The 2nd paragraph under 8.4 is very important: “Out-of -specification batches should not be
blended with other batches for the purpose of meeting specifications. Each batch incorporated
into the blend should have been manufactured using an established process and should have
been individually tested and found to meet appropriate specifications prior to blending.”
In order to answer the question above, there are a number of things that you need to take into
account, and that’s why Q7A does not say you must do full release testing prior to blending.
Some of the things you should take into account include: At what point is the batch broken into
pieces? What happens to those pieces separately? That’s why Q7A refers to appropriate testing.
The section on blending addresses blending of the API. It addresses blending of intermediates, if
those intermediates are intended for sale, otherwise you are continuing with the process and
typically that is not considered a blending operation.
