Archive for March, 2023

Will manufacturers of sterile medicines be able to implement GMP Annex 1 requirements by August?

In August 2022, the European Commission published the revised edition of Annex 1 “Manufacture of sterile medicinal products” in EudraLex – Volume 4 – Good Manufacturing Practices (GMP) guidelines. This document will have a significant impact on manufacturers of sterile medicines who[…]