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Registerreinjecting the sample due to bad peak shape [Bioanalytics]
Dear Ramya,
I would consider this to be acceptable. Make sure that you keep the chromatograms of the initial run, to be able to demonstrate that you indeed had a poor chromatography for this run (and that you did not reinject it just because the QCs fail, which any inspector will want to check
).
This would be in line with EMA's draft guideline on method validation (see lines 460 - 463).
Regards
Ohlbe
I would consider this to be acceptable. Make sure that you keep the chromatograms of the initial run, to be able to demonstrate that you indeed had a poor chromatography for this run (and that you did not reinject it just because the QCs fail, which any inspector will want to check
).This would be in line with EMA's draft guideline on method validation (see lines 460 - 463).
Regards
Ohlbe
—
Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- reinjecting the sample due to bad peak shape ramya 2010-04-13 13:45
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- reinjecting the sample due to bad peak shapeOhlbe 2010-04-13 16:09
- reinjecting the sample due to bad peak shape ramya 2010-04-14 06:19
- reinjecting the sample due to bad peak shapeOhlbe 2010-04-13 16:09
Ing. Helmut Schütz