subchapter_subject: "TOXIC SUBSTANCES CONTROL ACT (CONTINUED)"
part_code: "792"
part_subject: "GOOD LABORATORY PRACTICE STANDARDS"
subpart_code: "E"
subpart_subject: "Testing Facilities Operation"
section_number: "792.81"
section_subject: "Standard operating procedures."
cfr_reference: "40 CFR 792.81"
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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(a)A testing facility shall have standard operating procedures in writing, setting forth study methods that management is satisfied are adequate to insure the quality and integrity of the data generated in the course of a study. All deviations in a study from standard operating procedures shall be authorized by the study director and shall be documented in the raw data. Significant changes in established standard operating procedures shall be properly authorized in writing by management.
(b)Standard operating procedures shall be established for, but not limited to, the following:
(12)Transfer, proper placement, and identification of test systems.
(c)Each laboratory or other study area shall have immediately available manuals and standard operating procedures relative to the laboratory or field procedures being performed. Published literature may be used as a supplement to standard operating procedures.
(d)A historical file of standard operating procedures, and all revisions thereof, including the dates of such revisions, shall be maintained.