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

More documents

Recommendations

Info

Equipment‣Inadequate validation of sterile hold time forbioreactor‣Ineffective schedules and procedures forpreventive maintenance of equipment (largenumber of production process deviations dueto equipment failures)‣Inadequate validation of dirty hold times36
Production‣Discrepancies between manufacturing processsubmitted in the BLA and batch records‣Inadequate aseptic technique observedduring final bulk filtration‣Hold times for in-process intermediates andeluates not validated‣Effect of used and repacked resins on productquality not qualified‣UF/DF membrane lifetime not established37
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: Utilities‣High bioburden counts f
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 ...

Create successful ePaper yourself

Delete template?

Save as template?