ABSTRACT
Water is ubiquitous in the pharmaceutical industry. It is used as a support component [clean in place (CIP), presterilization preparation of vials and stoppers] as well as a major raw material in formulations. Microorganisms may be isolated from the purification, storage, and distribution portions of any water system. If water is used in the final product, these microorganisms or their byproducts may create a significant patient risk. Control of a water system is established through careful validation and the setting of specifications [temperature, total organic carbon (TOC), conductivity, flow rater, microbial load, endotoxin] that govern the routine operation of the system. Once validated, control of the system is demonstrated by careful and regular monitoring of the physical parameters of the system (volume, temperature, etc.) as well as the quality attributes of the water that is produced.
