Guidelines on General Principles of Validation : Solid, Liquid and Sterile dosage forms

Validation is a concept that has been evolving continuously since its first formal appearance in the United States in 1978. The concept of validation has expanded through the years to encompass a wide range of activities from analytical methods used for the quality control of the drug substances and drug products to computerized systems for clinical trials. Validation is therefore one element of quality assurance associated with a particular process, as the process differs so widely, there is no universal approach to validation. Then word validation simply means, assessment of validity' or action of proving effectiveness. According to European community for medicinal products, validation is 'action of proving', in accordance with the principles of Good manufacturing practices that any procedures, process, requirement, material, activity or system actually leads to expected results.