Journal of Harmonized Research in Pharmacy

IMPLEMENTATION OF CLEANING VALIDATION PROGRAM IN FORMULATION MANUFACTURING PLANT

Abstract

Author(s): Pankaj P Chandratreya and Dr. Deenanath Jhade

Equipment cleaning and equipment cleaning validation are two activities that play a critical role in preventing risk to patients by assuring that cross-contamination between products is curtailed to a cceptable levels. Incomplete or incorrect cleaning can lead to contaminated product, with residues from previous product batches, cleaning agent and / or other extraneous material being introduced into the product manufacturing process. Cleaning validation is important as current trends show an increase in potent and complex drug substances and biotechnology products. This article will cover all elements of cleaning validation in pharma industry. Index Terms: Validation, Cleaning Validation, Pharmaceuticals