Next to EMEA, the US Food and Drug Administration (FDA) certainly defines
the highest standards for drug quality and drug safety worldwide.
Therefore, today the FDA-compliant implementation of GMP regulations -
above all the avoidance of FDA Warning Letters - is one of the top
priorities for globally operating companies.
Against this background, to be selected
for special recognition by FDA is something extraordinary. The FDA has now
honoured the members of the working group that created the ICH Q7A Guide
'GMP for Active Pharmaceutical Ingredients.' This working group consisted
of representatives of the supervisory and medicines authorities in the
US, Europe, and Japan as well as representatives from the industry. So,
among others, Dr Lothar Hartmann, Hoffmann-La
Roche Basle, and Dr Norman Franklin (formerly BAYER AG) have
received the award. Both are active members of the Active Pharmaceutical
Ingredients Committee (APIC), a sector group of the European Chemical
Industry Council (CEFIC).
Through their work, for the first time in
the GMP-regulated sphere, an internationally harmonised GMP guideline for
API manufacturers could be developed. This is an enormous advantage for
globally active enterprises. FDA's Acting Commissioner,
Dr Lester M. Crawford, writes in his congratulation:
"... For outstanding cooperation and
achievement in developing an internationally harmonized good manufacturing
practice guidance for active pharmaceutical ingredients used in human drug
The contribution of Dr Lothar
Hartmann and Dr Norman Franklin in the ICH Q7A working group
made it possible to establish close relations with the supervisory
authorities, which have led to the fact that at this year's 7th European Conference on APIs
presented by APIC from 20-22 October a considerable number of authority
representatives will give lectures. Apart from the two award winners,
Dr Moheb M. Nasr, FDA, Dr Guirag Poochikian, FDA,
Dr Katrin Nodop, EMEA, and Corinne Pouget, EDQM, will be
among the 20 speakers in Lisbon.