Pharmaceutical Validation: An Overview Of Concepts And Guidelines

Abstract

Validation has a very significant role in pharmaceutical sector. It ensures safe, effective and consistent processes and products. Validation helps to alleviate the risks linked with pharmaceutical processes and products which result in production of high-quality products that are manufactured using suitable processes and also meet the required specifications. Validation studies are considered to be a vital aspect of GMP. The studies should to be performed according to the predefined protocols and guidelines, which include validation of process, equipment, testing and cleaning. This review provides an understanding on the concepts of validation and the guidelines to be followed for it in the pharmaceutical industry.