Incoming raw materials are not held to the same standards as APIs because raw materials are
not covered under the scope of Q7A. However, Section 7.2 does expect that you have assurance
that no cross contamination is occurring, and that could be done by certificate of cleaning, an
audit of supplier or testing of the material. So there is concern, but there’s no expectation in Q7A
that you have validation of raw material suppliers or their processes.
