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14 BioPharm International eBook December 2019 Revision Process for Global/National Pharmacopoeias This article describes the revision process and the resulting publication of proposed and official updates for pharmacopoeias around the world. T he first article of this series about com- pendial activities in the bio/pharmaceuti- cal industry stressed that 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 (1). The second arti- cle provided an end-to-end compendial framework to aid in understanding many of the challenges with ensuring compliance (2). One significant factor that makes compliance challenging is the multiple phar- macopoeias around the world and the lack of broad harmonization of the requirements and standards they each contain. Subsequent articles explored the history of pharmacopoeias and the current global situation (3), with consideration of the potential ben- efits of compendial harmonization and a description of current activities to achieve global pharmacopoeia standards (4, 5). Another challenge is the significant volume of new and revised requirements, which are published by the pharmacopoeias as both proposed and offi- cial changes. It is essential for bio/pharmaceutical companies to monitor these periodic updates to ensure ongoing compliance. The surveillance pro- cess used by the industry is driven by the revision process and publication schedules of the pharma- copoeias. Desig nating phar macopoeias as either 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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