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. CPP 26 GMP Compression tooling (PQS) CPP 2 IPC Tablet hardness (P.3.4)
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