part_subject: "GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES"
subpart_code: "E"
subpart_subject: "Testing Facilities Operation"
section_number: "58.81"
section_subject: "Standard operating procedures."
cfr_reference: "21 CFR 58.81"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 1 to 99"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 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 nonclinical laboratory 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 animals.
(c)Each laboratory area shall have immediately available laboratory manuals and standard operating procedures relative to the laboratory 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.