AMRI announced that the Medicines and Healthcare Regulatory Agency (MHRA) of the UK government has issued a Good Manufacturing Practice (GMP) certificate for AMRI's manufacturing facility in Holywell, Wales, UK, following an inspection in October 2011. The MHRA inspection follows a U.S. Food and Drug Administration audit of the facility in June 2011, in which no formal observations were issued. The successful completion of the US FDA and UK MHRA inspections means that AMRI's Holywell facility can now produce registered intermediates and active ingredients for use in humans and expands the range of projects that AMRI can now conduct at this facility.
AMRI Vice President, Pharmaceutical Development and Manufacturing Steven R. Hagen, Ph.D. said, "This certification completes an excellent year of regulatory cGMP audits for the Holywell facility and places it in a prime position to attract new business. The certification also closes a highly successful year of numerous audits across our global facilities that align us with best industry practices."
In 2011, AMRI's Rensselaer facility, which provides large-scale cGMP manufacturing, was inspected by FDA, in which no formal observations were issued. In addition, the Company received an approval in February 2011 from the Italian Medicines Agency (AIFA) for its Burlington, Mass. facility to manufacture a commercial drug product for a customer in the European Union.
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The Medicines and Healthcare products Regulatory Agency (MHRA) is the government agency which is responsible for ensuring that medicines and medical devices work, and are acceptably safe. The MHRA is an executive agency of the Department of Health. more