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

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Materials‣ Validated expiration or use-by dates forcritical raw materials not supported by data(cell culture medium)‣ Materials not appropriately segregated(quarantined, released, etc.)40
Additional Information/Resources‣ FD&C and PHS Acts‣ 21 CFR 210, 211, 600s‣ CP 7356.002M “Inspections of Licensed BiologicalTherapeutic Drug Products”‣ Investigations Operations Manual‣ Guidance documents‣ MAPP 4730.3 “Office of Biotechnology Products and Officeof Compliance Division of Manufacturing & Product QualityInteractions on BLA Assessments”‣ “CMC Microbiology Review of Biologics License Applicationsand Pre-License/Pre-Approval Inspections: TherapeuticBiological Proteins” in American Pharmaceutical Review,March 201041
Page 1 and 2: Regulatory Filing & Pre-License/Pre
Page 3 and 4: Regulatory Authority3
Page 6: 21 CFR Part 601 - LicensingRelevant
Page 9 and 10: “Specified” Biological Products
Page 11 and 12: 21 CFR 601.20 - Biologics licenses;
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: Laboratory‣Assays not appropriate
Page 43: Contact InformationAnastasia Lolas3

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

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