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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 returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.
Pharmacopoeia Compliance Series
A company initially discovers a new drug substance and develops it into a drug product, performing clinical studies to ensure it is safe and effective. During development, the company establishes standards of quality that are considered appropriate for the drug substance and product. When all the necessary drug development information is available, it is submitted to regulatory agencies to gain marketing approval for the product in countries around the world. During the regulatory review process, differences can emerge in the quality requirements that are approved for the product, based on determinations made by the health authorities in individual countries. These differences are often minor, but may also be quite significant, creating challenges for compliance in all countries where the product is approved.
This article is part of a series that will be published in 2019–2020. View all articles in this series.
eBook: Regulatory Sourcebook, March 2020
When referring to this article, please cite it as J.M. Wiggins and J.A. Albanese, “A Practical Approach to Pharmacopoeia Compliance," BioPharm International Regulatory Sourcebook eBook (March 2020).