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RegisterAcceptance criteria of analytical run [Regulatives / Guidelines]
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
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]
![[Mix]](https://static.bebac.at/img/mix.png "open in Mix view")
- 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 2021-10-19 18:54
- Acceptance criteria of analytical runqualityassurance 2021-10-19 15:25
- 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
- ’Percentage’ of few values Helmut 2021-10-20 14:06
Ing. Helmut Schütz