ABSTRACT
BACKGROUND OF REASONS FOR MANAGEMENT’S ROLE Although the dietary supplement GMPs are silent on the topic, it is well established that the FDA expects the top officers of a firm to take the initiative and responsibility for assuring full compliance with both the letter and the spirit of the regulations. It is both the expressed attitude toward earnestly striving for consistent excellence in quality and the company’s stated policy toward full voluntary compliance that others within the organization need to understand as being what is required of them, and management should make these points clear.
