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J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.
Joseph A. Albanese is the director of Analytical Strategy and Compliance at Janssen Research and Development, LLC.
This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world.
Pharmacopoeia Compliance Series
Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement for drug companies seeking to market products in that region. The multiple pharmacopoeias around the world are frequently revised and expanded, presenting challenges for bio/pharmaceutical companies that must monitor this activity. This article examines the revision process of global and national pharmacopoeias, the publication schedules, and describes differences between the procedures of the various authorities.
This article is part of a series that will be published in 2019–2020. View all articles in this series.
eBook: Regulatory Sourcebook, December 2019
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Revision Process for Global/National Pharmacopoeias," BioPharm International Sourcebook eBook (December 2019).