Almac’s Clinical Technologies Division Undergoes Successful Joint GCP-GMP MHRA Inspection

Almac's Clinical Technologies division has successfully passed one of the UK's first joint routine GCP/GMP Medicines and Healthcare Products Regulatory Agency inspections at its Craigavon (UK) site.

Almac’s Clinical Technologies division has successfully passed one of the UK’s first joint routine GCP/GMP Medicines and Healthcare Products Regulatory Agency (MHRA) inspections at its Craigavon (UK) site. This involved senior MHRA inspectors from both its GCP and GMP areas assessing compliance with UK and European legislation.

The MHRA inspection was conducted on the GMP side to determine whether Almac’s IXRS integrated phone and web response system was able to adequately ensure that expired products were not shipped to sites or dispensed to patients at clinical trial sites. In addition, the system was reviewed in general terms for its compliance with GCP. Almac Clinical Technologies received notice from MHRA that no serious findings were found in any of these areas or others investigated by the regulatory agency.

This was the first time in its history that Almac’s Clinical Technologies division has been inspected by a regulatory authority. The i