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GMP News No. 443
4 August 2004
Next to EMEA, the US Food and Drug Administration (FDA) certainly definesthe 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 toppriorities for globally operating companies.
Against this background, to be selectedfor special recognition by FDA is something extraordinary. The FDA has nowhonoured the members of the working group that created the ICH Q7A Guide'GMP for Active Pharmaceutical Ingredients.' This working group consistedof representatives of the supervisory and medicines authorities in theUS, Europe, and Japan as well as representatives from the industry. So,among others, Dr Lothar Hartmann, Hoffmann-LaRoche Basle, and Dr Norman Franklin (formerly BAYER AG) havereceived the award. Both are active members of the Active PharmaceuticalIngredients Committee (APIC), a sector group of the European ChemicalIndustry Council (CEFIC).
Through their work, for the first time inthe GMP-regulated sphere, an internationally harmonised GMP guideline forAPI manufacturers could be developed. This is an enormous advantage forglobally active enterprises. FDA's Acting Commissioner,Dr Lester M. Crawford, writes in his congratulation:
"... For outstanding cooperation andachievement in developing an internationally harmonized good manufacturingpractice guidance for active pharmaceutical ingredients used in human drugproducts. ..."