who-gmp培训(物料管理)

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1、BasicPrinciplesofGMPMaterialsPartOneSection13MaterialsObjectivesToreviewspecificrequirementsforeachtypeofmaterial:StartingmaterialsPackagingmaterialsIntermediateandbulkproductsFinishedproductsRejectedandrecoveredmaterialsRecalledproductsReturnedgoodsReagentsandculturemediaReferencestandard

2、sWastematerialsMiscellaneousmaterials.Toexamine(ingroups)theproblemsassociatedwithmaterials,andhowtoovercomethem.MaterialsPrincipleObjectiveofthepharmaceuticalmanufacturer:producefinishedproductscombinationofmaterialsMaterialscombined:activepharmaceuticalingredientsauxiliarymaterials(excip

3、ients)packagingmaterialsSpecialattentionPartOne13.2–13.3MaterialsGeneralrequirementsformaterialsAllincomingmaterialsandfinishedproducts:quarantinedafterreceipt,untilreleasedforusedistributionstoredunderappropriateconditionsorderlyfashion(batchsegregation)materialsmanagementstockrotation(FI

4、FOorEEFO))PartOne13.4–13.7MaterialsStartingMaterials–IPurchasingSuppliersConsignment:integritysealorderdeliverynotesupplier’slabelsCleanedandlabelledPartOne13.8–13.11MaterialsStartingMaterials–IIDamagedcontainersDifferentbatchesinoneconsignmentStartingmateriallabel:nameandinternalcodebatch

5、number(s),(supplierandmanufactureronreceipt)statusexpirydateorre-testdateSampledcontainersidentifiedMaterialsExamplesofLabellingofStartingMaterialsPartOne13.12–13.15MaterialsStartingMaterials–IIIUseonlyreleasedmaterialDispensing:designatedpersonswrittenprocedureaccuratelyweighedclean,label

6、ledcontainersIndependentchecksmaterialandweightDispensedmaterial:kepttogetherandlabelledPartOne13.16–13.20MaterialsPackagingmaterialsIPrimaryandprintedmaterials:asforstartingmaterialspurchasing,handlingandcontrolNounauthorizedaccessStorageandtransportavoidmix-upsissueandreturn:SOPPartOne13

7、.16–13.20MaterialsPackagingmaterialsIISpecificreferencenumberforbatchorconsignmentPackagingdepartmentchecks:quantity,identityandconformityOutdatedorobsoletematerialPartOne13.21–13.22MaterialsIntermediateandbulkproductsAppropriateconditionsPurchased:asstartingm