Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 17
Pharmacopoeia Compliance Series
T
he first article of this series about compendial ac-
tivities in the bio/pharmaceutical industry stressed
that compliance with requirements published by
pharmacopoeias around the world is a legal and
regulatory requirement in those countries and regions in
which the pharmacopoeia is applicable (1). The second ar-
ticle provided an end-to-end compendial framework to aid
in understanding many of the challenges with ensuring
compliance (2). One significant factor that makes compli-
ance challenging is the multiple pharmacopoeias around
the world and the lack of broad harmonization of the re-
quirements and standards they each contain. Subsequent
articles explored the history of pharmacopoeias and the
current global situation (3), with consideration of the po-
tential benefits of compendial harmonization and a descrip-
tion of current activities to achieve global pharmacopoeia
standards (4, 5).
Another challenge is the significant volume of new and
revised requirements, which are published by the pharmaco-
poeias as both proposed and official changes. It is essential
for bio/pharmaceutical companies to monitor these peri-
odic updates to ensure ongoing compliance. The surveil-
lance process used by the industry is driven by the revision
process and publication schedules of the pharmacopoeias.
Designating pharmacopoeias as either "global" or "national"
can help give visibility to some of the differences between
them, and can, in turn, assist individual companies in fo-
cusing their compendial work on those activities that help
ensure compliance with pharmacopoeial requirements.
Defining global and national pharmacopoeias
In the second article of this series (2), brief definitions were
provided for "national" and "global" pharmacopoeias.
• National pharmacopoeias form the legal requirements in
their individual countries and are important for ensuring
access to medicines for patients in these specific markets.
• Global pharmacopoeias form the legal requirements in
their country/region and are acceptable to regulatory
agencies well beyond the geographical boundaries cov-
ered by the pharmacopoeia, ensuring access to medi-
cines for patients at a global level.
Revision Process for
Global/National Pharmacopoeias
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
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
