eudralex volume 4

Sophisticated pharmaceutical manufacturing machines in progress.

Clinical Research Solutions

Revised Annex 1, EudraLex Volume 4: Deadline to Comply: August 2023

The deadline to comply with the revised EudraLex Volume 4, Annex 1 is August 25th, 2013. Only for a sole point (point 8.123: "product transfer/loading/unloading areas for lyophilizers“) a later...

Clinical Research Solutions

EudraLex Volume 4, Annex 1 Update: What You Need to Know

EudraLex Volume 4, Annex 1 provides guidance for the manufacturing of sterile medicinal products that are intended for the European market. It has been updated several times, with the latest revision...