Approaches to Process Validation, the expectation of having at least one validation batch completed at the time of the Pre-Approval Inspection was mentioned. Is this stated in Q7A?

While not specifically discussed in Q7A, section 12.4 states, “Prospective validation of an API
process should be completed before the commercial distribution of the final drug product
manufactured from that API”. Thus, validation of both the API process and the Drug Product
process should be completed prior to commercialization of the Drug Product.
During the Pre-Approval Inspection, a key focus of the inspection is the evaluation of technology
transfer. As such, production experience at a particular site provides some level of confidence
that the process has been adequately transferred and will operate as described. Production and
Inspectional history at the site may also play an important role in reinforcing this confidence.