Pharmaceutical good practice guide released
An
ISPE product story
Edited by the Engineeringtalk editorial team
Feb 12, 2007
ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, has just released a publication covering pharmaceutical water and steam systems.
ISPE, a global not-for-profit association of more than 23,000 pharmaceutical manufacturing professionals, has just released its latest 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 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 the basis of an educational session, Risk Assessment as a Tool of Design, Implementation and Management of Critical Utilities, at ISPE's Tampa Conference 12th-15th February held at the Hyatt Regency Tampa.
In addition, writers of the guide will also lead an educational session on critical utilities at ISPE's Washington conference from 2nd-6th June.
Both sessions will allow participants to get a first-hand look at information contained in the new guide and interact with its authors.
ISPE publications provide practical information to help companies build on current best practices to meet and exceed regulatory standards.
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