Remember the two fundamental concepts that are embodied in Q7A. GMPs begin to apply with
the introduction of API starting materials and manufacturers are expected to validate critical
process steps. So we’re talking about two different things here. The API starting material, once
that’s introduced into the process, that’s where GMPs begin to apply in the API process, but that’s
different from validating critical process steps. You should identify your critical process steps in
your API process and validate those critical process steps. So in general, it’s not related.
