21 CFR 58.31
§ 58.31 Testing facility management.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 58.31, § 58.31 Testing facility management, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/83505
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Full text
For each nonclinical laboratory study, testing facility management shall:
(a) Designate a study director as described in § 58.33, 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.
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.