EMA risk-based inspections – Pharma GMP

EMA’s Risk-Based GMP Inspection Planning

digi — Sat, 07 Jun 2025 20:38:53 +0000

EMA’s Risk-Based GMP Inspection Planning How EMA Applies Risk-Based Planning for GMP Inspections in the EU The European Medicines Agency (EMA), together with the national competent authorities (NCAs) of EU Member States, uses a sophisticated risk-based approach to plan and conduct GMP inspections. This strategy ensures efficient allocation of resources while maintaining robust oversight of...

EMA’s Role in Coordinating GMP Inspections

digi — Sat, 07 Jun 2025 09:44:06 +0000

EMA’s Role in Coordinating GMP Inspections Understanding the EMA’s Role in Coordinating GMP Inspections Across the EU The European Medicines Agency (EMA) plays a pivotal role in ensuring the quality and safety of pharmaceuticals across the European Union (EU). While GMP inspections are executed by national authorities of individual Member States, the EMA acts as...