Almac’s Clinical Technologies Division passes MHRA inspection

11 Oct 2010

Almac’s Clinical Technologies division has successfully passed one of the UK’s first joint routine clinical and manufacturing inspections by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) 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 Good Manufacturing Practice (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.

Additionally the system was reviewed in general terms for its compliance with Good Clinical Practices (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 that Almac’s Clinical Technologies division has been inspected by a regulatory authority. The inspection was conducted as part of a routine inspection plan and process of MHRA and was not triggered by any particular events, issues, or potential violations at Almac. MHRA routinely conducts inspections of both pharmaceutical companies and associated vendors who are involved in clinical trials. The results of the MHRA inspection were reported to Almac in September 2010 after the company was inspected from 23-25 August 2010.

Jim Murphy, President of Almac’s Clinical Technology division said: "The highly successful results of our first-ever regulatory inspection validate the efforts of all Almac employees to deliver the highest quality GCP and GMP systems and services to our clients. We take great pride in Almac’s specialized full supply chain solution involving patient, site and drug management services, which are delivered using our IXRS technology.

"As patient safety is a key concern for Almac, we employ every effort to assure that patients in clinical trials are provided with products that are managed carefully to prevent expiration and meet all the requirements defined and monitored by regulatory agencies.”

Bill Kane, Director of Quality Assurance for Almac’s Clinical Technologies division, notes that Almac was not surprised by the results, given the company’s long history of delivering quality systems and services to biopharmaceutical clients. “Almac has very stringent quality SOPs that clearly define and guide the way we build systems for our clients and manage the drugs that patients take during clinical trials. The MHRA inspection validates the quality procedures that Almac has put in place and offers another testimony to our focus on providing high quality technologies and services to biopharmaceutical companies worldwide. We typically excel at client audits and now have passed another key test — an MHRA inspection.”