Albany Molecular Research, Inc. (AMRI), a global contract research and manufacturing organization with more than twenty years experience in providing customers fully integrated drug discovery, development, and manufacturing services, has 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 US 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.
The MHRA is the UK regulatory agency and is recognized as one of the leading global authorities on GMP compliance. The MHRA inspection occurred in October 2011 with a formal closeout received in January 2012. The certificate covers general GMP manufacturing operations, and laboratory controls designed for the production and release of active pharmaceutical ingredients (APIs) and intermediates. The successful audit confirms AMRI’s compliance with European Medicines Agency GMP regulations and further demonstrates the Company’s commitment to operational quality.
AMRI Vice President, Pharmaceutical Development and Manufacturing Steven R. Hagen, 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 2010, 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 2010 from the Italian Medicines Agency (AIFA) for its Burlington, Mass. facility to manufacture a commercial drug product for a customer in the European Union.