WHO-GMP培训(物料管理).ppt

BasicPrinciplesofGMP Materials PartOneSection13 Materials ObjectivesToreviewspecificrequirementsforeachtypeofmaterial StartingmaterialsPackagingmaterialsIntermediateandbulkproductsFinishedproductsRejectedandrecoveredmaterialsRecalledproductsReturnedgoodsReagentsandculturemediaReferencestandardsWastematerialsMiscellaneousmaterials Toexamine ingroups theproblemsassociatedwithmaterials andhowtoovercomethem Materials PrincipleObjectiveofthepharmaceuticalmanufacturer producefinishedproductscombinationofmaterialsMaterialscombined activepharmaceuticalingredientsauxiliarymaterials excipients packagingmaterialsSpecialattention PartOne13 2 13 3 Materials GeneralrequirementsformaterialsAllincomingmaterialsandfinishedproducts quarantinedafterreceipt untilreleasedforusedistributionstoredunderappropriateconditionsorderlyfashion batchsegregation materialsmanagementstockrotation FIFOorEEFO PartOne13 4 13 7 Materials StartingMaterials IPurchasingSuppliersConsignment integritysealorderdeliverynotesupplier slabelsCleanedandlabelled PartOne13 8 13 11 Materials StartingMaterials IIDamagedcontainersDifferentbatchesinoneconsignmentStartingmateriallabel nameandinternalcodebatchnumber s supplierandmanufactureronreceipt statusexpirydateorre testdateSampledcontainersidentified Materials ExamplesofLabellingofStartingMaterials PartOne13 12 13 15 Materials StartingMaterials IIIUseonlyreleasedmaterialDispensing designatedpersonswrittenprocedureaccuratelyweighedclean labelledcontainersIndependentchecksmaterialandweightDispensedmaterial kepttogetherandlabelled PartOne13 16 13 20 Materials PackagingmaterialsIPrimaryandprintedmaterials asforstartingmaterialspurchasing handlingandcontrolNounauthorizedaccessStorageandtransportavoidmix upsissueandreturn SOP PartOne13 16 13 20 Materials PackagingmaterialsIISpecificreferencenumberforbatchorconsignmentPackagingdepartmentchecks quantity identityandconformityOutdatedorobsoletematerial PartOne13 21 13 22 Materials IntermediateandbulkproductsAppropriateconditionsPurchased asstartingmaterials PartOne13 23 13 24 Materials FinishedproductsQuarantineuntilreleasedStorageconditionsEvaluationanddocumentationproductrelease PartOne13 25 13 28 Materials RejectedandrecoveredmaterialsRejectedmaterialsClearlymarkedStoredseparatelyinrestrictedareasActionReprocessing exceptionalprocedureandrecordsbatchnumberadditionaltesting PartOne13 25 13 28 Materials RejectedandrecoveredmaterialsRecovery priorauthorizationadditionaltesting PartOne13 29 13 30 Materials RecalledproductsandreturnedgoodsRecalledproducts identifiedstoredseparatelyaccesscontrolledfateReturnedgoods SOP decisionregardingthefatenatureofproduct storageconditionshistory timelapserecords PartOne13 31 13 33 Materials ReagentsandculturemediaRecordeduponreceiptorpreparationReagents preparationinaccordancewithSOPlabel concentration standardisationfactor shelf life datethatre standardisationisdue storageconditionssignedanddatedCulturemedia positiveandnegativecontrols PartOne13 34 13 37 Materials ReferencestandardsOfficialreferencestandardsuseonlyaspermonographstorageReferencestandardspreparedbytheproducer tested releasedstoredinsamewayasofficialreferencestandardsSecondaryorworkingstandards appropriatechecksandtestsregularintervalsbasedonofficialreferencestandards PartOne13 38 13 40 Materials WastematerialsandmiscellaneousmaterialsWastematerialsproperandsafestoragetoxicandflammablema