16 Pharmaceutical Technology LABORATORY BEST PRACTICES 2018 P h a r mTe c h . c o m
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Analytical Methods
A
bout a decade ago, FDA and other regulatory agencies
introduced a series of pharmaceutical guidance docu-
ments that included risk management and quality by
design (QbD). These initiatives were aimed at modern-
izing the manufacturing of small-molecule drugs and biologics. The
topics on risk management and QbD were published as International
Council for Harmonization (ICH) guidance Q9 (1) and ICH guid-
ance Q8 (2), respectively. Both concepts have been widely accepted
by the industry within the manufacturing space and have been ap-
plied 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, unfortunately, has
been rather slow in adapting these concepts, 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.
Developing analytical methods
It is worth noting that, irrespective of the approach taken, ultimately
an assay (assay and method are terms used interchangeably through-
out the text) should be based on several fundamental principles,
which include the following:
• Sound scientific strategy as the basis for the method
• An assay that is suitable for the intended use
• An assay that is accurate, precise, and robust
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.
Mario DiPaola is senior
scientific director at Charles
River Laboratories, Woburn,
MA.
Mario DiPaola
