Following an inspection by the UK's Medicines and Healthcare products Regulatory Agency
Evonik Birmingham Laboratories in Alabama, US, has renewed its EU GMP certification following an inspection conducted by the UK's Medicines and Healthcare products Regulatory Agency (MHRA).
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-sterilised solids and implants.
The site is acknowledged to comply with the principles and guidelines of Good Manufacturing Practice for finished dosage forms as required by the Commission Directive 2003/94/EC.
'This successful audit serves as confirmation to our pharma clients that the Birmingham manufacturing site continues to achieve a high standard of quality resulting from full regulatory compliance,' said Dr Jean-Luc Herbeaux, Head of the Health Care Business Line at Evonik.
Evonik acquired the Birmingham Laboratories facility in November 2011.
The site is Evonik's hub for parenteral drug delivery and commercial drug product manufacturing.
It focuses primarily on the production of aseptic and terminally-sterilised complex dosage forms including drug loaded microspheres, implants and liposomes.