Quality Assurance Unit

Head: Eng. Rossella Strazza

The Biogem Test Facility obtained the first certification of compliance with Good Laboratory Practices (GLP) from the Ministry of Health in 2019.

The Quality Assurance Unit is committed to overseeing and supervising compliance with the GLP standards in all the activities.

The work of the unit is organized through a rigorous inspection plan concerning Studies, Processes and the Facility, based on GLP standards. In this way the unit guarantees the reliability of the experimental results of the Test Facility.

The Test Facility has an internal document system of Standard Operating Procedures (POS) that makes possible the standardized management of all critical operational phases during the experimental studies and processes performed at the facility.

The Quality Assurance Unit is also responsible for instructing the Test Facility in preparation to the biennial inspection by the National Control Body for GLP and for keeping the personnel of the Test Facility constantly updated with the aim of guaranteeing a uniform quality standard.

The types of studies for which the Test Facility is GLP certified concerning the following areas:

2) Toxicity

6) Residues

9.3) Biocompatibility

9.4) Biotechnology and Molecular Biology

9.7) Pharmacokinetics/Toxicokinetics and ADME.