Overview of EU and US GMP Inspection Procedures

The Compilation of Union Procedures on Inspections and Exchange of Information is an official EU reference that consolidates harmonised procedures, templates, and guidance used by EU/EEA GMP and GDP inspectorates, the EMA, and the European Commission to coordinate regulatory inspections.

EU GMP inspections follow a structured process: risk-based planning, an opening meeting, on-site inspection activities, a closing meeting, and formal reporting. Inspectors review facilities, documentation, quality systems, deviations, CAPAs, recalls, and personnel training. Findings are classified as critical, major, or other deficiencies. Based on compliance and corrective actions, authorities issue either a GMP certificate or a non-compliance statement, recorded in the EudraGMDP database.

In contrast, US FDA inspections apply a system-based approach, assessing key quality systems such as production, laboratory controls, and materials management. Any single failing system may place a company “out of control.” FDA observations are documented on Form 483, followed by a written company response and potential regulatory actions, depending on inspection outcomes.

02-02-2026