Typically an API manufacturer performs quality tests on intermediates. If it passes, then QC will release the intermediate for the next synthesis step. The quality unit then reviews the entire batch records at the end and releases the final API. It seems that Q7A requires that the quality unit review the batch records and test results at each step, prior to moving to the next step. This may not be practical in some cases.

That’s an incorrect interpretation of Q7A. “production and laboratory control records of noncritical process steps can be reviewed by qualified production personnel or other units following procedures approved by the quality unit (s).” In addition,it states that the quality unit is responsible for “reviewing completed batch production and laboratory control records of critical process steps” before the release of the API for distribution. It is up to the company to define which steps are critical. So the individual release of the intermediates can be performed by production according to systems that have been approved by the quality unit, and the timing for the quality unit review of the batch records is based on the release of the API.