NextPharma Technologies Has Successfully Completed an FDA Inspection at its Braine-l’Alleud site in Belgium
Published: Mar 24, 2010
Surrey, UK, 24th March 2010 - NextPharma, the leading European provider of product development, contract manufacturing and cold chain and logistics outsourcing services to the pharmaceutical and biotech industry, is pleased to announce that it has successfully completed an FDA inspection at its Braine-l’Alleud site, near Brussels in Belgium, a specialist facility with extensive know how in 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 (Good Manufacturing Practice) Six Systems, 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, who has offices in Europe and USA, NextPharma anticipates supplying this orphan medicinal product for the USA market from mid 2010. Bill Wedlake, Chief Executive Officer, NextPharma Technologies, commented: “We are delighted to be supplying this important product to the USA from our site in Braine-l’Alleud. I would like to commend the site team and quality specialists for their enthusiasm and professionalism during the inspection process. Our specialist knowledge can now be applied to the development of medicinal products, from cytotoxics to biologics in our new Sterile Product Development Centre (SPDC), through clinical material supply to commercial manufacture, for the global market-place including the USA. Overall, this outcome in Braine-l’Alleud is another major step forward for NextPharma in its objective to be the leading provider of world class, quality pharmaceutical product development and contract manufacturing services to the global pharmaceutical and biotechnology markets”. The FDA inspection in Braine-l’Alleud comes 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 additionally has active FDA readiness programmes at two further sites in Germany; at its site in Bielefeld (near Dortmund) where it specializes in pellet technology and at its site in Göttingen (near Hannover) where it specializes in the manufacture and packaging of traditional solid dosage forms and also in a fully separate facility for oral cephalosporins. NextPharma’s Belgian site, Braine-l'Alleud, has extensive know how in aseptic production and packaging including the manufacture of cytotoxic products (lyophilization and solutions) gained over more than fifteen years and a growing capability in biologics. NextPharma develops, manufactures, packages, and distributes a broad range of products and formulations for its customers including solids, liquids and semi-solid dosage forms, antibiotics, hormones and controlled release medicines. It has an established leadership position in the high technology area of injectables manufacturing (lyophilized and liquid fill), with particular expertise in product development and manufacture of oncology medicines.