Journal of Harmonized Research in Pharmacy

OVERVIEW OF CLEANING VALIDATION IN PHARMACEUTICAL INDUSTRY

Abstract

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

An essential part of any pharmaceutical manufacturing facility which operates under cGMP Guidelines and adheres to Quality Systems Regulations (QSR), is the availability of well-developed and validate d cleaning procedures for all installed equipment. This will ensure that the cleaned equipment is free from residues of active ingredient from the previous product manufactured on that equipment and also from traces of detergent, if used in cleaning process. Additionally, the equipment will also be free from microbial contamination which can be carried forward into the next batch.Documented evidence that demonstrates effectiveness of the cleaning methods employed within the facility to consistently reduce potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to levels which are below predetermined limits is the key to produce quality products.