Bioequivalence and Bioavailability Forum

In method validation CC range proved for three analytes are as mentioned below;
For analyte X :10.0 ng/ml to 11015.9 ng/ml
For analyte Y :15.1 ng/ml to 6037.2 ng/ml
For analyte Z :0.20 ng/ml to 9.84 ng/ml

During subject sample analysis following CC range prepared for three analytes and used for subject sample analysis;
For analyte X :10.0 ng/ml to 11031.0 ng/ml
For analyte Y :15.1 ng/ml to 6039.8 ng/ml
For analyte Z :0.20 ng/ml to 9.96 ng/ml

As you can see, the ULOQ of CC range used during subject sample analysis is above the ULOQ of method validation CC range.

We can see CC range used during subject sample analysis is not within the proved method validation CC range.

As per my knowledge this is not acceptable. we have to use CC range which falls within the proved method validation CC range. If there is change in the CC range then partial method validation needs to be proved for that new range which falls outside the proved method validation CC range.

Is there any accepted % deviation mention in any guideline for this change in the cocn. during method validation and subject sample analysis?