Does the quality assurance unit review of each final study report have to be reported to management?
Yes. The quality assurance unit must make periodic reports to management and the study director on each study. These reports should include the results of the final report review. 16. At our facility the quality assurance unit reports directly to the executive vice president of the company and not to the vice president of research and development. Is it necessary for us to formulate a separate quality assurance unit within the research and development department? The GLPs require that the quality assurance unit director and the study director cannot be the same person. The quality assurance unit must report to a level of management that has the authority to effect the corrective action as indicated by the quality assurance unit inspection reports. How this is accomplished organizationally is a management prerogative. 17. Is it acceptable for the quality assurance unit to report to the management person who is also responsible for drug safety evaluation? This is acceptable provided that
