[Code of Federal Regulations]

[Title 40, Volume 31]

[Revised as of July 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 40CFR792.81]



[Page 40]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 792_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                 Subpart E_Testing Facilities Operation

 

Sec.  792.81  Standard operating procedures.





    (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:

    (1) Test system room preparation.

    (2) Test system care.

    (3) Receipt, identification, storage, handling, mixing, and method 

of sampling of the test, control, and reference substances.

    (4) Test system observations.

    (5) Laboratory or other tests.

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

    (7) Necropsy of test systems or postmortem examination of test 

systems.

    (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 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.