Quality Assurance and Regulatory Compliance for Pharmaceutical Product.ppt

qualityassuranceandregulatorycomplianceforpharmaceuticalproduct prof dr basavarajk nanjwadem pharm ph ddepartmentofpharmaceuticskleuniversitycollegeofpharmacybelgaum 590010 karnataka indiae mail bknanjwade yahoo co incellno 00919742431000 04thoct 2011 1 maharashtracollegeofpharmacy nilanga qualityassurance qualityassuranceisawiderangingconceptcoveringallmattersthatindividuallyorcollectivelyinfluencethequalityofaproduct itisthetotalityofthearrangementsmadewiththeobjectofensuringthatpharmaceuticalproductsareofthequalityrequiredfortheirintendeduse qaistheheartandsoulofqualitycontrolqa qc gmp 04thoct 2011 2 maharashtracollegeofpharmacy nilanga thesystemofqualityassurance pharmaceuticalproductsaredesignedanddevelopedinawaythattakesaccountoftherequirementsofgmpandotherassociatedcodessuchasthoseofgoodlaboratorypractice glp andgoodclinicalpractice gcp productandcontroloperationsareclearlyspecifiedinawrittenformandgmprequirementsareadopted 04thoct 2011 3 maharashtracollegeofpharmacy nilanga thesystemofqualityassurance managerialresponsibilitiesareclearlyspecifiedinjobdescriptionarrangementsaremadeforthemanufacture supplyanduseofthecorrectstartingandpackagingmaterials allnecessarycontrolsonstartingmaterials intermediateproducts andbulkproductsandotherin processcontrols calibrations andvalidationsarecarriedout 04thoct 2011 4 maharashtracollegeofpharmacy nilanga thesystemofqualityassurance thefinishedproductsiscorrectlyprocessedandcheckedaccordingtothedefinedprocedures pharmaceuticalproductsarenotsoldorsuppliedbeforetheauthorizedpersonshavecertifiedthateachproductionbatchhasbeenproducedandcontrolledinaccordancewiththerequirementsofthemarketingauthorizationandanyotherregulationsrelevanttotheproduction controlandreleaseofpharmaceuticalproducts 04thoct 2011 5 maharashtracollegeofpharmacy nilanga thesystemofqualityassurance satisfactoryarrangementsexisttoensure asfaraspossible thatthepharmaceuticalproductsarestoredbythemanufacturer distributedandsubsequentlyhandledsothatqualityismaintainedthroughouttheirshelf life thereisaprocedureforself inspectionand orqualityauditthatregularlyappraisestheeffectivenessandapplicabilityofthequalityassurancesystem 04thoct 2011 6 maharashtracollegeofpharmacy nilanga thesystemofqualityassurance deviationarereported investigatedandrecordedthereisasystemforapprovingchangesthatmayhaveanimpactonproductqualityregularevaluationsofthequalityofpharmaceuticalproductsshouldbeconductedwiththeobjectiveofverifyingtheconsistencyoftheprocessandensuringitscontinuousimprovement 04thoct 2011 7 maharashtracollegeofpharmacy nilanga qc gmp qa qualityrelationships 04thoct 2011 8 maharashtracollegeofpharmacy nilanga qualityassurance itisthesumtotaloftheorganizedarrangementswiththeobjectiveofensuringthatproductswillbeofthequalityrequiredfortheirintendeduse 04thoct 2011 9 maharashtracollegeofpharmacy nilanga goodmanufacturingpractice isthatpartofqualityassuranceaimedatensuringthatproductsareconsistentlymanufacturedtoaqualityappropriatetotheirintendeduse 04thoct 2011 10 maharashtracollegeofpharmacy nilanga goodmanufacturingpractice raworstartingmaterialsfinishedproductspremisesandenvironmentequipmentpersonneltraininghygiene 04thoct 2011 maharashtracollegeofpharmacy nilanga 11 gmpcoversallaspectsofproductionincluding goodmanufacturingpractice 04thoct 2011 12 maharashtracollegeofpharmacy nilanga qualitycontrol isthatpartofgmpconcernedwithsampling specification testing documentation releaseprocedureswhichensurethatthenecessary relevanttestsareperformed theproductisreleasedforuseonlyafterascertainingit squality 04thoct 2011 13 maharashtracollegeofpharmacy nilanga qaandqc qcisthatpartofgmpwhichisconcernedwithsampling specifications testingandwithintheorganization documentation andreleaseprocedureswhichensurethatthenecessaryandrelevanttestsarecarriedout qaisthesumtotaloforganizedarrangementsmadewiththeobjectofensuringthatproductwillbeofthequalityrequiredbytheirintendeduse 04thoct 2011 14 maharashtracollegeofpharmacy nilanga qaandqc operationallaboratorytechniquesandactivitiesusedtofulfilltherequirementofquality allthoseplannedorsystematicactionsnecessarytoprovideadequateconfidencethataproductwillsatisfytherequirementsforquality 04thoct 2011 15 maharashtracollegeofpharmacy nilanga qaandqc qcislabbased qaiscompanybased 04thoct 2011 16 maharashtracollegeofpharmacy nilanga 04thoct 2011 17 maharashtracollegeofpharmacy nilanga 04thoct 2011 18 maharashtracollegeofpharmacy nilanga qualityassurance highlights inprocessqualitycheckinginmanufacturingvalidationoffacilities equipments process productsandcleaningcomplainthandlingstorageofqualityrecordsandcontrolsamplesstabilitystudies 04thoct 2011 19 maharashtracollegeofpharmacy nilanga qualityassuranceactivities technologytransfervalidationdocumentationcontrolassuringqualityofproductsqualityimprovementplans 04thoct 2011 20 maharashtracollegeofpharmacy nilanga 1 technologytransfer receiptofproductdesigndocumentsfromr ddepartmentdistributionofdocumentstodifferentdepartmentscheckingandapprovalofdocumentsgeneratedbasedonr ddocumentsi e batchmanufacturingrecordscale upandvalidationofproduct 04thoct 2011 21 maharashtracollegeofpharmacy nilanga 2 validation preparationofvalidationplansforfacility equipments processincludingcleaningapprovalofprotocolforvalidationoffacility equipment product processteammemberforexecutionofvalidationoffacility equipment product process 04thoct 2011 22 maharashtracollegeofpharmacy nilanga 3 documentationcontrol controlleddistributionandarchivingofdocumentscontrolofchangesmadebyproperchangecontrolprocedureapprovalofalldocuments 04thoct 2011 23 maharashtracollegeofpharmacy nilanga 4 assuringqualityofproducts cgmptrainingsopcomplianceauditoffacilityforcompliancelineclearancein processcountercheckscriticalsamplingrecordverificationreleaseofbatchformarketinginvestigationofmarketcomplaints 04thoct 2011 24 maharashtracollegeofpharmacy nilanga 5 qualityimprovementplans totakefeedbackfromdifferentdepartmentsproposalsforcorrectiveandpreventiveactionsannualproductsreviewtrendanalysisofvariousqualityparametersforproducts environmentandwater 04thoct 2011 25 maharashtracollegeofpharmacy nilanga factorsindrugqualityassurance drugproductquality labeling productinformation import exportcontrol rawmaterials active inactive manufacturingprocesses procedures storage transportdistributiondispensing use qc analysis humanresources professionals legislativeframework regulations packaging 04thoct 2011 26 maharashtracollegeofpharmacy nilanga 04thoct 2011 27 maharashtracollegeofpharmacy nilanga inprocessqualitycheckinginmanufacturing validationoffacilities equipments process productsandcleaning complainthandling storageofqualityrecordsandcontrolsamples stabilitystudies qualityassurance highlights 04thoct 2011 28 maharashtracollegeofpharmacy nilanga 04thoct 2011 29 maharashtracollegeofpharmacy nilanga equipment instrumentqualification beforeaprocesscanbevalidatedtheequipment facilities servicesusedinthatprocessmustthemselvesbevalidatedsuchanoperationisreferredtoasqualificationqualificationtherefore anintegralpartofprocessvalidationwhichinturnispartofgmp 04thoct 2011 30 maharashtracollegeofpharmacy nilanga equipment instrumentqualification 04thoct 2011 31 maharashtracollegeofpharmacy nilanga equipment instrumentqualification 04thoct 2011 32 maharashtracollegeofpharmacy nilanga whytoqualify iftheinstrumentisnotqualifiedpriortouse ifaproblemoccurs thesourceofproblemwillbedifficulttoidentify 04thoct 2011 33 maharashtracollegeofpharmacy nilanga qualificationinvolves 04thoct 2011 34 maharashtracollegeofpharmacy nilanga detailsrecordinchangecontrol requestforchangechangecontrolno datechangerelatedtoproduct document system facilityconcerneddocumentswithnumberdescriptionofchangereasonforchangeimpactofchange 04thoct 2011 35 maharashtracollegeofpharmacy nilanga detailsrecordinchangecontrol proposedmethodologyforimplementationcategoryofchangetypeofchangecomparisoncriteriaforevaluationofthechangeassessmentofimpactofchangeapprovalofchangeimplementationofchangeclosureofchange 04thoct 2011 36 maharashtracollegeofpharmacy nilanga detailsrecordedindeviationapproval deviationno deviationrelatedtoconcernedidentitynumber batchno codeno etc typeofdeviation planed unplaned descriptionofdeviationreason investigationwithdocumentcategoryofdeviationrootcauseanalysis 04thoct 2011 37 maharashtracollegeofpharmacy nilanga detailsrecordedindeviationapproval impactofdeviation onbatches products items etc immediateactioncapa correctiveandpreventiveaction impactofcapaintimationtoconcernedcommentsfromconcernedperiodicreviewfinalreviewdeviationclose outevaluationofimplementedcapa 04thoct 2011 38 maharashtracollegeofpharmacy nilanga detailsrecordedinoutofspecificationreport oosno outofspecification reportingofoosinformationofoostoimmediateseniorassessmentofanalyticaldatabyimmediateseniordiscussionbetweenanalystandimmediateseniorsamplingandanalysisdatacompilationassignablecauseidentificationfullscaleoosinvestigation causenotidentified evaluationconclusioncapaoosresultssummary 04thoct 2011 39 maharashtracollegeofpharmacy nilanga areaofselfinspection personal personaldetailspremisesincludingpersonnelfacilitiesmaintenanceofbuilding equipmentstorageofstartingmaterial finishedproducts stores equipmentproduction in processcontrolscephalosporinmfg packingmanufacturingpackingqualitycontroldocumentationsanitation hygienevalidationandrevalidationprogram 04thoct 2011 40 maharashtracollegeofpharmacy nilanga areasofselfinspection calibrationofinstrumentsormeasurementsystemrecallprocedurecomplaintsmanagementlabelscontrolcomputerizedsystemengineeringdocumentsrelatedtoregulatoryaffairsdiscardingofresiduesqualityassurancecontroloncontractanalysisresultsofpreviousselfinspection qualityauditandanycorrectivestepstaken 04thoct 2011 41 maharashtracollegeofpharmacy nilanga detailsrecordedincomplaintinvestigationreport complaintno productnamemanufacturingandexpiryofproductsourceofcomplaintdateofreceiptofcomplaintnatureofcomplaintcategoryofcomplaint 04thoct 2011 42 maharashtracollegeofpharmacy nilanga detailsrecordedincomplaintinvestigationreport investigationimpactofcomplaintonotherbatches productsbatches productsreviewcapaimpactofcapaimplementationofpreventiveactioncloseoutofcomplaint 04thoct 2011 43 maharashtracollegeofpharmacy nilanga acceptancecriteria 04thoct 2011 44 maharashtracollegeofpharmacy nilanga rpn riskprioritynumber 04thoct 2011 45 maharashtracollegeofpharmacy nilanga rootcauseanalysis 04thoct 2011 46 maharashtracollegeofpharmacy nilanga regulatorycomplianceforpharmaceuticalproduct 04thoct 2011 47 maharashtracollegeofpharmacy nilanga regulatoryrequirements regulatoryrequirementsarepartoftheprocessofdrugdiscoveryanddrugdevelopment regulatoryrequirementsdescribewhatisnecessaryforanewdrugtobeapprovedformarketinginanyparticularcountry intheus itisthefunctionofthefoodanddrugadministration fda toestablishtheseregulatoryrequirements theeuropeanmedicinesagency ema andjapanesepharmaceuticalsandmedicaldevicesagency pmda arealsoimportantregulatoryauthoritiesindrugdevelopment thesethreeagenciesoverseethethreelargestmarketsfordrugsales 04thoct 2011 48 maharashtracollegeofpharmacy nilanga regulatorycompliance ingeneral compliancemeansconformingtoarule suchasaspecification policy standardorlaw regulatorycompliancedescribesthegoalthatcorporationsorpublicagenciesaspiretointheireffortstoensurethatpersonnelareawareofandtakestepstocomplywithrelevantlawsandregulations 04thoct 2011 49 maharashtracollegeofpharmacy nilanga pharmaceuticalproductqualitycannotbetestedin itisbuiltin pharmaceuticalproductqualityisassuredbycomprehensivedevelopmentprogramextensivemanufacturingandenvironmentalcontrolsrigorousvalidationproceduresandrequirementscompliancetoregulatoryrequirementsthehighqualitythusbuiltintothefinalproductisensuredthroughin processcontrolsandverifiedinaseriesofconfirmatorytestsbeforeeachmanufacturedbatchisreleasedtothemarket 04thoct 2011 50 maharashtracollegeofpharmacy nilanga quality qualityofmanpower qualification training qualityofmaterials specifications approvedsuppliers qualityofmeans qualifiedequipments maintenance qualityofmedia gmppremises controlledenvironment qualityofmethods calibration validation compositionofquality 04thoct 2011 51 maharashtracollegeofpharmacy nilanga functionsofaqualityunit qualitycontrolsamplingandtestingofcomponents rawmaterials packingmaterials intermediatesandfinishedproductscompliancetogoodlaboratorypractices glps 04thoct 2011 52 maharashtracollegeofpharmacy nilanga functionsofaqualityunit qualityassurancedesigningrobustqualitysystemsensurecompliancetorelevantregulatoryrequirementsensurecompliancetorequirementsofgoodmanufacturingpractices gmp 04thoct 2011 53 maharashtracollegeofpharmacy nilanga valueadditioninqafunction qualityassurance performstructuredself inspectionauditsatregularintervalstopreventanyfailureornon conformancecriticallyanalyzethequalitynon conformanceissuesandsuggestcorrectiveandpreventiveactions 04thoct 2011 54 maharashtracollegeofpharmacy nilanga valueadditioninqafunction qualityassurance performdocumentationaudittoensurerealisticrecordingofalltherelevantprocessparametersreviewtheadequacyofin processcontrolcheckstopreventanypotentialfailures 04thoct 2011 55 maharashtracollegeofpharmacy nilanga valueadditioninqafunction qualityassurance training knowledgemanagementperformliteraturesurveyoffda ich isoguidelines revisionsinthepharmacopoeialspecificationsandthecurrentregulatoryrequirementsandprovidetrainingtotheproductionpersonnel 04thoct 2011 56 maharashtracollegeofpharmacy nilanga valueadditionofregulatoryfunctiontoenhancequalityassurance regulatorycompliance knowledgeofthecurrentinternationalregulatoryrequirementscomprehensivecompilationofthe productregistrationdossiers forthespecificcustomercountries 04thoct 2011 57 maharashtracollegeofpharmacy nilanga regulatoryapproval api drugproduct manufacturingplant cro bioequivalence clinicaltrials api drugproduct regulatorydossiers national regional global re registration renewal postapprovalchanges regulatorycompliance 04thoct 2011 58 maharashtracollegeofpharmacy nilanga regulatorycompliance national regional global regulatorycompliance 04thoct 2011 59 maharashtracollegeofpharmacy nilanga national india complianceto drugs cosmeticsact1940 rulesunder 04thoct 2011 60 maharashtracollegeofpharmacy nilanga national india 04thoct 2011 61 maharashtracollegeofpharmacy nilanga regional us 04thoct 2011 62 regional europe 04thoct 2011 63 regional others 04thoct 2011 64 global 04thoct 2011 65 regulatorydossier ctddossiercomponentmodule1 administrative prescribinginformation regionspecific module2 ctdsummaries qualityoverallsummary thenon clinicaloverview summaries clinicaloverviews summaries module3 quality cmc module4 nonclinicalstudyreports documentationontoxicologicalandpharmacologicaltests module5 clinicalstudyreports forgenerics bioequivalencestudy ctdorganizationisbasedonm4 organizationofthectdm4e thectd efficacym4q thectd qualitym4s thectd safety 04thoct 2011 66 maharashtracollegeofpharmacy nilanga 04thoct 2011 67 maharashtracollegeofpharmacy nilanga regulatorydossier regulatoryapproach 04thoct 2011 68 regulatorydossier regulatoryapproach 04thoct 2011 69 specificrequirementsofanusanda qos inqbrformat qualityoverallsummary question basedreview exhibitbatches 1batch stabilitydataatthetimeofsubmission 3months tse bsecertificate transmissiblespongiformencephalopatics bovinespongiformencephalopathy structuredproductlabeling spl sidebysidelabelingcomparisonovistatement organicvolatileimpurities financialcertification disclosurestatement bioequivalencestudy environmentalassessmentorclaimforcategoricalexclusiondeclarationundergenericdrugenforcementact debarmentcertification convictionstatement patentcertification exclusivitystatementappointmentofusagent letterofusagentauthorizationcopyofexecutedbatchrecords 04thoct 2011 70 maharashtracollegeofpharmacy nilanga specificrequirementsofaneudossier releasetestingineu qp exhibitbatches 2batches stabilitydata 6months processvalidationstudyreleaseandshelflifespecificationmicrobiologicalconsiderationstse bsecertificatespc summaryofproductcharacteristics braillelabeling justanotherwaytoreadandwriteenglish readabilitytesting 04thoct 2011 71 maharashtracollegeofpharmacy nilanga regulatoryapproval productapproval authorizationsuccessfulregistrationoftheproductinthetargetmarketinvolves successfulreviewofapidmf cossuccessfulauditofapiplant whereverapplicable successfulreviewofdrugproductdossier anda maaetc cmcdatareviewbioequivalencestudydatareviewadministrativedatareviewsuccessfulauditofthedrugproductmanufacturingplantsuccessfulauditofthebioequivalencestudycro 04thoct 2011 72 maharashtracollegeofpharmacy nilanga qualityassurance commonregulatorycomplianceissues apiinfringingrouteofsynthesisnotconsistentwithrespectivepharmacopoeialrequirementimpurityprofileoutoflimitresidualsolventsnotmeetingtherequirementsunapprovedsiteofmanufacture byconcernedregulatorybody unacceptablephysico chemicalproperties particlesize polymorphism bulkdensity etc frommanufacturerwhodoesnotassureuninterruptedsupplyofapiunapprovedvendor bydrugproductmanufacturer useofnondmf cosmaterial e g us europeetc highcost commercialviability 04thoct 2011 73 excipientuseofrarelyavailable orcommonlynotusedexcipientsuseofnongrasmaterials generallyrecognizedassafe incompatiblenotconsistentwithrespectivepharmacopoeialrequirementresidualsolventsnotmeetingtherequirementstse bse gmo geneticallymodifiedorganisms unapprovedvendorunacceptablephysico chemicalandfunctionalproperties particlesize bulkdensity viscositygrade surfacearea degreeofpolymerizationetc frommanufacturerswhodonotassureuninterruptedsupplyhighcost commercialviability qualityassurance commonregulatorycomplianceissues 04thoct 2011 74 maharashtracollegeofpharmacy nilanga formulationdevelopmentpre formulationimproperapicharacterizationintrinsicsolubilityphdependentsolubilitysaturationsolubilityparticlesizepolymorphbulkdensityhygroscopicitystudyimpurityprofileetc wrong