To survive in competitive market and to be successful, it is necessary to achieve high level of product quality Validation is one of the important steps in achieving and maintaining the quality of the final product batch after batch. Without equipment, we cannot manufacture a product. By validating each step of production process we can assure that the final product is of best quality. This review provides information on objectives and benefits of process validation, types of process validation, critical process parameters of parenteral product with special reference to the requirements stipulated by the United State Food and Drug Administration (USFDA).
