26 BioPharm International eBook March 2020 www.biopharminternational.com
A Practical Approach to
Pharmacopoeia Compliance
The authors present a case study at the intersection of monograph
development and compliance.
P
revious articles in this series detailed the
monograph development process, which is
accomplished through partnership between
the bio/pharmaceutical industry and the
pharmacopoeias (1,2). Rationale was pro-
vided to help companies decide whether they will
participate in the process as a potential advocacy
opportunity for the company through monograph
development for their drug substances and products.
In a broader context, however, the overall series of
articles is intended to address the challenges for the
industry to comply with pharmacopoeial require-
ments. This article returns to this important topic
with a case study at the intersection of monograph
development and compliance.
THE CHALLENGE OF COMPLIANCE
The drug product lifecycle described in the first arti-
cle of this series (3) provides context that is helpful for
considering compliance challenges. A company ini-
tially discovers a new drug substance and develops
it into a drug product, performing clinical studies to
ensure it is safe and effective. During development, the
company establishes standards of quality that are con-
sidered appropriate for the drug substance and product.
When all the necessary drug development informa-
tion is available, it is submitted to regulatory agen-
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 Analy tical Strategy and Compliance at Janssen Research and
Development, LLC.
J. MARK WIGGINS AND JOSEPH A. ALBANESE
Regulatory Sourcebook Pharmacopoeia Compliance Series
