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INTERNATIONAL PHARMACEUTICAL QUALITY
Inside the Global Regulatory Dialogue
IPQ Monthly Update – May 2021 in Review
The pressing need during the COVID-19 pandemic to accelerate product development and rapidly accommodate the shifting manufacturing and distribution demands has shed strong light on the constraints in the existing quality regulatory framework and the pathways to reducing them. The two-part feature story in this issue explores how the ICH Q8-12 efforts to evolve the lifecycle regulatory paradigm to be more transparent, internally coherent, knowledge and risk based, continuous improvement and supply friendly, and globally consistent have not yet been realized, and where the deeper solutions to the problems may lie.
