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1、ActivePharmaceuticalIngredientAdiscussionfromCGMPperspectiveApril20061WhatisanActive PharmaceuticalIngredient?Theintendeduseclause:Anysubstanceormixtureofsubstancesintendedtobeusedinthemanufactureofadrug(medicinal)productandthat,whenusedintheproductionofadrug,becomesanactiveingredientofthedrug
2、product.2WhatisanActive PharmaceuticalIngredient?Thepharmacologicalactivityclause:Suchsubstancesareintendedtofurnishpharmacologicalactivityorotherdirecteffectinthediagnosis,cure,mitigation,treatment,orpreventionofdiseaseortoaffectthestructureandfunctionofthebody3WhatisanIntermediate?Amaterialp
3、roducedduringAPIprocessingthatundergoesfurthermolecularchangeorpurificationbeforeitbecomestheAPIMayormaynotbeisolated4RegulatoryStatusofAPIsinUSDefinitionof“drug”intheFederalFood,Drug,andCosmeticActencompassesAPIsSection501(a)(2)(B)oftheActrequiresthatalldrugsbemanufactured,processed,packed,an
4、dheldinaccordancewithcurrentgoodmanufacturingpracticeCGMPregulations(21CFR210and211)applyonlytopreparationofdrugproducts5APIDrugProductChemical&BiologicalProcessing(synthesis,fermentation,extraction,purification)PhysicalProcessing(granulating,dissolving,mixing,compressing)DifferentFacilities,E
5、quipmentandProcessesProcessCharacteristicsAPIVs.DrugProduct6CharacteristicsofAPIProcessesAPIscanbeproducedbychemicalorenzymaticreactions,recombinantDNA,fermentation,recoveryfromnaturalmaterials,oracombinationoftheseprocessesUsuallyinvolvessynthesis,extraction,orcrystallizationresultinginsignif
6、icantchangestostartingmaterials/intermediatesTypicallyincludepurificationsteps7CharacteristicsofDPProcessesDrugproductsformulatedusingbulkrawmaterialsthatareusuallysubjectedtoqualitycontrolbyendusersGenerallyinvolvesphysicalprocessingandmanipulationsTypicallydonotincludepurificationsteps8ICHQ7
7、ASinceUSFDAdoesnothavearegulationspecificallyaddressingGMPrequirementregardingAPImanufacturingTherefore,ICHQ7AisusedasaGMPcompliancereference9ProcesswaterqualityStartingmaterialsBlendingofintermediatesandAPIsInprocesscontrolsProcessvali
