You mention the audit expectation for API starting material suppliers. What do you expect from audits of API suppliers by drug product manufacturers?

With Q7A we now have a GMP guidance document that can be used when drug manufacturers
audit an API supplier or manufacturer. It’s the same document that the API supplier uses, and it’s
the same document that the regulators use. For the first time in history, we have a GMP
document, which both industry and regulators can use, and everybody should have a clear
understanding of the GMP expectations.