Regulatory Filing & Pre- License/Pre-Approval Inspections of ...

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21 CFR 601.2 - Applications forbiologics licenses; procedures for filing(a) General. To obtain a biologics license…themanufacturer shall submit an application……and the address of each location involved in themanufacture of the biological product shall belisted in the biologics license application. Anapplication for a biologics license shall not beconsidered as filed until all pertinent informationand data have been received…10
21 CFR 601.20 – Biologics licenses;issuance and conditions‣Product examination - compliance withrequirements‣Availability of product for examination andinspection during all phases of manufacture‣Inspection - compliance with requirements‣One biologics license to cover all locations;each location subject to inspection by FDA11
Page 1 and 2: Regulatory Filing & Pre-License/Pre
Page 3 and 4: Regulatory Authority3
Page 6: 21 CFR Part 601 - LicensingRelevant
Page 9: “Specified” Biological Products
Page 13 and 14: Organization13
Page 16 and 17: Division of Manufacturing and Produ
Page 18 and 19: BMT Review of a BLADrug Substance
Page 20: BMT Review of a BLADrug Product (co
Page 23 and 24: Review Issues‣ Bulk thaw & hold l
Page 25 and 26: Purpose of Inspection‣Meet statut
Page 27 and 28: Inspection StrategySystems-based‣
Page 29 and 30: Inspection Outcome & Approval‣A r
Page 31 and 32: Quality Oversight‣Inadequate qual
Page 33 and 34: SOPs‣ SOPs are not executed consi
Page 35 and 36: Utilities‣High bioburden counts f
Page 37 and 38: Production‣Discrepancies between
Page 39 and 40: Laboratory‣Assays not appropriate
Page 41 and 42: Additional Information/Resources‣
Page 43: Contact InformationAnastasia Lolas3

Regulatory Filing & Pre- License/Pre-Approval Inspections of ...

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