What is GLP Good Laboratory Practice?

What is GLP Good Laboratory Practice?

GLP (Good Laboratory Practice) is a quality assurance system that sets the conditions and management practices for coordinating, carrying out, monitoring, recording, archiving, and reporting non-clinical health and environmental safety studies. It is not a clinical trial framework; it governs the studies that run outside the clinic and that feed regulatory decisions about chemicals, pharmaceuticals, and related products.

The regulatory position in Turkey

GLP in Turkey sits under the regulation on Good Laboratory Practice principles, harmonisation of test facilities, and review of GLP studies, published in the Official Gazette in 2010 under number 27516. Under that regulation, the National Monitoring Authority has the legal competence to oversee GLP compliance. Test facilities that want to enter the GLP Compliance Monitoring Programme are reviewed by TÜRKAK (the Turkish Accreditation Agency) against the OECD Principles of Good Laboratory Practice, and a GLP Compliance Statement is issued when the review is positive.

How Sistem Patent Kalite helps

Sistem Patent Kalite supports laboratories through the GLP application, from the preparation of the dossier to the TÜRKAK review. Clients have a clear view of what the OECD principles require, how the national monitoring programme applies to their specific studies, and what needs to be in place before the on-site assessment.