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A Proposal for a Comprehensive Quality Overall Summary

ISPE

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)

article thumbnail

A Proposal for a Comprehensive Quality Overall Summary

ISPE

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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Considerations for a Decentralized Manufacturing Paradigm

ISPE

POD is suitable for a wide range of products, including oral solid dosage forms, mAbs, and cell therapy. Developing the Biofacility of the Future Based on Continuous Processing and Single-Use Technology.” Review: Continuous Manufacturing of Small Molecule Solid Oral Dosage Forms.” Journal of Biotechnology 213 (2015):120–30.