subchapter_subject: "TOXIC SUBSTANCES CONTROL ACT (CONTINUED)"
part_code: "792"
part_subject: "GOOD LABORATORY PRACTICE STANDARDS"
subpart_code: "B"
subpart_subject: "Organization and Personnel"
section_number: "792.31"
section_subject: "Testing facility management."
cfr_reference: "40 CFR 792.31"
title_name: "Title 40"
title_subject: "Protection of Environment"
parts_covered: "Parts 790 to 999"
revised_date: "Revised as of July 1, 2019"
publication_date: "As of July 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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For each study, testing facility management shall:
(a)Designate a study director as described in § 792.33 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 § 792.35.
(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.