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NextPharma Completes FDA Inspection

Belgian site to produce lyophilized cytotoxic cancer treatment

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By: Tim Wright

Editor-in-Chief, Contract Pharma

NextPharma has successfully completed an FDA inspection at its Braine-l’Alleud site, near Brussels in Belgium, a facility for aseptic production and packaging, including the manufacture of cytotoxic products.

The inspection was in support of a patented lyophilized medicinal product for cancer treatment manufactured in the company’s dedicated cytotoxic facility. The main part of the inspection paid specific attention to NextPharma’s Quality Management System and compliance with FDA GMP, in addition to the company’s approach to facility qualification, sterility assurance and medicinal product containment. The inspection also addressed those elements of an FDA pre-approval investigation associated with process and analytical technology transfer, process optimization, process validation, stability testing and industrialization.

Working in conjunction with its customer, which has offices in Europe and the U.S., NextPharma anticipates supplying this orphan medicinal product to the U.S. market in mid-2010.

The inspection in Braine-l’Alleud came 14 months after the successful FDA inspection of the company’s Waltrop site near Dusseldorf, Germany, a site specializing in the manufacture of liquids, semi-solids and solid hormone products. NextPharma also has active FDA readiness programs at two other sites in Germany: Bielefeld (near Dortmund), which specializes in pellet technology, and Göttingen (near Hannover), which specializes in the manufacture and packaging of traditional solid dosage forms and also in a fully separate facility for oral cephalosporins.

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