WHO-GMP培训物料管理PPT课件.ppt

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1、BasicPrinciplesofGMPMaterialsPartOneSection13MaterialsObjectivesToreviewspecificrequirementsforeachtypeofmaterial:StartingmaterialsPackagingmaterialsIntermediateandbulkproductsFinishedproductsRejectedandrecoveredmaterialsRecalledproductsReturnedgoodsReagentsandculturemediaRefere

2、ncestandardsWastematerialsMiscellaneousmaterials.Toexamine(ingroups)theproblemsassociatedwithmaterials,andhowtoovercomethem.MaterialsPrincipleObjectiveofthepharmaceuticalmanufacturer:producefinishedproductscombinationofmaterialsMaterialscombined:activepharmaceuticalingredientsau

3、xiliarymaterials(excipients)packagingmaterialsSpecialattentionPartOne13.2–13.3MaterialsGeneralrequirementsformaterialsAllincomingmaterialsandfinishedproducts:quarantinedafterreceipt,untilreleasedforusedistributionstoredunderappropriateconditionsorderlyfashion(batchsegregation)ma

4、terialsmanagementstockrotation(FIFOorEEFO))PartOne13.4–13.7MaterialsStartingMaterials–IPurchasingSuppliersConsignment:integritysealorderdeliverynotesupplier’slabelsCleanedandlabelledPartOne13.8–13.11MaterialsStartingMaterials–IIDamagedcontainersDifferentbatchesinoneconsignmentSt

5、artingmateriallabel:nameandinternalcodebatchnumber(s),(supplierandmanufactureronreceipt)statusexpirydateorre-testdateSampledcontainersidentifiedMaterialsExamplesofLabellingofStartingMaterialsPartOne13.12–13.15MaterialsStartingMaterials–IIIUseonlyreleasedmaterialDispensing:design

6、atedpersonswrittenprocedureaccuratelyweighedclean,labelledcontainersIndependentchecksmaterialandweightDispensedmaterial:kepttogetherandlabelledPartOne13.16–13.20MaterialsPackagingmaterialsIPrimaryandprintedmaterials:asforstartingmaterialspurchasing,handlingandcontrolNounauthoriz

7、edaccessStorageandtransportavoidmix-upsissueandreturn:SOPPartOne13.16–13.20MaterialsPackagingmaterialsIISpecificreferencenumberforbatchorconsignmentPackagingdepartmentchecks:quantity,identityandconformityOutdatedorobsoletematerialPartOne13.21–13.22MaterialsIntermediateandbulkpro

8、ductsAppropriateconditionsPurchased:asstartingm