VALIDATION AND PROCESS DEVELOPMENT: A REVIEW

Abstract

Total Quality Management and specifications according to regulatory guidelines involved in pharmaceutical production has a great impact significantly on the quality of the products. The validation protocol includes inventory control and equipment inspections in the preliminary steps and in-process controls in the subsequent steps. Process controls are mandatory in good manufacturing practices (GMP). The purpose of setting validation parameters is to monitor the on-line and off-line performance of the manufacturing process, and hence, validate it^1,2. Thus validation is an integral part of quality assurance. This review critically evaluates the need for pharmaceutical validation, the various approaches and steps involved, and other pertinent considerations.