The agency has the authority to inspect clinical trial manufacturers generally following the provisions of 211. Q7A provides further guidance specific to API’s in addition to the general guidance found in the March 1991 Guideline on the Preparation of Investigational New Drug Products for Humans and Animals. This document provides guidance to the industry on how to apply 211 to the manufacture of drug products for clinical trial use. Section 19 provides additional clarification – it does not grant new inspectional authority.
