An Evaluation of Postapproval CMC Change Timelines
ISPE
SEPTEMBER 10, 2023
In addition to delaying optimization of manufacturing and controls, these types of long delays for approvals discourage continuous process improvements for approved products. Mission: Harmonisation for Better Health.” www.ich.org/page/mission 5 Beierle, J., Accessed 14 June 2023. Accessed 14 June 2023.
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