Bioequivalence and Bioavailability Forum

Dear All,

According to ICH Guideline M10 on Bioanalytical Method Validation and Study Sample Analysis, Step 5, Section 4.3.2, which outlines the acceptance criteria for an analytical run:

"Calibration standards from a failed batch cannot be used to validate or accept other batches within the same analytical run."

Please explain the statement, with respect to the acceptance of multiple batches in below scenario

If, within the analytical run, calibration standards are accepted in the first batch but QC samples in the first batch fail to meet acceptance criteria, subsequently second and third batches QC samples meet the acceptance criteria.

Whether the acceptance of subsequent, Multiple/distinct batches (the second and third) within the same analytical run is considered valid.

Thanks and Regards
NK