24 Pharmaceutical Technology REGULATORY SOURCEBOOK MARCH 2020 P h a r mTe c h . c o m
Pharmacopoeia Compliance Series
P
revious articles in this series detailed the mono-
graph development process, which is accomplished
through partnership between the bio/pharmaceu-
tical industry and the pharmacopoeias (1,2). Ratio-
nale was provided to help companies decide whether they
will participate in the process as a potential advocacy oppor-
tunity for the company through monograph development
for their drug substances and products. In a broader context,
however, the overall series of articles is intended to address
the challenges for the industry to comply with pharmaco-
poeial requirements. This article returns to this important
topic with a case study at the intersection of monograph
development and compliance.
The challenge of compliance
The drug product lifecycle described in the first article
of this series (3) provides context that is helpful for con-
sidering compliance challenges. A company initially dis-
covers a new drug substance and develops it into a drug
product, performing clinical studies to ensure it is safe and
effective. During development, the company establishes
standards of quality that are considered appropriate for
the drug substance and product. When all the necessary
drug development information is available, it is submitted
to regulatory agencies to gain marketing approval for the
product in countries around the world. During the regula-
tory review process, differences can emerge in the quality
requirements that are approved for the product, based on
determinations made by the health authorities in individual
countries. These differences are often minor, but may also
be quite significant, creating challenges for compliance in
all countries where the product is approved.
An extreme, but not uncommon, example can be imag-
ined for a drug product that contains a genotoxic impurity.
Differing views by different regulators as to the appropriate
control for this impurity can lead to more than 20 differ-
ent country-specific limits for the impurity. The company
can then test and release the drug product to the individual
limits that are approved in each country. A more common
approach, however, is to apply the tightest approved limit
to enable worldwide release of the product. Even with this
global approach, individual certificates of analysis are re-
quired to ref lect the approved limits in individual countries.
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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A Practical Approach to
Pharmacopoeia Compliance
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