Almac’s Sciences Business Unit has completed a successful inspection of its analytical facilities by the FDA at its Craigavon headquarters. The inspection concluded with no 483 observations or recommendations for improvements.
The inspection was in support of pre-approval inspections for several products and covered the quality and lab control systems, and included tours of all test labs and specialist analytical facilities including mass spectroscopy labs.
President and managing director, Stephen Barr, said,“We are delighted with the outcome of this inspection. We have now established a track record with both authorities, which highlights our strong focus on compliance and regard for regulatory standards. This outcome is even more significant with the completion of our expanded API facility, and focus on late phase clinical development projects. Our clients can be further assured that our systems and procedures are robust and their products will be delivered to the highest quality.”
Additionally, Almac is expanding its manufacturing and support facilities in Craigavon, including an extended API facility, which doubles the current GMP API manufacturing capacity, and an expansion of its stability storage chambers.