Stock solutions for CCs and QCs [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2022-05-04 14:48 (23 d 03:37 ago) – Posting: # 22960
Views: 269

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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