28 Pharmaceutical Technology REGULATORY SOURCEBOOK DECEMBER 2019 P h a r mTe c h . c o m
The challenges of monitoring proposed and official re-
visions published by global and national pharmacopoeias
can make it difficult to achieve on-time compliance with
updated requirements. This situation is further complicated
by complex global supply chains in the bio/pharmaceutical
industry, including multiple manufacturing sites, external
manufacturing sites, and excipient/component suppliers that
may be impacted by updated pharmacopoeia requirements.
Based on the experience of one of the authors, to address
these challenges, a large multi-national company assembled
the compendial affairs group and a wide range of impacted
stakeholders in an international, cross-divisional, multi-site,
multi-day Kaizen event with the specific aim of mapping the
existing process for compendial review and implementation
to identify possible improvements. This enabled the company
to develop a new process for pharmacopoeia surveillance that
emphasized monitoring pharmacopoeia revisions starting at
the proposal stage, stressed the importance of a comprehen-
sive tracking tool, and created new cross-functional teams
to assist in the impact assessment for the company. The en-
hanced process was more effective, efficient, and sustainable
in helping to ensure ongoing compliance with new and re-
vised pharmacopoeial requirements.
Industry surveillance process: People
As noted earlier, the industry's surveillance of pharma-
copoeia revisions is comprised of processes, people, and
tools. Throughout the detailed description of the process
(see Sidebar), the key players have been identified, and what
emerges is the broad network that is required to accomplish
this work. It is helpful to focus briefly on the people involved
in an effective surveillance process, as follows:
• Compendial affairs group
• Internal stakeholders/subject matter experts (SMEs)/
teams
• Local contact group/In-country partners
• Company leadership/functional area management
• Pharmaceutical industry associations.
The critical role played by the compendial affairs group in
the overall process was presented earlier. The internal stake-
holders, working individually 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 pro-
cess. These SMEs must clearly understand their role in the
compendial process, whether it be technical assessment or
driving 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 stakeholders is critical to
the effectiveness and sustainability of the compendial af-
fairs process. Additionally, to effectively manage changes
in the national pharmacopoeias, engagement with the local
contact group or in-country partner is vital, due to the chal-
lenges of irregular revision schedules and the potential need
for translation. To be truly successful in the overall effort,
the entire process and all the people involved need the sup-
port of company leadership and functional area manage-
ment, who must be aware of the time commitment needed
to properly assess a revision, develop appropriate comments,
or drive implementation of the change that potentially af-
fects multiple sites, products, and registrations. This time
commitment is not trivial and adequate resources need to
be available to ensure ongoing compliance with pharmaco-
poeial requirements.
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.
