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Quality

RiskManagement

ICHQ9

Executivesummary

forcompetentauthoritiesandindustryDisclaimer: Thispresentationincludestheauthor’sviewsonqualityriskmanagementtheoryandpractice.

Thepresentationdoesnotrepresentofficialguidanceorpolicyofauthoritiesorindustry.ThesituationtodayThesituationtodayforbothregulatorsandindustryIncreasingexternalrequirementsIncreasingeffortsandcosts

GrowingcomplexityandscopeofrisksEmpowerment&FlexibilityisneededMastercomplexityandstreamlinedecisionmakingProactivedisclosurebuildtrustandunderstandingImprovecommunicationthroughsharing

bestpracticeandsciencebasedknowledgeConvertdataintoknowledgeNewRegulatoryParadigmICHRegulators:FDA:Newparadigmwiththe21stCenturyGMPinitiativeEMEA:RevisedEUdirectivesMHLW:RevisedJapaneselaw(rPAL)EU&JapanbecameinvolvedatICH

GMPWorkshopinJuly2003:5yearvisionagreed:

“Developaharmonisedpharmaceuticalqualitysystemapplicableacrossthelifecycleoftheproductemphasizinganintegratedapproachtoqualityriskmanagementandscience”ConsequentICHExpertWorkingGroups(EWG):ICHQ8,

onPharmaceuticalDevelopment,doc.approved2005ICHQ9,

onQualityRiskManagement,doc.approved2005ICHQ10,onQualitySystems,topicaccepted2005“risk-based”conceptsandprinciplesThenewparadigmQ8Q9Q10PharmaceuticalDevelopment(Q8)

Past: Datatransfer/VariableoutputPresent: Knowledgetransfer/Science based/ConsistentoutputPharmaceuticalQualitySystems(Q10)

Past: GMPchecklist

Future: QualitySystemsacrossproduct

lifecycleQualityRiskManagement(Q9)

Past: Used,howeverpoorlydefinedPresent: Opportunitytousestructured

processthinkingIncrementalstepsChanged

ParadigmQ8Q9Q10ContinuousImprovementProcessUnderstandingRiskCMCregulatoryoversightCompany’sQualitysystemcGMPregulatoryoversightContinuousImprovementProcessUnderstandingRiskCMCregulatoryoversightCompany’sQualitysystemcGMPregulatoryoversightQ8

&

Q9BasedonA.Hussain,FDA,September2004Q10

&

Q9ProcessUnderstandingRisk(P/R)CMCregulatoryoversightCompany’sQualitysystemcGMPregulatoryoversightPostapprovalchangeProcessUnderstandingRisk

(perceived&real)CMCregulatoryOversight(Submission)Company’sQualitysystemcGMPregulatoryoversight(Inspection)PostApprovalChange(PAC)PACtoContinuousImprovementProcessUnderstandingRiskCMCregulatoryoversightCompany’sQualitysystemcGMPregulatoryoversightPACto

ContinuousImprovementProcess

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