Calibration is the process of comparing the reading of a measuring instrument, such as a thermometer, hygrometer or weighing scale, with a recognised, more accurate standard traceable to international or national standards, in order to determine and record its accuracy. If a deviation beyond the acceptable range is found, the instrument must be adjusted or replaced. In the wholesale of medicines, all instruments used to monitor and control critical parameters that affect medicine quality must be calibrated regularly. These include all probes used to monitor temperature and humidity in warehouses and refrigerators, temperature loggers used in cold-chain transport, and electronic scales used to weigh medicines. Calibration ensures that the data on which you rely to make quality decisions is accurate and reliable.
HONG KONG DRUG LICENSING
What is “Calibration”? Which instruments and equipment must be calibrated, and how often?
A complete explanation of the regulatory basis, Drew Tang’s recommendations and risk alerts. The original material dates from 2025; read it alongside the latest official requirements.
Original guide, 2025 edition: These FAQs are provided for topic-based reference and have not all been individually checked against current rules. Please confirm fees, personnel, renewal, changes and product requirements against the professional in-depth guide for the relevant licence type and the official requirements in force at the time.
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