Repeats as part of investigations, ja oder nein? [BE/BA News]
❝ Are you on basis of the wording on page 13 allowed to do a repeat analysis as part of an investigation?
I don't think it would prevent to re-analyse samples as part of an investigation (e.g. to identify a root cause or an explanation for anything weird) as long as:
- the repeat result is not used for PK calculations
- the repeats are clearly identified in advance as being investigation repeats, not to be used for PK
- the whole process is described in a SOP.
❝ Is for example absent or low IS response (without obvious poor chromatography) itself an assignable cause?
Well... Yes and no...
You may not find an assignable cause for the IS variation (was it a spiking error ? Blocked or dysfunctional SPE column ? Strict application of Murphy's Law ?). But IS variations could be considered an assignable cause for analytical repeats.
Unfortunately I was not able to attend the WRIB this year. They had a full day on IS variation, with folks from the FDA and EU Agencies. Last year there was a presentation from the FDA who talked about the importance of monitoring the IS response. Actually the guideline states An SOP should be developed a priori to address issues with IS variability.
- New FDA BMV guideline Ohlbe 2018-05-21 16:28 [BE/BA News]
- What a monster! Helmut 2018-05-21 17:47
- Repeats as part of investigations, ja oder nein? ElMaestro 2018-05-22 00:17