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Registeracceptance criteria of calibration standards [Bioanalytics]
Dear all,
We have 8 calibration standards in each study batches. If three of CC standards are out of range according to guidance (EMA), should we reject the batch directly or should we excluded the highest deviation CC first than calibration curve re-calculated again. If other CCs are still failing, the one with the highest deviation is excluded and so on?
Thank you for your interest.
Best regards.
Edit: category changed [Ohlbe]
We have 8 calibration standards in each study batches. If three of CC standards are out of range according to guidance (EMA), should we reject the batch directly or should we excluded the highest deviation CC first than calibration curve re-calculated again. If other CCs are still failing, the one with the highest deviation is excluded and so on?
Thank you for your interest.
Best regards.
Edit: category changed [Ohlbe]
Complete thread:
- acceptance criteria of calibration standardshaydonat 2012-01-30 14:27 [Bioanalytics]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- acceptance criteria of calibration standards Ohlbe 2012-01-30 18:11
- acceptance criteria of calibration standards haydonat 2012-01-31 15:02
- acceptance criteria of calibration standards Ohlbe 2012-01-31 18:05
- acceptance criteria of calibration standards haydonat 2012-01-31 15:02
- acceptance criteria of calibration standards Ohlbe 2012-01-30 18:11
Ing. Helmut Schütz