ISPE Publishes Guidance for Pharmaceutical Quality Laboratory Design
ISPE has published a new guidance titled ISPE Good Practice Guide: Quality Laboratory Facilities, which defines design guidelines for quality laboratories.
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.”
Thermo Fisher Opens Advanced Therapies Collaboration Center in California
April 18th 2025The 6000-square-foot facility will provide cell therapy developers the support they need to transition to CGMP manufacturing, and an expanded footprint of the new center is expected to open in Philadelphia later in 2025.
