24 BioPharm International eBook March 2020 www.biopharminternational.com
Regulatory Sourcebook Pharmacopoeia Compliance Series
pany in the monograph submission
reflects greater process and analytical
experience with the product, reduc-
ing the likelihood of revisions due to
additional product knowledge and
any associated regulatory updates.
The reference standards provided
by the innovator company to the
pharmacopoeias in support of the
monograph tests will become the
official compendial reference stan-
dard, eliminating the work required
to demonstrate comparability of the
in-house standard against the com-
pendial standard.
Perhaps one of the most signifi-
cant benefits for an innovator com-
pany in submitting a monograph
when theirs is the only approved
product is the opportunity to pursue
prospective or informal harmoniza-
tion in establishing the monograph
across multiple pharmacopoeias
(see
Sidebar). In the final analysis,
a company's decision of whether
and when to submit monographs
for drug substances and products is
critical to helping ensure compliance
with the requirements contained
in the monographs. A company
can leverage the knowledge gained
during the monograph elabora-
tion process, including anticipated
changes to test methods and limits,
to plan for implementation of the
official requirements.
ADDITIONAL CONSIDERATIONS
FOR MONOGRAPH DEVELOPMENT
Having explored the considerations
of whether and when a company
should submit a monograph to the
pharmacopoeias, once decided,
there are additional considerations,
including who within a company
should have responsibility for the
submission and what information
is necessary to support the develop-
ment of the monograph. There are
also practical considerations regard-
ing how to navigate the submission
process with the pharmacopoeias
and how to approach prospective
or informal harmonization of the
monograph. These additional points
are detailed in a companion arti-
cle (20), which can be accessed at
BioPharmInternational.com by click-
ing here.
CONCLUSION
The value of monographs is in the
publicly available quality standards
they provide for drug substances
and products, and the benefits for a
company to actively participate in
the monograph development pro-
cess are clear, with considerations
for the optimal timing for a spe-
cific monograph submission. The
next article returns to the chal-
lenges of pharmacopoeia compli-
ance through an illustration of the
difficulty with monograph require-
ments, which may differ f rom
approved product registrations,
even when a company is proactive
in the development process.
ACKNOWLEDGMENT
The authors gratefully acknowl-
edge the contribution of Susan J.
Schniepp for her technical review
and helpful suggestions during the
preparation of this series of articles.
REFERENCES
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