Non-Compliance Reports Analytics

Explore EudraGMDP non-compliance reports by year, country, GMP topic and regulatory action. Click chart elements to filter the dashboard and open reports to read source descriptions, evidence quotes and classification decisions.

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Default: All reports

Explore public EudraGMDP Non-Compliance Reports. Topics are supported by quotes from the report text. One report can have several topics; counts represent reports, not inspections or individual findings.

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Available records currently start in 2019. This does not establish complete historical coverage. The latest year is partial and is not directly comparable with complete years.

Reports in selection—
Countries in selection—
Manufacturing-site country

Reports by year

By issue date · click a year to filter

GMP topics

Regulatory action themes

Action themes do not mean completed actions.

The source can describe a recommendation, an action to consider, a conditional measure or a measure already taken. Read the quotes and full source text for its scope and status.

GMP topics across years

Click a cell to select its topic and year. Percentages use reports eligible for GMP counts in that year.

Reports

Open a report for full descriptions, evidence quotes and the review trail.

GMP topicsNCA themesSource detail
How to read these results

GMP and NCA themes are counted separately. A report with a pending GMP assignment stays in the report list, but its GMP tags are excluded from topic filters and counts. Accepted NCA themes can still contribute to NCA counts.

Ready means suitable for this analytics layer. It includes technically validated AI outputs, assistant-reviewed cases and explicit user decisions; it is not a regulatory compliance determination or an expert approval.

Review origin distinguishes assistant decisions from an explicit user GMP decision. The original AI output and evidence are retained. GMP99 identifies a report whose description does not support a specific GMP topic.

Percentages and topic counts are descriptive. They are not the probability of non-compliance, an inspection failure rate or a measure of site risk. Reports for different locations can describe the same inspection.

The EMA link opens the public search page. Use the document reference/report number to identify the record; a permanent direct report or PDF link is not available in this dataset.