ISPE (www.ispe.org), a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, released its latest technical publication, ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems.
The guide is designed to provide an expanded understanding of how principles discussed in the ISPE Baseline Guide on Commissioning and Qualification can be applied to direct impact water and steam systems. Ultimately, the goal of this Good Practice Guide is to increase understanding of direct impact water and steam systems in the pharmaceutical and biotechnology industries.
The guide also describes how the capital project management process, commissioning and qualification activities and on-going monitoring work together in the Validation Life Cycle for direct impact water and steam systems.
The importance of the risk assessment process used during design is crucial to ensuring quality product. The risk assessment process allows system designers and operators to gain “process understanding” of those project attributes, which affect water or steam quality, according to the authors.