EU GMP Requirements for Active Substances and Excipients

digi — Tue, 10 Jun 2025 23:09:20 +0000

EU GMP Requirements for Active Substances and Excipients Complying with EU GMP Requirements for Active Substances and Excipients In the EU regulatory framework, ensuring the quality of both active substances (APIs) and excipients is a critical component of pharmaceutical compliance. The European Medicines Agency (EMA), through its Good Manufacturing Practice (GMP) guidelines, imposes clear requirements...

EU GMP supplier audit – Pharma GMP

EU GMP Requirements for Active Substances and Excipients