If the Act does not make a distinction between API and dosage drug product and 21 CFR 211 is a regulation and ICH Q7A is a guidance document, then an FDA investigator may still choose to inspect an API manufacturer using specifically and only 21 CFR 211.

This is part of the reason why we have FDA investigators present in the audience at this training
session and we’ve had them present in the other training sessions of Q7A. It’s also part of the
reason why ORA and CDER, are sponsoring FDA national training courses to discuss Q7A, and
telling investigators and industry the same thing when auditing or inspecting API manufacturers.
However, if you find yourself in this situation pull out the preamble to the 1978 GMP regulations
and show the investigator the commissioner’s response to comment 270 where it clearly says
that 211 does not apply to bulk chemical manufacturing.