What the inspector wrote
Audit trail review during the inspection identified 23 sample injections in the preceding six months that were aborted or not processed and were named 'SST', 'test' or 'trial'. In eleven cases the sample was subsequently reinjected under the batch name and the passing result reported. No investigation, out-of-specification record or deviation existed for any of the aborted injections. Analysts interviewed stated that this was 'normal practice to check the system'.
Why it was cited
Any injection of a sample is a GMP record. Aborting a run that is heading towards a failing result, relabelling it and repeating the sample means the reported result is not the result the sample first gave. EU GMP Chapter 6 requires the record of every test to include all results, observations and calculations, and Chapter 4 requires the record to be complete.
Regulators write this finding more forcefully than almost any other because it changes what the certificate of analysis says. It leads to a statement of non-compliance on EudraGMDP more often than any other laboratory practice.
What would have prevented it
- System suitability is run with a standard, under a documented protocol, never with a sample. Sample injections that are aborted are recorded, investigated and, if the partial data suggest a failure, handled under the OOS procedure.
- Audit trail review that filters specifically on aborted, unprocessed and renamed injections, and asks why for each one.
- Analysts trained on why the practice is falsification, not just that it is prohibited, and a laboratory culture where a failing first injection is reportable without consequences for the analyst.