ASU Quality System

iBET’s has had, since 1993, a Quality System implemented and applied to its Analytical Services Unit (ASU). The original Quality System was developed to comply with the OECD Good Laboratory Practices for studies of pesticide decay in food crops. Along the years the overall specialization progressed towards the scope of pharmaceuticals and biopharmaceuticals characterization and quality control and since 2013 ASU has been certified and granted a manufacturer’s authorization under Good Manufacturing Practices (GMP) for Quality Control activities of medicines and new drug entities.

Considering the span of services offered at the international scenery by different departments within iBET, and for the sake of transparency and traceability, iBET top management also decided strategically to implement an umbrella Quality Management System covering departments offering those services, although not yet applying for certification. The quality management principles stated in EN ISO 9001:2008 were considered the most adequate model to reach this objective.