The Quality Lowdown: US FDA Renews Attention To Contamination Challenges
Executive Summary
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.
You may also be interested in...
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?
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.
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.