GLP- Good Laboratory Practice.
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.
Benefits
- Increased confidence in the reliability and trustworthiness of laboratory data.
- Reduced time spent on non-revenue earning investigations.
- Increased production of right first time results.
- Increased laboratory reputation.
- Increased overall productivity.
- Reduced need for re-work.
.