Good Laboratory Practices (GLP) Facility Certification Program

In August 2016, the FDA published—and is currently reviewing—a revised set of proposed Good Laboratory Practices (GLP) regulations. They are currently conducting surveillance inspections of laboratories, testing sites, and CROs to ensure that facilities comply with GLP and can maintain data integrity for their studies. If a Study Director does not have the ability to ensure both GLP compliance and data integrity, they can be subject to a Form 483, other Warning Letters, and more.

With this important need in mind, CfPIE offers a unique GLP Facility Certification Program that provides clients with the documentation required to prove that their facilities and quality systems are fully GLP compliant.

The Process

Prior to starting the 5-step process, a CfPIE auditor will conduct a Discovery Session to assess your information starting with a phone call or web conference. Contact us to learn more.

The Proof

Upon approval, clients who have completed the process with receive permission to show validation on their website and others materials with a unique seal of approval and a disclaimer. The seal serves as proof that their facilities have met the requirements for GLP compliance.




 

The Benefits

Up to this point, there has been no way for Study Directors and Facility Managers in the U.S. to provide evidence that their facilities and quality systems conform to GLP. With regulations subject to change and scrutiny from the FDA increasing, CfPIE is happy to provide our clients with something they have never had before—valuable documentation that proves their facilities comply with GLP regulations.

Meet Our Auditors

Kenneth Cleaver, Ph.D.

Erik Larsen

Gary Dimenna, Ph.D.