Out-of-specification investigation procedure formalised
Ergopharm has formalised its out-of-specification investigation procedure, requiring a documented laboratory phase before any retesting and forbidding the practice of testing until a passing result appears.
An out-of-specification result is information, and the temptation is always to explain it away. The procedure removes the discretion: the first phase examines the laboratory — the analyst, the method, the instrument, the standard, the calculation — and either identifies an assignable cause with evidence or it does not. No retest is authorised on the basis that the result was probably wrong.
“Testing into compliance is not an investigation. It is an opinion with extra steps.”
Where no laboratory cause is found, the investigation extends to manufacturing, and the original result stands as valid data. Any retesting that follows is performed to a protocol written before the samples are run, specifying the number of tests and how the results will be interpreted, so the outcome cannot be selected after the fact.
All results, including those from the invalidated first test, are retained; the record shows what was found, not only what was concluded.
Key facts
- Phase one
- Laboratory investigation before any retest
- Requires
- Documented assignable cause to invalidate a result
- Retesting
- Only to a protocol written in advance
- Records
- All results retained, including invalidated ones