Assume a 13-step process, in which step 8 is registered as the point where API starting material is introduced. Between steps 8 and 12, there are materials, including critical Intermediates, used. If the Intermediates are obtained from suppliers or manufacturers known not to have GMP facilities, applying Q7A’s sliding scale of GMP-ness, will this be interpreted as non-compliant or contrary to the spirit of Q7A?
