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What are the differences between equipment “Calibration” and “Validation”? Which equipment needs them?

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.

Drug Office, Department of Health Chinese Medicines Board

Q176 · Category D: Premises and Storage Requirements (Q151-Q200)
“Calibration” and “validation” are related but distinct concepts in quality assurance. “Calibration” is the process of comparing and adjusting the reading of a measuring instrument, such as a thermometer or weighing scale, against a recognised and more accurate standard to ensure the reading is accurate. It is a periodic activity carried out on an individual instrument. For example, sending your warehouse thermometer to a qualified laboratory each year to compare it with the laboratory’s standard thermometer is calibration. “Validation” is a broader, more systematic process that provides objective evidence that a process, system or item of equipment can consistently produce results that meet predetermined specifications and quality attributes. It does more than check accuracy: it demonstrates reliability and stability. For example, temperature mapping of a new cold room demonstrates that every corner can consistently be maintained at 2–8°C. This is a systematic validation process.

📘 Regulatory basis

Good Distribution Practice (GDP) and Good Manufacturing Practice (GMP) both set out clear requirements for calibration and validation. GDP requires all critical equipment used to monitor storage conditions, such as temperature and humidity recorders, to be calibrated regularly. Critical systems, such as the cold chain, must be validated.

📗 Drew Tang's recommendations

In simple terms, all measuring equipment that gives a specific reading needs to be “calibrated”, such as thermometers, hygrometers, weighing scales and pressure gauges. Systems or processes that need to be shown to function reliably as a whole need to be “validated”, such as cold rooms, refrigerated vehicles, computerised warehouse management systems (WMS) and cleaning procedures. Establish calibration/validation plans and records for all critical equipment and systems.

📕 Risk notice

Confusing these two concepts or failing to implement them is a common deficiency. If you provide a calibration certificate for a thermometer but cannot provide a temperature mapping validation report for the cold room, the Department of Health may consider that you have not demonstrated that the cold room is suitable. Any data obtained using uncalibrated instruments is invalid, which means all your temperature records may be considered unreliable.

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