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Bowman Cox

Executive Editor

Washington, DC
Bowman Cox leads the Pink Sheet's coverage of pharmaceutical manufacturing quality issues. He writes and edits articles on the challenges and opportunities that developments in science, technology and regulatory policy pose to drug manufacturers and their quality organizations.

Latest From Bowman Cox

HHS OIG: US FDA Inspection Manual Revision Could Reduce Unannounced Inspections Abroad

Poor inspection history was dropped as a criteria for unannounced inspections, OIG says in an audit report, even as support grows for surprise inspections of poor quality sites. An exhaustive review of foreign for-cause inspections shows the FDA reorganization has sped up a process that must go faster still. Meanwhile, whatever happened to experienced investigators’ training records?

Manufacturing Quality

ICMRA’s Pilot On Hybrid Inspections And CMC Changes Seeks Participants

Driven by COVID-19 pandemic challenges, regulatory authorities from multiple regions want to work with sponsors on new joint approaches for expediting manufacturing changes globally and streamlining preapproval and pre-licensing inspections.

Manufacturing Quality

US FDA Would Allow Separation Alternatives In Manufacture Of Low-Risk Beta-Lactams

Proposed guidance revision adds nuance to manufacturing facility separation expectations for beta-lactam compounds that pose less risk of anaphylaxis than penicillin and related antibiotics.

Manufacturing Quality

The Quality Lowdown: US FDA Renews Attention To Contamination Challenges

All-out efforts by agency staff to help industry supply COVID-19 treatments last year were applauded but now its attention returns to the top pre-pandemic priority, contamination risks. Edge Pharma consents to attack mold, Glicerinas blocked over inspection refusal, Bioiberica hit for ‘reprocessing’ contaminated drug substance, Rentschler bashed for inadequate monitoring.

Manufacturing Quality

Continuous Pharmaceutical Manufacturing Bill Hitches A Ride With US FDA User Fee Legislation

US legislation could advance new manufacturing platforms for drugs and biologics with academic R&D and workforce development and in turn spur domestic growth.

Platform Technologies Research & Development

US FDA Poses Next-Level GMP Challenges For Aurobindo's Polepally Site

Agency conducts follow-up inspection as Aurobindo's Polepally, India, manufacturing facility looks to move on from crippling OAI designation.

Manufacturing Quality
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