Will Change Ever Come Easy? Authorities Share Their Top ICH Q12 Challenges
Accelerating post-approval change oversight by focusing on ‘established conditions’ means trusting pharmaceutical quality management systems. But how?
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PIC/S document will help authorities see which manufacturing sites can manage less-significant changes effectively without oversight, as ICH Q12 allows.
Draft recommendation offers path to ICH Q12 regulatory relief.
Anticipating the eventual adoption of ICH Q12, the US FDA is training staff on some of its key principles. An agency official says ICH Q12 necessitates a new way of thinking about and reviewing regulatory submissions for post-approval changes and such training is necessary to ensure review consistency.