36 BioPharm International eBook September 2019 www.biopharminternational.com
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.