Reprinted from PHARMACEUTICAL ENGINEERING®
The Official Magazine of ISPE
July/August 2012, Vol. 32 No. 4
www.PharmaceuticalEngineering.org
©Copyright ISPE 2012
ISPE President
and CEO
Nancy S. Berg
discusses how
the Society
will lead the
industry’s
movement
toward a culture
of quality.
Message from the President
How ISPE is Answering the Battle Cry
for Unwavering Quality
by Nancy S. Berg
What would
you do if
you weren’t
afraid?
I have had the opportunity and privilege
to meet many business and political
leaders throughout
my career. Perhaps
the most memorable
meeting was with
one of the world’s most recognized United States
statesmen, retired four-star general in the United States Army, General Colin Powell. Powell’s
career and accomplishments go far beyond what
we can cover in Pharmaceutical Engineering
Magazine and frankly, his background is less
important than his call to leadership.
When I first met Powell, his public speeches
and presentations were centered on conviction,
doing what is necessary and what is right, and
he never failed to make it a point to emphasize
the relationship between leadership and making
the tough call in support of long-term results.
He always appreciated getting the full picture,
understanding root causes, and that doing the
right thing was almost always the most difficult.
He challenged audiences to have courage in
their decisions and convictions, often ending
his talks with this intriguing question “what
would you do if you weren’t afraid?”
Powell encouraged his audiences to face up
to difficult situations, to find compromise if possible and if not, to make right even the most difficult of circumstances. He encouraged leaders to
demand excellence and to model behaviors that
bred uncompromising commitment, the very
highest expectations and unwavering integrity.
My impression is that Powell believes that people
morally desire the best in all situations, much
like we morally desire uncompromising quality
in the production of safe medicines.
Are we doing everything we can
in the relentless quest for
unwavering quality?
I have been impressed that unwavering quality
is our industry’s battle cry. That makes patients
feel safe. What also strikes me is while there is
a relentless quality commitment, in many companies, “quality, quality leadership, and quality
management” are still viewed as assignments,
job titles, or company functions. Even more
startling is that some companies define quality
as “what regulators expect” rather than making
quality the predominant leadership philosophy
that drives their organizational culture and
decision-making.
Our industry goes above and beyond to ensure
the safety of our patients; it invests billions in
R&D and production to bring forward the most
innovative products, and it is working diligently
toward common best practices and harmonization to improve quality on all fronts. As a leader,
I still wonder how we could all do more. What
would we do if we weren’t afraid (of cost, of time,
of saying yes or no, of challenging a process, an
inspector, or being bold about getting the right
answers)?
There is much to be done to move industry
to the next level – where quality is our culture
and more than just a goal or a function. In
conversations with company and regulatory
leaders, ISPE is being asked to lead industry
toward greater awareness, knowledge, and application of enterprise-wide quality management
systems. Leaders also agree that the industry
May/June 2012 PHARMACEUTICAL ENGINEERING
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Message from the President
needs stronger commitments to leading change; removing
stop-gaps and short-term responses to quality concerns. They
desire to better understand how to cut costs and reduce risks,
and to discontinue the practice of rewarding short-term gains
without a complete understanding of the long term effects on
quality and the patient.
ISPE to Lead Quality Management
Systems, QbD, and Supply Chain
Education, Discussions
Breaking down silos and barriers is certainly difficult, especially in pharma where there are massively complex supply
chain and regulatory relationships. Complex yes, but impossible, no. Over the next year, ISPE will be forming groups
and leading special discussion meetings, where members and
industry will open up dialog with regulatory agencies to begin
the critical tasks of identifying and resolving issues to remove
barriers that one way or another penalize our product standards, technological innovation, and our industry’s integrity.
In other words, issues that prevent faster and more effective
implementation of quality management systems, including
QbD, as well as specific areas within supply chains that present the greatest obstacles, cost constraints, and patient risk.
As part of our expanded mission, ISPE will be engaging
the entire product lifecycle in discussions around design and
integration issues and our regulatory colleagues will be at the
table with us, much like they were during our recent CGMP
Conference cosponsored by the FDA (4-5 June, Baltimore).
It was at this meeting that industry agreed that our biggest
obstacle might be ourselves.
During this Conference, ISPE’s distinguished keynote
presenters from companies and regulatory agencies echoed
the need for the industry to step up to better decision-making,
particularly when challenged to reduce costs and in managing
challenging global supply chains. FDA leader Janet Woodcock
told the audience that “industry must get beyond the fear associated with meeting regulatory standards and drive their
companies toward producing safe, high quality medicines.”
To build on Powell’s question, what could we do if we weren’t
afraid? I suggest that to achieve more reliable outcomes, we
must remove the roadblocks and barriers and stop suggesting we need to do something and just do it. What are your
suggestions? How would you like to lead or be involved with
ISPE in advancing industry? I want to hear from you.
Mission Possible
So there we have it. Industry and regulators aligned. ISPE
leading a plan to focus industry on its core purpose; let’s
bypass distractions and do what is necessary to achieve our
desired future. I think our future is bright and our mission
is possible. Won’t you join us in our pursuit?
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PHARMACEUTICAL ENGINEERING July/August 2012