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RegisterFT at -20 storage [Bioanalytics]
Dear Compliance,
As far as I know, studying stability for some time at -20°C in addition to -70°C, is not required by any guideline if the samples will only be stored at -70°C. That's really playing it safe, and you could very well decide to do it only if you indeed have freezer problems. It would only take a few days and would not delay the work any further. If you store the QC samples in the same freezer as the study samples, you could very easily demonstrate that the integrity of the study samples was not affected at any time.
In my opinion doing freeze/thaw stability at -20°C in addition to -70°C is not required in such a case.
Regards
Ohlbe
As far as I know, studying stability for some time at -20°C in addition to -70°C, is not required by any guideline if the samples will only be stored at -70°C. That's really playing it safe, and you could very well decide to do it only if you indeed have freezer problems. It would only take a few days and would not delay the work any further. If you store the QC samples in the same freezer as the study samples, you could very easily demonstrate that the integrity of the study samples was not affected at any time.
In my opinion doing freeze/thaw stability at -20°C in addition to -70°C is not required in such a case.
Regards
Ohlbe
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Regards
Ohlbe
Regards
Ohlbe
Complete thread:
- FT at -20 storage Compliance 2012-02-29 05:36
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- FT at -20 storageOhlbe 2012-02-29 18:44
- FT at -20 storage Compliance 2012-03-01 07:36
- FT at -20 storageOhlbe 2012-02-29 18:44
Ing. Helmut Schütz