[Code of Federal Regulations]

[Title 40, Volume 23]

[Revised as of July 1, 2006]

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

[CITE: 40CFR160.63]



[Page 148-149]

 

                   TITLE 40--PROTECTION OF ENVIRONMENT

 

         CHAPTER I--ENVIRONMENTAL PROTECTION AGENCY (CONTINUED)

 

PART 160_GOOD LABORATORY PRACTICE STANDARDS--Table of Contents

 

                           Subpart D_Equipment

 

Sec.  160.63  Maintenance and calibration of equipment.



    (a) Equipment shall be adequately inspected, cleaned, and 

maintained. Equipment used for the generation, measurement, or 

assessment of data shall be adequately tested, calibrated, and/or 

standardized.

    (b) The written standard operating procedures required under Sec.  

160.81(b)(11) shall set forth in sufficient detail the



[[Page 149]]



methods, materials, and schedules to be used in the routine inspection, 

cleaning, maintenance, testing, calibration, and/ or standardization of 

equipment, and shall specify, when appropriate, remedial action to be 

taken in the event of failure or malfunction of equipment. The written 

standard operating procedures shall designate the person responsible for 

the performance of each operation.

    (c) Written records shall be maintained of all inspection, 

maintenance, testing, calibrating, and/or standardizing operations. 

These records, containing the dates of the operations, shall describe 

whether the maintenance operations were routine and followed the written 

standard operating procedures. Written records shall be kept of 

nonroutine repairs performed on equipment as a result of failure and 

malfunction. Such records shall document the nature of the defect, how 

and when the defect was discovered, and any remedial action taken in 

response to the defect.