Stock solutions for CCs and QCs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-05-04 16:48 (209 d 17:27 ago) – Posting: # 22960
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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. :-D

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