Freshly spiked calibration standard in validation [Bioanalytics]

posted by chandru – India, 2018-02-14 06:28  – Posting: # 18415
Views: 1,361

Hi all,
According to EMA "Calibration standards shall preferably be prepared using freshly spiked samples, it is allowed to use previously prepared and stored calibration samples, if supported by appropriate stability data."

So shall we use stored calibration standards for evaluation of PA during validation, if we prove Long term matrix stability at the end of validation?

Regards,
Chandru

Thanks in advance

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