ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design - - BioPharm International

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ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design



The International Society for Pharmaceutical Engineering (ISPE) announced the publication of a new guidance document on the design of pharmaceutical quality laboratories. The document, titled ISPE Good Practice Guide: Quality Laboratory Facilities, defines design guidelines for quality laboratories supporting GxP-regulated facilities producing pharmaceutical products for human and animal applications.

It is intended to be used to facilitate communication between laboratory owners, engineers, and builders about the function, operation and design parameters that must be met in order to ensure that the finished laboratory is fit for intended use. One of the study authors, James O’Brien, president of NAMA Industries, explains in the ISPE press release, “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.”

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