Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 23
labeling because its methods will be designated as "Test 1"
when subsequent revisions are introduced in the monograph
to ref lect products from other companies. The information
provided by the innovator company in the monograph sub-
mission ref lects greater process and analytical experience
with the product, reducing 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 mono-
graph tests will become the official compendial reference
standard, eliminating the work required to demonstrate
comparability of the in-house standard against the com-
pendial standard.
Perhaps one of the most significant benefits for an in-
novator company in submitting a monograph when theirs
is the only approved product is the opportunity to pursue
prospective or informal harmonization 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 elaboration pro-
cess, including anticipated changes to test methods and lim-
its, 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 pharmacopoe-
ias, once decided, there are additional considerations, includ-
ing who within a company should have responsibility for the
submission and what information is necessary to support the
development of the monograph. There are also practical con-
siderations regarding how to navigate the submission process
with the pharmacopoeias and how to approach prospective
or informal harmonization of the monograph. These addi-
tional points are detailed in a companion article (20), which
can be accessed by visiting PharmTech.com.
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 process are clear, with consid-
erations for the optimal timing for a specific monograph
submission. The next article returns to the challenges of
pharmacopoeia compliance through an illustration of the
difficulty with monograph requirements, which may differ
from approved product registrations, even when a company
is proactive in the development process.
Acknowledgment
The authors gratefully acknowledge the contribution of
Susan J. Schniepp for her technical review and helpful sug-
gestions during the preparation of this series of articles.
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