www.biopharminternational.com eBook December 2019 BioPharm International 29
• C ompa ny le ade r sh ip/f u nc-
tional area management
• Pharmaceutical industry asso-
ciations.
The critical role played by the
compendial affairs group in the over-
all process was presented earlier. The
internal stakeholders, working indi-
vidually as SMEs or as part of a team,
and those functional areas that are
impacted by specific pharmacopoeia
revisions are also necessary in the
process. These resources reside over
the entire company, as identified
earlier in the detailed description of
the surveillance process. These SMEs
must clearly understand their role
in the compendial process, whether
it be technical assessment or driv-
ing the implementation of a change
across the company. Without clearly
defined roles and responsibilities,
items may not be properly assessed
or implemented. The engagement of
internal SMEs and impacted stake-
holders is critical to the effectiveness
and sustainability of the compen-
dial affairs process. Additionally, to
effectively manage changes in the
national pharmacopoeias, engage-
ment with the local contact group
or in-country partner is vital, due to
the challenges of irregular revision
schedules and the potential need for
translation. To be truly successful
in the overall effort, the entire pro-
cess and all the people involved need
the support of company leadership
and functional area management,
who must be aware of the time com-
mitment needed to properly assess a
revision, develop appropriate com-
ments, or drive implementation of
the change that potentially affects
multiple sites, products, and registra-
tions. This time commitment is not
trivial and adequate resources need
to be available to ensure ongoing
compliance with pharmacopoeial
requirements.
All of the groups mentioned are
internal to a company, but the dis-
cussion of people that support the
surveillance process is not com-
plete without consideration of a
key external connection: phar-
maceutical industry associations.
These associations may be found
in many countries and regions
around the world and a list of
some key industr y g roups that
monitor the pharmacopoeias are
included in
Table I.
The value gained by a company
through connecting with the com-
pendial interest or discussion groups
in these industry associations should
not be underestimated. It should be
noted that these groups do not talk
about pharmacopoeia changes that
impact only one or a few compa-
nies, such as specific monographs for
drug products or ingredients. Rather,
Regulatory Sourcebook Pharmacopoeia Compliance Series
Acronym Association name
United States
NJPQCA
New Jersey Pharmaceutical
Quality Control Association
MWCDG Mid-West Compendial Discussion Group
WCDG Western Compendial Discussion Group
PhRMA Pharmaceutical Research and Manufacturers of America
BIO Biotechnology Innovation Organization
AAM Association for Accessible Medicines
CHPA Consumer Healthcare Products Association
United Kingdom
ABPI Association of the British Pharmaceutical Industry
Europe
EFPIA
European Federation of Pharmaceutical
Industries and Associations
EBE European Biopharmaceutical Enterprises
Japan
JPMA Japan Pharmaceutical Manufacturers Association
China
RDPAC R&D-Based Pharmaceutical Association Committee
International
IFPMA
International Federation of Pharmaceutical
Manufacturers & Associations
IGBA International Generic and Biosimilar Medicines Association
IPEC* International Pharmaceutical Excipients Council
GSCF Global Self-Care Federation
PDA Parenteral Drug Association
* The IPEC Federation is a global organization consisting of IPEC Americas, IPEC China, IPEC
Europe, IPEC Japan, and IPEC India.
Table I. Pharmaceutical industry associations engaged in surveillance of
pharmacopoeia revisions.
Contin. on page 35