AM Cleanroom Build and Performance (AMCBP) recently completed a critical assessment of a 503B compounding facility in the Southwest U.S. region.
AMCBP was asked to consult on the completion of a 503B facility to assess the potential risks from the perspective of certification and clean build.
Our services were vital to support the facility construction to ensure compliance with the recent FDA requirements for businesses engaged in compounding drug products. (See the Facility Definition Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry.)
AMCBP Leverages Our Cleanroom Expertise to Provide Support
AMCBP has completed more than 5,000 cleanroom projects. Because of our track record and experience, our team was grateful for the opportunity to serve as a consultant for the engineering firm involved in the 503B compounding facility project.
“We understand the latest FDA requirements for cleanroom construction so that drug manufacturers can achieve approval and certification,” says Robert Logston, Cleanroom Project Lead. “As the FDA continues to implement new regulations to ensure safe manufacturing, we look forward to supporting more companies engaged in cleanroom construction projects.”
AMCBP is an NEBB Certified company that supports clients through cleanroom build and consultancy. Our projects include softwall cleanroom construction, construction management, cleanroom authentication, and more projects.
To find out more about working with our cleanroom team for your next project, contact AMCBP today.