Log in
RegisterEvaluation of repeat on new curve [Bioanalytics]
Dear Auditor,
I am totally agree with the Ohlbe.
While switch over to new calibration range obviously you had perform partial validation.
If your method is partially validated properly there is no problem to analyse old identified repeats under new calibration curve.
Believe me we had done the same in USFDA submission study and it was accepted by regulators provided that your Repeat Analysis SOP should be very much clear on such issues.
Regards,
Swapnil D. Kuche
I am totally agree with the Ohlbe.
While switch over to new calibration range obviously you had perform partial validation.
If your method is partially validated properly there is no problem to analyse old identified repeats under new calibration curve.
Believe me we had done the same in USFDA submission study and it was accepted by regulators provided that your Repeat Analysis SOP should be very much clear on such issues.
Regards,
Swapnil D. Kuche
Complete thread:
- Eealuaiton of repeat on new curve auditor 2011-07-04 08:57
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Evaluation of repeat on new curve Ohlbe 2011-07-04 18:52
- Evaluation of repeat on new curve auditor 2011-07-05 09:01
- Evaluation of repeat on new curveswapnil.kuche 2011-07-05 09:46
- Evaluation of repeat on new curve auditor 2011-07-05 09:01
- Evaluation of repeat on new curve Ohlbe 2011-07-04 18:52
Ing. Helmut Schütz