Why Temperature Calibration is Necessary From a Regulatory Perspective
In effect, regulations require calibrated thermometers and data loggers in good distribution practice (GDP) environments involving the packaging, storage, and distribution of pharmaceutical products. In addition, most GDP guidance documents, e.g., U.S. Food & Drug Administration (FDA), EU , and WHO, call for calibrated sensors. Some interpretations even insist on an ISO 17025 calibration for every cold chain shipment.
Often, FDA auditors request calibration certificates and reference documents. An example might be to produce a copy of the data from a specific temperature data logger used for a product release shipment two years ago.
Similarly, an auditor might also ask to see the then valid calibration certificate for that same data logger. Ideally, digital copies of certificates should be available from anywhere with internet access and at any reasonable time. It is prudent, therefore, to store files securely in a reliable cloud database.
The Swiss Accreditation Service (SAS) and the Swiss Calibration Service (SCS) are the relevant national authorities in Switzerland. Similarly, DaaKs (Deutsche Akkreditierungsstelle GmbH) is Germany's exclusive accreditation agency for sensor calibration and testing.
In GreatBritain, the United Kingdom Accreditation Service or UKAS is the relevant accreditation body. Its experts assess organizations that provide calibration, testing, inspection and certification services.
In contrast, the US National Institute of Standards and Technology (NIST) is now part of the Department of Commerce. Its authority is to ensure excellence in measurement infrastructure to support economic and scientific capability.