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Almac Successfully Completes MHRA Audits

Confirms IMP/GMP compliance at Craigavon, Elvingston sites

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By: Tim Wright

Editor-in-Chief, Contract Pharma

Almac’s Sciences unit has achieved successful MHRA inspections at its Craigavon Headquarters in Northern Ireland and at its Elvingston, Scotland site, confirming compliance with Investigation Medicinal Products (IMP) licenses and GMP certificates.
 
The first inspection audited Almac’s isotope chemistry facility in support of its IMP license. The inspection involved tours of the new manufacturing finishing suite and associated infrastructure, in support of the extended API facility. The license covers both radiolabelled and non-labeled IMPs.

The second inspection covered Almac’s analytical laboratory in Elvingston, supporting its GMP certificate as a contract analytical facility. As a result of this audit, two GMP certificates will be issued for human and veterinary applications.

President and managing director Stephen Barr said, “We are delighted with the outcome of these inspections.  It is reassuring to know that the value we place on our staff and facilities is recognized in this way, and adds further credibility to our wealth of experience and services we offer.”

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