QRM Principles & Process课件

QRMTrainingMaterial-Principles&Process
Objectives
EstablishaconsistentfoundationofQRMprocessknowledge.
Increaefficiencyacrossallsites–applicationofefforts.
Encouragescienceanddata–cure“blind”compliance.
Reinforcegooddocumentationofriskasssment.
BetheSMEforQRMprocessandfacilitatingriskasssmentsandrisk-badinitiatives.
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CourAgenda
IntroductiontoQRMprocessandguidingprinciples(ICHQ9)
InitiateQRMprocess
Riskasssment
Riskcontrol
Riskcommunication
RiskReview
ApplicationofQRM
IntroductionofRiskManagementTools
Riskdefinitionandscores(exercission)
In-depthstudyofriskanalysistable(exercission)
In-depthstudyofFMEAandPHA(exercission)
Properdocumentationofriskasssment(exercission)
Practicalmodule(posttraining)
Thiscourdoesnotfocusonprojectmanagement
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CourRequirements&Expectation
2dayscour
Classsize:notmorethan15person
Lesstheoryandmoreexercissions
Attheendofthecour,theparticipantshouldknowhowto
definerisklevelandtscores.
applyRiskAnalysisTable,FMEAandPHA.
Practicalmodule
Afterthecour,allparticipantsshallcompleteaQRMproject(usinganytools)withproperdocumentation.Assistancewillbeprovided.
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MotivationFactors
Weareallequalandrespecteachother.
Weareheretoshareourexperiences,knowledgeandideas.
Wecanlearntogetherbecauwearesubjectmatterexpertofdifferentareas.
Wewillparticipantactivelyinthiscour.
Andcontinuetobelf-motivatedafterthiscourbyimprovingtheprocessusingriskbad.
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Introduction
PQSQ1236–QualityRiskManagement
GPB-QS1045–SupplierQualityRiskAsssmentProcess
GPB-QS1004–ApplicationofQRMtoPeriodicReviewofSOPs
GPB-QS1003–QRMApplication:CriticalInstrumentCalibrationIntervalChangeviaRiskAnalysis
GPB-QS1027–QRMApplicationtoIdentifyDeviationsVersusEvents
GPB-QS1052–MelamineQRMProcessandTools
GPB-QS1055–QualityRiskAsssmentforContractors
ICHGuideline–QualityRiskManagementQ9
Aguidancedocumentonprinciplesandtoolsfortheasssment
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ScopeofICHQ9
Providesprinciples
Providexamplesoftoolsfortheasssment
QRMcanbeappliedindifferentaspectofpharmaceuticalqualitywhichincludedevelopment,manufacturing,distribution,inspection,andsubmission/reviewprocessthroughoutthelifecycleofdrugsubstances,drugproducts,biologicalproducts(includingtheuofrawmaterials,solvents,excipients,packagingandlabeling).
Isthescopeapplicabletonutrition?
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RiskManagementMethodology
Ascientificandpracticalapproachtodecision-making.
Itprovidesdocumented,transparentandreproduciblemethodstoaccomplishstepsofthequalityriskmanagementprocessbadoncurrentknowledgeaboutasssmenttheprobability,verityandsometimesdetectabilityoftherisk.
UofQRMtoolsand/orstatisticaltools.
Thedegreeofrigorandformalityofqualityriskmanagementshouldreflectavailableknowledgeandbecommensuratewiththecomplexityand/orcriticalityoftheissuestobeaddresd.
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WhatisQRM?
QRMis:
Reduceoreliminaterisk
Science-bad
Dataorinformationdriven
Practicalapproach
Systematicprocess
Multidisciplinary
Focudonpatientsafetyandproductquality
Applicablethroughoutprojectlifecycles
Itshouldonlybeascomplicatedasitneedstobe.
QRMisnot:
Hidingrisk
Abox-checkingexerci,doingforthesakeofdoing
AwaytogetoutofrequiredGMPactivities
Ameanstodolesswork
JusttoimpressBoH
Toeradicaterisktotally
Personalobjectiveormotive
Alwayscomplex
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WhatisRisk?
WhatisRisk?
Risk=ProbabilityxSeverity
WhatisProbability?
Probability=Occurrenceofharm
WhatisSeverity?
Severity=Extentofharm
Risk=No.oftimesithasoccurredxDegreeofharm
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