Monograph Development: Why and When to Participate (eBook)

March 15, 2020
J. Mark Wiggins

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

,
Joseph A. Albanese

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Pharmaceutical Technology, Pharmaceutical Technology-03-15-2020, Volume 2020 eBook, Issue 1
Pages: 14-23

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.

Read this article in Pharmaceutical Technology’s March 2020 Regulatory Sourcebook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, March 2020
March 2020
Pages: 14–23

Citation

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).