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26 BioPharm International eBook December 2019 Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions An effective surveillance program for monitoring the activities of pharmacopoeias around the world requires processes, people, and tools from across a company. T he pharmacopoeial revision process and the resulting publication of proposed and official updates were described in a previous article in this series (1). To maintain ongoing com- pliance with current pharmacopoeia require- ments as expected by regulators around the world, it is essential for bio/pharmaceutical companies to be aware of these periodic updates, so they can determine the potential impact and implement appropriate changes to their quality and regulatory documentation, as well as impacted 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. COMPENDIAL AFFAIRS ORGANIZATION, ROLES, AND RESPONSIBILITIES At a high level, effective surveillance is comprised of processes, people, and tools. These factors were described in an article written 15 years ago (2), and what is, perhaps, remarkable is that the issues and challenges have not substantially changed since then. Before delving into the details anew, it is helpful to look iQoncept - Stock.adobe,com 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. J. MARK WIGGINS AND JOSEPH A. ALBANESE Regulatory Sourcebook Pharmacopoeia Compliance Series

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