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
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