An approved CAPA plan is not the finish line. A recent GDP non-compliance report published by the Latvian competent authority shows what happens when corrective actions stay on paper: a veterinary medicinal products wholesaler was refused a GDP certificate because critical and major inspection findings were not corrected within the agreed timelines and sufficient evidence of compliance was not provided.
What happened
During inspection follow-up, the authority found that the wholesaler had not implemented the corrective and preventive actions it had committed to. The authority confirmed that product quality and patient and animal safety were not impacted, but that did not matter for the outcome: the failure to execute and close the CAPA actions on time was enough to refuse certification.
Why this matters for every licence holder
Inspectors increasingly judge companies on execution, not intentions. An approved CAPA plan creates a commitment and missing the agreed deadlines turns that commitment into a finding of its own. Three points deserve attention in every CAPA programme: realistic, risk-based timelines you can actually meet, documented evidence of implementation for each action, and a verification step that confirms the action was effective.
How MPCA can help
We support companies with both the development and the execution of CAPA plans: root cause investigation, practical risk-based actions, implementation follow-up, compliance evidence and effectiveness checks. See our RP and GDP services and our auditing services, and the original case report.
This article is for general information and reflects the situation at the time of writing. Always consult the official publications of the competent authorities for binding requirements.