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

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Biotech Manufacturing Team‣Ensure that safe, pure and potenttherapeutic biological products areavailable to the public‣Accomplished through CMC reviews <strong>of</strong> BLAand supplement submissions, PLI/PAIinspections and formal meetings withindustry in close collaboration with ONDand OBP14
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: Organization13
Page 17 and 18: Application Review17
Page 19 and 20: Drug ProductBMT Review of a BLAMicr
Page 22 and 23: Review Issues‣ Facility registrat
Page 24 and 25: Pre-License & Pre-ApprovalInspectio
Page 26 and 27: Pre-License & Pre-ApprovalInspectio
Page 28 and 29: Inspection Classification‣No acti
Page 30 and 31: FDA Form 483 Observationsfrom BMT-l
Page 32 and 33: RecordsRecord control is inadequate
Page 34 and 35: Facility Premises‣ Pest control i
Page 36 and 37: Equipment‣Inadequate validation o
Page 38 and 39: Production (cont.)‣ Product “Y
Page 40 and 41: Materials‣ Validated expiration o
Page 42 and 43: Acknowledgements• Patricia Hughes

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