Abstract

A REVIEW ON PHARMACEUTICAL PROCESS VALIDATION –AN INDUSTRIAL PERSPECTIVE

Tanya Sehgal* and Alka N. Choudhary

ABSTRACT

Validation is the process of verifying that a system or a product meets its predefined standards in order to confirm the quality and safety of the product. Process validation establishes recorded evidence that gives an extreme level of confidence that a given process continuously produces pharmaceutical products which fulfill its predefined parameters and quality attributes. Previously, Process Validation was viewed as a hassle since it was assumed that PV was simply a regulatory need, and it was heavily condemned by so many. However, research from the last three decades indicates that pharmaceutical process validation has progressed and is now widely acknowledged and affirmed as an important component of total quality and effective process management. As a result, PV is an essential component of quality assurance, and this article highlights on process validation and its many kinds, and the benefits of PV.

Keywords: Validation, Process Validation, Quality assurance, Process Management.