160.31—Testing facility management.
For each study, testing facility management shall:
(b)
Replace the study director promptly if it becomes necessary to do so during the conduct of a study.
(d)
Assure that test, control, and reference substances 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.