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.
(g) Assure that any deviations from these regulations reported by the quality assurance unit are communicated to the study director and corrective actions are taken and documented.
[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]
Title 21 published on 2014-04-01
no entries appear in the Federal Register after this date.