21 CFR 58.81 - Standard operating procedures.

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§ 58.81 Standard operating procedures.

(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:

(1) Animal room preparation.

(2) Animal care.

(3) Receipt, identification, storage, handling, mixing, and method of sampling of the test and control articles.

(4) Test system observations.

(5) Laboratory tests.

(6) Handling of animals found moribund or dead during study.

(7) Necropsy of animals or postmortem examination of animals.

(8) Collection and identification of specimens.

(9) Histopathology.

(10) Data handling, storage, and retrieval.

(11) Maintenance and calibration of equipment.

(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.

[ 43 FR 60013, Dec. 22, 1978, as amended at 52 FR 33780, Sept. 4, 1987]

This is a list of United States Code sections, Statutes at Large, Public Laws, and Presidential Documents, which provide rulemaking authority for this CFR Part.

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United States Code

Title 21 published on 2015-12-03

The following are ALL rules, proposed rules, and notices (chronologically) published in the Federal Register relating to 21 CFR Part 58 after this date.

  • 2016-10-31; vol. 81 # 210 - Monday, October 31, 2016
    1. 81 FR 75351 - Good Laboratory Practice for Nonclinical Laboratory Studies; Extension of Comment Period
      GPO FDSys XML | Text
      DEPARTMENT OF HEALTH AND HUMAN SERVICES, Food and Drug Administration
      Proposed rule; extension of comment period.
      FDA is extending the comment period on the proposed rule published August 24, 2016 (81 FR 58342). Submit either electronic or written comments by January 21, 2017.
      21 CFR Parts 16 and 58
The section you are viewing is cited by the following CFR sections.

Title 21 published on 2015-12-03.

No entries appear in the Federal Register after this date, for 21 CFR Part 58.