The European Medicines Agency (EMA) published a complete new version of the Compilation of Union Procedures on Inspections and Exchange of Information in June 2026. This document serves as the master reference for all guidelines, templates, and procedures governing GMP (Good Manufacturing Practice) and GDP (Good Distribution Practice) inspections across the EU/EEA regulatory network, and is used by national competent authority inspectors as well as by industry to prepare for and respond to inspections. The revised compilation reflects updates to inspection procedures, updated guidance templates, and alignment with recent legislative and procedural changes across the EU pharmaceutical framework. For compliance and audit professionals, this update has immediate operational significance. All internal audit checklists, inspection readiness packages, SOPs governing inspection management, and mock audit frameworks must be reviewed and updated to align with the revised compilation. Specifically, teams should assess whether current GMP/GDP audit programs reflect the latest EU inspection procedures — including documentation requirements, process validation expectations, data integrity standards, and exchange-of-information protocols between EMA and national competent authorities. Organizations with manufacturing sites or distribution networks operating under EU GMP/GDP certificates should conduct a gap assessment against the revised compilation as a priority.
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