ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems

Published: February 2007 Pages: 45, plus appendices Table of Contents Executive Summary Work smarter, not harder, when it comes to the commissioning and qualification of your pharmaceutical water and steam systems. This Guide will show you how to change your focus from a “qualify everything” approach, to a more efficient and cost-effective risk-based evaluation of individual system components or process steps.

The ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems provides an alternative approach, based on “risk assessment” principles and “process understanding” for the commissioning and qualification of direct impact water and steam systems.

Specifically, this Guide:

• Provides an understanding of the importance of C&Q and how it fits into the Validation Life Cycle
• Explains and demonstrates the impact assessment process for water and steam systems and typical system boundaries and non-critical components
• Discusses critical parameters – critical quality attributes and critical process operating parameters
• Discusses business essential parameters – key business considerations for design, construction, commissioning, and qualification. Some of these relate to non-product quality items like Health, Safety, and Environmental (HSE) considerations, IT, or other “commissioning only” project scope items.
• Provides identification of and discussion of project scope activities included in the qualification of water and steam systems
• Provides information on the User Requirement Specification (URS), Functional Design Specification (FDS), and Detailed Design Specification (DDS)
• Demonstrates theories by providing examples

The Guide, intended as a supplement to the ISPE Baseline® Guide on Commissioning and Qualification, aims to apply the principles discussed in the ISPE Baseline® Guide to direct water and steam systems.

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