPA有何措施

IneffectiveCAPAsystemisoneofthemostcommonlyfoundproblemsinFDAinspectionreportandwarningletters.Nonconformitiesarecitedduringinspection,andcorrectiveactionplanrequired.WarningLetter–moreserious,availabletothepublicFines,stopproductshipmentIsyourCAPAsystemeffective?

你们的CAPA系统如何？

Writtenprocedures?ExampleCAPAteam/Investigationcommittee?有无文件？预防纠偏团队/调查委员会Results?DoyouhavealogofCAPA?ExampleDoyouhaveaclosedCAPAcase?ExampleDoyouhaveanactiveCAPAcase?Example8ElementsofanEffectiveCAPAProcess

有效CAPA流程的组分

Documentedprocedure(s)DefinedCAPAinputsRiskassessmentandprioritizationInvestigationdisciplinesVerification/validationWelldefinedactionplanDisseminateinformationDocumentationrulesEffectivenesschecks

Complete?Effective?TimelyDefinedcriteriaforManagementReviewManagementescalationMetrics-abilitytomonitorprogress9CAPASimplified简单流程

DefinetheProblemInitiateCAPAInvestigateCauseSolution(ActionPlan)Verify/ValidateConductEffectivenessCheckImplementCloseCAPA12WherecanCAPAcomefrom?

CAPA可以从哪里产生？

DiscrepanciesUnexplainabledeviationsAuditResultsRecurringauditobservations,internalauditsandexternalauditsQualityRecordsPeriodicreviewProcesscontrolTestingresults,trends,etcPostMarketdataFrequencyandoccurrenceasexpected?ServiceRecordsComplaintsReturnedProducts13ProblemDefinition

描述问题

Statetheprobleminmeasurabletermshowoften,howmuch,when,andwhereEmphasizetheeffects(risk)safety,death,injury,rework,cost,etc.Theproblemstatementisthedifferencebetweenwhatisandwhatshouldbe

Focusonfacts–notemotionswhatiswrong,notwhyit’swrongAvoidnegativedescriptors,inflammatorystatementswordsthatarebroadanddonotdescribetheconditionsorbehaviorsuchascareless,complacency,neglect,oversightIs/IsNotDiagram

是非表

WHAT

WHENWHEREEXTENTIS

ISNOT16InvestigationMethods方法DefinemethodofinvestigationIncludequalitytoolsusedCauseandEffect,6M’s5Why’s,etc.Document

DatesofinvestigationDatareviewed(datasources,records,dates)CorrectionsorContainmentmeasuresResults:StatementofCause17DifferentCauses不同原因

PresumptiveCause可能原因apparentduringearlyinvestigation,hypothesesthatmayexplaintheeffectbutneedsvalidationContributingCause侧面原因secondaryandpossiblecausesRootCause根本原因primaryreasonfortheproblemwhichifcorrectedwillpreventrecurrenceMethod1--FiveWhys五个为什么？Aquestions-askingmethodusedtoexplorerootcauseofaproblem.Example:Mycarwillnotstart.(theproblem)Why?-Thebatteryisdead.(firstwhy)Why?-Thealternatorisnotfunctioning.(secondwhy)Why?-Thealternatorbelthasbroken.(thirdwhy)Why?-Thealternatorbeltwaswellbeyonditsusefulservicelifeandhasneverbeenreplaced.(fourthwhy)Why?-Ihavenotbeenmaintainingmycaraccordingtotherecommendedserviceschedule.(fifthwhy,arootcause)Method2–6M’s六个MMethod3:ParetoCharts图表Method4-FishboneCharts鱼骨图寻找/执行方案集思广益挑战方案短期和长期解决方案28Execution/ImplementationImplementation/Executionisthekey!Doyouhavesufficientresourcesandmanagementsupport?Doyouhavetherightpeopletoexecutetheplan?DoyouhaveatimeframefortheCAPAactionplan?Doyouhaveregularmeetingsonp