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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.
Compliance with requirements published by pharmacopoeias around the world is a legal and regulatory requirement in those countries and regions in which the pharmacopoeia is applicable. Awareness and understanding of this need for pharmacopoeia compliance is crucial.
There is often insufficient understanding, however, by stakeholders at all levels of the need to comply with requirements in the pharmacopoeias. This situation can lead to a lack of appropriate attention and resources allocated to ensure compliance.
This series of articles were written to provide a common understanding and to detail practical ways that pharmacopoeia compliance may be addressed.
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, “Why Pharmacopoeia Compliance Is Necessary," BioPharm International Regulatory Sourcebook eBook (September 2019).