[Code of Federal Regulations]

[Title 21, Volume 1]

[Revised as of April 1, 2006]

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

[CITE: 21CFR58.63]



[Page 307]

 

                        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 D_Equipment

 

Sec.  58.63  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.  

58.81(b)(11) shall set forth in sufficient detail the 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 date of the operation, 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.



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

67 FR 9585, Mar. 4, 2002]