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

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Production (cont.)‣ Product “Y” commercial process lacks consistentprocess control (significant adjustments after processvalidation, inconsistent yields)‣ Incomplete process validation (addition of processcontrol parameters, modifications to set points,changes to process design after “validation”)‣ Inadequate microbial control‣ Resin and UF/DF lifetime not monitored formicrobial control‣ Inadequate management of buffer and productcontacthoses38
Laboratory‣Assays not appropriate for their intendedpurpose and/or not qualified‣Laboratory records for the potency assay donot have sufficient detail, do not crossreference appropriate procedures to ensureconsistent method execution, and do notdescribe all steps‣Inappropriate handling and storage of thereference standard39
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: Production‣Discrepancies between
Page 41 and 42: Additional Information/Resources‣
Page 43: Contact InformationAnastasia Lolas3

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

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