26 BioPharm International eBook September 2019 www.biopharminternational.com
Regulatory Sourcebook Pharmacopoeia Compliance Series
F
or the bio/pharmaceutical industry, compliance
with requirements published by pharmacopoeias
around the world is a legal and regulatory require-
ment in those countries and regions in which
the pharmacopoeia is applicable. This article pro-
vides a comprehensive, end-to-end framework to help
companies who discover, develop, manufacture, and/or
distribute small-molecule drug products, biotherapeutic
products, and vaccines, as well as the drug substances
and excipients used in these products, to better under-
stand the external and internal challenges that make
pharmacopoeia compliance difficult. Understanding the
challenges enables an exploration of the approaches that
may be taken to help ensure ongoing compliance with
pharmacopoeia requirements.
AN END-TO-END FRAMEWORK
FOR PHARMACOPOEIA COMPLIANCE
The critical question that must be asked is: what is
necessary for compendial compliance? The answer is
provided in an article describing the bio/pharmaceu-
tical industry's pharmacopoeial surveillance process
(1): a company must comply with current pharma-
copoeia requirements. This was true when the arti-
cle was written 15 years ago and is still true today.
Ongoing compliance requires timely and effective
J. MARK WIGGINS AND JOSEPH A. ALBANESE
This article provides an end-to-end compendial framework to understand
why compliance with pharmacopoeia standards is challenging.
Why Pharmacopoeia Compliance
Is Difficult
iQoncept-
Stock.adobe.com
J. MARK WIGGINS is owner and compendial consultant with Global
Pharmacopoeia Solutions LLC. JOSEPH A. ALBANESE is the director
o f A n al y tical St rat e g y an d Co mp lian ce at J ans s en Re s e arch an d
Development, LLC.