Q7A does not specifically address the need for process development reports. In Section 6.1, it
does indicate that summary reports be available regarding the development history, scale-up and
technology transfer of the API process.
Generally, during development of the API, the R&D group writes a report that includes all the
fundamental information that drives your eventual manufacturing on a commercial scale and your
process validation. Regardless of what you call those reports, (they may have different names in
the industry), the bottom line is that a company should have some level of documentation
showing that the process has been fully developed and transferred to the commercial facility.
