Chemistry Reference
In-Depth Information
3. Center for Drug Evaluation and Research (CDER)
4. Center for Food Safety and Applied Nutrition (CFSAN)
5. Center for Veterinary Medicine (CVM)
6. National Center for Toxicological Research (NCTR)
7. Office of the Commissioner (OC)
8. Office of Regulatory Affairs (ORA)
The two centers that are most important to any discussion of compliance and valida-
tion from a laboratory perspective are the CBER and CDER. The CBER regulates
biological products for disease prevention and treatment that are inherently more
complex than chemically synthesized pharmaceuticals, including
• Blood and blood products, such as plasma, blood-derived proteins includ-
ing clotting factors for hemophilia, tests used to screen blood donors, and
devices used to make blood products
• Vaccines and allergenic products
• Protein-based drugs, such as monoclonal antibodies and cytokines that
stimulate the immune system to fight cancer, and enzyme therapies that
stop heart attacks
The CDER promotes and protects health by assuring that all chemically synthe-
sized prescription and over-the-counter drugs are
safe and effective
. The CDER
evaluates all new drugs before they are sold, and serves as a consumer watchdog
for the more than 10,000 drugs on the market to be sure they continue to meet the
highest standards
.
FDA chemists review proposed analytical procedures submitted as part of NDAs
and abbreviated new drug applications (ANDAs). But while the FDA provides guide-
lines to follow, it is not a research organization designed to improve or troubleshoot
a method once submitted. Therefore, proper care and attention must be given so
that the validation package submitted is as complete as possible, with no errors or
omissions. Having to resubmit a validation package for review is like waving a red
flag and is bound to draw the wrong type of attention! Getting it right the first time
decreases the time to market and the associated costs.
1.4 InternAtIonAl conFerence on HArmonIzAtIon
For years, many countries around the world have had national regulatory systems to
evaluate the quality, safety, and efficacy of pharmaceutical products. While formed
on the same basic commitments, detailed technical requirements diverged over time
to such an extent that the pharmaceutical industry found it necessary to duplicate
many time-consuming and expensive test procedures in order to market new prod-
ucts internationally.
In response to the growing global pharmaceutical market, the International
Conference on Harmonization of Technical Requirements for Registration of
Pharmaceuticals for Human Use (ICH) was first conceived in 1990 at a meeting hosted
by the European Federation of Pharmaceutical Industries and Associations (EFPIA) in
