Swedish Body Certifies Bend Research for EU GMP Compliance
The Oregon based research and manufacturing company has received an EU Certificate of GMP (good manufacturing practice) after voluntary inspections at its facilities by the Swedish Medical Products Agency (MPA).
The Swedish body is one of only a few European agencies which regularly conducts inspections outside Europe. The approval will allow Bend to increase its services to clients who need European compliance in the research and manufacture of oral and inhaled drug-product intermediates, as well as drug products such as tablets and capsules.
Debra Katter, Vice President of Corporate Quality, explained that Bend chose the MPA because it is covered under a Confidentiality Agreement which is part of the FDA’s (US Food and Drug Administration) Initiative for Global Product and Safety.
The two regulatory bodies “entered into the Confidentiality Agreement,” Katter told Outsourcing-Pharma.com, allowing the sharing of “information that would not be available for public disclosure under U.S. laws and regulations.”
The certification covers both of Bend’s manufacturing Oregon facilities in manufacturing and testing bulk drug products and drug-product intermediates. The GMP extends to the laboratories associated with the plants.
In providing a service that will appeal to its clients on a global scale, Katter added that: “The Swedish MPA inspection was very informative and assisted us greatly in our efforts.”
'Around the Bend'
Bend has inked deals with several big pharma companies including Eli Lilly and Merck over access to its spray-dried dispersion technology and thus European compliance is the latest in proactive achievements as it attempts to increase its services to clients.
A series of upgrades and new technologies were implemented last year, including a new 18mm hot melt extruder which led the way to offering hot melt extrusion capability. This is on top of spray-drying, which also saw an expansion last August when a new spray-drying facility let the company work with high-potency ingredients.
