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41
Qualit
y
the "opportunity costs" of undependable operations.
Some efforts have been made in the pharmaceutical
industry to evaluate the benefits (77, 103, 104, 105,106,
107, 108) of upgrading technology, but more efforts
are needed to ensure that the costs and benefits are
fully accounted for and the opportunity is not missed
to demonstrate the value of modernization.
Ultimately, by reviewing detailed ROI models from
various industries, best practices can be gleaned that
may assist in creating a more comprehensive model
for assessing pharmaceutical quality ROI.
Summary
Our landscape analysis of quality-related and techno-
logical literature from various industries review has
confirmed it is possible to demonstrate the financial
benefits of enhanced manufacturing capability and
reliability.
However, this concept has not been well devel-
oped by the pharmaceutical industry. Therefore, we
propose that a pharmaceutical-specific quantitative
model is needed to better demonstrate how improved
manufacturing reaps quality benefits while also in-
creasing profits (109).
Further research should evaluate the quality and
business synerg y linkages in the pharmaceutical
industr y, with a focus on the long-term financial
outcomes f rom investing in a more robust manu-
facturing infrastructure. Special attention should
be given to how more capable technologies compare
to less capable options, and how ROI models can be
improved to analyze these options. The practices of
organizations who improve pharmaceutical man-
ufacturing capability, and those that maintain the
status quo, could also be explored to better under-
stand the facilitators and barriers to manufacturing
infrastructure improvement.
Acknowledgments
The authors would like to acknowledge the sage ad-
vice and encouragement of Peter Doukas, PhD, Pro-
fessor Emeritus and former Dean of Temple Univer-
sity School of Pharmacy, Wendy Lebing, Assistant
Dean of Temple School of Pharmacy, and Lucinda
Buhse, PhD, Deput y Director of Operations in the
Office of Pharmaceutical Quality in FDA/CDER.
Disclaimer
This paper reflects the views of the author and should
not be construed to represent FDA's views or policies.
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