14 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m
Pharmacopoeia Compliance Series
T
his article is a continuation of the series intended to
provide a practical guide to pharmacopoeia compli-
ance for the bio/pharmaceutical 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
historical and global perspective of the pharmacopoeias (3)
and described the benefits of global pharmacopoeia standards
(4) that may be achieved through ongoing harmonization ef-
forts (5). The process used to revise the pharmacopoeias was
described (6) as was the associated surveillance process used
by the industry to monitor these revisions (7) to facilitate on-
going compliance with current pharmacopoeia requirements.
It was noted that monitoring only the official revisions pub-
lished by the pharmacopoeias puts a company in a reactive
position to achieve compliance with updated requirements.
Working further upstream to include surveillance of pro-
posed updates published by the pharmacopoeias provides an
opportunity for companies to take a more proactive position
by providing comments to potentially influence the new and
revised requirements that are proposed.
This article explores another proactive advocacy approach
that a bio/pharmaceutical company may take through par-
ticipation in the development of new and revised mono-
graphs in the various pharmacopoeias. Monographs are
developed based on the submission of information and
materials from a company having regulatory approval for
the product, and this submission feeds into the pharmaco-
poeia revision process (6). The monograph is published by
the pharmacopoeia as a proposed update, which in most
cases moves forward to become the official standard for the
material. Aligning the monograph with approved product
registrations makes it easier for a company to achieve com-
pliance with the requirements in the monograph. There is
a need to answer practical questions regarding a company's
participation in this monograph development activity, for
example:
• Why should a company submit a proposal for a new or
revised monograph to the pharmacopoeia?
• What is the appropriate timing—in various situa-
tions—for submitting a monograph? How long will it
take for the monograph to be completed?
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.
iQoncept
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Monograph Development:
Why and When to Participate
J. Mark Wiggins and Joseph A. Albanese
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. Published articles in this series are
available online at www.PharmTech.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