Quality

The Test Facility (Advanced Technology Corporation) complies with GLP (Good Laboratory Practice) regulations. It was certified for the first time in 1995 by the Belgian Scientific Institute of Public Health. The statement of GLP compliance has been renewed every 2 years.

Its scope involves pharmacokinetic and metabolic studies, residue studies and toxicity studies with respect to the OECD and the EU principles.

The Test Facility has an independent Quality Assurance unit, which has acquired a great deal of expertise in working with the OECD GLP guidelines.

The Quality Assurance System is based on Standard Operating Procedures (SOPs), personnel training, study-related audits performed during all critical phases and internal audits.

Bioanalytical methods are validated according to international standards (FDA guidelines) prior to routine analysis and all study protocols and study reports are audited.

The Quality Assurance Unit could also audit different phases of non-GLP studies on request of the Sponsor.