Cleaning Validation: A Crucial Step in Assuring Quality During Pharmaceutical Manufacturing

Abstract

Cleaning procedures for manufacturing equipment have been shown to prevent product contamination through the cleaning validation process. This review aims to understand how the cleaning validation plays a critical role in managing contamination or cross-contamination issues during good manufacturing practices (GMP). Emphasis on the quantity of cleaning required for the machinery, the elimination of contamination during manufacturing procedures are discussed here. The article describes various cleaning agents as well as sampling methods for cleaning equipment. Focus is laid on the elements of cleaning validation, objectives of the cleaning validation, regulatory significance of requirements for cleaning validation, etc. Also, it provides information on the different cleaning standards to meet regulatory requirements by the pharmaceutical industry.