Does three-batch testing of raw material have to include all tests listed on the supplier Certificate of Analysis? If your company’s specifications do not include all of those listed by the supplier, would it be acceptable to test to you specifications?

When Q7A refers to complete testing, it is referring to complete testing against your specification.
It is well recognized, particularly, for solvents that are sold in many industries, that the
manufacturer will list on their Certificates of Analysis lots of things that may be of very little
consequence to you as the API manufacturer. So this is where it’s important that you set a good
specification, and the complete testing that’s done should be against your specification. If this is
questioned during an audit, you may need to justify why your specifications are different from the
suppliers, but you should have the underlying science, when you set the specification, to be able
to do that.