A Proposal for a Comprehensive Quality Overall Summary
ISPE
MARCH 29, 2023
Ultimately, the summary was not adopted during the QbD pilot, but was reintroduced in 2014 when a Pharmaceutical Research and Manufacturers of America (PhRMA) team prepared a white paper describing the content and format of an improved Module 2. From there, a preliminary list of CQAs is identified. July–August 2020).
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