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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.
In this series of articles, the authors provide an understanding about the need for pharmacopoeia compliance and practical guidance to assist those who perform this work.
Pharmacopoeias are embedded within the current regulatory and legal framework of the country or region in which they are applicable. The intersection of the pharmacopoeias and regulatory agencies impacts the direction and approaches taken to move toward harmonization at a global level.
Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/pharmaceutical manufacturing and supply, which ultimately benefits global patients who rely on these medicines to extend and improve their lives. This article provides some industry perspective on the need to harmonize compendial standards, which may be helpful in considering the future direction of pharmacopoeias.
This article part of a series that will be published in 2019–2020. View all articles in this series.
eBook: Regulatory Sourcebook, September 2019
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “Global Pharmacopoeia Standards: Why Harmonization is Needed," BioPharm International Regulatory Sourcebook eBook (September 2019).