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J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.
Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC
Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.
Pharmacopoeia Compliance Series
This article explores another proactive advocacy approach that a bio/pharmaceutical company may take through participation in the development of new and revised monographs in the various pharmacopoeias.
This article is part of a series that will be published in 2019–2020. View all articles in this series.
eBook: Regulatory Sourcebook, March 2020
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Monograph Development: Why and When to Participate," Pharmaceutical Technology Regulatory Sourcebook eBook (March 2020).