Abstract The aim of present review article is to focus light on process validation and its basic concepts in pharmaceutical industry. Validation is a key aspect of Quality system. Prime requirement of quality is that everything should be validated (process, system, equipment etc.). “Process validation is establishing documented evidence which provides a high degree of assurance that a specified process will consistently produce a product meeting its pre- determined specifications and quality characteristics.” Process Validation emphasize on process design elements and maintaining process under control during commercialization and communicate that process validation is an ongoing program and align process validation activities throughout product lifecycle. Process validation provides assurance that the drug product can meet standards for the identity, strength, quality, purity, and stability of the drug product.
Keywords Process validation, parameters, protocol, commercialization, inspection, cGMP, Food and Drug Administration (FDA).