Bioequivalence and Bioavailability Forum

Dear all forum members and HS

Goodmorning.

I have some doubts regarding the IS variation in QC samples.

If the specification for the sampels in the run is, the IS response should be with in 50% of the average IS repsonse of the accepted calibration curve standards.

The specification for the QCs in a run is, 50% of QCs at each level should pass the accuracy specification (+/- 15%)

1) In a run one of the QC has failed in the accuracy acceptence i.e., out of 15% accuracy, and the other is meeting the accuracy specification, but the IS response of the QC is not within the +/- 50% specification.

Now , whether the run can be accepted, since one of the QC is meeting the specification. Or, since the passed QC is not meeting the IS acceptance limit, the run has to be declered as failed run?

2) What is the best practice for the IS variation specification.

Means, considering the IS responses only from the accepted CCs, or from the aceepted CCs and all the QCs in a run.

Thanks in advance,

nvs.