Abstract

PROCESS VALIDATION: AN ESSENTIAL PROCESS IN PHARMACEUTICAL INDUSTRY

*Imrankhan M. Bhaishaikh, Aakash V. Chavan, Vivek P. Kadam, Sudhir Desai, Nilesh N. Gurav

ABSTRACT

A present review article focus on introduction and general overview on validation in pharmaceutical industry. The concept of validation was first proposed by Food and Drug Administration officials, Ted Byers and Bud Loftus in 1970 in order to improve the quality of pharmaceuticals. In drug development, pharmaceutical validation and process controls are important to assure that the drug product can meet standards for the identity, strength, quality, purity, and stability of the drug product. This establishes the flexibility and strict quality control in the manufacturing process control in the attainment of desirable attributes in the drug products while preventing undesirable properties. Through this review the authors make an effort to explain, the overview of validation concept of conducting validation trials and provide an insight to its importance in the pharmaceutical industry.

Keywords: Validation process, cGMP, Food and Drug Administration, quality control.