LearningFromOtherIndustries

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

Critical Quality Attributes

Process
Materials
Controls
API Attributes
Impurities

2.

Description
Identity
Assay
CU
Impurity
Dissolution

1.

10

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.
13

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

Where Right is Measured

14

Learningfromotherindustries:
ProcessMaturity
SYSTEM E:

COMPRESS

FILM
COATING

There

BOTTLE
PACKAGING

(e.g. direct compression,

Continuous processing)

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

e.g. Wet Granulation

BLEND
MILLING

COMPRESS

Here

FILM
COATING

BOTTLE
PACKAGING

15
WEIGHING

FB DRY

BLEND

Learningfromotherindustries:
Change

16

Learningfromotherindustries:
QualityandBusinessBenefit
FINANCIAL INVESTMENT ($)

FINANCIAL RETURNS ($)

- Industry
- Society

- Industry
- Society

LEVERAGES

PERFORMANCE

- New Products (Strategic)

- Existing Products (Tactical)

Knowledge

-Cost, Quality, Time

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

Red Zone Products Have 25% COQ% Improvement Opportunity

Yellow Zone Products Have 10% COQ% Improvement Opportunity
Green Zone Can Capture Opportunity Now
20

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

Cost as a Percent of Development

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

26