Bioequivalence and Bioavailability Forum • Acceptance criteria of analytical run

Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – 2021-10-19 17:25 (912 d 20:14 ago) – Posting: # 22641
Views: 2,027

Dear dshah, ElMaestro and Ohlbe,

Thank you for the response.

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).

May we specify in our SOP that 2/3 (67%) of the QC should be within ±15% of the nominal values? or It is advisable to reject such runs (having 66.67% passed QCs)?

Regards,
Qualityassurance

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 run dshah 2021-10-18 12:36
  - Acceptance criteria of analytical runqualityassurance 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