21 CFR 58.63: Maintenance and calibration of equipment
Requires labs to inspect, clean, maintain, test, and calibrate equipment under detailed written SOPs naming responsible persons and remedial actions, and to keep dated records of routine and nonroutine maintenance and repairs.
Part 58, Good Laboratory Practice for Nonclinical Laboratory Studies · Subpart D, Equipment
Recent 483s citing 58.63
- BASF Corporation · East Setauket, New YorkNot all electronic systems used in the conduct of Animal Rule studies were… May 29, 2025
- Ricerca Biosciences, LLC · Painesville, OhioNot all equipment used for the generation, measurement, or assessment of data is… Aug 13, 2021
- Forest/Inwood Laboratories, Inc. · Farmingdale, New YorkReference standards are weighed on an analytical balance and the weights recorded… Oct 23, 1998
The regulation text
§ 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 § 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]
Questions
What does 21 CFR 58.63 require?
Requires labs to inspect, clean, maintain, test, and calibrate equipment under detailed written SOPs naming responsible persons and remedial actions, and to keep dated records of routine and nonroutine maintenance and repairs.
Which sections are cited alongside 58.63?
In the same 483s, investigators most often also cite 58.190 (Storage and retrieval of records and data), 58.35 (Quality assurance unit), 58.81 (Standard operating procedures), 58.33 (Study director).