www.biopharminternational.com eBook December 2019 BioPharm International 39
I m p l e m e n t i n g c o m p e n d i a l
updates is made more difficult by
the large number of revisions that
must be addressed, and the assess-
me nt s ne e de d b y m a ny S M E s
and functional areas in the com-
pany. There are likely instances
where a proposed or official revi-
sion that impacts the company
may not have been identified, or
the impact of the change has not
been fully assessed by all stake-
holders. Even if identif ied and
assessed appropriately, there are
times when the change control
process is delayed, awaiting key
decisions on implementation, as
well as assessments by impacted
a r e a s , i nc lu d i n g m a nu f a c t u r-
ing sites and reg ulatory affairs.
Updates to product registrations
and gaining approval from regu-
latory agencies around the world
may take a long time due to the
complexity of the work. In these
situations, a manufacturing site
may have to perfor m duplicate
testing, using the old pharmaco-
poeia requirements and the new
ones, managing appropriate com-
pliance in the interim until every-
thing is realigned.
These situations are often noted
by leadership as failures in the pro-
cess, and while this may be a valid
perspective, it does not ref lect
the majority of cases where these
"misses" did not happen. Ideally,
management expectations of the
process will reflect this reality. In
the authors' experience, one mea-
sure of success for the compendial
affairs function is "flying under
the radar", going unnoticed by
management because everything
is proceed ing as expec ted a nd
no compliance gaps emerge. All
this success, however, may be for-
gotten when a potential compli-
ance gap is found. At this point,
the success of the process relates
to how quickly and how well the
company's stakeholders can come
toget her a nd add ress t he gap.
Sufficient resources are needed for
these implementation activities,
potentially including method com-
parability studies, to reach a suit-
able outcome in a short time while
other routine work is also main-
tained by the f unctional areas.
Learning from these situations can
lead to continuous improvement
in the surveillance process to min-
imize the likelihood of another
such occurrence in the future.
CONCLUSION
Details of the bio/pharmaceutical
industry surveillance process have
been provided to help address the
compliance challenges resulting
from pharmacopoeia revisions. The
goal for an individual company is
to establish an effective, efficient,
sustainable, scalable, and successful
process to accomplish the work. It is
the people and tools that contribute
to the effectiveness, efficiency, and
sustainability of the process, and
the benefits of advocacy activities
are clear. The process can evolve
over time, with more people and
new tools added as resources are
made available, which can also sup-
port the scalability of the process
to add more pharmacopoeias or
products to the overall monitoring.
Consideration of all these details
determines the ultimate success of
the process.
Recalling the fundamental prin-
ciple stated in the first article of this
series (4), compliance with official
requirements published by phar-
macopoeias around the world is a
legal and regulatory requirement
in those countries and regions in
which the pharmacopoeia is appli-
cable. However, there is flexibility
in how a company complies, and
this will be explored in later arti-
cles. A future article will describe
another advocacy opport unit y:
collaboration with the pharma-
copoeias for the submission and
development of monographs.
ACKNOWLEDGMENT
The authors gratefully acknowl-
edge the contribution of Susan J.
Schniepp for her technical review
and helpful suggestions during the
preparation of this series of arti-
cles. Sincere appreciation also goes
to the compendial affairs group
at Merck & Co., Inc. for valuable
discussions over many years that
helped shape the concepts and pro-
cesses described in this article.
REFERENCES
1. J.M. Wiggins and J.A. Albanese,
"Revision Process for Global/National
Pharmacopoeias," BioPharm International
Regulatory Sourcebook eBook, 14–24
(December 2019).
2. N. A. Schwarzwalder and R. H. Bishara,
American Pharmaceutical Review 7 (4),
53-57 (July–August 2004).
3. J. M. Wiggins and J.A. Albanese, "Why
Pharmacopoeia Compliance Is Difficult,"
BioPharm International Regulatory
Sourcebook eBook, 26–34 (September
2019).
4. J.M. Wiggins and J.A. Albanese,
"Why Pharmacopoeia Compliance Is
Necessary," BioPharm International
Regulatory Sourcebook eBook, 18–25
(September 2019).
BP
The success of a
surveillance process
can be measured by
the on-time
implementation of
official pharmacopoeia
revisions, a challenge
due to the large
number of revisions.
Regulatory Sourcebook Pharmacopoeia Compliance Series