Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by dshah  – India/United Kingdom, 2021-10-18 12:36 (216 d 10:03 ago) – Posting: # 22634
Views: 1,215

(edited by dshah on 2021-10-18 19:13)

Dear Qualityassurance!
I believe that the run shall be rejected. As per guidlence-" In case these criteria are not fulfilled the analytical run should be rejected, and the study samples re-extracted and analysed." Further the CRO's SOP is equally important as many times the SOP's are stringent compared to guideline (to keep a single SOP for many regulaotries).

» What if we have 12 QCs in run (3 replicates of each Low, Low-mid, Mid and High) and 1 replicate of each Low, Low-mid, Mid and High failed leading to pass 66.67% of QCs (8 out of 12).
»
» May we accept the analytical run and considered as pass? :confused::confused:

The point of interest is weather all the QC's in same sequence failed? There could be error in sampling sequence or levels failed in different sequence?
Ideally 1 more passes sample to meet the acceptance criteria may have qualified the analytical run.
Regards,
Dshah

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