[Code of Federal Regulations]
[Title 21, Volume 1]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR58.63]
[Page 309]
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
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]
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