14 BioPharm International eBook March 2020 www.biopharminternational.com
tially influence the new and revised
requirements that are proposed.
This article explores another pro-
active advocacy approach that a
bio/pharmaceutical company may
take through participation in the
development of new and revised
monographs in the various phar-
m a c o p o e i a s . Mo no g r aph s a r e
developed based on the submis-
sion of information and materials
from a company having regulatory
approval for the product, and this
submission feeds into the phar-
macopoeia revision process (6).
The monograph is published by
the pharmacopoeia as a proposed
update, which in most cases moves
forward to become the official stan-
dard for the material. Aligning the
monograph with approved prod-
uct registrations makes it easier for
a company to achieve compliance
with the requirements in the mono-
graph. There is a need to answer
practical questions regarding a com-
pany's participation in this mono-
graph development activity, for
example:
• Why should a company sub-
mit a proposal for a new or
revised monograph to the
pharmacopoeia?
• What is the appropriate tim-
ing—in various situations—
for submitting a monograph?
How long will it take for the
monograph to be completed?
• To which pharmacopoeias
should the monograph be
submitted?
• Which functional group in
the company should submit
the monograph? How does
the company connect with
the pharmacopoeias? Who
should follow-up regarding
the submission?
• What information is needed
for the submission? How
should the information be
pulled together? What phys-
ical materials (e.g., samples,
impurities, potential refer-
ence standards) are needed
to support monograph devel-
opment?
• Does the company need a
procedure for monograph
submission? What is the pro-
cedure that the pharmaco-
poeias follow to develop a
monograph?
• What can Company A do if
a monograph is developed
based on a submission from
Company B? Can Company
A inf luence the outcome?
Does Company A still need
to comply?
VALUE OF PUBLIC STANDARDS
IN THE PHARMACOPOEIAS
Before considering the factors that
impact a company's decision on
whether and how to participate in
the development of new and revised
monographs, it is helpful to differ-
entiate the various sectors within
the broad scope of the bio/pharma-
ceutical industry. For the purpose of
these articles, the term "bio/phar-
maceutical" includes innovator,
generic-drug, virtual, and start-up
companies that discover, develop,
manufact ure, and/or distribute
small-molecule drug products, bio-
therapeutic products, and vaccines,
as well as the drug substances and
excipients used in these products. In
this context, the value of the public
quality standards published by the
pharmacopoeias around the world
can be explored.
The Good Pharmacopoeial Practices
(GPhP) guidance published by the
World Health Organization states,
"A pharmacopoeia's core mission
is to protect public health by cre-
ating and making available public
Regulatory Sourcebook Pharmacopoeia Compliance Series
A Practical Guide to Pharmacopoeia Compliance: A Series
In this series of articles, the authors provide an understanding about the need for
pharmacopoeia compliance and practical guidance to assist those who perform this work
to establish effective processes, partnerships, and tools to maintain appropriate and
timely compliance across the bio/pharmaceutical industry to the benefit of patients.
The following articles can be found within this ebook and online at
www.BioPharmInternational.com/compendia:
• Why Pharmacopoeia Compliance is Necessary
• Why Pharmacopoeia Compliance is Difficult
• A Brief History of Pharmacopoeias: A Global Perspective
• Global Pharmacopoeia Standards: Why Harmonization is Needed
• Harmonization Efforts by Pharmacopoeias and Regulatory Agencies
• Revision Process for Global/National Pharmacopoeias
• Surveillance Process for Industry: Monitoring Pharmacopoeia Revisions
• Monograph Development: Why and When to Participate
• Monograph Development: How to Participate; How to Harmonize
• A Practical Approach to Pharmacopoeia Compliance
• A Case Study in Pharmacopoeia Compliance: Excipients and Raw Materials
• Pharmacopoeia Compliance: Putting it All Together; What is on the Horizon
