Bioequivalence and Bioavailability Forum • Acceptance criteria of analytical run

Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by dshah – India, 2021-10-18 14:36 (1081 d 20:26 ago) – Posting: # 22634
Views: 3,030
(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:

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

Complete thread:

Acceptance criteria of analytical run qualityassurance 2021-10-18 07:00 [Regulatives / Guidelines]
- Acceptance criteria of analytical run ElMaestro 2021-10-18 08:35
- Acceptance criteria of analytical rundshah 2021-10-18 12:36
  - Acceptance criteria of analytical run qualityassurance 2021-10-19 15:25
    - Acceptance criteria of analytical run Ohlbe 2021-10-19 18:54
      - Acceptance criteria of analytical run qualityassurance 2021-10-21 16:51
- Acceptance criteria of analytical run Ohlbe 2021-10-18 14:43
  - ’Percentage’ of few values Helmut 2021-10-20 14:06
    - ’Percentage’ of few values qualityassurance 2021-10-21 16:57