exact matching of CCs (validation’s and study’s) [Regulatives / Guidelines]

posted by Helmut Homepage – Vienna, Austria, 2017-05-31 14:41 (2809 d 18:07 ago) – Posting: # 17430
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Hi Sushil,

welcome to the BEBA-Forum! Before asking for help: What are your own thoughts?
Bioanalysts should be blinded for treatment but not blind. Science first, regulations second. SCNR. :-D

IMHO, exceeding the upper limit of the CCs in the study compared to the validation by 0.12% (X), 0.04% (Y), or even 1.22% (Z) is simply irrelevant. However, I’m not aware of any GL giving a specific limit.
See also a similar thread (whether it is possible to match CCs and QCs).

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