There is a lot that goes into keeping equipment records for GLP audits. They are broken down by topic, relevance to the FDA, EPA, and the equipment used. You’ve come to the right place for information about different equipment records for GLP audits. Read on if you’d like to learn more!
For both the FDA and the EPA, equipment used within the generation, measurement, or assessment of any data and equipment used for any facility environmental control shall be appropriate design and proper capacity to function according to any protocol and should be suitably located for inspection, operation, cleaning, and maintenance as well.
The equipment, and OECD specifically, Apparatus, which includes Ivalidated computerized systems, used for the generation, storage, and retrieval of data and for controlling different environmental factors relevant to the study, should all be suitably located of proper design and proper capacity.
Equipment Maintenance and Calibration
For both the FDA and the EPA, equipment should be adequately inspected, maintained, and cleaned. Equipment used to measure, generate, or assess data should be adequately tested, calibrated, and standardized.
For equipment, the Apparatus used within a study should be inspected periodically, cleaned, maintained, and calibrated according to any Standard Operating Procedures. Records of these activities should be maintained. Calibration should, where appropriate, be traceable to any international or national standards of lab measurements.
Equipment Effect on Test System
Equipment, Apparatus, and materials used in a study shouldn’t interfere adversely with the test systems.
SOPs for Equipment Maintenance and Calibration
The written standard operating procedures that are required under Section 58.81 and Section 792.81 shall outline in sufficient detail the different methods, materials, and schedules to be used in the other routine inspection, cleaning, maintenance, testing, calibration, and standardization of equipment, and should specify when appropriate, remedial action to be taken just in case of a malfunction of failure of equipment. The written standard operating procedures should designate the person responsible for the performance of every operation.
Records of Equipment Maintenance and Calibration
Written records of all maintenance, inspection, testing, calibration, or standardizing operations should be maintained. These records containing the operation date should then describe whether the maintenance operations were truly routine and followed the standard operating procedures. Written records of non-routine repairs performed on equipment due to malfunctions and failures should be kept. Such records should document the nature of the defect, when and how the defect was discovered, and remedial action taken in response to a fault.
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