Validation is an essential part of Good Manufacturing Practices (GMP). It is therefore an element of the quality assurance programme associated with a particular product or process. Validation is a component of cGMP (current good manufacturing practice). Numerous definitions exist including that of the food and drug administration (FDA, USA) which has defined process validation as establishing documented evidence which provides a high degree of assurance that a specific process will consistently produce a product meeting its predetermined specifications and quality characteristics.