ISPE, a leading authority on publishing best practices documents for the pharmaceutical industry, 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 at www.ISPE.org.