Quality review is not specifically mandated in Section 19. What is specifically mandated is that the quality unit should approve or reject each batch of API for use in clinical trials. Use good common sense. If this is a really sophisticated process using some sort of really intricate chemistry, your normal quality people may not be qualified to do the review of those records, and you may be using someone in the research group to review the records. Q7A does not specify who has to review records for API used in clinicals. You have the flexibility to make that decision yourself, based upon your organization.