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G.K.Raju,PhD
LightPharmaInc.
October2011
OUTLINE
Background
ICHQ10
LookingatOtherIndustries
General
Specific
Summary
2
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
Summary
6
ICHQ10
ICHQ10describesonecomprehensivemodelforan
effectivepharmaceuticalqualitysystemthatisbased
onInternationalOrganizationforStandardization
(ISO)qualityconcepts,includesapplicablegood
manufacturingpractice(GMP)regulations,and
complementsICHQ8PharmaceuticalDevelopment
andICHQ9QualityRiskManagement.3
ICHQ10
ImplementationofICHQ10throughouttheproduct
lifecycleshouldfacilitateinnovationandcontinual
improvementandstrengthenthelinkbetween
pharmaceuticaldevelopmentandmanufacturing
activities.
OUTLINE
Background
ICHQ10
LookingatOtherIndustries
General
Specific
Summary
9
QUALITY
Cmax
AUC
Quality System
3c.
3b.
3a.
1.
Clinical
Performance
2.
Description
Identity
Assay
CU
Impurity
Dissolution
1.
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QUALITY
Quality
FitnessForUse[J.M.Juran]
ConformancetoRequirements[Crosby]
PlanDoCheckAct(PDCA/PDSA)[Deming/Shewhart]
Quality
QualityofProduct
QualityofProcess
QualitySystem
11
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
CONSENT DECREE
WARNING LETTER
External Failure
Common Focus
FDA 483
RECALLS
COMPLAINTS
Cost
Of
Quality
REJECTS
QA APPROVAL
FINAL QC TESTING
Internal Failure
Appraisal
IN-PROCESS TESTING
DEVELOPMENT
Prevention
Learningfromotherindustries:
ProcessMaturity
SYSTEM E:
COMPRESS
FILM
COATING
There
BOTTLE
PACKAGING
WEIGHINGBLEND
SYSTEM D:
GRANULATION
WEIGHING
SYSTEM C:
FB DRY
GRANULATION
WEIGHING
MILLING
COMPRESS
MILLING
COMPRESS
SYSTEM A:
MILLING
FB DRY
GRANULATION
FILM
COATING
BOTTLE
PACKAGING
FILM
COATING
BOTTLE
PACKAGING
BLEND
SYSTEM B:
WEIGHING
BOTTLE
PACKAGING
BLEND
FB DRY
GRANULATION
FILM
COATING
COMPRESS
BLEND
MILLING
COMPRESS
Here
FILM
COATING
BOTTLE
PACKAGING
15
WEIGHING
FB DRY
BLEND
Learningfromotherindustries:
Change
16
Learningfromotherindustries:
QualityandBusinessBenefit
FINANCIAL INVESTMENT ($)
- Industry
- Society
- Industry
- Society
LEVERAGES
PERFORMANCE
Knowledge
System
Capability
(Robustness)
Knowledge
GRANULATION
MILLING
GRANULATION
MILLING
GRANULATION
MILLING
OUTLINE
Background
ICHQ10
LookingatOtherIndustries
General
Specific
Summary
18
Learningfromotherindustries:
MaturityModels
General
QualityManagementMaturity(Crosby)
PeopleMaturityModel
BusinessProcessMaturityModel
ISO9004
Specific
CapabilityMaturityModel
19
Learningfromotherindustries:
SigmaLevel&CostofQuality
Semicon
Pharma/Biotech
Learningfromotherindustries:
IndustrySpecificModel
General
ISO9001:2008
IndustrySpecific
TickIT
TickITPlus
CMMi
21
Learningfromotherindustries:
ProcessMaturityandProductQuality:
SOFTWARE
Defect
Density
Process Maturity
Reference:CaperJones,SoftwareAssessment,Benchmarks&BestPractices
DefectDensitymeasuredintermsof#defects/functionpoint
22
Learningfromotherindustries:
ProcessMaturityandCostofQuality:
SOFTWARE:Knox(1993)
Prevention
Appraisal
Int Failure
Ext Failure
TCoSQ
60
50
40
30
20
10
0
1
3
SEI CMM Level
23
Learningfromotherindustries:
QualityandOtherMeasuresof
Performance
SOFTWARE:SoftwareEnterpriseInstitute(2006)
24
OUTLINE
Background
ICHQ10
LookingatOtherIndustries
General
Specific
Summary
25
SUMMARY
OurQualitySystemsmustenablemoreofthekindand
extentoflifecycleimprovementandinnovationwe
needandseek
Q10isasignificantstepinthatdirection
Additionallevelofgranularitycanhelptobuildonit
Learningfromotherindustriescanhelpusdothat
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