Abstract

A FUNDAMENTAL REVIEW ON ‘CLEANING VALIDATION & CLEANING PROCEDURE’

Dr. Ravindra B. Saudagar* and Mr. Santoshkumar R. Mulik

Abstract

Cleaning Validation and Cleaning Procedure are two separate activities during implementation, but both are supportive to each other and in complete without others existence. Cleaning Validation and Cleaning Procedure have the largest opportunity / probabilities to prevent patient risk by assuring the no cross-contamination can occur. Ineffective cleaning can lead to adulterated product, which may be the traces of previous product, cleaning agent &/or other extraneous material introduced &/or generated during the process. To establish the validated cleaning procedure is becoming more and very important, as we deals with potent, complicated drug substances and complex biotechnology products. This article will over all the elements of cleaning validation & main focus one the current gaps in cleaning validation study & in establishment of cleaning procedures with respect to quantity used for rinse, selection of batch size for cleaning validation & dirt cleaning study.

Keywords: Validation, Cleaning Validation, Cleaning Procedures, Cleaning agent, Pharmaceuticals Products, CIP.