Integrated Annex 1 Compliance – The Impact On Parenteral Filling, Cleanrooms, And Robotics

By Declan O’Shea

The recent changes to EU GMP Annex 1 display a more serious approach to the filling of parenteral drug products and the quality assurance expected for those products administered into both human beings and animals. With any change in regulation comes the eventual need for compliance. In order to meet new auditing requirements, in line with the new Annex 1 document, changes will need to be made in both the areas of the drug manufacturing process as well as the equipment required to support that process.

Learn about the critical changes in the Annex 1 guidance from a process equipment provider's perspective, several areas where process and product change could take place, and more.