18 BioPharm International eBook September 2019 www.biopharminternational.com
Regulatory Sourcebook Pharmacopoeia Compliance Series
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.
C
ompliance 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. This
fundamental principle of pharmacopoeia compliance
is an important consideration for the bio/pharmaceu-
tical industry, including innovator, generic, virtual,
and start-up companies who discover, develop, manu-
facture, and distribute small-molecule drug products,
biotherapeutic products, and vaccines, as well as the
drug substances and excipients used in these prod-
ucts. Across the entire industry and within any given
company, it is crucial that there is awareness and
understanding of this need for pharmacopoeia compli-
ance—from the CEOs of multi-national innovator and
generic-drug companies to the leadership at small start-
ups and contract manufacturers, to managers in their
respective functional areas, to the analytical bench
chemists and microbiologists testing active ingredi-
ents and excipients for use in drug products—so that
global patients have uninterrupted access to the criti-
cal medicines that extend and improve their lives.
J. MARK WIGGINS AND JOSEPH A. ALBANESE
This article provides the legal and regulatory basis for pharmacopoeia
compliance and illustrates pharmacopoeia impact throughout the drug
product lifecycle.
Why Pharmacopoeia Compliance
Is Necessary
iQoncept-
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