26 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m
Pharmacopoeia Compliance Series
T
he pharmacopoeial revision process and the result-
ing publication of proposed and official updates were
described in a previous article in this series (1). To
maintain ongoing compliance with current pharma-
copoeia requirements as expected by regulators around the
world, it is essential for bio/pharmaceutical companies to be
aware of these periodic updates, so they can determine the
potential impact and implement appropriate changes to their
quality and regulatory documentation, as well as impacted
processes and procedures. This article details the surveillance
activities carried out by industry to monitor pharmacopoeia
revisions so that companies can establish effective, efficient,
sustainable, scalable, and successful processes to address
these compliance challenges.
Compendial affairs organization,
roles, and responsibilities
At a high level, effective surveillance is comprised of processes,
people, and tools. These factors were described in an article
written 15 years ago (2), and what is, perhaps, remarkable is
that the issues and challenges have not substantially changed
since then. Before delving into the details anew, it is helpful
to look at one particular group that carries out key steps in
the overall process.
Although identified by a variety of names, in many compa-
nies there is a group or function known as compendial affairs.
The activities carried out by the compendial affairs group
were described using the end-to-end framework in the second
article of this series (3). The compendial affairs responsibili-
ties include surveillance of the pharmacopoeial revision pro-
cess, which may include publications for both proposed and
official updates; advocacy, through responses to proposed
changes; and compliance, through involvement in change
control to enable implementation of official updates within
the company. Another potential advocacy role for compendial
affairs is through the submission of new or revised mono-
graphs to provide quality standards in the pharmacopoeias
for a company's drug products and ingredients. This activ-
ity may also involve coordination within the company and
with the pharmacopoeias to provide samples and standards to
support monograph elaboration. Direct engagement with the
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
-
Stock.adobe.com
Surveillance Process
for Industry: Monitoring
Pharmacopoeia Revisions
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
Upcoming articles in this series will include the following:
• 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
