Bioequivalence and Bioavailability Forum

Dear Qualityassurance,

❝ IMHO (definitely others may have different opinion than me) first of all your in house SOP should be updated to include acceptance criteria for each run with respect to calibration curve and quality control samples during validation.

We should differentiate QCs for acceptance of runs and stability samples. Even in an analytical run for the determination of stability you should include quality control samples (either fresh or within their previously established storage period), used for the acceptance of the run following the usual criteria (67% of the samples within 15% of the nominal concentration). If the run is valid: then you can look at the results of the stability samples.

If you don't have QC samples in your stability runs: if your stability samples fail, you won't know if this is because you have a stability issue or because the run failed.

It is standard practice to have acceptance criteria for the accuracy of the stability samples (as this is what the guidelines define), but I can't remember seeing acceptance criteria for their precision. But I may not have paid a particular attention and have missed it.