Building Global API Supply Chains on Solid Foundations: The Role of the PH. Eur. And the EDQM’s Primary Reference Standards

In an increasingly globalised pharmaceutical landscape, harmonised and reliable quality standards are essential to ensure consistency and robustness across API supply chains. As a cornerstone of EU pharmaceutical legislation, the European Pharmacopoeia (Ph. Eur.) and the EDQM's primary reference standards provide a strong scientific and regulatory framework for the development, manufacture and control of APIs worldwide.

This session will highlight how the use of EDQM primary reference standards helps minimise analytical variability, facilitate method transfers and support effective impurity control strategies, thereby enhancing supply chain reliability and reducing regulatory challenges throughout the API lifecycle.