Holywell facility can now produce registered intermediates and APIs for use in humans
The UK Medicines and Healthcare regulatory Agency (MHRA) has issued a Good Manufacturing Practice (GMP) certificate to AMRI’s plant in Holywell, Wales, 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 both 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 the contract manufacturer can now conduct at this facility.
AMRI received the formal closeout of the MHRA inspection this month. 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.
Steven Hagen, AMRI vice president of pharmaceutical development and manufacturing, 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.’
In 2010, the FDA inspected AMRI’s Rensselaer, New York facility, which provides large-scale cGMP manufacturing, and no formal observations were issued. In the same year, the Italian Medicines Agency (AIFA) approved the Burlington, Massachusetts facility to manufacture a commercial drug product for a customer in the European Union.