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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. CPP 3 IPC Film coat weight gain (P.3.4)

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A Proposal for a Comprehensive Quality Overall Summary

ISPE

Application of this innovative approach will quickly orient regulators to the content of Module 3, “present product quality benefit-risk considerations, summarize the pharmaceutical development, present an overall understanding of the product quality,” 1 and facilitate continuous improvement. CPP 3 IPC Film coat weight gain (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.” September 2006. doi:10.1016/j.jbiotec.2015.06.388