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Considerations for a Decentralized Manufacturing Paradigm

ISPE

Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. 24 August 2018. Published 2018. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.”

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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. Published 12 September 2002. Cauchon, T.

article thumbnail

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. Published 12 September 2002. Cauchon, T.