Almac's Clinical Technologies Division Undergoes Successful Joint GCP-GMP MHRA Inspection
By Almac Group, PRNEMonday, September 20, 2010
YARDLEY, Pennsylvania, September 21, 2010 - Almac's Clinical Technologies division announced today that it had
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. 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 in its history 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 on 3 September 2010 after the
company was inspected from 23-25 August 2010.
Jim Murphy, President of Almac's Clinical Technology division comments on
this significant milestone: "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."
About Almac Group
The Almac Group comprises five closely integrated divisions offering a
broad range of services from R&D, biomarker discovery and development, API
manufacture, formulation development, clinical trial supply and IXRS
technology (IVRS/IWRS), to commercial-scale manufacture. Almac provides
services to more than 600 companies, including all the world leaders in the
pharmaceutical and biotech sectors.
The company employs over 2,700 individuals and is headquartered in
Craigavon, Northern Ireland. US operations are based in Pennsylvania, North
Carolina and California. Almac has officially gained full possession of its
new $120m North American Headquarters which started in July 2008 and
employees will relocate during the fall. .
Almac's Clinical Technologies division specializes in interactive
technology and service solutions to increase the quality and efficiency of
the clinical trial process. Our solutions include Interactive Voice and Web
Response Systems (IXRS(TM)) for patient randomization, tracking and clinical
supply management, electronic-patient-reported- outcomes data collection, and
Web drug reconciliation. Almac's technologies have been deployed in over 1500
clinical trials, incorporating over 1.5 million patients in over 80
countries, and more than 60 languages.
For more information about the Almac Group, please visit
www.almacgroup.com or e-mail info@almacgroup.com.
www.almacgroup.com
Contact: Joseph Bedford, T: +1-267-685-4284, E: clinicaltechnologies at almacgroup.com
Tags: Almac Group, Pennsylvania, September 21, Yardley