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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.
An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company.
Pharmacopoeia Compliance Series
To maintain ongoing compliance with current pharmacopoeia requirements, bio/pharmaceutical companies must be aware of periodic updates, determine the potential impact, and implement appropriate changes to their quality and regulatory documentation, processes, and procedures. This article details the surveillance activities carried out by industry to monitor pharmacopoeia revisions so that companies can establish effective, efficient, sustainable, scalable, and successful processes to address these compliance challenges.
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, “Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions," BioPharm International
Regulatory Sourcebook eBook (December 2019).