During clinical trials, is it acceptable to transfer the analytical methods to quality control for conducting of stability testing and for release testing prior to final validation of the method being completed? Does analytical need to continue the routine executing of the method until final validation?

As per Q7A, you define how and what your firm will do. Chapter 19 defines specific guidance
regarding the manufacture and control of APIs for use in clinical trials. Specifically, Section 19.8
states, “While analytical methods performed to evaluate a batch of API for clinical trials may not
yet be validated, they should be scientifically sound”.