Glasgow, U.K., 4th July 2008 – Bio-Images Research Ltd., Glasgow, has today announced that it has completed validation of a fully compliant cGMP manufacturing facility at its clinical research unit based with Glasgow Royal Infirmary. The site now meets cGMP requirements defined by the EU Directive for the manufacture of Investigational Medicinal Products.
The company has been granted a Manufacturing Authorisation by the Medicines and Healthcare products Regulatory Agency (MHRA) and has undergone a successful inspection by the MHRA to confirm cGMP compliance.
The Authorization is a major event in the company’s evolution bringing manufacturing operations in-house providing a streamlined service to clients.
“The grant of a cGMP manufacturing licence to the company represents a significant advance for Bio-Images. It greatly facilitates our manufacturing processes and ends our reliance on external contractors. This will significantly enhance our capability to provide an efficient, comprehensive service to our customers, from the manufacture of radiolabelled clinical supplies through to clinical scintigraphic studies in humans.” Professor Howard Stevens, Chairman and Qualified Person.
