AN OVERVIEW: THE ROLE OF PROCESS VALIDATION IN PHARMACEUTICAL INDUSTRY

Abstract

The present review article focus on introduction and general overview on process validation in pharmaceutical industry. The word validation simply means “Assessment of validation or action of proving effectiveness”. The process is developed in such a way that the required parameters are achieved and it ensures that the output of the process will consistently meet the required parameters during routine production, the process is validated. The process validation process parameters are derived from the specifications for the device, component or other entity to be produced by the process. A manufacturer can assure through careful design of the device, processes, process controls and packaging that all manufactured units will meet specifications and have uniform quality. However, in-process and finished product testing still play an important role in assuring that products meet specifications Validation is defined as a collection and evaluation of data , from the process design stage through commercial production, which establishes scientific evidence that a process is capable of consistently delivering quality product. The validation protocol includes inventory control and equipment inspection in the preliminary steps and in-process controls in the subsequent steps. Process controls are mandatory in good manufacturing practices (GMP). The goal of a quality system is to consistently produce products that are fit for their intended use. This review covers need of validation, elements of validation, principles of validation, phases of validation, types of validation.