AstraZeneca Ab, Sweden

Sweden Operations is AstraZeneca's largest production and product support unit, and the majority of production facilities are located in Södertälje. The largest tablet factory in the world is located here. The pharmaceutical industry is strictly controlled by institutions and regulations, such as the Food and Drug Administration's (FDA) Good Manufacturing Practice requirements (GMP). Calibration is one of the fields fenced by very strict regulations. The GMP requirement 21 CFR Part 11, which regulates how the calibration certificate is documented and signed electronically, is essential to the working process.

All equipment and instruments in the production process must be calibrated regularly to ensure they function as they should and, for example, give the correct dosing of all the various substances. This involves testing if a sensor gives the correct measurement result in various conditions, such as temperature, atmospheric pressure, air humidity, and so on. It's vital that the instrument stays within the acceptable tolerances and that their readouts give correct measurement values, otherwise the final products may be faulty. Calibrating the instruments and devices is of great importance to avoid this type of risk altogether.