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Departments

Center for Validation technology and Analytics History

Center for Validation Technologies and Analytics (CVTA) started its activites in 1993 as a part of the Department of Food Chemistry (D06). From 1988 to 2007 it was led led by Mirko Prošek, Ph.D., who, as a former employee of Lek, introduced the knowledge of good laboratory and manufacturing practices (GLP and GMP), while also utilizing connections with former colleagues to introduce industrial projects on a larger scale. This cooperation began on in the field of bioequivalence studies, and cooperation with Krka three years later (after 1996) in the field of OTC drug analysis.

Due to higher workload and the tightening of the GMP requirements a separate GMP department was establised. In this way we separated academic research work and GMP work as they became incompatible. This was due to requirements of strict quality standards, GMP workflows and general dynamics of work for GMP. CVTA was this established as an independent unit with seven employees on November 4th, 2002. led by dr. Janko Žmitek (also formerly LEK employee). The connection with D06 was  maintained by the end of 2008, where, dr. Mirko Prošek., dr. Andrej Šmidovnik, dr. Alenka Golc Wondra, dr. Breda Simonovska, dr. Irena Vovk and Dr. Mitja Križman participated as occasional task holders. On August 31, 2008 dr. Golc-Wondra became the head of department. Dr. Maja Gričar Lokar led the department as an acting head from April to June 2014. From 18.06. 2014 the Head of CVTA position was dr. Samo Andrenšek (also former LEK employee).

At the time of its establishment in 2012, CVTA moved from D06 to free basement premisses (140 m2). In 2015 - after securing EU funds for renovation – CVTA moved to the east wing of the second floor of main NIC building, to new, modern lab spaces (450 m2).This wing was previously used by FKKT (Faculty of Chemistry and Chemical Technology, UNI-LJ) and has been without substantial investment in infrastructure since the construction of NIC. In 2014, CVTA also used its funds to complete the construction of a modern fireproof GMP archive with 450 running meters of shelves in the Pregl Research Center. This investment was essential to ensure data integrity. The value of all investments in 2014 and 2015 amounted to almost EUR 1.9 million.

CVTA has specialized in working according to the standard of good manufacturing and laboratory practice (GMP and GLP) and has operated and still operates exclusively with market services. Customer demand has initiated CVTA to introduce two other NIC departments to the GMP environment from 2012 onwards, when D04 and D05 joined and in 2017, when D15 (NMR center) joined also. As in 2018 D05 merged with D09, CVTA took over their GMP activities and activities related to the ISO 17025 standard. At the same time CVTA became holder of the national aethalon for the quantity of substances and started managing the colaboration with the National Office for Metrology (MIRS) of the Republic of Slovenia formerly activities of D05.

In the second half of 2020 dr. Vid Simon Šelih became acting head of CVTA .By the end of 2021 due to the need for rationalization of operations CVTA suspended the ISO 17025, national aethalon and related activities. By 2022 CVTA became part of the Department of analytical chemistry, D04, thus consolidating the activities related to analytical chemistry of NIC.

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