Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions (eBook)

December 15, 2019
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-12-15-2019, Volume 2019 eBook, Issue 3
Pages: 26–37

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.

Read this article in Pharmaceutical Technology’s December 2019 Regulatory Sourcebook.

Article Details

Pharmaceutical Technology
eBook: Regulatory Sourcebook, December 2019
December 2019
Pages: 26–37

Citation

When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions," Pharmaceutical Technology Regulatory Sourcebook eBook (December 2019).