EMA inspection strategy

Preparing for an Inspection by a European Regulatory Authority

June 8, 2025 digi

Preparing for an Inspection by a European Regulatory Authority Best Practices for Preparing for an Inspection by a European Regulatory Authority GMP inspections conducted by European regulatory authorities, including the European Medicines Agency (EMA) and national competent authorities (NCAs), are critical checkpoints for pharmaceutical manufacturers. Whether as part of pre-approval, routine surveillance, or for-cause triggers,…

EMA and EU GMP Inspection Practices, International GMP Inspection Standards and Harmonization

EMA’s Risk-Based GMP Inspection Planning

June 7, 2025 digi

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 and EU GMP Inspection Practices, International GMP Inspection Standards and Harmonization