34 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m
Pharmacopoeia Compliance Series
C
ompliance with requirements published by phar-
macopoeias around the world is a legal and regu-
latory requirement in those countries and regions
in which the pharmacopoeia is applicable. This
fundamental principle of pharmacopoeia compliance has
been explored throughout this series of articles intended to
bring greater visibility and understanding to the bio/phar-
maceutical industry, where compendial processes are not
always well understood (1–11). The articles present many
facets of the processes, people, and tools needed for a com-
pany to comply with the pharmacopoeia as well as their
product registrations. The articles ref lect the continuing
evolution of the pharmacopoeias, their requirements, and
the need for harmonization to achieve truly global pharma-
copoeia standards.
This final article in the series has two purposes: to sum-
marize all the considerations that go into a company's com-
pendial affairs program and to look ahead at topics that
will likely result in further evolution in the pharmacopoeias
around the world. This look into what is on the horizon
is important to help companies prepare for the inevitable
changes and ensure the continued supply of quality medi-
cines to patients globally.
Putting it all together
Figure 1 presents a holistic view of the roles, responsibili-
ties, activities, and other considerations of the compendial
affairs function, which are necessary to ensure pharmaco-
poeia compliance across the bio/pharmaceutical industry.
This figure captures four major areas that define a com-
pany's strategy and approach to determine its compendial
affairs program. A successful program establishes many
processes and maintains a series of complex internal and
external partnerships to ensure a company can comply. The
articles in this series touch on all four areas to provide guid-
ance and clarity to companies struggling to set a strategy
or to improve their current processes. They also provide
rationale to support a business case to justify the people,
processes, and tools necessary to enable compliance. The
information can serve as the basis for standard operating
procedures (SOPs) or work instructions for compendial af-
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
Pharmacopoeia Compliance:
Putting It All Together;
What Is on the Horizon
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
