12 BioPharm International eBook March 2020 www.biopharminternational.com
Monograph Development:
Why and When to Participate
This article explores another proactive advocacy approach that a
bio/pharmaceutical company may take through participation in
the development of new and revised monographs in the various
pharmacopoeias.
T
his article is a continuation of the series
intended to provide a practical guide to phar-
macopoeia compliance for the bio/pharma-
ceutical industry. The first articles provided
details on why pharmacopoeia compliance is
necessary (1) and why compliance is difficult to achieve
and maintain (2). Subsequent articles provided a his-
torical and global perspective of the pharmacopoeias
(3) and described the benefits of global pharmacopoeia
standards (4) that may be achieved through ongoing
harmonization efforts (5). The process used to revise
the pharmacopoeias was described (6) as was the associ-
ated surveillance process used by the industry to mon-
itor these revisions (7) to facilitate ongoing compliance
with current pharmacopoeia requirements. It was noted
that monitoring only the official revisions published by
the pharmacopoeias puts a company in a reactive posi-
tion to achieve compliance with updated requirements.
Working further upstream to include surveillance of
proposed updates published by the pharmacopoeias
provides an opportunity for companies to take a more
proactive position by providing comments to poten-
iQoncept
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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
