The inspectors made no verbal or written observations
Almac Group, the global contract development and manufacturing organisation headquartered in Craigavon, Northern Ireland, has completed a successful US Food and Drug Administration (FDA) inspection at its Clinical Services Business in Durham, NC, US.
The non-scheduled FDA visit lasted three days and a variety of documentation including validation, e-records and audits were reviewed. The documents covered deviation, change control, data integrity and training. The inspectors made no verbal or written observations and no 483 was issued.
Christi Gimber, Director of Quality at Almac Clinical Services, said 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 programme and the variety of topics covered,' she said.
'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 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.'
Almac’s Durham site was opened in 2000 and currently employs more than 300 people. Almac Clinical Services also has operations in Pennsylvania and San Francisco, as well numerous locations worldwide.