Abstract

A COMPREHENSIVE REVIEW OF PROCESS VALIDATION: A VALUE ADDING QUALITY CONCEPT

Pankti Patel* and Dr. Vidhi Kotadiya

ABSTRACT

Validation is the most recognized and important parameter of GMPs. This review article provides knowledge about the process validation of the pharmaceutical manufacturing process and its importance according to guidelines. Process validation of a process will ensure production of a drug of reproducible quality. Process validation is the process for improving the safety and quality of the dosage form which is manufactured in the pharmaceutical industry. Process validation is an integral part of quality assurance as per cGMP.

Keywords: Validation, Process Validation.