The science of pharmaceutical continuous manufacturing (PCM) may not be entirely new but increasing interest in adoption of advanced manufacturing technologies (AMT) including PCM among industry and policymakers in recent years has been accompanied by strong support by FDA.

Pharmaceutical continuous manufacturing (PCM) is suitable for some medicines, but not every product or situation, and potential hurdles abound, participants generally agreed at USP’s workshop on “

This summer, a wave of regulatory activity on nitrosamines has taken place, with agencies from around the world recently publishing new or revised guidances on nitrosamines.