Asian Journal of Pharmacy and Technology

This article provides an introduction and a brief of process validation in the pharmaceutical manufacturing process. Process validation deals with process design aspects and maintaining process control during commercialization. It also conveys that process validation is an ongoing program and aligns process validation activities with the product life cycle. When considering any product, quality is always a mandatory must-have. As a result, drugs must be produced with the greatest quality requirements. Process validation is a key stage in assessing and maintaining the quality of the final product. This article goes over the following topics: introduction, validation type, prospective validation, retrospective validation, concurrent validation, revalidation validation, process validation elements, documentation, validation master plan, validation methodology, and validation report. Process validation also emphasizes the role of objective statistics, statistical tools, and analyses, as well as understanding, identification, and control of variability, and assures consistent quality/productivity throughout the product's lifecycle. The validation research establishes and documents the accuracy, sensitivity, specificity, and repeatability of the firm's test techniques. Thus, validation is a vital component of quality assurance. In recent years, the importance of validation has grown significantly.