Evonik Receives GMP Certification
Evonik reports that th Medicines and Healthcare Products Regulatory Agency (MHRA), the UK’s national regulatory authority, renewed the company’s European Union (EU) GMP certification for Evonik Birmingham Laboratories in Alabama. The renewal followed an inspection by the MHRA in May 2016. The facility first received its EU GMP certificate in 2013 after a successful pre-approval inspection for a new commercial product.
The certification covers the manufacturing of sterile human medicinal products for terminally sterilized solids and implants. It acknowledges that the site complies with the principles and guidelines of good manufacturing practice for finished dosage forms as required by the European Commission Directive 2003/94/EC.
The Birmingham Laboratories facility was acquired by Evonik in November 2011. The site serves as the Evonik hub for parenteral drug delivery and commercial drug-product manufacturing. It focuses primarily on the production of aseptic and terminally sterilized complex dosage forms, including drug loaded microspheres, implants and liposomes.