Almac achieves full GMP compliance across global sites

Almac Clinical Services has completed a successful inspection of its Durham, North Carolina, US operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

Almac Clinical Services has completed a successful inspection of its Durham, North Carolina, US operations by the UK Medicines and Healthcare products Regulatory Agency (MHRA).

This was the final inspection covering the group’s main sites for clinical supplies and follows those performed at its Craigavon (UK) and Audubon (US) facilities within the last four months.

The voluntary inspection, which took place in November, observed that the Durham site was fully compliant with EU Good Manufacturing Practices, with no critical or major failures noted.

Commenting on the global significance of the inspections, Paul O’Connor, vice president of quality, said: ‘The inspection at our Durham site is the third and final outcome in demonstrating global GMP compliance for Almac Clinical Services. Once again we have proven our company wide attitude towards a total quality ethos and this has been reflected in the results of the recent inspections.’

Almac Clinical Services is focused on clinical trial supply solutions. Services provided include blinding, packaging, labelling, global distribution, QP release, analytical testing, drug supply management and online randomisation.

Featured Companies

Almac Group (more information, website)