---
kind: "section"
citation: "40 C.F.R. § 160.31"
title: "40"
number: "160.31"
heading: "Testing facility management."
url: "https://uscodex.org/cfr/40/160.31"
---

# §160.31. Testing facility management.


For each study, testing facility management shall:

- (a) Designate a study director as described in [§ 160.33](/cfr/40/160.33.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 [§ 160.35](/cfr/40/160.35.md).
- (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.
- (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

### Authority

Authority: 7 U.S.C. 136a, 136c, 136d, 136f, 136j, 136t, 136v, 136w; 21 U.S.C. 346a, 371, Reorganization Plan No. 3 of 1970.

### Source

Source: 54 FR 34067, Aug. 17, 1989, unless otherwise noted.