Validation of Pharmaceutical Water System

The purpose of performing validation is to demonstrate that the process generates the product with a high degree of assurance of consistency and specified quality when operated within specified limits. Validation of the water system is necessary to obtain water of the desired quality, purity, and other requisite specifications. The validation method not only produces high-quality water, but it also offers a uniform framework for assessing process outcome and safety. This discussion aims to examine the numerous validation issues, including water treatment system components, equipment qualification, multiple qualification phases, documentation, validation, change control, and post validation monitoring.