www.biopharminternational.com September 2019 BioPharm International eBook 25
Regulatory Sourcebook Pharmacopoeia Compliance Series
Act. USP <1121> also contains a
section on the monograph nam-
ing policy for drug products con-
taining salt drug substances. The
USP Salt Policy stipulates that USP
will use the name of the active moi-
ety, which is the molecule or ion
responsible for the physiological or
pharmacological action of the drug
substance, instead of the name of
the salt, when creating drug product
monograph titles for such a drug
product. The policy also stipulates
that USP will base the strength of
the product on the active moiety.
Companies need to be aware of the
USP Salt Policy, which is enforced
by FDA (6, 7), to avoid issues with
the name and strength listed on
drug product labeling and in reg-
istrations. The FDA guidance (6)
states that a drug product with
labeling that contains a name that
is inconsistent with the applicable
USP monograph title risks being
misbranded. Another example of
t he i mpac t of pha r macop o e ia
nomenclature is the transition from
the excipient name hydroxypro-
pyl methylcellulose to the short-
ened title hy promellose, which
resulted in significant revisions to
the ingredient listing on labels and
in registrations.
Once a product is launched and
reaches the end of exclusivity, com-
pendial monographs for drug sub-
stances and drug products will be
developed by the pharmacopoeia.
This is generally accomplished with
the support of companies who have
received regulatory approval for
these products, to provide a pub-
lic quality standard in the phar-
macopoeia that is applicable to
the product or material from all
approved sources. Considerations
for monograph development, look-
ing at the impact to both innova-
tor and generic-drug companies,
will be provided in a later article
in this series.
CONCLUSION
In this article, the first in a series
about compendial activities in the
bio/pharmaceutical industry, the
basis for pharmacopoeia compli-
ance expectations was provided,
along with consideration of how
the pharmacopoeias impact drugs
throughout their product lifecycle.
The increasingly global environ-
ment for industry, regulators, and
pharmacopoeias, where expecta-
tions and standards do not always
agree, represents one of the signif-
icant challenges to ensuring con-
sistent and sustained compendial
compliance.
The increasingly
global environment
represents one
of the significant
challenges to ensuring
consistent and
sustained compendial
compliance.
S u b s e qu e nt a r t ic le s i n t h i s
series will cover a wide range of
topics: providing information to
help in the creation of an effec-
tive compendial review process;
presenting a case study in com-
plia nce for exc ipients a nd raw
mater ia ls; d isc ussi ng consider-
ations for monog raph develop -
ment; giv ing recommendations
concer ning globa l vs. nat iona l
pha r macopoeias a nd t he need
for ha r mon i zat ion i n order to
establish consistent, global phar
-
macopoeia standards, which will
help industry deliver medicines
with consistent quality to extend
and improve the lives of patients
around the world while meeting
health authority expectations. It is
the authors' goal for these articles
to prov ide clear understanding
about the need for pharmacopoeia
compliance and practical guidance
to assist those who perform this
work to establish effective pro
-
cesses, partnerships and tools to
maintain appropriate and timely
compliance across the bio/pharma-
ceutical industry to the benefit of
patients.
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 articles.
REFERENCES
1. WHO, "Review of World Pharmaco-
poeias," World Health Organization,
Working Document QAS/12.512/
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medicines/areas/quality_safety/qual-
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MeetingWorldPharmacopoeias_QAS13-
512Rev1_25032013.pdf?ua=1
2. N. A. Schwarzwalder and R. H. Bishara,
American Pharmaceutical Review 7 (4),
pp. 53-57 (July-August 2004).
3. EDQM, "EDQM Inspections and Trends
of Deficiencies–Overview 2006 to
2018," EDQM, Certification of Sub-
stances Department, Public Document
PA/PH/CEP (18) 56 (April 2019),
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4. WHO, Good Pharmacopoeial Practices,
WHO Expert Committee on Specifica-
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Fiftieth Report, Technical Report Series
No. 996, Annex 1, pp. 67-85 (2016),
www.who.int/medicines/publications/
pharmprep/WHO_TRS_996_annex01.
pdf?ua=1.
5. BP, "How to Use the BP," British Pharma-
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com/how-to-use-the-bp
6. FDA, Naming of Drug Products Contain-
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BP
