US FDA Expands KASA Platform To Probe API Synthesis, Conduct NDA Quality Reviews

 
• By Bowman Cox

Agency builds on success with last year’s KASA-based ANDA quality reviews to widen and deepen the software tool’s functionality, says CDER OPQ leadership. CMC assessors are adapting quickly to a platform that could soon alert them to issues like possible genotoxic impurity formation during API synthesis.

pharmaceutical analytics
kasa will enable quicker, more insightful assessments. • Source: Shutterstock

More from Manufacturing

More from Compliance