fda官员原料药检查指南(中)

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1、EDIT:MadeavailablebyORA/OE/DCIQA01/29/03-undatedMSWordfilereceivedfromCDER&tableformatrevisedFoodandDrugAdministrationComplianceProgramGuidanceManualPROGRAM7356.002FCHAPTER56-DRUGQUALITYASSURANCE第56章—药物质量保证SUBJECT:主题IMPLEMENTATIONDATE*ACTIVEPHARMACEUTICALINGREDIENTS(A

2、PIs)*活性药物成分UponReceiptCOMPLETIONDATEContinuingDATAREPORTINGPRODUCTCODESPRODUCT/ASSIGNMENTCODESIndustryCodes:54and56SeeBelow56002F-ActivePharmaceuticalIngredientProcessInspections(DrugQualityAssurance)56008A-DrugProductSurveillance,CDERInitiated56008H-DrugProductSurvei

3、llance,ImportedDrugs,CDERandDistrictInitiatedsurveys56R806-ForeignRoutineDrugSurveillanceInspections*FIELDREPORTINGREQUIREMENTSOAIALERTSWhenthedistrictbecomesawareofanysignificantadverseinspectional,analytical,orotherinformationthatcouldorshouldaffecttheagency'snewpro

4、ductapprovaldecisionswithrespecttoan*activepharmaceuticalingredientmanufacturerreferencedinanapplication,*thedistrictshouldimmediatelynotifyHFC-240,MedicalProductsQualityAssuranceStaff,viaEMSorFAX.HFC-240willthenconveytheinformationbyFAXorequivalentexpeditiousmeanstot

5、he*DivisionofManufacturingandProductQuality(HFD-320)inCDER'sOfficeofCompliance.*Whenthedistrictbecomesawareofanysignificantadverseinspectional,analytical,orotherinformationthatcouldorshouldaffecttheagency'snewproductapprovaldecisionswithrespecttoan*activepharmaceutica

6、lingredientmanufacturerreferencedinanapplication,*thedistrictshouldimmediatelynotifyHFC-240,MedicalProductsQualityAssuranceStaff,viaEMSorFAX.HFC-240willthenconveytheinformationbyFAXorequivalentexpeditiousmeanstothe*DivisionofManufacturingandProductQuality(HFD-320)inCD

7、ER'sOfficeofCompliance.*PROCESSPROFILEREPORTING*InDecember1995,attherequestofCDER,theMedicalProductsQualityAssuranceStaff(HFC-240)addedprofileclassesCSN(NonSterileAPIbyChemicalSynthesis)andCSS(SterileAPIbyChemicalSynthesis)tothedrugprofileclassificationsystem.Thischan

8、gewasrequestedbecauseseparateprofileclassesexistedfornonsterileandsterileactivepharmaceuticalingredientsproducedbyfermentati