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Regulators Discuss QbD Challenges While Industry Attests That Business Benefits of QbD Still Unknown

This article was originally published in The Gold Sheet

Executive Summary

Regulators in the European Union and U.S. say that the concepts of design space, control strategy, and critical quality attributes are confusing to pharmaceutical manufacturers and are working to address this to ease quality by design implementation. In the meantime industry representatives say that it is still too early to make a definitive business case for QbD but that early signs are promising.

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