2025, Vol. 5, Issue 2, Part A

The pharmaceutical industry uses water more than any other material. Water can be a solvent, excipient, processing aid, or cleaning agent. Given that water can affect a product’s quality, purity, and most importantly, patient safety, it is vital that pharmaceutical-grade water be water compliant with cGMP and international regulations established by the WHO and various compendia (USP, EP, JP, and JP). This work focuses on assessing the design, installation, operation, and performance validation pertaining to a purified water system in one of the pharmaceutical manufacturing facilities. Primary components like stainless steel 316L storage tanks, sanitary centrifugal pumps, UV disinfection units, spray balls, and some automated monitoring systems were examined for critical variable compliance. To maintain consistent water quality, validation of design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) across Phases I–III as well as the validation of the system were implemented. The system produces water that meets the pharmacopoeia, thereby ensuring compliance with GMP regulations and the continuous operation of the water system in manufacturing activities.