21 CFR 58.31 - Testing facility management.
(b) Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
(d) Assure that test and control articles or mixtures have been appropriately tested for identity, strength, purity, stability, and uniformity, as applicable.
(e) Assure that personnel, resources, facilities, equipment, materials, and methodologies are available as scheduled.
(f) Assure that personnel clearly understand the functions they are to perform.