PQ procedureLABS.ppt

,prequalificationprogramme,qualitycontrollaboratories,oliviergross,jitkasabartovaprequalificationprogramme:priorityessentialmedicineshtp/psm/qsm,unprequalificationprogrammeforpriorityessentialmedicines,actionplanofunfrom2001forexpandingaccessofprioritymedicinestopatientswithhiv/aidsmalariatuberculosisreproductivehealthpotentiallyothercategoriesofproductsantiviralmedicinesefficaciousforavianfluepaediatricformulations,unprequalificationprogrammeforpriorityessentialmedicines,whopqteamworkinginco-operationwithpartnersunicefunpopulationfund(unfpa)unaidsunitaidtheglobalfundworldbankanti-malarialandanti-tbproducts:rollbackmalariaandstoptb(globaldrugfacility);hiv/aidsdepartment,elementsofprequalificationprogramme,objective:toensurequality,efficacyandsafetyofmedicinesprocuredusinginternationalfunds(e.g.gftam,unitaid)components:evaluationofquality,safetyandefficacyofprioritisedessentialmedicines,inspectionsofmanufacturersandmonitoringoftheproductsaftertheirprequalificationprequalificationofqualitycontrollaboratoriesbuildingcapacityofregulators,manufacturersandqualitycontrollaboratories,prequalificationofqclaboratories,needtoincreasetheaccesstoqclaboratoriesthatmeetrecommendedstandardsfortestingofmedicinesarecommittedtoprovideaserviceoftestingofmedicines,includingbutnotlimitedtohiv/aids,tuberculosisandmalariaproductstounagenciesprocedureestablishedin2004participationofaqclaboratoryisvoluntary,procedureforassessingtheacceptability,inprinciple,ofqualitycontrollaboratoriesforusebyunagencies,publishedin2004(whotrs,no.917,annex4)revisionpublishedin2007(whotrs,no.943,annex5)relateddocumentsgoodpracticesfornationalpharmaceuticalcontrollaboratories(whotrs,no.902annex3)whogmp:mainprinciplesforpharmaceuticalproducts.in:qualityassuranceofpharmaceuticals.acompendiumofguidelinesandrelatedmaterials.vol.2,2ndupdatededition.goodmanufacturingpracticesandinspection(geneva,worldhealthorganization,2007)guidelinesforpreparingalaboratoryinformationfile(whotrs,no.917,annex5),basedonthefollowingprinciples,relianceontheinformationsuppliedbythenationaldrugregulatoryauthoritygeneralunderstandingofthequalitycontrolactivitiesofthelaboratoryevaluationofinformationsubmittedbythelaboratoryassessmentofconsistencyinqualitycontrolthroughcompliancewithgmp(s)andwhoguidelines,invitationforexpressionofinterest,3rdeoipublishedinseptember2007/prequal/info_applicants/eoi/eoi-qclabsv3.pdfpreviousinvitationslimitedtoqclaboratoriesinafrica,currentlynoregionallimitationpriorityintheassessmentwillbegiventonationalqclaboratoriesandlaboratoriesprovidingtestingservicestothegovernmentqclaboratoriesinareaswhereunagenciesidentifytheneedforqualitytestinganylaboratory(privateorgovernmental)canparticipate,stepsoftheprocedure,expressionofinterestsubmissionoflaboratoryinformationlaboratoryinformationfile-lifneededtogetbasicinformationonlaboratorysactivitiesandsuggestedscopeofprequalificationagoodlifmakestheprocedurefasterguidelinesforpreparinglifavailabledocumentationandqasystem,personnel,handlingofsamples,materials,premises,equipment,contractoperationsandactivities,out-of-specificationinvestigation,self-inspectionstabilitytesting,microbiologicaltesting,watersystem,whereapplicablequalitymanualcanbesubmitted(amendedasnecessary)evidenceofparticipationinproficiencytestingschemes,stepsoftheprocedure,screeningofsubmittedlaboratoryinformationformalcompletenessamendmentrequested,ifnecessaryevaluationofthelaboratoryinformationwhocarriesoutevaluationoflifstoassessthelaboratoryspotentialtopasssuccessfullytheinspectionifthelifindicatesthatthelaboratorywouldcomply-whostartsarranginganinspectionifthelifisnotadequatewhostartsarranginganinventoryauditorasksformoreinformationorreturnsthelif,stepsoftheprocedure,siteinspection/inventoryauditplannedandcoordinatedbywho(normallyfor2-3days)expertsappointedbywhopreferablyfromregulatoryauthorityinspectorates,experiencedinqualitycontrolrequiredtosigndeclarationofinterestandconfidentialitydeclarationcompliancewithwhorecommendedstandardsgoodpracticesfornationalpharmaceuticalcontrollaboratoriesgoodmanufacturingpracticesasrecommendedbywhoforsuchlaboratoriesisocertificationencouragedandconsideredhowever,gmpaspectstobetakenintoaccountduringinspection,stepsoftheprocedure,siteinspection/inventoryaudit(cont.)fortheinspectionrepresentative(s)ofthedraofthecountrywherethelaboratoryislocatedinvitedinventoryauditlessformal,combinedwithdiscussionsofproblemsandassessmentofneedoftechnicalassistance,stepsoftheprocedure,reportandoutcomeofevaluationfinalreportintheestablishedwhoformatcommunicatedtothelaboratoryandacopysenttothenationaldraifcorrectiveactionstobetakenbythelaboratory,whopostponeitsfinalrecommendationsuntilthecorrectiveactionhasbeenevaluatedandfoundsatisfactoryincaseofdisagreement,possibilityofanappealownershipofthereportlieswithwhoresultsofassessmentinformationissenttothelaboratoryandnationaldraifcompliant,laboratoryisincludedinthepublishedlistandwhopirispublishedthelistwillbesubjectedtoreviewatleastonceayear,stepsoftheprocedure,re-evaluationafterprequalificationon-goingmonitoringre-inspectionsatregularintervals(normally3years)evaluationofresultsfromparticipationinproficiencytestingschemeswhoexternalqualityassurancescheme,afssapsnetworkoffrancophoneafricancountrieswhomaysuspendorwithdrawalaboratoryfromthelistwhenthereisevidenceofnoncompliance,stepsoftheprocedure,monitoringofcomplaintswhowillinvestigatecomplaintsconcerningtheresultsofanalysisorserviceprovidedbythelaboratorywrittenreportandwhereappropriaterecommendationsforactioncopyofthereporttothelaboratory,manufactureroftheproductanddraofthecountrywherethemanufacturingsiteislocateddracouldalsobeinvitedtoparticipateintheinvestigationofthecomplaintcostrecoverywhoreservestherighttochargeforthequalityassessmentprocedureonacost-recoverybasis,statusofprequalificationofqclabsnovember2007,4qclaboratoriesprequalifiedsouthafrica,cenqam-6/2005southafrica,riip-7/2005algeria,lncpp-10/2005southafrica,adcockingram8/20072qclaboratoriesneartopq11qclaboratoriesaudited,correctivemeasuresproposed6qclaboratoriesexpressedinterest,butnotsendlifyet,frequentdeficienciesandweakpoints(1),qualitysystemsopsnotcovering,notproperlymaintainednoqualityresponsiblenoornotenoughself-auditspersonnelnoqualificationsystemnotenoughtraining,notrainingprogrammesresponsibilitiesandtasksnotclearlydefinedonpersonallevel,vagueorganizationpremisestoosmallandunfitlimitedandunfitstorageareas(lotofcupboardsetc.needed)noregularenvironmental(atleasttemperature)monitoringarchivesnotgood,norsecured,frequentdeficienciesandweakpoints(2),maintenanceoftheequipmentnoproperoronlypartialqualificationsdocumentationingeneralverydeficientnotadequatetrainingbythesuppliersinthebeginningnopre-maintenanceprogrammereferencematerialsandreagentsmaintenancesystemandrecordsnotefficient,norclearnoworkingstandardssysteminstructions/methodsnoclearsystemastowhichpharmacopoeialormanufacturersmethodtousevalidations/verificationsofmethodsnotsufficientornon-existing,frequentdeficienciesandweakpoints(3),wastemanagementnotproperlyorganizedsafetyfumehoodslackingortoofewnoorinsufficientprotectionofthepersonnel(e.g.insufficientprotectivegarments,notraining,nosafetysheetsofthechemicals)noclassificationnorproperstorageofdangerouschemicalmaterials(e.g.toxics,caustic/volatilereagentsetc.),technicalassistance,technicalassistanceprovidedto5nationalmedicinesqualitycontrollaboratoriesassistanceinimplementationofqualitysystemassistanceinmicrobiologicaltesting13weekscapacitybuildingandtechnicalassistanceprovidedtonationalqclaboratoriesoutofthescopeoftheprequalificationprocedure,training,participationinqualityassurancetrainingofomclsorganizedbyedqmoctober2005,5participantsfromafroandemroseptember2007,12participantsfromafro,emroandeurotrainingsinqualityassurance,qualitycontrolandph.int.underpreparationnovember2007,morocco,40participantsfromfrancophonecountries(afro,emro),cooperationwithedqmdecember2007,tanzania,40participantsfromanglophonecountries(afro,emro)trainingsplannedin2008marketsurveillanceprojects,networkingofafricanlaboratories,samplingandtesting(1),surveyofthequalityofantiretroviralmedicinescirculatinginselectedafricancountriescarriedoutinjune-december2005,reportnowfinalized7countries(cameroon,drofcongo,kenya,nigeria,tanzania,ugandaandzambia)monocomponentproducts(didanosine,efavirenz,lamivudine,nevirapine,stavudine,zidovudine),fdcs(lamivudine/zidovudine,stavudine/lamivudine,stavudine/lamivudine/nevirapine)394samplesfromofficialprocurementandtreatmentcentres,bothprivateandpublictestingaccordingph.int.,usp,indianpharmacopoeia,validatedin-houseswissmedicmethods(laboratoryswissmedic)testsperformed-appearance,labelling,identification,uniformityofmass(capsules/tablets),dissolution/disintegration,ph(oralsolutions-dependinguponthematrix),relatedsubstances,contentofeachactiveingredient,samplingandtesting(2),surveyofthequalityofantiretroviralmedicinescirculatinginselectedafricancountries-findings,verylowfailureof1.8%,nocriticaldeficiencies1samplewithbrokentablets,2samplesinsufficientlylabelled