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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.

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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. Leave this field blank

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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Nature Communications 12, no. 65: Technology Transfer (revised 2022), aims to standardize the approach to technology transfers, which would include conducting risk assessments, process comparisons, and knowledge transfers. September 2006. Biotechnology Progress 36, no. 3 (2020):e2970. 34 Maschan, M., 1 (2021):7200.