www.biopharminternational.com eBook December 2019 BioPharm International 15
"global" or "national" can help
give visibility to some of the dif-
ferences between them, and can,
in turn, assist individual compa-
nies in focusing their compendial
work on those activities that help
ensure compliance with pharma-
copoeial requirements.
DEFINING GLOBAL AND
NATIONAL PHARMACOPOEIAS
In the second article of this series
(2), brief definitions were provided
for "national" and "global" phar-
macopoeias.
• National pharmacopoeias form
the legal requirements in their
individual countries and are
important for ensuring access
to medicines for patients in
these specific markets.
• G l o b a l p h a r m a c o p o e i a s
form the legal requirements
in their country/region and
are acceptable to reg ulatory
agencies well beyond the geo-
graphical boundaries covered
by the pharmacopoeia, ensur-
ing access to medicines for
patients at a global level.
It is helpful to consider these
designations in more detail (see
Sidebar pp. 20 –21). Throughout
t h e s e a r t i c l e s , t h e E u r o p e a n
Phar macopoeia (Ph. Eur.), British
Phar macopoeia (BP), and United
S t a t e s P h a r m a c o p e i a – N a t i o n a l
Formulary (USP–NF) are considered
global pharmacopoeias, based on
t hei r accepta nce by reg u lators
a round t he world. Ma ny ot her
i mpor ta nt pha r macopoeias are
considered national.
REVISION PROCESS FOR
GLOBAL PHARMACOPOEIAS
In their article (6), Schwarzwalder
a n d B i s h a r a m a d e t h e c r it i -
ca l poi nt, "… pha r macopoeia l
requirements are not static, and
continued compliance demands
that companies in this regulated
industry be alert to changes." The
article continues, "(a) program for
rev iew ing pharmacopoeial pro -
posals and implementing changes
is needed to ensu re cont inued
compliance."
Surveillance activities used by
bio/pha r maceut ic a l compa n ies
are triggered by the publication
of new a nd rev ised pha r maco -
poeial requirements. The publica-
tion schedule, in turn, is driven
by the pharmacopoeia rev ision
process. T he ongoi ng rev ision
of pharmacopoeias can be initi-
ated in several ways. For exam-
ple, pharmacopoeia changes can
be driven by a significant tech-
n o l o g y u p d a t e t h a t r e q u i r e s
a general chapter to be revised.
Changes could be started to reflect
a new International Council for
Har monization (ICH) g uidance
(e.g., Q3D) with impact to both
e x i st i ng ge ne ra l c hapte r s a nd
to monographs for many mate-
r ia ls. Pha r macop o e ia l up d ates
may be driven by collaborative
e f for t s to ac h ieve ha r mon i z a-
tion, as with the activities of the
Pharmacopoeial Discussion Group
(PDG), which is comprised of rep-
resentatives from the Ph. Eur., USP,
and the Japanese Phar macopoeia
( JP). Phar macopoeial evolution
can be sparked by industry with
the submission of a new or revised
monograph. With so many pos-
sible avenues for change, the sit-
uat ion clea rly dema nds t hat a
company have a process for moni-
toring and staying up to date with
the continuous revisions in the
pharmacopoeias. But obviously,
monitoring is not enough, since
impac t assessment a nd cha nge
control are needed to enable ongo-
ing compliance with the current
re qu i re me nt s. T hese con side r-
ations will be discussed in later
articles.
Regulatory Sourcebook Pharmacopoeia Compliance 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
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
A Practical Guide to Pharmacopoeia Compliance: A Series
