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RegisterStock solutions for CCs and QCs [Regulatives / Guidelines]
posted by Helmut 
– Vienna, Austria, 2022-05-04 16:48 (209 d 17:27 ago) – Posting: # 22960
Views: 575
Hi PSU,
Not new. Similar in the EMA’s guideline of 2011 and the FDA’s guidance of 2018.
If you screw up in preparing either the stock solution for calibrators or QCs, likely many batches will fail.
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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Dif-tor heh smusma 🖖🏼 Довге життя Україна!
Helmut Schütz
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- Stock solutions for CCs and QCsHelmut 2022-05-04 14:48
- ICH guideline M10 on BA method validation paulhurleyuk 2022-05-05 11:47
Ing. Helmut Schütz