Successful Inspection by FDA of Almac Clinical Services North Carolina Facility
June 14, 2016
Durham, N.C., USA – 13 June 2016 – Almac Group, the global contract development and manufacturing organisation, is pleased to announce that it’s Clinical Services Business has completed a successful inspection of their Durham, North Carolina facility.
The inspection was concluded on Wednesday, 8 June, 2016 by the US Food and Drug Administration (FDA).
The non-scheduled FDA visit lasted three days. The inspection was extensive and a variety of documentation including validation, e-records, and audits were reviewed. The requested documents covered deviation, change control, data integrity, and training. There were no verbal or written observations and consequently no 483 was issued.
Christi Gimber, Director of Quality at Almac Clinical Services commented on the inspection:
“We are delighted with the results of this latest inspection. Almac prides itself on delivering an exceptional level of quality and complete adherence to best practice for our industry. The inspector commented that we are doing GXP training the way it should be done and was very impressed with the program and the variety of topics covered. He also noticed from review of the Site Master File that most of our staff have been with Almac for many years and felt that said a lot about the kind of company Almac is. I would like to thank all the staff who supported the inspection. The result is a testimony to the dedication and effort of our employees who are committed to ensuring that the highest standards are always delivered by Almac.”
About Almac Clinical Services
Almac Clinical Services provides the most comprehensive global clinical supply chain solution in the marketplace. Guided by extensive supply experience, they provide the physical resources and supportive technologies that ensure their client’s clinical supply chain continually delivers across the globe.
Almac’s Durham, North Carolina site was opened in 2000 and currently employs over 300 employees. Almac Clinical Services also have facilities in Pennsylvania and San Francisco, as well as numerous locations across the globe.
About Almac Group
‘Partnering to Advance Human Health’
The Almac Group is an established contract development and manufacturing organisation that provides an extensive range of integrated services to over 600 companies globally within the pharmaceutical and biotech sectors. The services range from R&D, biomarker discovery and development, API manufacture, formulation development, clinical trial supply, IXRS® technology (IVRS/IWRS) through to commercial-scale manufacture.
The international company is a privately owned organisation that has organically grown over 40 years and now employs in excess of 4,000 highly skilled personnel. Almac is headquartered in Craigavon, Northern Ireland with operations across the US (Pennsylvania, North Carolina and California) and in Asia (Singapore and Tokyo).