Stock solutions for CCs and QCs [Regulatives / Guidelines]
Hi PSU,
» Referring to ICH guideline M10 on BA method validation step2b …
Not new. Similar in the EMA’s guideline of 2011 and the FDA’s guidance of 2018.
» Can you explain how separate stock solution can avoid biased estimations?
If you screw up in preparing either the stock solution for calibrators or QCs, likely many batches will fail.
» and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?
If you use different ones, you demonstrate that you can utilize the analytical balance, volumetric flasks, and pipettes properly.
» Referring to ICH guideline M10 on BA method validation step2b …
Not new. Similar in the EMA’s guideline of 2011 and the FDA’s guidance of 2018.
» Can you explain how separate stock solution can avoid biased estimations?
If you screw up in preparing either the stock solution for calibrators or QCs, likely many batches will fail.
» and what are the bias estimations that happen regarding this sentence, if we use the same stock solution ?
If you use different ones, you demonstrate that you can utilize the analytical balance, volumetric flasks, and pipettes properly.

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Helmut Schütz
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Dif-tor heh smusma 🖖
![[image]](https://static.bebac.at/pics/Blue_and_yellow_ribbon_UA.png)
Helmut Schütz
![[image]](https://static.bebac.at/img/CC by.png)
The quality of responses received is directly proportional to the quality of the question asked. 🚮
Science Quotes
Complete thread:
- ICH guideline M10 on BA method validation PSU 2022-05-03 15:53 [Regulatives / Guidelines]
- Stock solutions for CCs and QCsHelmut 2022-05-04 14:48
- ICH guideline M10 on BA method validation paulhurleyuk 2022-05-05 11:47