Bowman Cox
Executive Editor
Latest From Bowman Cox
US FDA Won't Budge On Nitrosamines Compliance Despite Complaints Of Possible Drug Shortages
Industry requests for deadline extensions, short-duration adjustments and other accommodations go nowhere as FDA expresses concerns about nitrosamines’ mutagenic potency.
How Inspectorates Will Judge Quality Systems' Ability To Manage Manufacturing Changes
PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.
Pandemic Response Strains Global Biopharmaceutical Reactor Capacity
Distress grows as manufacturers wait for suppliers to boost production. One idea: stretch inventories by qualifying single-use bioreactors for reuse.
Final PIC/S Data Integrity Guidance Encourages Foolproof Approaches To Drug Manufacturing Data
Association of inspectorates provides most detailed blueprint yet of how to assure pharmaceutical data integrity.
Lupin’s Corporate Quality Oversight Questioned In FDA Warning Letter
Two-month inspection during pandemic highlighted cross-contamination risks and process validation shortfalls at New Jersey plant.
Revamped Manufacturing Process Yields Fast-Track Ryplazim Approval Three Years Later
Plasminogen therapy for unmet need licensed after Prometic took the time to develop a manufacturing process it could validate.