Latest From Bowman Cox
ICH general assembly adopts guidelines on continuous manufacturing and risk management; US FDA opens pilot project to expedite CMC reviews for products with accelerated review timelines; other recent topics include quality maturity inspections and compounding standards.
Pharmaceutical supply chains may grow less efficient and less risk prone as US government gets more involved to ensure availability of pandemic and essential medicines. But what about pediatric oncology medicines and other treatments that save lives even though they may not be considered essential?
Bristol-Myers Squibb’s Abraxis Unit, Nephron and Lupin hit with warning letters; Lupin and Jubilant 483 inspection reports posted.
Insights from US drug approval packages include how CMP Development navigated inspection challenges, how Novitium built a better scientific bridge, how Fresenius Kabi delivered on leachables & extractables, and how BMS addressed dissolution.
HDA finds much progress to report in seventh annual Serialization Readiness Survey, but quite a lot of work remains for many drug manufacturers and distributors if they are to meet November 2023 compliance deadline.
The US FDA revised two drug good manufacturing practice inspection programs in its compliance manual to reflect certain ICH guidance documents, efforts to control nitrosamine impurities and the use of inspection alternatives for evaluating facilities. Plus more recent developments in GMP and CMC compliance.