22 BioPharm International eBook October 2018 www.biopharminternational.com
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Best Practices in Analytical Method
Development and Testing
This article discusses why it is important to apply risk analysis, QbD,
and DoE in the development of analytical methods.
A
bout a decade ago, FDA and other reg-
ulatory agencies introduced a series of
pharmaceutical guidance documents that
included risk management and quality
by design (QbD). These initiatives were
aimed at modernizing the manufacturing of small-
molecule drugs and biologics. The topics on risk man-
agement and QbD were published as International
Council for Harmonization (ICH) guidance Q9 (1)
and
ICH guidance Q8 (2), respectively. Both concepts have
been widely accepted by the industry within the man-
ufacturing space and have been applied effectively to
minimize production failure risks and define a design
space where quality target product profiles can be
managed and maintained.
The pharmaceutical analytical community, unfor-
tunately, has been rather slow in adapting these con-
cepts, as well as design of experiment (DoE) (3), for
in-process testing or release and stability assessment
of drug substance and drug product. In this paper,
the author outlines the reasons why it is important to
apply risk analysis, QbD, and DoE in the development
of analytical methods.
MARIO DIPAOLA
MARIO DIPAOLA is senior scientific director at Charles River Laboratories,
Woburn, MA.
Biopharma Laboratory Best Practices Analytical Methods
