Freshly spiked calibration standard in validation [Bioanalytics]
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
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
Complete thread:
- Freshly spiked calibration standard in validationchandru 2018-02-14 06:28 [Bioanalytics]
- Freshly spiked calibration standard in validation Obinoscopy 2018-05-02 12:45