pharmaceutical quality system
DESCRIPTION
QSTRANSCRIPT
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LearningFromOtherIndustries
G.K.Raju,PhD
LightPharmaInc.
October2011
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OUTLINE
Background ICHQ10 LookingatOtherIndustries
General Specific
Summary2
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THEECONOMIST:August31st2002 Pharmaceuticals:Troubleinthemaking
Foralltheglamourofinvention,thelatest blockbustermedicine,likethehottestnew fashion,canunravelifmanufacturingfalters.
Witnesstheslewofdrugmakersthathave fallenfouloftheFDA,theirregulatorin
America..
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TheWallStreetJournal:September3rd
2003 NewPrescriptionForDrugMakers:UpdatethePlants
ThePharmaceuticalIndustryHasALittle Secret:Evenasitinventsfuturisticnew drugs,itsmanufacturingtechniqueslagfar
behindthoseofpotatochipandlaundry soapmakers.
Youneedtoimprove
Dr.McClellanlectured theindustry..
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TheWallStreetJournal:September3rd
2003 NewPrescriptionForDrugMakers:UpdatethePlants
JanetWoodcockwasamongthearchitectsofanFDA Crackdownunderwhichtheagencyfineddrug
makersasmuchas$500millionformanufacturing failuresinrecentyears.Yetwestillwerentseeing acceptablelevelsofquality, shesaysbecause
manufacturingtechniqueswereoutmoded.Just refiningproceduresanddocumentationwasnt
goingtochangethat.
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OUTLINE
Background ICHQ10 LookingatOtherIndustries
General Specific
Summary6
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ICHQ10describesonecomprehensivemodelforan effectivepharmaceuticalqualitysystemthatisbased
onInternationalOrganizationforStandardization (ISO)qualityconcepts,includesapplicablegood
manufacturingpractice(GMP)regulations,and complementsICHQ8PharmaceuticalDevelopment
andICHQ9QualityRiskManagement.3
ICHQ10
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ImplementationofICHQ10throughouttheproduct lifecycleshouldfacilitateinnovationandcontinual improvementandstrengthenthelinkbetween
pharmaceuticaldevelopmentandmanufacturing activities.
ICHQ10
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OUTLINE
Background ICHQ10 LookingatOtherIndustries
General Specific
Summary9
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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.
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Quality FitnessForUse[J.M.Juran] ConformancetoRequirements[Crosby] PlanDoCheckAct(PDCA/PDSA)[Deming/Shewhart]
Quality QualityofProduct QualityofProcess QualitySystem
QUALITY
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Learningfromotherindustries: QualityPhilosophies
W.EdwardsDeming SystemofProfoundKnowledge
System,Variation,Knowledge,Psychology 14Principles
PhilipCrosby QualityisFree
(1979)
QualityManagementMaturity
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Learningfromotherindustries: W.EdwardsDeming
Abadsystemwillbeatagoodpersoneverytime Lackofknowledge...thatistheproblem. Learningisnotcompulsory...neitherissurvival. Qualityiseveryone'sresponsibility. Weareheretomakeanotherworld.
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Learningfromotherindustries: FocusandCostofQuality
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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
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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
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Learningfromotherindustries: Change
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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
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OUTLINE
Background ICHQ10 LookingatOtherIndustries
General Specific
Summary18
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Learningfromotherindustries: MaturityModels
General QualityManagementMaturity(Crosby) PeopleMaturityModel BusinessProcessMaturityModel ISO9004
Specific CapabilityMaturityModel
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Learningfromotherindustries: SigmaLevel&CostofQuality
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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
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Learningfromotherindustries: IndustrySpecificModel
General ISO9001:2008
IndustrySpecific TickIT TickITPlus CMMi
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Learningfromotherindustries: ProcessMaturityandProductQuality:
SOFTWARE
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DefectDensity
Process MaturityReference:CaperJones,SoftwareAssessment,Benchmarks&BestPractices
DefectDensitymeasuredintermsof#defects/functionpoint
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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
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Learningfromotherindustries: QualityandOtherMeasuresof Performance
SOFTWARE:SoftwareEnterpriseInstitute(2006)
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OUTLINE
Background ICHQ10 LookingatOtherIndustries
General Specific
Summary25
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SUMMARY
OurQualitySystemsmustenablemoreofthekindand extentoflifecycleimprovementandinnovationwe
needandseek Q10isasignificantstepinthatdirection Additionallevelofgranularitycanhelptobuildonit Learningfromotherindustriescanhelpusdothat
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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