Good Calibration Practices
Good Calibration Practices is the foundation of meaningful measurement.
According to regulatory (e.g., US FDA, EU, etc.) and standards (e.g., ISO) requirements, each operation must ensure that all measuring equipment is suitable for its intended purposes and is capable of producing valid results. Therefore, each facility must establish and maintain procedures to ensure that equipment is routinely calibrated. Good Calibration Practices include:
- Calibrator validated for its intended calibration and is capable of producing valid result within the required specification
- For computerized systems 21 CFR Part 11 compliance requirements are met
- Calibration procedures shall be performed according to valid SOP(s)
- The SOP shall include specific directions and limits for the following:
- dynamic range,
- accuracy,
- precision, and
- uncertainty of calibration measurement
- Calibration remedial action is implemented to reestablish the limits when dynamic range, accuracy, and precision limits are not met
- Performance Qualification of the calibrations and evaluation of the data-logger whether there was any adverse effect on the device's quality in case out-of-calibration results
- Calibration standards used shall be traceable to national or international standards
- If national or international standards are not practical or available, then an independent reproducible standard shall be used
- If no applicable standard exists, then an in-house standard shall be established and maintained
- Calibration records shall include:
- The identification of the calibrated device,
- Dates of calibration,
- The individual performing each calibration,
- The next date of calibration shall be documented,
- Calibration results for the device to be calibrated and the reference standard
- Evaluation of the calibration
- Statistical analysis relative to deviations and uncertainty of calibration measurement
- Approval of the Certificate of Calibration.
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