GLP

Good Laboratory Practices
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.



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