Bioequivalence and Bioavailability Forum • Freshly spiked calibration standard in validation

chandru
☆

India,
2018-02-14 07:28
(3042 d 18:43 ago)

Posting: # 18415
Views: 4,474

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

Obinoscopy
★

USA,
2018-05-02 14:45
(2965 d 12:26 ago)

@ chandru
Posting: # 18750
Views: 3,047

Freshly spiked calibration standard in validation

Post reply

Hi,

❝ 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?

Yes you can, as long as you demonstrated the long term matrix stability of your analyte.

But the critical question is this: which CC did you use in demonstrating long term stability? Was the curve gotten from freshly prepared calibration standards? This is because only CCs from freshly prepared standards are to be used for stability determination.

Regards,

—
Scopy