1. Quick start
- Check the Dataset export timestamp and issue-year coverage above the filters.
- Choose an issue year, site country or topic. All cards, charts and the report table update together.
- Click a GMP topic or a heatmap cell to inspect the corresponding reports.
- Choose View report to read the literal evidence quotes and full source descriptions.
- Use Export filtered CSV to download the complete current selection, or Reset filters to return to all reports.
Example: select 2025 and GMP01 — Quality Unit / Pharmaceutical Quality System, then open a report to see the text supporting that assignment. Search for 177879 to find that document directly.
2. Data and coverage
The source is the public EudraGMDP Non-Compliance Reports database. Coverage uses the earliest and latest issue years in the loaded dataset. It describes available records, not proof that every historical report has been captured.
Issue year is derived from the report issue date, not the inspection date. Inspection end dates appear in report details. Treat the latest year as partial when comparing annual totals.
| Label | Meaning |
|---|---|
| Dataset export | When the published dataset was generated; displayed in Warsaw time. This is distinct from the dashboard build date. |
| Verified data file | The dashboard loaded the published data file and passed its consistency checks. |
| Bundled snapshot | The dashboard is using the copy packaged inside the HTML. On a website, a warning explains when the external file could not be loaded or validated. |
| Page views | A server counter of dashboard openings and reloads. It is not a count of unique people, does not distinguish automated requests, and is unrelated to data freshness. |
Consistency checks confirm report identifiers, source/classification/review integrity and calculated totals. They do not establish completeness of the source database or correctness of every substantive classification.
3. Filters and search
Open a filter and tick one or more options. Selections use OR within a filter and AND across filters: choosing 2025 and 2026 includes either year; adding India restricts that result to sites in India.
| Filter | What it selects |
|---|---|
| Issue year | Year of the report issue date. |
| Site country | Manufacturing-site country, with some country-name variants normalized. |
| Issuing authority | The authority named in the source report. |
| GMP topic | Accepted GMP assignments eligible for topic counts. |
| NCA action theme | Accepted themes in the authority's action description. |
| Analysis status | Ready or pending GMP review. |
| Classification / review origin | AI validation, assistant review or an explicit user GMP decision. |
Search reports and source text looks through company/site details, document reference, report number, country, authority, the full non-compliance and action descriptions, and the review note. All entered words must match somewhere in that combined text. Search ignores case and accents.
Filter-option counts respect the other active filters and search, while ignoring that filter's own selection. Remove one selection with its chip, clear one filter inside its menu, or use Reset filters to clear every filter and search. Reset keeps the current table sort, rows-per-page setting and heatmap display mode.
Click Ready for topic analysis or Pending GMP review to toggle the corresponding status filter. The four overview cards describe the current selection.
4. Charts and heatmap
Reports by year
Counts reports by issue year, including those pending review. Clicking a year toggles that year in the filter; several years can be selected.
GMP topics
Shows how many eligible reports carry each GMP topic. A report can contribute to several topics, so adding the bars may exceed the report total. Click a topic to toggle its filter. Scroll inside the chart if necessary to see additional topics.
Regulatory action themes
Shows eligible reports mentioning each NCA theme. NCA means the national competent authority. Theme counts do not establish that an action was completed: the text may describe a recommendation, a conditional measure, an action to consider or an action already taken.
GMP topics across years
Switch between Report counts and % of eligible reports. A percentage is the number of eligible reports carrying that topic divided by all GMP-eligible reports in that year and the current selection.
Clicking a cell replaces the current GMP-topic and issue-year selections with that cell's single topic and year. Other filters remain active. Clicking a topic label or year heading toggles its respective filter.
Example: 6 reports with a topic out of 10 GMP-eligible reports in a year gives 60%. Multiple topics can appear in the same reports; percentages across topics do not need to add to 100%.
5. Reports and evidence
The table lists the current selection. Click the Issued, Manufacturing site, Country or Analysis status heading to sort; click it again to reverse the order. Choose 20, 50 or 100 rows per page and use Previous / Next to move through the results. The initial sort is newest issue date first.
View report opens a detail window with:
- Document reference, report number, site address, country, authority and dates.
- Effective GMP and NCA assignments with literal quotes from the corresponding source field.
- Full nature of non-compliance and NCA actions descriptions.
- Review origin, recorded decisions and review note. Some notes are in Polish.
- An expandable original AI output section with original codes, status, model/version information and review reasons.
Use the close button or Escape to close the window. The EMA link opens the public search page; locate the record using its document reference or report number. This dataset does not provide a permanent direct report/PDF link.
6. Status and review origin
| Label | Interpretation |
|---|---|
| Ready | The effective assignments are eligible for this analytics layer. This includes technically validated AI results and accepted review decisions. |
| Pending GMP review / GMP review | The GMP assignment is held. The report stays visible in the list and annual totals, but is excluded from GMP-topic filters and counts. Accepted NCA themes can still count. |
| AI validation | Original AI output passed technical validation; it was not necessarily reviewed by a person. |
| Assistant review | An assistant resolved the flagged classification under the user's instruction. |
| User GMP review | The effective GMP assignment includes an explicit user decision. NCA decisions can retain their previous origin; see the detail window. |
Effective assignments drive the charts. The original AI classification and review trail remain available for inspection. A Ready label is not a new regulatory compliance determination or a guarantee of expert approval.
GMP99 means the description does not support a specific GMP topic. GMP00 is Other / Unclassified. These are distinct labels, not interchangeable missing-data markers. Full code labels are visible in the filters, charts and report details.
7. CSV export
Export filtered CSV downloads every report in the current selection, not just the visible page, in the current table sort order.
The UTF-8 CSV contains document reference, report number, site name, country, issue and inspection-end dates, authority, analysis status, GMP and NCA codes, their count-eligibility flags, review origin and decision note. Multiple codes are separated with semicolons.
The export does not include the full source descriptions or evidence quotes; read those through View report. If a spreadsheet does not split columns automatically, import the file using UTF-8 and a comma separator. Export is disabled when no reports match.
8. Interpretation
- Counts represent reports, not independent inspections, individual findings, completed enforcement measures or affected batches.
- Different reports or locations may describe the same inspection.
- Countries refer to manufacturing sites; authority filters refer to issuers.
- Multiple assignments overlap. A high topic count does not establish severity or site risk.
- These descriptive percentages are not inspection failure rates or probabilities of non-compliance.
- Read the full source and quoted evidence before drawing a substantive conclusion. Topic labels summarize the text and do not replace it.
9. Practical tips
No reports match
Remove a chip, broaden the search, or reset filters. A topic may have no eligible reports under the other selections. A report pending GMP review can still be found by document reference even when excluded from GMP topics.
Data warning or unexpected date
Check whether the page says Verified data file or Bundled snapshot, and read the warning and export timestamp. Reload after updated data have been published. If validation fails for both copies, the dashboard displays the error instead of analytics.
Page views shows “—”
The counter is unavailable, or the HTML is opened locally rather than from the website. Analytics can still work independently of the counter. Opening this help page does not increment the dashboard counter.
Keyboard and small screens
Use Tab to reach controls and Space or Enter to operate them. Chart years support keyboard activation; Escape closes the report window and filter menus. On a narrow screen, scroll the table or heatmap horizontally to reveal additional columns.