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news.Almac's Clinical Technologies division, specialised in interactive technology and service solutions to improve clinical trial process efficiency, 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.
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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.
Almac’s Clinical Technology division president Jim Murphy said that the successful results of 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.
Almac’s Clinical Technologies Quality Assurance director Bill Kane said that the MHRA inspection validates the quality procedures that Almac has put in place and offers another testimony to focus on providing technologies and services to biopharmaceutical companies worldwide.