Almac Receives FDA Inspection Approval
February 20, 2013
Following from 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 Food and Drug Administration (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 are named as the contract test laboratory. The 3-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 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.”
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 is also pleased to announce expansion of its manufacturing and support facilities at its Craigavon plant. These include an extended API facility, which doubles the current GMP Active Pharmaceutical Ingredients (API) manufacturing capacity, and expansion of its stability storage chambers with also a doubled capacity increase.
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Notes to Editors
The Almac Group provides a broad range of services from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply and IXRS® technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides services to more than 600 companies, including all the world leaders in the pharmaceutical and biotech sectors.
The company employs over 3,300 individuals and is headquartered in Craigavon, Northern Ireland. US operations are based in Pennsylvania, North Carolina and California.