quality management课件

QualityRiskManagement
AdvisoryCommitteeoftheOfficeofPharmaceuticalScienceManufacturingSubcommittee
July20,2004
FrederickRazzaghi
ICHQ9EWG/WSMI/CHPA
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Agenda
WhatisQualityRiskManagement
Background
Initialstepsinguidelinedevelopment
Theguideline
Scope
Process
Tools
IntegrationofQualityRiskmanagement
Nextstep
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QualityRiskManagement(Q9)
Processconsistingofwell-definedstepswhich,whentakeninquence,supportbetterDecisionMakingbycontributingtoagreaterinsightintorisksandtheirimpacts.
Itincludelementssuchasriskidentification,asssment,mitigation,eliminationandcommunication.
Risk=probabilityandverity
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Background
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Priordialogue
UofRiskManagementinPharmaceuticalManufacturing
AProcessRiskAsssmentModel
Therelationshipbetweenriskandknowledgeandhowtoapplythempreandpostapproval(e.g.Regulatoryscrutiny,postapprovalchangesandGMP’s,etc).
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BackgroundoftheQ9workinggroup
July2003,Brusls:initialmeetingtodiscusstopicandmeritsofmovingahead
November2003,Osaka:Developedconceptpaperandreceivedapproval
March2004,London:Draftedoutlineandagreedongeneralapproach
June2004,Washington:Developedthefirstdraftoftheguideline
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Approach
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Whatistheproblembeingsolved
Productmaynotbeavailabletopatients,whenneeded
Mayincreathepotentialforthereleaofunacceptableproducttothemarket
Newproductintroductionstothemarketplacemaybedelayed
Delaysmayoccurduringimplementationofchangesandimprovementstoprocess
Safeandeffectivedrugsmaybediscardedorrecalledfromthemarket
Manufacturersmaybereluctanttoimplementnewtechnologiesorcontinuousimprovementstotheproductsorprocess
Scarceresourcesmaynotbeoptimallyallocated
Lackofappropriatedatatoevaluateriskmosteffectively
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Benefits
Enhancedpatientconfidenceindecisionmakingonpharmaceuticalquality
Promotesmoreeffectiveuofregulatoryagencyandindustryresources
Establishesasystematic,well-informedandthoroughmethodofdecisionmakingwhichleadstogreatertransparencyandpredictability
Increadknowledgeofexposuretorisk
Fostersqualitybydesign,continuousimprovementandnewtechnologyintroduction,whichgenerallyleadstoenhancedproductquality
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Scope
ThisguidelineprovidesaframeworkthatmaybeappliedtoallaspectsofpharmaceuticalqualityincludingGMPandsubmission/reviewprocessthroughoutthelifecycleofdrugsubstances(API)anddrug(medicinal)products,biologicalandvaccineproducts,andtheuofexcipientsandpackagingmaterials.
Thisguidelineisnotintendedtoapplytoriskmanagementudinapharmacovigilancettinginvolvingsafetyandefficacy.
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