Abstract

PROCESS VALIDATION: AN OVERVIEW

*Prachi Patil, Shraddha Pethkar, Manisha Phoujdar and Hargovind Seth

ABSTRACT

The present article gives an introduction and general overview on process validation. Validation is one of the important steps in achieving and maintaining the quality of the product, each step of production process is validated we can assure that the final product is of best quality. Validation of the individual steps of the processes is called the process validation. Process validation is the key element in assurance of pharmaceutical product. It is the most important and recognized parameters of cGMP. Here this article concentrates on the reasons, advantages and objective of process validation, types, phases, validation protocol preparation and validation report.

Keywords: Process validation, cGMP, Food and Drug Administration, WHO.