EU GMP Inspection Preparation Explained: Complete Guide to EMA Compliance, Audit Readiness, and Best Practices Proven Strategies for EU GMP Inspection Preparation and Audit Readiness Introduction to EU GMP Inspections European Union (EU) GMP inspections are conducted by the European Medicines Agency (EMA) and national competent authorities such as MHRA (UK), BfArM (Germany), and ANSM (France). These inspections ensure compliance with EudraLex Volume 4: EU Guidelines for Good Manufacturing Practice. Companies manufacturing or exporting medicines to the EU must demonstrate full compliance with EU GMP requirements, or risk non-compliance statements, license suspensions, or product recalls. By 2025, EU inspections increasingly…