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

by ISPE

Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities within pharmaceutical or biopharmaceutical operations. Systems that generate and distribute water and steam that may come into contact with product/or process contact surfaces, or that are used in the testing of product, are subject to commissioning and qualification (verification) practices. This second edition of the ISPE Good Practice Approaches to Commissioning and Qualification of Pharmaceutical Water and Steam Systems, discusses practices and activities associated with the commissioning and qualification (verification) of pharmaceutical water and steam systems. The guide focuses on items which directly affect quality attributes of water or steam during production, storage, and distribution. Both High Purity Water and Pure (Clean) Steam are considered and information on other types of pharmaceutical water and steam is also provided. This Guide aims to provide an example of how the principles discussed in the ISPE Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment, and the ISPE Good Practice Applied Risk Management for Commissioning and Qualification may be applied to GMP water and steam systems. This Guide should be considered as supporting guide to the ISPE Baseline Volume 4 – Water and Steam Systems (Second Edition), and the ISPE Good Practice Applied Risk Management for Commissioning and Qualification, and is complementary to the ISPE Good Practice Project Management for the Pharmaceutical Industry.

120 pages, Paperback

Published January 1, 2014