Acceptance criteria of analytical run [Regulatives / Guidelines]

posted by qualityassurance – Jordan, 2021-10-19 15:25 (215 d 05:50 ago) – Posting: # 22641
Views: 1,166

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

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