BioPharm International - September 2019

BioPharm - Regulatory Sourcebook

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Page 35 of 44

36 BioPharm International eBook September 2019 Regulatory Sourcebook Pharmacopoeia Compliance Series T his series of articles continues to take a thor- ough look at compend ia l ac t iv it ies t hat impact the bio/pharmaceutical industry to help ensure compliance with requirements published by the pharmacopoeias. In these articles, the term "bio/pharmaceutical" should be con- sidered in the broadest sense and includes innovator, generic, virtual, and start-up companies who discover, develop, manufacture, and/or distribute small-mole- cule drug products, biotherapeutic products, and vac- cines, as well as the drug substances and excipients used in these products. One aspect of the history of the pharmacopoeias should be apparent; there is a long-standing tradition of evaluating existing, diver- gent drug standards and establishing instead a unified system that supports patient access to medicines with consistent quality. This is true whether the divergent standards existed at the city-level, as were addressed through the creation of the country-specific British Pharmacopoeia (BP), or if the existing standards were at the state-level, as were addressed through the creation J. MARK WIGGINS AND JOSEPH A. ALBANESE Pharmacopoeia harmonization provides better support for global regulatory agencies and addresses the global nature of bio/ pharmaceutical manufacturing and supply. Global Pharmacopoeia Standards: Why Harmonization Is Needed 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.

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