Pharmaceutical Quality

Quality manufacturing underpins the industry with regulatory modernisation and continuous manufacturing transformation. The session covers ICH Q12 lifecycle management, continuous manufacturing across small molecule and biologic platforms, process analytical technology (PAT) and real-time release testing, nitrosamine impurity management following the 2018 sartans recall, ICH Q9(R1) quality risk management, and GMP modernisation. Discussion addresses cell-therapy CMC scaling, the comparison of continuous vs batch for cell and gene therapy, single-use disposables, regulatory inspection trends, and emerging quality frameworks for AI-controlled manufacturing.