The calibration process that is implemented by a medical device company may be as simple or as sophisticated as required for the measurements to be made.
Some instruments need only be checked to see that their performance is within specified limits, while others may require extensive calibration to a finite specification. Based upon a risk assessment conducted during the design process, the extent of a company's calibration process will be judged primarily by the accuracy of the measuring devices needed to confirm meeting specifications.
According to one industry benchmark, the instrument being used to measure should be four to 10 times more accurate than the measurement requirement. For instance, if a three-decimal-point accuracy for a device drawing is required, then the instrument being used to measure this accuracy should be accurate to four decimal points.
Proper and periodic calibration will ensure that the selected equipment continues to have the desired accuracy. Simply put, good manufacturing practice GMP calibration requirements and objective evidence include the following:. Accurate and concise documentation for purposes of objective evidence: a clear second-level procedure, work-instruction-level documents for calibrating each piece of equipment, a signed and dated calibration record with all of the appropriate information, and the specified limits of uncertainty.
Specification of accuracy and precision limits: as indicated in the specified work instruction and carried over to the calibration record. Competent calibration personnel: training records and successful performance indicators. Use of traceable standards: certificates that contain traceability numbers and limits of uncertainty. Provisions for remedial action when an instrument is, for example, found to be out of calibration : a strong and inclusive nonconforming corrective action form used as a tool for quality review board decision making.
The QSR requires that measuring equipment be calibrated according to written procedures that include specific directions and limits for accuracy and precision. Precision has no unit of measure and only indicates a relative degree of repeatability, i. Repeatability is the result of resolution and stability. Bias is a measure of how closely the mean value in a series of replicate measurements approaches the true value.
The mean value is that number attained by dividing the sum of the individual values in a series of measurements by the total number of individual values. And last but not least, accuracy is the measure of an instrument's capability to approach a true or absolute value.
Accuracy is also a function of precision and bias. Because different medical devices have different accuracy requirements, each manufacturer should decide the level of accuracy required for each measurement and provide equipment to achieve that accuracy.
Remedial action includes recalibration and evaluation of the impact of out-of-tolerance measurements on the device design or process validation parameters or data; on the quality of existing components, in-process, or finished devices; and appropriate corrective action plans that include the impact of risk-based decision making made by a cross-functional team of qualified individuals, e. A sobering scenario could be that the frequency of calibration is once every 12 months, and the yearly check for calibration indicates an out-of-calibration situation for a measuring device being used to release, at least in part, finished goods.
Such a scenario could mean that sometime during the past year the instrument went out of calibration, and now every device or component that was measured using this instrument is suspect for possibly not meeting the accuracy and precision requirements aligned with the acceptance criteria in the DMR. Preventive action for this type of situation could entail performing frequent, documented, and interim calibration checks to preclude letting too much time pass between checks.
Device manufacturers include on each device a decal, label, or tag that contains information about the calibration of each piece of equipment. At a minimum, these documents include the equipment identification, the calibration date, the name of the individual performing the calibration check, and the date the next calibration is due to be performed.
If performed by a supplier, who must be qualified using the purchasing controls element of the Quality System, the calibration certificate must be on the company's letterhead, which includes the company's logo and all accreditation information and registrar and accreditation numbers aligned with the scope of same. There should also be an area for referencing the calibration check history and an obvious place to denote any out-of-calibration result.
The inspection, measuring, and test equipment calibration process must be well thought out, proceduralized as appropriate, and commensurate with the complexity of the QMS. Top clipped slide. Download Now Download Download to read offline. Process selection.
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Apoorva Bauskar. Lovely Kam's. Show More. Views Total views. Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results. Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained.
These activities shall be documented. Calibration procedures shall include specific directions and limits for accuracy and precision.
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