Oxford BioMedica Announces Successful MHRA Inspection for its Proprietary Manufacturing Facility
Oxford BioMedica plc announces that it has received approval from the UK Medicines and Healthcare products Regulatory Agency (MHRA) to manufacture bulk drug material for Investigational Medicinal Products (IMPs) at the Company’s specialist manufacturing facility in Cowley, Oxford. This represents an extension of Oxford BioMedica’s existing Good Manufacturing Practice (GMP) certification which covers the established in-house activities for testing and subsequent release of IMPs for clinical development.
The MHRA conducted an initial site inspection in March 2012, and a follow-up inspection in May 2012, to evaluate whether the Company’s processes, facilities and quality management systems were in accordance with EU GMP standards. The inspection had a successful outcome as the MHRA confirmed that Oxford BioMedica’s operations are in general compliance with the principles and guidelines of GMP as laid down in Commission Directive 2003/94/EEC. Having attained GMP certification, the manufacturing plant is now fully-operational and authorised to perform GMP manufacturing activities in support of clinical supply.
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