GLP (Good Laboratory Practices) Certification
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.
The essential advantage of following current Good Laboratory Practice is the making of an archive trail giving detectability to all estimations. This prompts the making of in fact defendable logical information, by which its quality, dependability, and reliability can be guaranteed.
This in turn will lead to many other benefits for both the laboratory and its customers, including:
- Increased confidence in the reliability and trustworthiness of laboratory data
- Increased production of right-first-time results
- Increased overall productivity
- Increased laboratory reputation
- Reduced need for re-work
- Reduced time spent on non-revenue earning investigations