Althea obtains European GMP certificate from HPRA for commercial aseptic filling and testing

Jun 16 2015

Ajinomoto Althea, Inc. ("Althea"), a leading provider of biopharmaceutical contract development and manufacturing services announced today that it has officially received its European GMP certificate from the Health Products Regulatory Authority (HPRA) for commercial aseptic filling and testing. The HPRA conducted a five day on-site inspection which commenced on February 2, 2015. Upon conclusion of the inspection, the agency reported that there were no critical or major observations to address. By issuing this certification, the HPRA officially recognizes that Althea's manufacturing controls, laboratory controls and overall quality systems are in strict compliance with the European GMP requirements. Furthermore, on May 19, 2015, Althea passed two additional European Pre-Approval Inspections (PAI) for drug applications submitted by two of its clients for new commercial drug programs. Both the European GMP certification and successful commercial PAIs highlight Althea's readiness to serve the European commercial markets as a full service contract manufacturing and testing organization for commercial drug product programs.

"Althea is very pleased to announce this new European certification paired with two highly successful PAI inspections. This is further evidence of our continued commitment to global GMP compliance." stated Elaine Sapinoso, Vice President of Quality and Regulatory of Althea. "These accomplishments validate the hard work and investments we have made over the years to maintain our quality systems at a level that meets current regulatory expectations. We take pride in offering quality services to our clients while ultimately ensuring safety of the patients receiving these new drugs."