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4 November 2004
BioReliance has been granted a Manufacturer's Authorisation for Investigational Medicinal Products by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) for its facilities in Glasgow, Scotland.
This is the result of a recent inspection of BioReliances Facilities and Quality Systems by the MHRA. BioReliance was able to demonstrate compliance in accordance with the European Union (EU) Clinical Trials Directive 2001/20/EC, which was introduced in the UK on 01 May 2004.
The licence gives authority for BioReliance to manufacture and test a range of biological active substances under contract for EU clinical trials.
The Clinical Trials Directive aims to improve patient protection by ensuring that clinical trial materials are manufactured under strictly controlled conditions. Under the Directive, all products released for clinical trials in Europe must be manufactured in accordance with EU Good Manufacturing Practice or the GMP of a third country recognised as an equivalent. Each batch of clinical trial material must also be certified by a Qualified Person before release.
This latest success is in addition to an MHRA audit of the GLP systems in June 2004 in which BioReliance Glasgow demonstrated continued excellence following their successful GLP audits in 1999 and 2002, and were awarded a Certificate of Compliance for practices in accordance with directive 2004/9/EC.
Founded in 1947, BioReliance has since become the worlds largest specialist provider of contract biologics safety testing, GMP manufacturing and pre-clinical and clinical testing services. In 2004, the company became a subsidiary of Invitrogen; strengthening company resources and expanding the range of services available to clients.
Jon Marshall, Operations Director, Manufacturing commented:
The grant of a Manufacturer's Licence recognises the existing high standards in production and testing at the facility. Since its inception, our facility in Glasgow has consistently proved itself ahead of the competition. This reinforces that BioReliance continues to have the confidence of many clients in producing a high quality product.
Irene Aylott, Director, Quality Systems, continued:
This is the latest of many successful audits & inspections which acknowledge the high standards and years of compliance at the facility. Clients can be confident that BioReliance products and services conform to the very highest standards in the industry."
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