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

More documents

Recommendations

Info

FDA Form 483 Observationsfrom BMT-led <strong>Inspections</strong>30
Quality Oversight‣Inadequate quality oversight• Drug substance batches with high bioburdencounts released• Batches that exceeded validated parameterranges upstream and were processeddownstream• Missed water samples, inadequate tracking anddocumentation to ensure that water andenvironmental monitoring samples are obtainedat the specified frequencies31
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: Inspection Outcome & Approval‣A r
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 ...

You also want an ePaper? Increase the reach of your titles

Delete template?

Save as template?