[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.81]
 
[Page 314-315]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN
                                SERVICES
 
PART 58--GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES--Table of Contents
 
                 Subpart E--Testing Facilities Operation
 
Sec. 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
 
[[Page 315]]
 
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]