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News|Articles|September 1, 2016
PTSM: Pharmaceutical Technology Sourcing and Management
- PTSM: Pharmaceutical Technology Sourcing and Management-09-07-2016
- Volume 11
- Issue 9
Evonik Birmingham Laboratories Receives Renewal of EU GMP Certification
Author(s)Pharmaceutical Technology Editors
Evonik’s parenteral drug delivery and commercial drug product manufacturing in Alabama passes EU GMP inspection.
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Evonik Industries announce on Aug. 31, 2016 that Evonik Birmingham Laboratories in Alabama successfully renewed its European Union GMP certificate following inspection by the British health authority, Medicines and Healthcare products Regulatory Agency. An inspection was conducted in May 2016.
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 Commission Directive 2003/94/EC. The facility first received its EU GMP certificate in 2013 after a successful pre-approval inspection for a new commercial product.
The Birmingham Laboratories facility 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.
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