Q7A states in Section 8.4 that out-of-spec batches should not be blended with other batches for
the purpose of meeting specifications. Appropriate testing is needed to ensure that no blending of
OOS material is occurring. This does not imply that you have to do the full set of USP testing, for
example, both before and after the blend, to look for things like heavy metals, residue on ignition,
things that historically have never been an issue. One would typically include tests where
variability is seen, for example, impurity test, assay, moisture, etc.