---
kind: "section"
citation: "21 C.F.R. § 58.31"
title: "21"
number: "58.31"
heading: "Testing facility management."
url: "https://uscodex.org/cfr/21/58.31"
---

# §58.31. Testing facility management.


For each nonclinical laboratory study, testing facility management shall:

- (a) Designate a study director as described in [§ 58.33](/cfr/21/58.33.md), before the study is initiated.
- (b) **Replace the study director promptly if it becomes necessary to do so during the conduct of a study.**
- (c) Assure that there is a quality assurance unit as described in [§ 58.35](/cfr/21/58.35.md).
- (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.**
- (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.

## Notes

### Amendments

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]

### Authority

Authority: 21 U.S.C. 342, 346, 346a, 348, 351, 352, 353, 355, 360, 360b-360f, 360h-360j, 371, 379e, 381; 42 U.S.C. 216, 262, 263b-263n.

### Source

Source: 43 FR 60013, Dec. 22, 1978, unless otherwise noted.

### Amendments

[43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]