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1. QualityControl(QC)
119
Aug-22 1
By: Biset A.(B.Pharm,MSc)

2. QualityControl(QC)
Qualitycontrol:
❖isatermthatreferstoprocessesinvolvedinmaintainingthequalityand
validityofamanufacturedproduct.
❖Eachholderofamanufacturingauthorizationshouldhaveaquality
controldepartment.
❖QCdepartmentshouldbeindependentfromotherdepartment.
Aug-22 2

3. Quality Control(QC)…
❖TheQCdepartmentmusthaveadequateresource.
❖i.eadequatelaboratoryfacilitiesoraccesstothem.
✓ToensurethatalltheQualityControlarrangementsareeffectivelyandreliablycarriedout.
❖Appropriatelyqualified,trainedandexperiencedpersonnel
❖Approvedwrittenprocedures
Aug-22 3

4. Theoperationaltaskofthequalitycontroldepartment:
❖Sampling
❖Inspecting
❖Analyticaltesting-toconfirmcompliancewithspecification
❖Monitoringofallmaterialsandenvironmentalconditionsinthefactory
❖Releasingorrejectingmaterialforproductionuseandfinishedproducts
❖Monitoringproductqualityduringstorage/distribution/use
❖Approve/rejectdrugproductsmadebyothercompany
❖Approveorrejectallproceduresorspecificationsaffectingdrugproduct.
❖Musthaveadequatelabfacilitiesfortesting/approval/rejectionofcomponents
122
Aug-22 4

5. Thetargetoftheseactivitiesare:
i.Startingmaterials
ii.Packagingmaterials
iii.Intermediates
iv.Bulkproducts
v.Finishedproducts
vi.Environmentalconditions
123
Aug-22 5

6. Basicrequirementsforqualitycontrol:
1.Adequatefacilities,trainedpersonnelandapprovedproceduresareavailable:
✓Forsampling,inspectingandtesting:
i.Startingmaterials
ii.Packagingmaterials
iii.Intermediateproducts
iv.Bulkandfinishedproducts
v.AndwhereappropriateformonitoringenvironmentalconditionsforGMP
purposes.
Aug-22 6

7. Basicrequirementsforqualitycontrol:
2.Sampling should be undertaken by methods and personnel approved by the
QC department:
✓Starting materials, packaging materials, intermediate products, bulk products
and finished products.
❖It must be carried out in such a way that it is representative of the batch
and in accordance with an SOP.
✓QC personnel must have access to the production area to undertake sampling
when necessary.
Aug-22 7

8. Basicrequirementsforqualitycontrol…
3. Validated test methods should be applied.
✓The validation of test methods include verification:
❖Accuracy
❖Precision
❖Linearity
❖Repeatability
❖Robustness
❖Specificity
❖LimitofDetection(LOD)
❖LimitofQuantification(LOQ)
✓Test methods should be challenged to be able to demonstrate that the tests
are able to give an accurate result on repeatable bases.Aug-22 8

9. Basicrequirementsforqualitycontrol…
4.Recordsforsampling,inspecting,testingprocedurewereactuallycarriedout.
✓This means that there will be traceability on what happened.
✓Any deviations are fully recorded and investigated.
Aug-22 9

10. Basicrequirementsforqualitycontrol…
5.Recordsaremadeoftheresultsofinspectionandthattestingofmaterials,is
formallyassessedagainstspecification.
✓Productassessmentincludesareviewandevaluationofrelevantproduction
documentationandanassessmentofdeviationsfromspecifiedprocedures.
✓Thisreviewneedtocoverallqualityaspects-toassurenoerrorshave
occurred.
✓EnsuresmanufacturingdocumentationsandtheQAdocumentationarein
harmony.
Aug-22 10

11. Basicrequirementsforqualitycontrol…
6.Nobatchofproductisreleasedforsaleorsupplypriortocertificationbyan
authorizedperson.
7.QCensuresthatingredientsusedcomplywiththequalitativeandquantitative
compositionofthefinishedproductasapprovedinmarketauthorization.
8.QCensurethatpropercontainersareusedandcorrectlabelingoffinished
products.
Aug-22 11

12. Basicrequirementsforqualitycontrol…
10.Sufficientreferencesampleofstartingmaterials&finishedproductsareretained.
✓Sufficientretentionsamplesofthestartingmaterialsandthefinished
productsinitsfinalpackshouldbekeptforoneyearpasttheexpiredate
exceptLVPsolutionsw/cmustkeptforatleast30daysafterexpiration.
✓Referenceandretentionsamplesshouldberetainedatleastexp.date+1year.
✓Thisistoallowforanevaluationoftheproductafterithasbeendistributed
shouldtherebeaneed.
✓Itwillalsoallowongoingstabilitytrialtobedone.
Aug-22
12

13. 1.Approveorrejectionofmaterials:
❖Rawmaterial
❖Packagingmaterial
❖Intermediateproducts
❖Bulkandfinishedproducts
2.Evaluationofbatchrecords??
3.Carryingoutnecessarytesting???
Aug-22 13
HeadofQCresponsibilities

14. 4.ApprovalofnecessaryQCprocedures:
✓Samplinginstruction
✓Specifications
✓TestmethodsandotherQCprocedures.
5.Maintenanceofqualitydepartment,premisesandequipment
6.Validation(includinganalyticalprocedureandcalibrationofequipment)
7.InitialandcontinuoustrainingofQCpersonnel.
Aug-22 14
HeadofQCresponsibilities…

15. Assessment of finished products
❖Assessmentoffinishedproductsshouldembraceallrelevantfactors:
❖Including:
➢Theproductioncondition.
➢Theresultsofin-processtesting.
➢Themanufacturing(includingpackaging)documentation.
➢Compliancewiththespecificationforthefinishedproduct,and.
➢Anexaminationofthefinishedpack.
Aug-22 15

16. Testing References:
✓Specificationconsistsoftestmethodsandtheirassociatedacceptance
criteria:
❖Pharmacopoeial standards (USP, Ph.EU, BP, etc)
✓References should be available and retained like sample.
✓Criteriaapplicabletoalldrugproducts:
❖Identity,Strength&Purity
❖Testingmethods:
✓Physico-chemicalanalysis
✓Microbiologicalanalysis
Aug-22 16

17. Factorsaffectingthechoiceoftestingmethods:
i.Thetypeofanalysisrequired:elementalormolecular.
ii.Possibleinterferencefromcomponentsofthematerial.
iii.Theconcentrationrangewhichneedstobeinvestigated
iv.Theaccuracyrequired
v.Thefacilitiesavailable
vi.Thetimerequiredtocompletetheanalysis
Aug-22 17

18. vii.Thenatureoftheinformationwhichissought.
viii.Thenatureofthesample(destructivevsnon-destructivemethodofanalysis)
ix.Thesizeofsampleavailableandtheproportionoftheconstituenttobe
determined
x.Thepurposeforwhichtheanalyticaldataarerequired.
Aug-22 18

19. Oncethemostappropriatemethodofdeterminationchosentheanalysis
shouldbecarriedoutin:
i.Duplicateanalysis
ii.Preferablyintriplicateanalysis
❖Theaverageofthreereplicatesofthesamplewasshowedthatthevalidity
oftheemployedmethodsandgoodprecisionandaccuracyfortheanalysis
ofsamples.
Aug-22 19

20. Asimplecalculationwillthenconverttheexperimentaldataintothe
informationwhichissought:
➢Thiswillusuallybethepercentageoftherelevantcomponentinthe
analyticalsample.
Whenusingcomputer-interfacedinstrumentstheprintoutwillgivethe
requiredpercentagevalue.
Thispercentagevaluecomparedwiththestandard/specificationofd/t
pharmacopeiasandmaketherightdecisions.
Aug-22 20

21. ScopeofQualitycontrol
◼Rawmaterialcontrol
◼In-processcontrol
◼Dosageformcontrol
◼Environmentcontrol
Aug-22 21

22. .
Aug-22 22

23. ❑IPQC:
✓Isconcernedwithprovidingaccurate,specificanddefinitedescriptionofthe
procedurestobeemployedfromthereceiptofrawmaterialstothereleaseofthe
finisheddosageform.
❖Tocontroltheprocedureinvolvedinmanufacturing
❖Tomonitorallfeatureswhichaffectthequality
❖Todetecterrorswhenoccursbyothers.
❖Tomaintainthequalityofproduct.
✓IPQC is the activity performed between QC and QA which involved.
Inprocessqualitycontrol(IPQC)test
Aug-22 23

24. ❑ConditionsfordesigningofIPQC-test:
✓Identifythetypesofformulation(tab,liquids,ointments).
✓Identifythecriticalstepsinvolvedinmanufacturingoftheproduct.
✓Identifythespecificationofparameterswhichconformtheparametersare
withincontrol.
✓Definethefrequencyofcheckingforeachparameter.
Aug-22 24
Inprocessqualitycontrol(IPQC)test…

25. IMPORTANCEOFIPQC:
✓Tominimizehumanerror.
✓Toaccuratedescriptionoftheproceduretobeemployed.
✓Toidentifymaterial,equipment,processesandoperation.
✓Todetecttheerror.
✓Toenforcetheflowofmanufacturingandpackagingoperationaccordingto
establishedrouteandpractice.
✓Todetectanyabnormalityimmediately.
Aug-22 25
Inprocessqualitycontrol(IPQC)test…

26. IPQCTESTSINDIFFERENTDOSAGEFORM
✓Disintegrationtest
✓Dissolutiontest
✓Potencytest
✓Blisterorstripsealing test
138
1-SOLIDDOSAGEFORM-TABLETS
✓Weightvariation
✓Hardness
✓Thickness
✓Friability
✓Contentuniformity
Aug-22 26

27. ✓Weightvariation
✓Assays
✓Contentuniformity
✓Dissolutiontest
✓Disintegrationtime
✓Moisturecontent
✓Bloomstrength
✓Hardnessandflexibilityofshell
✓Lossondrying
✓Stabilitytestingatdifferenttemperature
✓Blisterandstripsealing
2-SOLIDDOSAGEFORM-CAPSULES
Aug-22 27

28. ✓Appearance–colour,odour,taste
✓Productischeckedforuniform
distributionofcolourabsenceof
airbubbles
✓Particlessizeofdispersephase
✓pHofdifferentvehiclesbefore
andaftermixing
✓Drugcontent
✓Stabilitytest
✓Rheology
✓QC of water being used
✓Sedimentation volume
✓Sedimentation rate
✓Clarity
✓Re-dispersibility
✓Compatibilityofproductandcontainer
/closure
3–LiquidDosageForm–Suspension
Aug-22 28

29. ✓Appearance-colour,odour,taste
✓Drugcontent
✓Rheology
✓Stability
✓Clarity
✓QCofwatertobeused
✓pHofdifferentvehicles
✓Compatibilityofproduct/container/
closure
✓Breakingandcracking
4–LiquidDosage Form–Emulsion
Aug-22 29

30. ✓pH
✓Volumecheck
✓Claritytest
✓Contentuniformity
✓Integrityofseals
✓Particulatematter
✓Pyrogentest
✓Conductivitytest
✓Liquidlosstest
✓Fillvolumetest
5–LiquidDosageForm–Parenterals
Aug-22 30

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Aug-22 31
QualityAssessmentParametersforsoliddosageforms:
✓Allofthetestsweredoneusingofficialandnon-officialprocedures:
1.Visualinspection
2.Identificationtest
3.Weightvariation/contentuniformitytest
4.Hardnesstest
5.Friabilitytest
6.Disintegrationtest
7.Dissolutiontest
8.Assaytestetc...

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1.Visualinspection:
✓Uniformityofshape/uniformitycolor
✓Nophysicaldamage
✓Manufacturersaddress,manufacturingdate,batchnumber,countryoforigin,
expirydate.
✓Cracks,packaging,andlabellinginformationwerecheckedusingthemodified
WorldHealthOrganization(WHO)checklist.

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Aug-22 33
2.Identificationtest:
✓Identificationtestwasdoneusingdifferentanalyticalmethodslike:
❖HPLCbytheretentiontimeofthemajorpeakinthechromatogramof
thesamplesolutioncorrespondstothatinthechromatogramofthe
standardsolution.

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Aug-22 34
2.Identificationtest…
❖Identificationisdonebycomparingtheabsorptionspectrumwiththespectraof
knowncompounds.
1)Absorptionmaxima
2)Molarabsorptivity(ε)orA
1%
1cm
3)Absorbanceratioattwomaxima

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Aug-22 35

36. 143
Aug-22
36
4.Friabilitytest:
✓Friabilitywasthemeasurementofthetendencyoftablettocrack,crumbleor
breakwhencompressedbyusingfriabilitytester
➢Subjectedtorotationat25revolutionsperminute(rpm)forfourminutes(100times).
✓Aftertheprocedurewascompleted,tentabletswerededustedandweighed.
✓Theweightswerecomparedwiththeirinitialweightsandthenpercentagefriability
wascalculated.
✓AccordingtoUSPforfriability,theweightlossshouldnotmorethan1%.

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Aug-22
37
5.HardnessTest:
✓Itisanimportantparametersincetabletsmusthavesufficientabilitytosurvivethe
handlingforcesduringpackaging,breakage,underconditionsofstorageand
transportation.
✓Thehardnessofeachtabletwasdeterminedbyselectingtentabletsrandomlyfrom
eachbrandsusingahardnesstester.
✓Ifthehardnessoftabletexceedsacertainlimit,whichultimatelyaffectsthe
bioavailabilityandalsoinfluencesfriabilityanddisintegrationtime.

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6.Disintegrationtime:
✓Disintegrationwasprocessinwhichtabletswerebreakupintogranulesor
smallerparticlesandisthefirststeptowardsdissolution.
✓Atablettobecomefullyavailableforabsorption,itmustfirstdisintegrate
anddischargethedrugtothebodyfluidsfordissolution.
✓Thedisintegrationtimewascarriedouttodeterminethetimerequiredfor
thetablettodisintegrate.
✓Sixtabletswereplacedindisintegrationtesterfiledwithdistilledat37±0.50C.
✓Theaveragedisintegrationtimeofallbrandsofthetabletwerecompared
withpharmacopeialspecification.

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7.Dissolutiontest:
✓Thedissolutionprofileofallbrandofthetabletwereperformedtoprovide
informationonbiologicalbioavailabilityandbatchtobatchconsistency.
✓Sixsampleswereweighingandplaceddissolutiontestereachbrand
aqueous.
✓Andanalyzedat5mlsamplewithdrawnat5,10,15,30,45and60minutesat
thewavelengthofmaximumabsorbanceofeachdrugs.
✓ThepercentagereleaseofAPIeachminutesforeachbrandcomparedwith
thepharmacopeialspecifications.
Aug-22

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Result = (As/A std) ×(Cstd /L) ×V×100
Where:
✓As=absorbanceofthesamplesolution
✓Astd=absorbanceofthestandardsolution
✓Cstd=concentrationofthestandardsolution(mg/mL)
✓v=volumeofmedium
✓L=labelclaim(mg/tablet).
7.Dissolutiontest…
Aug-22

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8.AssayTest:
✓AssaydeterminestheconcentrationoftheAPlfoundinthesample.
✓TheassaytestforeachtabletwasdonebyusingtheHPLCorother
methodsafterconductedsystemsuitabilitytest.
✓Thepercentageconcentrationofthedrugwasdeterminedandcompared
withpharmacopeiaspecification.
Aug-22

42. ✓Lineclearance-mustbegivenbeforestartingpackagingoperation.
✓Printdetails-onlabelsmustbecertified.
✓Leaktesting-bottles,ampoules,vials,mustbeperformed.
✓Detailsofmeasuringcups,spoons,droppersetcmustbechecked.
✓No.ofunitstrips,corton,bottlesetcmustbechecked.
✓Resultsmustberecordedinstandardformats.
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IPQCDURINGPACKAGING
Aug-22 42

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