ØThe concept of validation was first proposed by Food and Drug Administration(FDA) officials, Ted Byers and Bud Loftus, in the mid 1970s in order to improve the quality of pharmaceuticals.
ØValidation is "Establishing documented evidence that provides a high degree of assurance that a specific process will consistently produce a product meeting its pre-determined specifications and quality attributes.
ØThis is to maintain and assure a higher degree of quality of food and drug products.
