disposables, and these trends are following
those international firms into China.
McElkearney [Ireland]: Three
innovations spring to mind. The first is the
use of disposables; these items of hardware
are reducing cost to the plant but in some
cases need higher levels of calibration to
ensure GMP parameters are still being met.
The second are factories created in a
modular design, which allows for retooling
to be done very quickly and will let you
repurpose an existing production system
relatively quickly. Again this does need a
more flexible approach to calibration. The
third is automated condition monitoring.
Instruments are getting smarter.
They can now communicate to us when
their health and will warn us when they
are starting to fail. These are very useful
reliability tools when working in the
Q. What are some of the
improvements being made
to current pharmaceutical/
services, or processes?
Yuan [China]: In 2011, the State Food
and Drug Administration, P.R. China
(CFDA) published the revised Good
Manufacturing Practice (GMP) for
Drugs, aka GMP 2010 Version. Since
the new GMP requirements have been
in place, all local pharmaceutical
companies are making many
modifications to achieve the standards
set by the new requirements.
International pharmaceutical companies
already met these requirements because
they are GMP requirement standards set
by other regulatory bodies such as the
FDA. But the type of quality standards
imposed by the CFDA here is expensive
to achieve, and (unfortunately) some small
local companies went bankrupt or were
acquired by larger companies because
they could not afford to operate according
to the new standards. Even some big
companies decided not to renovate some
product lines to meet GMP 2010 after
looking into the financial study.
McElkearney [Ireland]: Everyone
is trying to build efficiencies into their
processes. The investment in these
factories is huge. When a new system is
up and running and licensed product is
being shipped out the door. Everyone is
concentrating on how to produce more
for less with no impact on quality. New
technology is helping with this issue,
either reducing downtime, bringing
greater accuracy, or even making
Q. Describe the pharmaceutical
regulatory body that you work with.
What are some of the everyday
challenges you face?
Yuan [China]: Century 3 is a specialized
services company here in China — more
accurately, we are a project/program
management and design build company.
Our mission is to provide engineering
capabilities for clients in addition to helping
them receive a manufacturing certificate
for production so they can take their
product to market.
Century 3 provides these services for their
clients because many don’t know how to
apply for a manufacturing certificate. This
involves a regulatory process with the
CFDA and is often very time-consuming
and involves a lot of paperwork.