Site continues to be compliant with EU Good Manufacturing Practices, with no critical or major failures observed
Almac has announced the successful inspection of its Clinical Services operations located in Craigavon by the UK Medicines and Healthcare products Regulatory Agency (MHRA). The inspection, which occurred from 17–20 September 2012, was a routine inspection conducted by a MHRA inspector from the regulatory body who concluded that the site continues to be compliant with EU Good Manufacturing Practices, with no critical or major failures observed.
’Once again we are extremely pleased with the outcome of our inspection,’ said Paul O’Connor, vice president of quality. ‘Quality is at the forefront of all our operations and all our employees continuously strive to ensure we have all the necessary processes in place to support our reputation in delivering global regulatory compliance and quality management excellence.
‘This latest inspection is even more significant as it comes at an exciting time as we prepare to implement our new multi-million pound ERP system. This was reviewed intensively – one and a half days in total during the inspection period and resulted in no findings - testimony to our confidence that this exciting new development will further enhance our position as the premium supplier of global clinical supply chain solutions to the Pharmaceutical and Biotech industries.’
Almac has three MHRA approved clinical services facilities globally, including its additional FDA-assessed US facilities in Souderton, PA and Durham, NC.