Process Validation: An Overview

Validation is an act of demonstrating a procedure, process, and activity which will consistently lead to the expected results. In pharmaceuticals there are wide varieties of procedures and processes which need to be validated. The validation process consists of identifying and testing all aspects of a process that could affect the final test or product. Prior to the testing of a process, the system must be properly qualified. A properly designed system will provide a high degree of assurance in order to evaluate every step, process and change before its implementation. In this paper, statistical issues, regulatory requirements required for process validation options in drug development are discussed.