There is no expectation in Q7A to audit a manufacturer of an API starting material because Q7A
is very clear and states that the document does not apply to the manufacture of an API starting
material. In general, API starting materials are subject to the sections of Q7A regarding
qualification of a raw material vendor, and an API starting material supplier should be qualified
like any other raw material supplier. The language in Q7A does not specifically talk about and
does not mention auditing as a function. It talks about verifying the laboratory test results from
your vendor by doing your own testing in house and comparing your laboratory test results
against the test results received on a Certificate of Analysis. That doesn’t prohibit you from
auditing an API starting material manufacturer if you feel that there is a need, in your particular
situation.