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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.
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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.
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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