CFR section
21 CFR 58.63(b): Maintenance and calibration of equipment
PART 58-GOOD LABORATORY PRACTICE FOR NONCLINICAL LABORATORY STUDIES · Subpart D-Equipment
Key facts
| Citation | 21 CFR 58.63(b) |
|---|---|
| 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 | Biologics, General |
| Regulation text (excerpt) | (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… |
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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.