Abstract

REVIEW ON CLEANING VALIDATION USED IN PHARMACEUTICAL INDUSTRY

Pratik K. Shinde*, Sakshi S. Deshpande, Bharatee P. Chaudhari and Vivekkumar K. Redasani

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Abstract

In the pharmaceutical industry, to ensure the safety, efficacy and quality of subsequent batches of drug products, care must be taken to avoid cross-contamination, contamination of the drug or agent with other principles active ingredients, unintended compounds, microbial sources, or contamination from cleaning or disinfecting agents. Therefore, it becomes necessary for the validation to strictly follow the guidelines and cleaning procedures of the method developed for it. Cleaning is done to remove contamination from products and other products, as ineffective cleaning can result in adulterated and contaminated products. This includes different cleaning methods, cleaning procedures, sampling procedures, selection of cleaning agents, etc. quality products.

Keywords: Cleaning validation, cleaning methods, cleaning agents, sampling technique, factors of cleaning.