Issues regarding the calibration of instruments used on-site
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I have a few questions regarding instrument calibration that I’d like to ask everyone: 1. How is the calibration of instruments such as those used for measuring pressure, temperature, flow rate, liquid level, and weight in pharmaceutical manufacturing facilities carried out? What are the procedures for calibration? 2. What are the differences and similarities between calibration and verification? In the Measurement Laws and their implementing regulations, only the term “verification” appears; however, GMP requirements state that instruments used in pharmaceutical companies must be calibrated. Are these two terms equivalent? If not, what are the differences and connections between them?
It is necessary to take it for calibration at the local metrology bureau every year
There are two ways to calibrate instruments: one is for the company itself to establish standards, and after passing the approval by the metrology authorities, the company’s metrology technicians carry out the calibration of the instruments； One option is to send it to the metrology department for authorized calibration. The choice between the two options depends primarily on the number of measuring instruments in the enterprise. If there are a large number of such instruments, it is convenient for the enterprise to conduct calibrations after establishing relevant standards, and this approach also saves costs. If the number of measuring instruments is small, it is simpler and more cost-effective to send them directly to the calibration department for inspection.
Checksum and verification are two different concepts. 1. Verification is a simple inspection and check of the equipment in use carried out by the maintenance staff at the using unit. 2. There are also two types of calibration: one involves the calibration personnel of the using unit, who, after obtaining the necessary qualification certificates, carry out calibration on the relevant instruments such as thermometers, flow meters, and alarms. . . . (This type of verification does not require very high standards; a certification document is provided, and the requirements are relatively lower compared to calibration). Another option is to take the instrument or device to a specialized verification facility for testing (calibration), and in this case as well a certification document is issued, with higher standards applied.