EMA plans to revise process validation guidance
This article was originally published in The Gold Sheet
Executive Summary
The European Medicines Agency announced plans to revise its process validation guidance, which has been in effect since 2001. The current guide, said EMA, does not reflect the recent regulatory developments affecting pharmaceutical manufacture, such as process analytical technology, quality by design and real-time release testing. These plans were announced in a concept paper published Feb. 25. EMA's Quality Working Group will be developing the guidance, in cooperation with the European Union competent authorities, the EMA PAT Team, and the Biologics Working Party. Pharmaceutical manufacturers and other interested parties are urged to provide input on the forthcoming guide, and have until May 31 to do so