ISPE Releases New Guidance for Designing Pharmaceutical Quality Laboratory Facilities

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Guide establishes a baseline for the design of pharmaceutical quality laboratories supporting GxP regulated facilities producing pharmaceutical products and helps lab owners and engineers communicate effectively during the design process, saving time and money.

This new Guide gives laboratory owners a better understanding of all of the different considerations they must keep in mind so they can avoid giving incorrect or incomplete instructions to the engineer.

ISPE, a leading authority on publishing best practices documents for the pharmaceutical industry, announced today that it has produced the industry’s first Guidance Document to establish a baseline for the design of pharmaceutical quality laboratories supporting GxP regulated facilities producing pharmaceutical products. The ISPE Good Practice Guide: Quality Laboratory Facilities describes how to apply a risk assessment to a quality laboratory facility and identify issues to be considered. Applying the principles in the Guide will help companies save time and money by facilitating effective communication between lab owners, engineers and builders about the function, operation and design parameters that must be met in order to ensure that the finished lab is fit for intended use.

“There’s often a disconnect between the laboratory owner, the designer and the builder when a quality lab facility is being planned and built, which can result in costly mistakes in the design process,” said James O’Brien, President, NAMA Industries, Inc., who is one of the Guide’s authors. “This new Guide helps put all three parties on the same page and gives owners a better understanding of all of the different considerations they must keep in mind so they can avoid giving incorrect or incomplete instructions to the engineer.”

The Guide provides a step-by-step process that guides the reader through all phases of producing a quality lab and all the factors that must be considered at each phase. Additionally, it can help lab owners explain lab requirements and justify budget to senior management. The Guide is a valuable tool for engineers, who can use the Guide’s contents to help their clients focus on the type of information needed to successfully complete a project.

The ISPE Good Practice Guide: Quality Laboratory Facilities is available for purchase on the ISPE website.

About ISPE
ISPE, the International Society for Pharmaceutical Engineering, is the world’s largest not-for-profit association serving its Members through leading scientific, technical and regulatory advancement throughout the entire pharmaceutical lifecycle. The 20,000 Members of ISPE are building solutions in the development and manufacture of safe and effective pharmaceutical and biologic medicines and medical delivery devices in more than 90 countries around the world. Founded in 1980, ISPE 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 http://www.ISPE.org for additional Society news and information.

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Danielle Hould
ISPE
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