Résumé
The manufacture of sterile medicines is subject to numerous requirements due to the risky nature of their administration. Since they pass directly into the bloodstream, they must be and free from contamination, sterile. Appendix 1 of the GMP is dedicated to sterile drug manufacturing. It sets out several requirements to be met by manufacturers of sterile drugs. This appendix was recently revised and published in Eudralex in August 2022 for application in August 2023. The aim of this thesis is to provide the reader with the keys to understanding this new annex by introducing the key concepts of sterile drug manufacturing. It then analyzes the impact of this new annex for a manufacturer of aseptically filled liquid dosage forms.