ficient, significant effort is needed to comply
with cGMP regulations, the supply chain is
inefficient and profits are low. This suggests
that there are consolidation, technology and
supply chain improvement opportunities that
can make QbD a way of life ( 10, 11).
How does this discussion and analysis
bring jobs home? Pharma companies never
thought they would see competition from the
developing countries to the degree they are
seeing today. Had the companies been diligent
and farsighted about their business model
from the start, they would have always been
competitive while under patent and could
have easily warded off competitors from the
developing countries after patent expiry and
kept jobs at home.
The combination of drying pipelines and expiring patents are forcing companies to review
their business model. Companies fulfilling the
needs of more than 10% of the global population will have a sustained increase in revenue,
profits and will create much more jobs than
companies fulfilling the needs of 1% or less of
the population. In either case QbD Is a must.
Companies have to decide their course as
their longevity might depend on the strategy
they choose. One thing is sure - that if they
incorporate QbD from the start, they will have
the best technology and may not need CMOs
and retain jobs at home.
1. Malhotra, Girish Can Falsified Medicine and
Other Directives Backfire? January 31, 2013
2. Juran, J. M. Juran on Quality by Design,
The Free Press, 1992
3. Malhotra, Girish: Focus on Physical
Properties To Improve Processes:
Chemical Engineering, Vol. 119 No. 4 April
2012, pgs. 63-66
4. Malhotra, Girish Are The Savings of $120-
$150 Billions Worth Having? August 30, 2012
5. Malhotra, Girish Financial Justification for
QbD and Cost of Regulation Compliance
May 22, 2012
6. Malhotra, Girish: Does the Pharmaceutical
Industry Need A Steve Jobs, Profitability
through Simplicity, November 8, 2011
7. Schumpeter, Joseph A. Capitalism,
Socialism and Democracy, Chapter VII: The
Process of Creative Destruction 3rd Edition
1950, Harper Torchbooks, New York, 1962
ABOUT THE AUTHOR:
Girish Malhotra, President EPCOT
International can be reached at girish@
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