CDMO Receives FDA Inspection Approval
Following successful MHRA audits in 2011, Almac’s Sciences Business unit has completed a successful inspection of its analytical facilities at its Craigavon headquarters, Northern Ireland, from the US FDA. The inspection concluded with no objectionable conditions (483 observations) nor recommendations for improvements.
The inspection of the control testing laboratory was in support of pre-approval inspections for products for which Almac Sciences is named as the contract test laboratory. The three-day inspection covered the quality and laboratory control systems and included tours of all test laboratories and specialist analytical facilities, including mass spectroscopy laboratories.
Commenting on the approval, 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 that 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.”
Alan Chambers, Head of Quality Assurance, added: “This success confirms Almac’s dedication to delivering the highest quality standards. To complete this inspection with no findings is testament to the knowledge and expertise of the entire Almac workforce. We are committed to building on these strong foundations with continual investment within our quality systems.”
Almac has also announced the expansion of its manufacturing and support facilities at its Craigavon plant. These include an extended API facility, which doubles the current GMP APIs manufacturing capacity, and expansion of its stability storage chambers also with a doubled capacity increase.
Almac Group, +44 2838 363363, tania.davis@almacgroup.com, www.almacgroup.com.