Articles
RSSISPE Releases Pharmaceutical Water And Steam Systems Guide
February 15, 2007
ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, has just released its latest industry-impacting technical publication, ISPE Good Practice Guide: Commissioning and Qualification of Pharmaceutical Water and Steam Systems.
The Guide provides 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.
"This guide offers an approach that can benefit companies by using an efficient and cost-effective use of resources," said Alex Konopka, chairperson, of the Guide's Task Team.
"We've had lots of participation over a two year period from those involved with all aspects of pharmaceutical water and steam systems in preparation of this Good Practice Guide," said Konopka, "A solid basis of 'process understanding' can lead to the economical commissioning and qualification within a direct impact water or steam system's Validation Life Cycle. We've tried to pull together information that will allow practitioners to logically understand important considerations for the commissioning and qualification of these systems."
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.
The Guide will be available for sale at the Tampa Conference 12 February for $145 for Members (110 Euros) and $215 for non-members (165 Euros) or by calling ISPE Customer Service at +1-813-960-2105 or e-mailing customerservice@ispe.org.
ISPE publications provide the practical, "real world" information to help companies build on current best practices to meet and exceed regulatory standards. ISPE Technical Publications are indispensable references for industry professionals and regulators worldwide. In addition to the world-recognized Good Automated Manufacturing Practice (GAMP) Guide Series, ISPE's Baseline® Pharmaceutical Engineering Guides cover topics that provide a basic foundation for the design, construction, commissioning, and validation of a manufacturing facility, including topics such as Bulk Pharmaceutical Chemicals, Commissioning and Qualification, Biopharmaceuticals, and more.
About ISPE
ISPE is the Society of choice for more than 23,000 pharmaceutical manufacturing professionals from 81 countries. ISPE aims to be the catalyst for "Engineering Pharmaceutical Innovation" by providing Members with opportunities to develop technical knowledge, exchange practical experience, and collaborate with global regulatory agencies. Founded in 1980, ISPE has its worldwide headquarters in Tampa, Florida, USA; a European office in Brussels, Belgium; and an office in Singapore to serve Asia-Pacific. Visit www.ispe.org for Society news and more information.
Source: ISPE
