An EU-GMP inspection assesses how well a plant complies with requirements for the quality system, facilities, records and data.
Documentation
Review valid SOPs and Batch Records, and ensure every change has gone through Change Control.
Data & computer systems
Check that Audit Trails are enabled and periodically reviewed, access is role-appropriate, and GxP systems are validated (CSV).
Remediation & CAPA
Every observation from the previous audit should have a closed or in-progress CAPA with clear evidence.