Q7A does not require identification of an API starting material for every process. Q7A tells us in
the introduction that the company should designate and document the rationale for the point in
the process at which production of the API begins and hence the point at which increasing GMP
expectations as described in the Guideline should start to be applied. For synthetic processes,
this is known at the point which API starting materials are entered into the process. For other
processes, e.g., fermentation, extraction, purification, this rationale should be established on a
case-by-case basis. In other words Q7A gives you the responsibility to identify the point in your
process where you consider the API process starts. However there is no requirement for you to
define an API starting material but you need to be clear about the starting point for applying GMP
according to Q7A guidance, and also get regulatory concurrence, because this will be used as
basis of inspections.
