Quality by design, B.PHARMACY, 6TH SEM, PHARMACEUTICAL QUALITY ASSURANCE, UNIT-I

Quality by design, QBD

1. Quality Assurance and Quality Management concepts
BP606T
Unit-1
Part-IV
(QUALITY BY DESIGN (QBD): DEFINITION, OVERVIEW, ELEMENTS OF
QBD PROGRAM, TOOLS )
SnigdhaRaniBehera
Associate Professor
ARKA JAIN UNIVERSITY

2. QUALITY BY DESIGN (QBD)
Definition:
Qualitybydesign(QbD)isasystematicapproachtoproductdevelopmentthat
beginswithpredefinedobjectivesandemphasizesproductandprocess
understandingandcontrolsbasedonsoundscienceandqualityriskmanagement
(ICHQ8).
QbDisaconceptfirstdevelopedbythequalitypioneerDr.JosephM.Juran.He
belivedthatqualityshouldbedesignedintoaproduct,andthatmostqualitycrises
andproblemsrelatetothewayinwhichaproductwasdesignedinthefirstplace.
ARKA JAIN University, Jamshedpur, Jharkhand

3. ARKA JAIN University, Jamshedpur, Jharkhand
ObjectiveofQbD:
ThemainobjectiveofQbDistoachievethequalityproducts.
Toachievepositiveperformancetesting.
Ensurescombinationofproductandprocessknowledgegainedduring
development.
Fromknowledgeofdataprocessdesiredattributesmaybeconstructed.
BenefitsofQBD:
Betterunderstandingoftheprocess.
Eliminatebatchfailures.
Moreefficientandeffectivecontrolofchange.
Avoidregulatorycomplianceproblems.
Empowermentoftechnicalstaff.
Increasemanufacturingefficiency,reducecostsandProjectrejectionsandwaste.

4. ARKA JAIN University, Jamshedpur, Jharkhand
Cont…..
Ensurebetterdesignofproductwithlessproblem.
Buildscientificknowledgebaseforallproducts.
Betterinteractwithindustryonscienceissues.
Ensureconsistentinformation.
Incorporateriskmanagement.
Reduceend-producttesting.

5. Flow of QbD
ARKA JAIN University, Jamshedpur, Jharkhand
Define Target product profile (TPP) and Quality
Target Product profile (QTPP)
Identify critical quality attributes (CQA)
Carry out risk assessment, linking material
attributes and process parameters
Establish the design space
Describe control strategy
Life cycle management and continuous
improvement

6. ELEMENTS OF QBD PROGRAM
ARKA JAIN University, Jamshedpur, Jharkhand
Target
product
Profile(TPP)
Target product
Quality Profile
(TPQP)
Critical Quality
Attributes
(CQAs)
Critical
Material
attributes
(CMAs)
Process
Parameters
(PP)
Design Space
(DS)
Key Element
of QBD

7. 1.Target product Profile(TPP):
ItisatheorybasedonPatientandLabeling.(Becauseitidentifiesthedesired
performancecharacteristicsoftheproduct,relatedtothepatient’sneed&itis
organizedaccordingtothekeysectioninthedruglabeling)
Targetproductprofileshouldincludes-
Dosageform
Routeofadministration
Dosagestrength
Pharmacokinetics
Stability
TargetnumberofPatients
ARKA JAIN University, Jamshedpur, Jharkhand

8. 2.Target product Quality Profile(TPQP):
ItisaProspectiveanddynamicreviewofqualitycharacteristicsofadrugproduct.
Itcanbeachievedtoensurethatthedesiredquality,safety&efficacyofadrug
productareachieved.
ItincludeQuantitativeimpurityandstabilitytargets,Dissolutionreleaseprofile,
identity,assay,dosageformproductspecificperformance.
ARKA JAIN University, Jamshedpur, Jharkhand

9. 3.Critical Quality Attributes (CQAs):
Itisdefinedas“aphysical,chemical,biologicalormicrobiologicalpropertyor
characteristicsthatshouldbewithinanappropriatelimit,range,ordistributionto
ensurethedesiredproductquality.
CQAsaregenerallyassociatedwiththedrugsubstance,excipients,intermediates
anddrugproduct.
Thequalityattributesofadrugproductmayincludeidentity,assay,content
uniformity,degradationproducts,residualsolvents,drugrelease,moisture
content,microbiallimits.
Physicalattributessuchascolor,shape,size,odor,scoreconfiguration,and
friability.
Theseattributescanbecriticalornotcritical.
ARKA JAIN University, Jamshedpur, Jharkhand

10. 4.Critical Material Attributes (CMA):
CMAofadrugsubstance,excipient,andin-processmaterialsisaphysical,
chemical,biological,ormicrobiologicalcharacteristicofanrawmaterialthat
shouldbeconsistentlywithinanappropriatelimittoensurethedesiredqualityof
thatdrugsubstance,excipient,orin-processmaterial.
TheCMAislikelytohaveanimpactonCQAofthedrugproduct.
Amaterialattributescanbeanexcipientsrawmaterial,drugsubstances,reagents,
solvents,packaging&labelingmaterials.
ARKA JAIN University, Jamshedpur, Jharkhand

11. 5.Critical Process Parameters (CPP):
ACPPofmanufacturingprocessaretheparameterswhich,whenchanged,can
potentiallyimpactproductCQAandmayresultinfailuretomeetthelimitofthe
CQA.
Thisisdependonoperationalparameterofasystemorunitoperation.(Mixing
speed,flowrate,mobilephaseratio,molarityofbuffer,pHofbuffer)andprocess
statevariables(Temp,Pressure,viscosity,density,angleofrepose)
ARKA JAIN University, Jamshedpur, Jharkhand

12. 6.Design Space (DS):
AsperICHQ8-Thisisthemultidimensionalcombinationandinteractionofinput
variables(e.g.,materialattributes)andprocessparametersthathavebeen
demonstratedtoprovideassuranceofquality.
Adesignspacemaybebuiltforasingleunitoperationorfortheensureprocess.
ARKA JAIN University, Jamshedpur, Jharkhand

13. ARKA JAIN University, Jamshedpur, Jharkhand
Tools of QBD
2. Risk assessment
methodology
3. Process Analytical
Technology
1. Design of
Experiment (DoE)
Tools of QBD

14. 1. Design of Experiment (DoE):
Astructured,organizedmethodfordeterminingtherelationshipbetweenfactors
affectingaprocessandtheoutputofthatprocessisknownas“Designof
Experiments”.
Thisisasystematicapproachappliedtoconductexperimentstoobtain
maximumoutputaccordingtoapre-specifieddesign.
Itcanhelpidentifyoptimalconditions,CMAs,CPPsandultimatelytheDesign
Space.
WehavecapabilityandexpertizetoperformDoEinproductdevelopmentusing
softwarelikeMinitabandStatistica,Stat-Ease.
ARKA JAIN University, Jamshedpur, Jharkhand

15. 1. Risk Assessment Methodology:
Itisasystematicprocessoforganizinginformationtosupportariskdecisionto
bemadewithinariskmanagementprocess.
Nextstepsofqualityriskmanagementprocessisriskcontrol,riskreview.
TherearethreecomponentsofRiskassessmentmethod.i.e.Risk
identification,Riskanalysis,Riskevaluation.
ARKA JAIN University, Jamshedpur, Jharkhand

16. 3. Process Analytical Technique (PAT):
Itisdefinedas“Toolsandsystemsthatutilizerealtimemeasurementsorrapid
measurementduringprocessing,ofevolvingqualityandperformanceattributesof
inprocessmaterialstoprovideinformationtoensureoptimalprocessingto
producefinalproductthatconsistentlyconformstoestablishedqualityand
performancestandards”.
InQ8GuidelinestheuseofPATtoensuretheprocessremainsinanestablished
DesignSpace.
TherearethreestepprocessinPATi.e.design,analyze,control.
ARKA JAIN University, Jamshedpur, Jharkhand

17. THANKYOU
STAY SAFE
&
STAY HEALTHY
ARKA JAIN University, Jamshedpur, Jharkhand