Overview of Cleaning Validation in Pharmaceutical Industry

Abstract

Manufacturing of Pharmaceutical drug products and drug substances shall demonstrate a control to reproduce consistently the desired quality of product, wherein the control of cross-contamination plays an important roll. Residual materials from the previous batch of the same product or from different product may be carried to the next batch of the product, which in-turn may alter the impurity profile of the subjected product. An effective cleaning shall be in place to provide documented evidence that the cleaning methods employed within a facility consistently controls potential carryover of product (including intermediates and impurities), cleaning agents and extraneous material into subsequent product to a level which is below predetermined levels.