CFR section
21 CFR 58.63(c): Maintenance and calibration of equipment
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart D-Equipment
Key facts
| Citation | 21 CFR 58.63(c) |
|---|---|
| Section | Maintenance and calibration of equipment |
| Part | PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES |
| Subpart | Subpart D-Equipment |
| Subchapter | 21 CFR A General |
| Product types cited | Drugs, General, Veterinary |
| Regulation text (excerpt) | (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… |
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About CFR sections cited by the FDA
Title 21 of the Code of Federal Regulations contains the FDA's regulations, including current good manufacturing practice and quality system requirements that inspections cite.