If centrifuge loads are not blended when they are combined, is it necessary to evaluate centrifuge load uniformity during process validation, i.e., first, fifth, tenth load?

That’s something you are going to have to determine based on knowledge of your process. If you
tend to form impurities when your crystal is in the liquid longer, then obviously your later
centrifuge loads may have more impurities than your first centrifuge loads. If that is something
you have reason to believe may happen, then you should probably take a look at that either
during your development of the process or during your process validation. But this is why we
wanted to be very clear that combining of multiple centrifuge loads in a dryer was not considered
blending. On a routine basis, Q7A does not expect that you will do testing of centrifuge loads prior
to recombining those in a dryer.