design qualification, equipment selection,
and commissioning and qualification. This
is driving the integration of risk management tools as part of the overall project
planning exercise rather than a checkbox
activity. In the U.S. many large multinationals are transforming their development programs to leverage knowledge management
and utilized formal risk management tools.
This trend can only help move the industry
toward a more scientifically-based development philosophy.
4.Drug serialization will gain momen- tum. Anti-counterfeiting activities are
rapidly becoming the central focus of many
countries’ regulatory landscape. Global
pharmaceuticals face counterfeiting problems as well as theft, diversion and false
returns to manufacturers. The World Health
Organization (WHO) estimates counterfeit
drugs to constitute approximately 1% of the
supply in developed countries and 30% to
40% in developing countries. While this 1%
figure seems small, it means millions of prescriptions in the U.S. alone.
In November 2013 the Senate passed the
Drug Quality and Security Act (H.R. 3204).
The culmination of nearly 10 years of effort
by the Health Distribution Management
Association (HDMA), this act will preempt
all state laws relating to drug pedigrees and
track-and-trace systems, to assure the secu-
rity and safety of our nation’s drug supply
chain. The rollout will take place over the
next decade with the goal of acheiving unit
level traceability for all drugs manufactured
in the U.S. Serialization regulations are in
place today in Turkey, India, China, Brazil,
Argentina and South Korea. At the latest
Global Track and Trace Roundtable3 held in
October 2013 almost every major pharma-
ceutical market stated plans to formalize
serialization between now and 2017.
2014 promises to be a year for recovery
for the industry. As markets around the
world mature industry best practices will
begin to converge and true solutions will surface. Looking ahead, organizations capable
of recognizing trends such as the integration
of QRM in program planning will become the
foundation for future quality arguments and
will be more broadly integrated into product
development practices. Markets will continue
to evolve and while China’s participation will
still play a role, in 2014 the Europe and the
U.S. will step up to contribute more to the
overall symbiotic growth of the market.
1. EvaluatePharma, “World Preview 2013,
Outlook to 2018-Returning to Growth,”
2. Armstrong, Drew “China’s Pharma
Potential Diminished,” www.businessweek.
com, Nov 14, 2013
Global Pharma Outlook for 2014, by
Bikash Chatterjee, Pharmatech Associates
(Dec 2013) ■
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