Inspection supports cancer drug made in cytotoxic facility
NextPharma’s FDA inspection at its Braine-l’Alleud site, near Brussels in Belgium, was in support of a patented lyophilised medicinal product for cancer treatment manufactured in the company’s dedicated cytotoxic facility.
The plant has extensive expertise in aseptic production and packaging, including the manufacture of cytotoxic products.
The inspection paid specific attention to NextPharma’s Quality Management System, and compliance with FDA GMP (Good Manufacturing Practice) Six Systems, in addition to its 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 optimisation, process validation, stability testing and industrialisation.
NextPharma anticipates supplying this orphan medicinal product for the US market from June.
‘I would like to commend the site team and quality specialists for their enthusiasm and professionalism during the inspection process,’ said Bill Wedlake, chief executive of NextPharma Technologies.
‘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 marketplace.’
The company has also had successful FDA inspections at its Waltrop site near Dusseldorf, Germany, a site specialising in the manufacture of liquids, semi-solids and solid hormone products.
NextPharma additionally has active FDA readiness programmes at two further sites in Germany, a pellet technology specialist in Bielefeld, and at Göttingen, which specialises in the manufacture and packaging of traditional solid dosage forms.