|Published: July 2014
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Water and steam may be used in the manufacture of products, cleaning operations, and laboratory activities with in 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 Guide: 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 Guide: Science and Risk-Based Approach for the Delivery of Facilities, Systems and Equipment, and the ISPE Good Practice Guide: 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® Guide: Volume 4 – Water and Steam Systems (Second Edition), and the ISPE Good Practice Guide: Applied Risk Management for Commissioning and Qualification, and is complementary to the ISPE Good Practice Guide: Project Management for the Pharmaceutical Industry.
This Guide can be used by industry professionals involved in the design, construction, commissioning, and qualification of new or newly renovated water and steam systems, which are regulated by the international healthcare authorities. It addresses compliance with international regulations and guidelines for water and steam systems, and considers new systems, extensions to existing systems, and existing validated systems.
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