GMP News No. 443
4 August 2004
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 products. ..."
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.