Pharmaceutical Quality System

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  • LearningFromOtherIndustries

    G.K.Raju,PhD

    LightPharmaInc.

    October2011

    1

  • OUTLINE

    Background ICHQ10 LookingatOtherIndustries

    General Specific

    Summary2

  • THEECONOMIST:August31st2002 Pharmaceuticals:Troubleinthemaking

    Foralltheglamourofinvention,thelatest blockbustermedicine,likethehottestnew fashion,canunravelifmanufacturingfalters.

    Witnesstheslewofdrugmakersthathave fallenfouloftheFDA,theirregulatorin

    America..

    3

  • TheWallStreetJournal:September3rd

    2003 NewPrescriptionForDrugMakers:UpdatethePlants

    ThePharmaceuticalIndustryHasALittle Secret:Evenasitinventsfuturisticnew drugs,itsmanufacturingtechniqueslagfar

    behindthoseofpotatochipandlaundry soapmakers.

    Youneedtoimprove

    Dr.McClellanlectured theindustry..

    4

  • TheWallStreetJournal:September3rd

    2003 NewPrescriptionForDrugMakers:UpdatethePlants

    JanetWoodcockwasamongthearchitectsofanFDA Crackdownunderwhichtheagencyfineddrug

    makersasmuchas$500millionformanufacturing failuresinrecentyears.Yetwestillwerentseeing acceptablelevelsofquality, shesaysbecause

    manufacturingtechniqueswereoutmoded.Just refiningproceduresanddocumentationwasnt

    goingtochangethat.

    5

  • OUTLINE

    Background ICHQ10 LookingatOtherIndustries

    General Specific

    Summary6

  • 7

    ICHQ10describesonecomprehensivemodelforan effectivepharmaceuticalqualitysystemthatisbased

    onInternationalOrganizationforStandardization (ISO)qualityconcepts,includesapplicablegood

    manufacturingpractice(GMP)regulations,and complementsICHQ8PharmaceuticalDevelopment

    andICHQ9QualityRiskManagement.3

    ICHQ10

  • 8

    ImplementationofICHQ10throughouttheproduct lifecycleshouldfacilitateinnovationandcontinual improvementandstrengthenthelinkbetween

    pharmaceuticaldevelopmentandmanufacturing activities.

    ICHQ10

  • OUTLINE

    Background ICHQ10 LookingatOtherIndustries

    General Specific

    Summary9

  • 10

    QUALITY

    ClinicalPerformance

    Critical Quality Attributes Process Materials Controls

    API Attributes Impurities

    1.

    Cmax AUC

    Description Identity Assay CU Impurity Dissolution

    1.

    3b.

    Quality System

    2.

    3a.

    3c.

  • 11

    Quality FitnessForUse[J.M.Juran] ConformancetoRequirements[Crosby] PlanDoCheckAct(PDCA/PDSA)[Deming/Shewhart]

    Quality QualityofProduct QualityofProcess QualitySystem

    QUALITY

  • Learningfromotherindustries: QualityPhilosophies

    W.EdwardsDeming SystemofProfoundKnowledge

    System,Variation,Knowledge,Psychology 14Principles

    PhilipCrosby QualityisFree

    (1979)

    QualityManagementMaturity

    12

  • Learningfromotherindustries: W.EdwardsDeming

    Abadsystemwillbeatagoodpersoneverytime Lackofknowledge...thatistheproblem. Learningisnotcompulsory...neitherissurvival. Qualityiseveryone'sresponsibility. Weareheretomakeanotherworld.

    13

  • Learningfromotherindustries: FocusandCostofQuality

    14

    CostOfQuality

    Where Right is Measured

    DEVELOPMENT

    WARNING LETTER

    FDA 483RECALLS

    COMPLAINTS

    FINAL QC TESTINGQA APPROVAL

    IN-PROCESS TESTING

    REJECTS

    CONSENT DECREE

    Prevention

    Appraisal

    Internal Failure

    External FailureCommon Focus

  • Learningfromotherindustries: ProcessMaturity

    15WEIGHING

    GRANULATION

    FB DRY

    MILLING

    BLEND

    FILMCOATINGCOMPRESS

    BOTTLEPACKAGINGSYSTEM A:

    WEIGHING

    GRANULATION

    FB DRY

    MILLING

    BLEND

    FILMCOATINGCOMPRESS

    BOTTLEPACKAGING

    SYSTEM B:

    WEIGHING

    GRANULATION

    FB DRY

    MILLING

    BLEND

    FILMCOATINGCOMPRESS

    BOTTLEPACKAGING

    SYSTEM D:

    SYSTEM E:

    WEIGHINGBLEND

    FILMCOATINGCOMPRESS

    BOTTLEPACKAGING

    WEIGHING

    GRANULATION

    FB DRY

    MILLING

    BLEND

    FILMCOATINGCOMPRESS

    BOTTLEPACKAGING

    SYSTEM C:

    There(e.g. direct compression,Continuous processing)

    Heree.g. Wet Granulation

  • Learningfromotherindustries: Change

    16

  • Learningfromotherindustries: QualityandBusinessBenefit

    FINANCIAL INVESTMENT ($)- Industry- Society

    Knowledge

    Capability(Robustness)

    PERFORMANCE-Cost, Quality, Time

    FINANCIAL RETURNS ($)- Industry- Society

    GRANULATIONMILLING

    GRANULATIONMILLING

    GRANULATIONMILLING

    System

    LEVERAGES- New Products (Strategic)- Existing Products (Tactical)

    Knowledge

  • OUTLINE

    Background ICHQ10 LookingatOtherIndustries

    General Specific

    Summary18

  • Learningfromotherindustries: MaturityModels

    General QualityManagementMaturity(Crosby) PeopleMaturityModel BusinessProcessMaturityModel ISO9004

    Specific CapabilityMaturityModel

    19

  • Learningfromotherindustries: SigmaLevel&CostofQuality

    20

    Pharma/Biotech

    Semicon

    Red Zone Products Have 25% COQ% Improvement Opportunity Yellow Zone Products Have 10% COQ% Improvement Opportunity Green Zone Can Capture Opportunity Now

  • Learningfromotherindustries: IndustrySpecificModel

    General ISO9001:2008

    IndustrySpecific TickIT TickITPlus CMMi

    21

  • Learningfromotherindustries: ProcessMaturityandProductQuality:

    SOFTWARE

    22

    DefectDensity

    Process MaturityReference:CaperJones,SoftwareAssessment,Benchmarks&BestPractices

    DefectDensitymeasuredintermsof#defects/functionpoint

  • Learningfromotherindustries: ProcessMaturityandCostofQuality:

    SOFTWARE:Knox(1993)

    230

    10

    20

    30

    40

    50

    60

    Cos

    t as

    a P

    erce

    nt o

    f Dev

    elop

    men

    t

    1 2 3 4 5 SEI CMM Level

    Prevention Appraisal Int Failure Ext Failure TCoSQ

  • Learningfromotherindustries: QualityandOtherMeasuresof Performance

    SOFTWARE:SoftwareEnterpriseInstitute(2006)

    24

  • OUTLINE

    Background ICHQ10 LookingatOtherIndustries

    General Specific

    Summary25

  • SUMMARY

    OurQualitySystemsmustenablemoreofthekindand extentoflifecycleimprovementandinnovationwe

    needandseek Q10isasignificantstepinthatdirection Additionallevelofgranularitycanhelptobuildonit Learningfromotherindustriescanhelpusdothat

    26

    Learning From Other IndustriesOUTLINETHE ECONOMIST: August 31st 2002Pharmaceuticals: Trouble in the makingThe Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants The Wall Street Journal: September 3rd 2003New Prescription For Drug Makers: Update the Plants OUTLINEICH Q10ICH Q10OUTLINEQUALITYQUALITYLearning from other industries:Quality PhilosophiesLearning from other industries:W. Edwards DemingLearning from other industries:Focus and Cost of QualityLearning from other industries:Process MaturityLearning from other industries:ChangeLearning from other industries:Quality and Business BenefitOUTLINELearning from other industries:Maturity ModelsLearning from other industries:Sigma Level & Cost of QualityLearning from other industries:Industry Specific ModelLearning from other industries:Process Maturity and Product Quality:SOFTWARELearning from other industries:Process Maturity and Cost of Quality:SOFTWARE: Knox (1993)Learning from other industries:Quality and Other Measures of PerformanceSOFTWARE: Software Enterprise Institute (2006)OUTLINESUMMARY