FOR IMMEDIATE RELEASE
—Guide has been FDA reviewed and addresses ten years of
changes in regulations and industry practices —
(TAMPA, FLORIDA, USA, 1 November 2011) – ISPE announced today that it will soon release the long-awaited ISPE Baseline® Guide Volume 4: Water and Steam Systems (Second Edition). The revised and expanded second edition builds on the ground-breaking Water and Steam Systems Guide first published ten years ago. The second edition has been completely revised to address changes in industry practices and global regulations over the past decade. Additionally, this comprehensive, industry-driven document will promote consistent and practical interpretation of regulatory requirements for water and steam systems worldwide. It includes tools to help pharmaceutical manufacturers meet safety requirements while avoiding unnecessary cost. The Second Edition can be pre-ordered now and will be ready to ship by 15 December 2011.
This Guide, which is the only comprehensive guidance of its kind, aims to assist with the design, construction, operation, and maintenance of new water and steam systems that meet current Good Manufacturing Practices (cGMPs) and comply with existing regulations and related guidance. The Guide was written by a global team of critical utilities experts with a combined experience of more than 500 years. Much of the team responsible for the original Water and Steam Systems Baseline Guide has returned to contribute to the revised Guide, providing continuity and longevity of vision to the Guide’s contents. The Guide also has been reviewed by the US Food and Drug Administration (FDA), and their comments have been taken into consideration in the final version of the Guide.
“In light of the fact that ISPE has literally ‘written the book’ on water and steam systems, we know the industry is highly interested in this revision. We’re glad to say that it is complete, the FDA has reviewed it, and the Guide is headed to the printer,” says Cameron Sipe, leader of the Task Team responsible for authoring the Guide. “Water is involved in the manufacture of every pharmaceutical product in every facility around the world, so the updates in this Guide are incredibly important to the manufacture of safe, pure medicines for patients all over the globe.”
The ISPE Baseline® Guide: Water and Steam Systems (Second Edition) has been expanded to include new chapters on laboratory water systems and the latest theories and industry practices addressing the rouge phenomenon in high purity water and pure steam systems. New chapters also cover microbiological considerations, such as biofilm formation, use of sanitizers, sampling, testing, and control levels, as well as the overall impact of microbial considerations on unit operations and finished water.
The ISPE Baseline® Guide: Water and Steam Systems (Second Edition) will be available for pre-order at the 2011 ISPE Annual Meeting, taking place November 6-9 in Grapevine, Texas, and will be available for purchase on the ISPE website by 15 December 2011.
For more information on ISPE Guidance Documents, including the FDA-reviewed Baseline Guides series, or to order copies in either bound or electronic form, visit www.ISPE.org.
ISPE, the International Society for Pharmaceutical Engineering, is a Society of 22,000 pharmaceutical professionals in 90 countries who use expert knowledge to create high-quality, cost-effective GMP solutions. ISPE is “Connecting a World of Pharmaceutical Knowledge” by providing Members with opportunities to develop their technical knowledge, exchange practical experience within their community, enhance their professional skills, and collaborate with global regulatory agencies and industry leaders. Founded in 1980, ISPE offers online learning opportunities for a global audience and has its worldwide headquarters in Tampa, Florida, USA; its European office in Brussels, Belgium; an Asia Pacific office in Singapore; and its newest office in Shanghai, China. Visit www.ISPE.org for additional Society news and information.
Reading Roundup: Top Blog Posts from April 2016
Thursday, 05 May 2016 18.05
Clinical Labeling of Medicinal Products: EU Clinical Trial Regulation
Tuesday, 03 May 2016 18.05
Design Considerations for WFI Distillation Systems Part 2
Thursday, 28 Apr 2016 18.04