FDA Suggests Preoperational Review Meetings Before Submitting NDAs For Continuous Manufacturing
This article was originally published in The Gold Sheet
FDA suggests early site visits before submitting NDAs and supplements for continuous manufacturing to smooth over rough patches before pre-approval inspections. Agency also shares some insights on what inspectors will be looking for during PAIs of continuous manufacturing facilities.
You may also be interested in...
Performance-Based Conditions Could Ease Post-Approval Changes For Process Analytical Technologies, Experts Say
Pharmaceutical industry officials are promoting the idea of “marrying” the concepts of performance-based approaches and process analytical technology in the draft ICH Q12 guideline. Embedding this idea in ICH Q12 would give industry more flexibility in managing post-approval changes and aligns with the guideline’s concept of lifecycle improvement.
2020 is when supply chain partners must agree on a vision for the track-and-trace anticounterfeiting system due in November 2023, experts tell the Pink Sheet.
US FDA warns that Health Pharma USA was shipping product before its quality unit could review and test it.