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1. 1
Pharmaceutical Quality control and quality Assurance
(Phar 4255)
Aug-22 1

2. ??????Outline
??????Introduction
??????Qualitymanagement system
??????Elementsofqualityassuranceforpharmaceuticals
??????GMP&basicelementsofGMP
??????GLP&itsbasiccomponent
??????QC&operationaltaskofQC
??????Qualityassuranceofdrugprocurement
??????Validation(processandsystemandutility)
2
Aug-22 2

3. Objectivesofthiscourse:
??????Attheendofthiscoursestudentsableto:
??????Understandqualityterminology
??????Explainqualitymanagementsystem
??????Describeschemeofqualityassurance
??????Describecomponentofqualityassurance
??????UnderstandGMPanditscomponent
??????DescribequalitycontrolandoperationalactivityofQC
??????Understandqualityassuranceofdrugsupplymanagement
??????Understandvalidationanddifferentkindsofvalidationwhichincludeprocess,cleaning,HVAC,water
purificationvalidation.
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4. Rationale for this course
4
Aug
-
22
4

5. RationaleforthisCourse
QualityAssuranceprinciplescanbeusedto:
??????Detecterrorsorproblemsinproduction
??????Ensuresuppliersconformtostandardsandexpectations
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6. Introduction
??????Toensuresthesafety,efficacyandqualityofpharmaceuticalproducts:
??????Itisimportanttogaintheinformationaboutthequalitativeand
quantitativecompositionofsubstances.
??????I.e.tofindoutwhatasubstanceiscomposedofandexactlyhow
much.
??????Quantitativetest
✓Measurestheamountofasubstancepresent
??????Qualitativetest
✓Determineswhetherthesubstancebeingtestedforispresentorabsent
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7. Introduction…
⚫Focuspointis:
✓Whattotest?
✓Whytotest?
✓Howtotest?
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8. Introduction…
❖Instrumentalmethod:
✓Electroanalyticalmethod
✓Electro-analytical methods
✓Opticalmethod
✓Chromatographicmethod
✓Others-X-Ray,MS,polarimetry, termal analysis
❖Microbiologicalmethod
❖Biologicalmethod
7
❖Analyticalmethodused:
??????Classicalmethods
⚫Gravimetricanalysis
⚫Volumetricanalysis
Aug-22 8

9. Whatis the sourceofthese Methodology?
✓OfficialCompendia
??????TheUnitedStatesPharmacopeia(USP)
??????BritishPharmacopea(BP)&
??????InternationalPharmacopea(IP)
??????Ph.EU
✓JournalsandOtherLiterature
??????Thereareapplicableproceduresfoundintheliterature.
✓Manufacturing methods /in-houseMethod
8
Aug-22 9

10. Introduction cont’
Thequalityofadrugisdeterminedafterestablishingitsauthenticity:-
??????Bytestingitspurityandthequalityofpuresubstanceinthedrugandits
formulations.
??????Qualityisimportantineveryproductorservicebutitisvitalinmedicineasitinvolves
life.
✓Unlikeordinaryconsumergoodstherecanbeno-secondqualityindrugs.
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Aug-22 10

11. What is Quality?
✓Qualityisthedegreew/capharmaceuticalproductconformsthestandard
/specification.
✓Ameasureofaproduct’sorservice’sabilitytosatisfythecustomer’sstatedor
impliedneeds.
✓Customersatisfactionisthemaindeterminantofquality.
✓Inthepharmaceuticalindustryrepresentsbothfunctionandprocess.
✓“Fitnessforpurposewithcustomersatisfaction.”
Aug-22 11

12. Cont...
✓Whenthemedicineisgiventopatientsitmusthavebeenappropriately
manufactured,testedandpackagedtoassurethat:
❖Itisthecorrectproduct.
❖Itisthecorrectstrength.
❖Ithasnotdegraded.
❖Itisfreefromharmfulimpuritiesandmicro-organisms.
❖Ithasnotbeencontaminated.
❖Itiscorrectlylabelled.
❖Itisproperlysealedinasuitablecontainer.
Aug-22 12

13. 13
Qualityin pharmaceuticalterms
❖Generally,everypharmaceuticalproductmustmeetfourattributesnamely:
i.Identity?
ii.Strength?
iii.Safety?
iv.Andpuritytoachievethedesiredeffectivenessoftheproduct.
❖Inshort-achievingqualitymeansachievingtheseattributesforproduct.
Aug-22 13

14. 14
QUALITYCONCEPT
❖AccordingtoU.S.F.D.A
✓Qualityshouldbebuiltintotheproduct,andtestingalonecannotbereliedontoensureproduct
quality.
✓BuildQualityintotheproductinvolveshavingcontrolsateverystageofmanufacturingandnotonly
terminalcontrols.
✓Controlsonallinputresourceslike:
❖People
❖Facilities
❖Equipment
❖Materials
❖Processandtestingetc.
Aug-22 14

15. Main Causes of Poor Quality
Therearesixmaincausesofpoorquality:
1.Man-Lackofmotivation,training,skills,interest
2.Machine-Lackofcapability,maintenance,outdated
3.Material-Lowgrade,unspecified,variation
4.Management-Lackofvision,mission,decisionmaking&communication
5.Method-Lackofprocedures,proceduresnotfollowed
6.Mothernature-Humidity,temperature,lighting
Aug-22 15

16. Why Quality control is needed?
❖ImproveQuality
❖IncreaseProductivity
❖ImproveCustomerSatisfaction
❖SuccessinBusiness
❖ReduceCosts,Rework,Delays&Errors
Aug-22 16

17. Cont…
❖Toimprovequality,patientsatisfactionetc:
✓Analysisisimportantineveryproductorservice.
✓Butindrugitisveryimportantasitinvolveslife.
✓Qualityoftheproductscomesfromseriesoftestsfromqualitycontrol:
A.Startingfromrawmaterials
B.Inprocessduringmanufacture
C.Finishedproduct
Aug-22 17

18. Aug-2218
➢Duringdruganalysisanyofthequestionsbelowshouldbeanswered:
❖Dothepurityofapuredrugsubstancemeetspecification?
❖Whatisthepercentageofthestatedcontentofadrugpresentinaformulation?
❖Doesthisformulationcontainsolelytheactiveingredientorareadditionalimpurities
present?
❖Whatisthestabilityofadrugintheformulationandhencetheshelf–lifeofthe
product?

19. Aug-2219
❖Dotheidentityandpurityofexcipientsmeetspecification?
❖WhatarethephysicalconstantslikePkavalue(s),solubilities,stabilityetc.ofadrug
substanceunderdevelopment?
❖Atwhatrateisthedrugreleasedfromitsformulationsothatitcanbeabsorbedbythe
body?

20. 28
Aug-22 20

21. ▪Man
▪Material
▪Machinery
▪Manuals/Methodology(SOP)
▪Motivation
29
Aug-22 21

22. QualityManagement
❖Qualityrelationships:
QM
QA
GMP
QualityControl
&Production
Aug-22 22

23. Qualitymanagementsystems
Objectives:
✓Topreventrisks
✓Todetectdeviations
✓Tocorrecterrors
✓Toimprove efficiency
✓Toreducecosts
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Aug-22 23

24. QualityManagement…
organization'squality??????Thedesignandimplementationofan management
systemisinfluencedby:
✓Itsorganizationalenvironment
✓Changesinthatenvironment
✓Therisksassociatedwiththatenvironment
??????Itsparticularobjectivesoftheproductsitprovides,theprocessesitemploys,its
sizeandorganizationalstructure.
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25. QualityManagement…
??????WhatisQualityManagement?
??????Theaspectofmanagementfunctionthatdeterminesandimplementsthequalitypolicy.
??????Theoverallintentionanddirectionregardingquality,asformallyexpressedandauthorizedby
topmanagement.
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26. Quality Management…
??????Thebasicelementsare:
??????Anappropriate infrastructure or qualitysystem encompassing
theorganizationstructure,procedures,processes andresources
??????Thesystematicactionsnecessarytoensureadequate
givenConfidencethataproduct(orservice)willsatisfy requirementsfor
Quality
??????ThetotalityoftheseactionsistermedQualityAssurance.
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27. QualityAssurance-QA
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Aug-22 27

28. Quality Assurance (QA)
✓QualityAssurance(QA)isamanagementmethodthatisdefinedas:
❖“Allthoseplannedandsystematicactionsneededtoprovideadequateconfidence
thataproduct,serviceorresultwillsatisfygivenrequirementsforqualityandbefitfor
use”.
✓QAprogramisdefinedas“thesumtotaloftheactivitiesaimedatachievingthatrequired
standard”.
✓QA,GMPandQualityControlareinterrelatedaspectsofQualityManagement.
Aug-22 28

29. QualityAssurance….
??????DefinitionofQualityAssurance(QA)byWHO
??????Wide-rangingconcept
??????Coversallmattersthatindividuallyorcollectivelyinfluencethequalityofaproduct.
??????Totalityofthearrangementsmadewiththeobjective:
??????Toensurethatthepharmaceuticals products are oftherightqualityrequiredforthe intendeduse.
??????Quality Assuranceincorporates GMP.
??????alsoproductdesignanddevelopment
??????QualityAssurance=QC+ GMP+GLP+GCP+GSP+GDP+GPP
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30. Quality Assurance….
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31. GxPRegulationAlongtheDrugLife
60
NOGMP/GLP!!!
GLP
GCP
GMP
Studybased
processbased
Clinicalbased
GSP&
GDP
Storage&
Distribution
Aug-22 31

32. QualityAssurance….
??????QA:
??????Isnotthedutyofoneorganizationunitinthecompanyalone.
??????Theresponsibilityofallstaffmemberswhocaninfluence productquality.
??????Mustbeindependentoffinancial pressure
??????Mustensurethequalitypolicies arefollowed.
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33. ComponentsofQualityassurance
??????InternalQualitycontrol:IQC
??????Nature:Concurrent
??????Performed by:labstaff
??????Objective:Reliableresultsonadailybasis
??????Externalqualityassessment: EQA
??????Nature:RetrospectivetoevaluateIQC
??????Performedby: Independentagency
??????Objective:Ensureinter-laboratorycomparability
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34. FACTORSINDRUGQUALITYASSURANCE
41
DRUG
PRODUCT
QUALITY
7.PACKAGING
Aug-22 34

35. RawMaterial
Processing
Equipments
Manufacturing Plant
Operators
Environment
Manufacturing
InProcess
Testing
FinishProduct
Packaging
Storage
Dispatch
Customer
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36. ??????It ismusttolook and control overeverything relatedtothe makingof product like
❑RawMaterialQuality
❑AncillaryMaterialQuality
❑OperationalQuality
❑EquipmentandInstrumentQuality
❑Personsengagedinwholeoperation(Store,QC,QA,Production,Logistics)
❑ManufacturingandtestingQualityetc.
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Aug-22 36

37. ??????Ifphar‘icalfactoryhaveGMP→20–30%moreworkneededtogetISO
??????Ifphar‘icalfactoryhaveISO→65–75%moreworkneededtogetGMP
??????ThatworkandrequiredmoreworkwillbethegreateffortoftheQUALITY
ASSURANCE
44
ISO:(InternationalOrganizationfor
Standardization)
•Itworkinfavorofcustomer
•Itsfocus isonproductQuality
•ISOconsistsmoreBusiness
operations
•Optional
GMP:(Good ManufacturingPractice)
•Itworksinfavorof
Manufacturer
•ItsfocusisonManufacturing
•GMPconsistsofmoretechnical
operations
•Mandatory
Aug-22 37

38. ??????Technologytransfer
??????Validation
??????Documentation
??????Assuringqualityofproducts
??????Qualityimprovementplans
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Aug-22 38

39. 1–Technologytransfer
➢Distributionofdocumentsreceivedfromresearchcenter.
➢Checkingandapprovalofdocumentsgeneratedbasedonresearchcenter
documents.
➢Scale-upandvalidationofproduct.
Aug-22 39

40. 2. Validation
Validationprovesthatamanufacturingprocesswillconsistently
producetheproducttopredefinedspecifications.
Theoperationofeverypartoftheplantthataffectsquality
mustbevalidated.
Ifamanufacturingprocessischangedorifanewproductis
introduced,allprocessesandequipmentthataffectqualitymust
bevalidated.
Validationscientistsandengineershaveextensiveexperience
becausetheymustbeveryfamiliarwiththeregulations.
Aug-22 40

41. Quality Assurance Activities for validation
➢PreparationofValidationMasterplansforfacility/equipment's/process,utility,
cleaningandallthesectionsofthevalidation.
➢Approvalofprotocolforvalidationoffacility/equipment/product/process/Utility.
➢Validationoffacility/equipment/product/process
➢Finalapprovalofthefacility/equipment/product/process/Utilityvalidation.
Aug-22 41

42. 3.Documentation
➢Mainobjective:
✓Toestablish,monitorandrecord-QualityforallaspectsofGMPandotherQuality
Systempertaining.
➢Typeofdocuments:
❑Standardoperatingprocedures
❑Protocolsoftests
❑Results
❑Reports
Aug-22 42

43. ??????Anauthorizedwrittenproceduregivinginstructionsforperforming operations.
??????SOPsarenotnecessarilyspecifictoagivenprocess,productormaterial:
❖E.g.Equipmentoperation,maintenanceandcleaning
❖Validation
❖Cleaningofpremises
❖Environmentalcontrol
❖Samplingandinspection
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Aug-22 43

44. ??????Standardoperatingproceduresdescribeinadetailedformthe activities
performedinthelaboratory.
ineachofthe??????Provideuniformity,consistencyandreliabilityactivities
performedinthelaboratory
??????Reducesystematicerrors
??????Providetrainingandguidancefornewstaff.
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45. ??????Writteninstructionsthatspecify
??????howatestorproceduresistobeperformed.
??????Howapieceofequipmentisqualified,operated,maintainedandcalibrated.
??????Describes―Standardapprovedprocedures.
??????Revision…whenplannedchangesaremadeorannually
??????Original–maintainedinacentralfile.
??????Copies–distributedtolocations.
??????Writtenbythepersonperformingorknowstheprocedurewell.
??????SupervisorreviewSOPsforcompletenessandcontent.
??????QAorQCstaffapproval
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Aug-22 45

46. SOP…
??????AparticularSOPshouldhave:
??????Atitle(concise&descriptive)
??????Testname,testprocedure,reagentusedincludingthelimitationofthe
procedureandcalculationexplanation.
??????Principleofthetest(typeofrxn,sampleortestorganisminvolved,reasonfor
performingthetest,formulatodeterminethefinalresult).
??????Samplestoragepreservativecondition
??????Reporthandling procedure(reportingrange,test&criticalvalue)
??????Chemicalhandlingtechnique
??????Referencematerialspertinenttospecificprocedure
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Aug-22 46

47. 4 –Assuring Quality of products by:
❖CGMPtraining
❖SOPcompliance
❖Auditoffacilityforcompliance
❖Lineclearance
❖In-processcounterchecks
❖Criticalsampling
❖Recordverification
❖Releaseofbatchformarketing
❖Investigationofmarketcomplaints
Aug-22 47

48. 5–Qualityimprovementplan
➢Feedbackreceivedfromthecomplianceteam
➢Customercomplainthistory
➢Proposalsforcorrectiveandpreventiveactions
➢Trendanalysisofvariousqualityparametersforproducts,environmentandwater.
➢Reviewofthedeviations,changecontrols,outofspecificationsandFailures.
Aug-22 48

49. 5 –Quality improvement plan…
Flow Chart RM/PM Inspection
Aug-22 49

50. 5 –Quality improvement plan…
Flow chart finished product inspection
Aug-22 50

51. ReceivedInprocessrequisition alongwithsample
TestingasperspecsorRequisition SamplingbyQA
Resultsconveyedtoproduction
FlowChartInprocessCheck
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5 –Quality improvement plan…

52. ??????QualityAssurance:
??????Manufacturer isresponsibleforthequalityoftheproductwhichensurethat:
??????theproductisFitforintendeduse
??????TheproductComplywithmarketingauthorization
??????TheproductisSafe,effectiveandquality
??????Seniormanagementandcommitmentofallstaff
??????RequiresacomprehensivelydesignedandwellimplementedQAsystem
??????Fullydocumented,andeffectivenessmonitored
??????Competentpersonnel,sufficientpremises,equipmentandfacilities
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Principal activities of QA

53. ConsequencesofQAbreaches
??????PoorTreatmentoutcomes
????????????TreatmentFailures&Deaths
??????LossofConfidenceintheHealthServices
??????EnormousEconomicLosses
??????NationalSecurityIssue
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Aug-22 53

54. Causesofproliferationofpoorqualitydrugs
❖Poorhealthsystemsindevelopingcountries
❖Lackoflegislation
❖Weakorabsentdrugregulatory
❖Weaklawenforcementandpenalsanctions
❖Highdrugdemandswithshortsupplies
❖illegaltradeinthebordersandinformalmarkets
❖Corruptionandconflictofinterest
❖Highcostofdrug–lucrativebusiness
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Aug-22 54

55. ??????Howtominimizetheflowofpoor-qualitymedicines?
✓Inspection
✓Port-of-entrycontrol
✓Documentverification
✓Registrationetc.
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56. 76
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57. WHATISGoodManufacturingPractice?
??????GoodManufacturingPractice(GMP)
??????TheregulationdevelopedbyunitedstateFoodAndDrugAdministration(FDA)for
pharmaceuticalindustryInmeetingminimumrequirementsinthemanufacturing
processing,packaging,orholdingofhumanandveterinarydrugs.
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58. GMP…
??????GoodManufacturingPractices(GMP)
??????ThatpartofQA thatensuresthatproductsareconsistentlyproducedand controlled
??????Qualitystandards
??????Appropriatetotheirintendeduse
??????Marketingauthorization
??????Aim:Diminishingrisksthatcannotbecontrolledbytestingofproduct
??????Contaminationandcross-contamination
??????Mix-ups(confusion)
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59. Whatisc-GMP?
❖Usuallysee-cGMP-wherec=current,toemphasizethattheexpectationsaredynamic.
❖Qualityofamedicinalproductismeasuredbyit‘sfitnessforpurpose.
❖SafetyandefficacyarenotseparablefromQualitybutpartofit.
❖TheQualityofaformulationorabulkdrugdependsontheQualityofthoseproducingit.
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60. GoodManufacturingPractice…
??????GMPImplementationbyCountries
??????DifferentcountrymayusedifferentGMPGuidelines:
??????WHOandRegionalGuidelines
??????Country specificGuidelines(Eg.FDA)
??????PIC/SGMPGuidelines
??????Product specificGMPGuidelines
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61. GoodManufacturingPractice…
??????HenceGMPcomplianceiscrucialifadrugproductisbeof requiredquality,safe,andefficacious.
??????WhatdoesGMPdotoassurequalityandsafetyofmedicines?
??????RequirecompliancewiththebasicelementsofGMPwhichis verifiedbyGMPinspection.
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62. AdvantageofGMP
Preventerrorsthatcannotbeeliminatedthroughqualitycontroloffinished products
??????unexpectedcontaminationofproducts,causingdamagetohealthoreven
death.
??????incorrectlabelsoncontainers,whichcouldmeanthatpatientsreceivethewrong
medicine.
??????insufficientortoo muchactiveingredient,resultinginineffectivetreatmentor adverse
effects.
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63. AdvantageofGMPare…
Ensureallunitsofamedicineareofthesamequality(withinaspecified
parameters).
Granteescredibility
??????Apoorqualitymedicinemaycontaintoxicsubstancesthathavebeen
unintentionally added.
??????Amedicinethatcontainslittleornoneoftheclaimedingredientwillnot have
theintendedtherapeuticeffect.
??????PoorQualitymedicineleadstolossforeveryone:
◼Manufacturers
◼Healthy careworkers
◼Governments
◼Drugusers(endusers)
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64. GMPhelpsboostpharmaceuticalexportopportunities
??????Mostcountrieswillonlyacceptimportandsaleofmedicinesthathave
beenmanufacturedtointernationallyrecognized GMP.
??????Governmentsseekingtopromotetheircountriesexportof pharmaceuticalscandoso:
??????bymakingGMPmandatoryforall pharmaceuticalproductionand
??????bytrainingtheirinspectorsinGMPrequirements.
86
Aug-22 64

65. GMPrequirements
??????ALLaspectsofproduction:
✓Materials
✓Premises
✓Equipment
✓Personal
✓SOP
✓Documentation
✓Environment
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66. 1.Premises:
Incleanareas,allexposedsurfaces:
◦Smooth,impervious,unbrokenFloors,walls,andceilings
◦Minimizesheddingandaccumulationofparticles,microorganisms
◦Permitcleaninganddisinfection
◦Slidingdoorsundesirable
August 9, 2022 66

67. 2.Equipment
Effectivesterilizationofequipment
Maintenanceandrepairsfromoutsidethecleanarea:
➢Iftakenapart,re-sterilizedbeforeuse
➢Usecleaninstrumentsandtools
Plannedmaintenance,validationandmonitoring:
➢Equipment,airfiltrationsystems,sterilizers,watertreatmentsystems.
August 9, 2022 67

68. 3.Personnel
Minimumnumberofpersonnelincleanareas:
✓Especiallyduringasepticprocessing
Trainingtoallincludingcleaningandmaintenancestaff:
◦Initialandregular
◦Manufacturing,hygiene,microbiology
Specialcases:
◦Supervisionincaseofoutsidestaff
◦Inspectionsandcontrolsfromoutside.
August 9, 2022 68

69. 3.Personnel…
Periodichealthchecks
Nointroductionofmicrobiologicalhazards
Nooutdoorclothing
ChangingandwashingprocedureingradeBandCroom
Nowatches,jewelleryandcosmetics
August 9, 2022 69

70. 4.EnvironmentalMonitoring
August 9, 2022 70

71. August 9, 2022 71

72. August 9, 2022 72

73. August 9, 2022 73

74. 5. Validatedcriticalstepsofproductionprocess
??????Duetovariabilityinqualityofmaterials&performanceofequipments,thereisaneedto
checkwhethertheprocessworkswithallvariabilitythatcanarise.
??????Itcarryoutcontrolledexperimentstoensurethatwhatevervariablesdooccur,theycan
stillproduceproductsmeetingspecifications.
??????Validationisrequiredifthereisachangeinanypartoftheprocess(materialorequipment
used)
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75. 6.Clearlywrittenmanufacturingprocedure
??????IncludingbatchmanufacturingandtestinginstructionsandtheSOPsneedforeverydepartment.
??????Preparingtheseproceduresanddocumentsisavery importanttaskthat
needscarefulthought.
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76. 7.Properstorageanddistributionoftheproducts
??????Whenaproductisdeveloped,stabilitytestingisundertakeninordertodeterminethe
storageconditionanditsshelflife.
??????Properstorageanddistributionoftheproductminimizetherisktotheirquality
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77. 8. Completerecorddocumentofmanufacturingprocess
??????appropriateinvestigationsarecarriedoutifqualityproblemcomeup.
◼Itmustalsohaverecordsthatshowwhatisactuallydoneeach timeit
makesandteststhoseproducts
??????Therecordsareveryimportantinthefutureastheyshowwhatwas doneby
whomandwhethertheworkconfirmedtostandards.
Aug-22 77

78. 9.A recall system,incase quality problems are detected afterrelease ofproducts
??????Ifaproductinthemarketisfoundtobedefective,thereneedofgetting thatthe
productoffthemarket.(recall)
??????Recallcanbedoneind/twayandwithd/tdegreesofseverity,dependingupon
thereasonforrecall.
??????Usuallyrecallprocedureswillneedtobeagreedwiththedrug regulatoryauthorityof
eachcountrywheretheproductissold.
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79. 10.Complainthandlingproceduresareestablishedtoreacttofeedbackfromthemarket.
??????Forthoseproductsthatdevelopqualityproblemswhilemarketed acomplaint
handlingprocedureisrequired.
??????Investigatingandwherenecessarytakeappropriateactiontoimprovetheprocessto
preventre-occurrence.
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80. Majorriskinpharmaceuticalproduction
??????Contaminationofproducts(microbial,particulateetc.)
??????Incorrectlabelsincontainers
??????Insufficientactiveingredients
??????Excessactiveingredients
??????Poorqualityrawmaterials
??????Poorformulationpractices
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81. QualityAssurancefordrugsupply management
144
Aug-22 81

82. QualityAssurancefordrugsupplymanagement
??????CriticalElementsinQAforProcurement
–Productselection
–Supplierqualificationformedicine
selection
–Productcertification
–Contractspecification
??????Inspectionofshipment
??????laboratorytesting
??????appropriatestorage,
transport,dispensing&
useprocedure
??????Productmonitoring
system
145
Selection
Procurement
Distribution
Use
Rationaluse
Storagecondition,
expirydate
Quality
Assuran
ce
NationalDrugPolicy&LegalFramework
-Qualityrequirement
-DrugRegistration
Localmanufacturer
Aug-22 82

83. QualityAssurancefordrugsupplymanagement…
??????Qualityassurance
??????Referstothemanagementactivitiesrequiredtoensurethatthemedicines(orother
healthproducts)thatreachpatientsaresafe,effectiveandacceptabletothe
patient.
??????Theseactivitiesmayinclude,butarenotlimitedto,(drug)registration,pre-
qualificationandqualitycontrol.
146
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84. GoalsofMedicineQAPrograms
147
▪Tomake certainthateachmedicinereachingapatientissafe, effective,andof
standardquality
▪Obtainingqualityproducts
▪thataresafeandeffectivethroughstructuredselectionandprocurement
methods
▪Maintainingqualityproducts
▪throughtheappropriatestorage,distribution,monitoring,anduseby:
✓Prescribers
✓Dispensers
✓Consumers
Aug-22 84

85. Characteristics ofaComprehensiveQAProgram
148
▪Medicinesareselectedonthebasisofsafetyandefficacy:
▪Inanappropriatedosageform
▪Withthelongestshelflife
▪Supplierswithacceptablequalitystandardsareselected
▪Medicinesreceivedfromsuppliersanddonorsaremonitored
▪tomeetqualitystandards
▪Medicinepackagingmeetscontractspecifications.
Aug-22 85

86. CharacteristicsofaComprehensiveQAProgram…
149
▪Repackagingactivitiesanddispensingpracticesmaintainquality
▪Adequatestorageconditionsinallpharmaceuticalareasaremaintained
▪Transportationconditionsareadequate
▪Productqualityconcernsarereportedandmonitored
Aug-22 86

87. ImpactsofLow-QualityMedicines
150
?
MEDICINE QUALITY
▪Manufacturing process
▪Packaging
▪Transportation
▪Storage condition
✓Lackoftherapeuticeffect:
➢Prolongedillness
➢Death
✓Toxicandadverse reaction
✓Waste of limited financialresources
✓Lossofcredibility
Aug-22 87

88. DeterminantsofMedicineQuality
151
▪Identity:Activeingredient
▪Purity:Notcontaminatedwithpotentiallyharmfulsubstances
▪Potency:Usually90–110%ofthelabeledamount
▪Uniformity:Consistencyofcolor,shape,size
▪Bioavailability:Interchangeableproducts?
▪Stability:Ensuringmedicineactivityforstatedperiod
Identity,purity,potency,uniformityaredefinedin
pharmacopoeias andstatedincertificateof analysis(COA)
Aug-22 88

89. HowIsQualityAssessed?
▪Inspectionofproductsonarrival
▪Visualinspection
▪Productspecification review(includingexpirationdates)
▪LaboratoryTestingforcompliancewithpharmacopoeialstandards
▪InternationalPharmacopoeia
▪EuropeanPharmacopoeia
▪U.S.Pharmacopeia
▪BritishPharmacopoeia
▪NationalPharmacopoeia
▪Bioavailabilitydata
152
COA
Aug-22 89

90. WhoEnsuresMedicineQuality?
▪Drugregulatory authority
157
Medicine Quality
▪Physicians and other
prescribers
▪Drug and Therapeutics
Committee
▪Hospital procurement
office
▪Pharmacy(anddispensers)
▪Patients
Aug-22 90

91. Qualityassuranceindrugsupplymanagement
??????Targets:
??????Productselectionandspecification
??????Suppliersselection
??????Productcertification
??????Contractspecification
??????Inspectionofshipment
??????Targetedlaboratorytesting
??????Maintainingdrugqualityduringstorage,distributionanduse
158
Aug-22 91

92. Summary
159
▪Ensuringqualityofaproductfromselectiontouse:
▪Obtainingqualityproductsthataresafeandeffectivethroughstructured selectionand
procurementmethods
▪Maintainingqualityproductsthroughappropriatestorage,distribution,monitoring,anduse
methods
▪Assessingqualityincludes:
▪Inspectionofmedicines
▪Laboratorytestingwhennecessary
Aug-22 92

93. Summary….
▪Assuringqualityincludes:
▪Selectionofmedicines,dosageforms,andpackaging
▪Useofprequalifiedsuppliers
▪Productcertification
▪Preparationandenforcementofquality-relatedspecification
▪Appropriatestorage,transport,dispensing,anduse
▪Productmonitoringsystems
Aug-22 93

94. Aug-22 94