■ FROM THE EDITOR
Is Anyone Listening?
■ Michael Auerbach, Editor in Chief
Let’s face it – when you were growing up – perhaps mostly in your teen years – you never really listened to your parents. You might have pretended to, or developed that uncanny ability to not really listen – yet be able to recite the last sentence of whatever was said. A great skill indeed.
Has anyone been listening to the FDA?
In 2004, the FDA proposed the idea of Quality by Design. According
to an article in this month’s issue by Ron Snee, QbD’s purpose “was
The FDA, however, is not above reproach.
Congressional hearings into the worst of
the quality failures, the NECC case which
lead to dozens of deaths from meningitis,
has revealed that the FDA knew of
the problems, but failed to act.
to design quality into the product and process rather than try to
test quality into the product at the end on the production line. It has
been known for a long time that “quality by testing” is a low-yield and
costly strategy. In 2005 ICH outlined the concept of design space in its
Q8 guideline that focused on product development. Since that time,
pharmaceutical and biotech companies – despite depending on inno-
vation for their livelihood – have been slow to adopt QbD.”
I mention this in light of the many recent recalls regarding qual-
ity problems at compounding pharmacies around the nation. As a
subscriber to the FDA’s email alerts it’s quite sobering to read the
almost constant stream of recall notices and tally up how many are
related to quality control problems at compounding pharmacies.
The FDA, however, is not above reproach. Congressional hear-
ings into the worst of the quality failures, the NECC case which
lead to dozens of deaths from meningitis, has revealed that the
FDA knew of the problems, but failed to act.
All of this leads me to my question – if these firms had had lis-
tened to the FDA back in 2004 and implemented the recommenda-
tions proposed – would we even be in this situation?
Sometimes a little listening goes a long way – just ask your parents.
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EDITORIAL ADVISORY BOARD
Michael J. Beier,
Senior Vice President of Operations
TITAN PHARMACEUTICALS, INC.
Dr. James V. Blackwell, PhD, Consultant
BIOPROCESS TECHNOLOGY CONSULTANTS, INC.
Ronald C. Branning,
Vice President Global Quality
Robert F. Dream, Vice President
H.D.R. COMPANY LTD.
Johanna Carmel Egan,
VGP Project Management
Girish Malhotra, President
Allan F. Pfitzenmaier, President
VECTECH PHARMA CONSULTANTS INC.
Susan Polizzotto, Manager,
R&D QA GMP Compliance
US SANOFI PASTEUR
Carlos Villalobos, Sr. Dir. Global Engineering
Richard G. Whitfield, Senior Director
Patrick Wong, Director of Global Engineering
BRISTOL-MYERS SQUIBB (BMS)