38 BioPharm International eBook March 2020 www.biopharminternational.com
Compliance
T he cr it ica l outcome f rom t he
c o m p e n d i a l a f f a i r s f u n c t i o n
is compliance (orange bubble in
Figure 1). To help achieve this, two
articles focused on the details of
the pharmacopoeia revision pro-
cess and the industry surveillance
process that enable implemen-
t at ion of compend ia l c ha nges
needed for a company's compli-
ance (6,7). The compendial affairs
function must develop the appro-
priate tools that allow quick access
to project status, ongoing com-
munications, expected next steps,
and the generation of metrics usu-
a lly requested by ma nagement
to measure success. The compen-
dial affairs function needs man-
agement commitment to ensure
the accountability of the people
throughout the company assigned
to execute the processes effectively
and efficiently to maintain compli-
ance. Case studies were presented
to demonstrate why the compen-
dial affairs function must estab-
lish and maintain strong internal
partnerships across the company
to ensure the established processes
run well (10,11).
Advocacy
T h e s i g n i f i c a n t o p p o r t u n i t y
for the compendial affairs func-
tion is advocacy (green bubble
in
Figure 1). The decision a com-
pany makes on advocacy efforts
is an important part of its com-
pendial affairs strategy, determin-
ing whether the organization will
be proactive or reactive in their
interaction with the pharmaco-
poeia authorities. A company can
choose to participate in the devel-
opme nt of monog raph s, com-
ment on draft proposals, and join
teams to elaborate or revise general
chapters. Alternatively, a company
may choose to have no advocacy
role and only to implement the
updated requirements that appear
in official pharmacopoeia publi-
cations. This decision has a sig-
nificant impact on the resources
needed for the compendial affairs
function and from other impacted
areas to support a company's estab-
lished compendial processes.
A d vo c a c y a p p r o a c h e s w e r e
explored in several articles that
focused on monograph develop-
ment, compendial responses, and
external partnerships with bio/
pharmaceutical trade organizations.
The deep-dive into the advocacy
processes highlighted the pros and
cons of choosing to participate or
not. A list was provided of several
external organizations a company
can join to enable open discussions
and to leverage their responses on
issues with broad impact (7). The
effectiveness of an organization's
advocacy is a critical part of their
compendial success. If a company
submits comments on proposals
that are adopted by the pharma-
copoeia, it may be easier for the
company to implement the official
revision than it would have been
if no comments had been submit-
ted. A roadmap was provided to
help a company define its strategy
for the important advocacy effort
of monograph development: why
and when to participate with the
pharmacopoeia authorities (8). The
operational aspects of who in the
company should own monograph
submissions, how to participate,
and how to achieve harmonized
monographs were also explored (9).
The details presented in these arti-
cles provide the basis for a check-
list that a company can utilize if
it decides to proactively engage in
monograph development.
Regulatory Sourcebook Pharmacopoeia Compliance Series
A Practical Guide to Pharmacopoeia Compliance: A Series
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
to establish effective processes, partnerships, and tools to maintain appropriate and
timely compliance across the bio/pharmaceutical industry to the benefit of patients.
The following articles can be found within this ebook and online at
www.BioPharmInternational.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
