1. What is validation?

1.1 History

The Kefauver-Harris Amendment was signed in the United States in 1962, following the malformations of newborn babies in Europe linked to the use of thalidomide by surrogate mothers. This amendment required drug manufacturers to provide the Food and Drug Administration (FDA) with evidence of the efficacy and risks of taking the drugs.

This was the beginning of validation, which has continued to evolve and diversify ever since. From manufacturing processes to information technology, from analytics to cleaning, from sampling to personnel assessment, everything that goes by the name of "method" needs to be validated.