Last week the ICH published a reflection paper “Advancing Biopharmaceutical Quality Standards to Support Continual Improvement and Innovation in Manufacturing Technologies and Approaches.”
The ICH contines to move beyond the prescriptive guidances of Q1-7 and focus more on strengthening the conceptual framework of Q8-Q11 (see some of my thoughts here). There is a lot of talk about strengthening relationships and alignment between regulatory agencies, which is definitely needed. Q12 has had a bumpy road of it (EU saying they might not implement, US FDA issuing a guidance that’s not all that aligned). We see a firm commitment to continuing the QbD work with Q13 (continuous manufacturing) and Q14 (Analytical methods).
Interesting timing with the FDA recent announcement on generics.