One of the most critical words used in Q7A in Q7A is “critical”. Is it not essentially implied in Q7A that there be documented bases for identifying critical materials, critical steps, critical operating parameters, etc., whether or not it be called a product development report?

With respect to validation, Section 12 of Q7A says that you should validate critical process steps.
Each company is responsible for defining what steps are considered critical. During an inspection
by a regulatory agency of a company’s validation packages, it would be reasonable for the
investigator to ask you how you determined which of the steps in your eight-step synthesis are
critical, and how you determined the critical process parameters. It is expected that data are
available to show that the critical process steps are in fact critical and support by the range of
critical process parameters.