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

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Pre-License & Pre-ApprovalInspections24
Purpose of Inspection‣Meet statutory obligation in FD&C and PHSActs‣Verify compliance with CGMP and applicablesections of 21 CFR 600 and 21 CFR 210 and 211‣Verify compliance with commitmentssubmitted in the application‣Evaluate process consistency for safe, pureand potent products25
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: Review Issues‣ Bulk thaw & hold l
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

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