Quality_Management_System_for_Pharmaceutical_Compa

QualityManagementSystemforActivepharmaceuticalIngredientsmanufacturersIntegratingGMPintoISO9001December1997QualityManagementSystem-integratingGMPintoISO1TableofcontentsA.Acknowledgement.................................................................................................3B.Introduction..........................................................................................................5C.Glossary.................................................................................................................8D.Qualitysystem......................................................................................................161.Managementresponsibility.....................................................................162.Qualitysystem........................................................................................193.Contractreview......................................................................................214.Designanddevelopmentcontrol.............................................................235.Documentcontrol...................................................................................276.Purchasing..............................................................................................297.Controlofcustomer-suppliedproduct....................................................318.Productandequipmentidentificationandtraceability..............................329.Manufacturingprocesscontrol...............................................................3410.Inspectionandtesting.............................................................................3811.Controlofinspection,measuringandtestequipment...............................4312.Inspectionandteststatus........................................................................4513.Controlofnonconformingproduct.........................................................4614.Correctiveandpreventiveaction.............................................................4715.Handling,storage,packaging,preservationanddelivery.........................4916.Controlofqualityrecords.......................................................................5217.Internalqualityaudits.............................................................................5418.Training..................................................................................................5519.Servicing................................................................................................5620.Statisticaltechniques..............................................................................57AnnexA:Hygiene............................................................................................58AnnexB:Facilitiesandcleaning,utilitiesandengineering..................................60AnnexC:Validation.........................................................................................64AnnexD:Changecontrol.................................................................................68E.Rationaleandbenefits........................................................................................70F.Qualitysystemperformancemeasurements..................................................73G.Matrix..........................................................................................................….....75H.References.....................................................................................................…....85QualityManagementSystem-integratingGMPintoISO2A.AcknowledgementsTheBPCC,asectorgroupofCEFICacknowledgesthefollowingdocumentswhichhavebeenusedasbasisfortheestablishmentofthepresentguideline:-EFPIA/CEFICGoodManufacturingPracticesforActiveIngredientManufacturerspublishedinAugust1996,and-ENISO9001QualitySystems:ModelforQualityAssuranceinDesign,Development,Production,InstallationandServicingpublishedinJuly1994.ThemembersoftheBPCCadhocworkinggroupwhodevelopedandpreparedthisdocumentareasfollows:•W.Adams(MerckSharp&Dohme)•L.Hartmann(Hoffmann-LaRoche)•R.Hopkins(GlaxoWellcome)•L.deMorsier(Chair,Novartis)•A.Rossetti(Pharmacia&Upjohn)•J.Ruiz(EsteveQuimica)•J.M.Teward(GlaxoWellcome).WewishtothanktheSecretaryGeneraloftheEuropeanCommitteeforStandardisationforconfirmingthatthisdocumentdoesnotviolateanyCENcopyrightrules.QualityManagementSystem-integratingGMPintoISO3B.IntroductionBecausethepharmaceuticalindustryhastraditionallyfocusedupontheapplicationofGoodManufacturingPractice(GMP),ithasbeenslowtoconsiderthepotentialbenefitstobegainedbyimplementinganENISO9001QualityManagementSystem(QMS).Overthelastfewyearstheglobalpharmaceuticalmarkethasundergonesignificantchange,forcingpharmaceuticalcompanies,morethaneverbefore,tofocusoncustomerneedsandupontheirowninternalefficiencyinordertocontinuetocompeteeffectively.WiththisinmindCEFICcommissionedaworkinggroupofexpertsdrawnfromseveralmajorActivePharmaceuticalIngredients(API)producerstoprepareapractical,user-friendlyguidancedocumentintegratingcurrentGMPrequirementsintotheEN-ISO9001QMSframework.Toachievethis