This states “Manufacturers of intermediates and/or APIs should have a system for
evaluating the suppliers of critical materials.” The API Starting Material would typically be critical
to the process, so you should have assurance of the quality of that API Starting Material. For
purchased API Starting Materials, this involves establishing the reliability of the supplier’s analysis
through qualification of the supplier’s test results at appropriate intervals, as described in Section
7.3. API manufacturers may choose to audit the manufacturer of the API starting material, but this
is not mentioned in nor is it an expectation in Q7A.
