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Center for Validation technology and Analytics History

Center for Validation Technologies and Analytics (CVTA) started its activity in 1993 within Department of Food Chemistry (D06). During 1988 and 2007, this department was led by Mirko Prošek, Ph.D., who, as a former employee of Lek, brought 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.

With the increase in workload and the tightening of the quality of work (GMP) requirements, there was a need to create a separate department, because academic research work and services for the market according to strict quality standards cannot be merged on a larger scale. CVTA (or D16) was established as an independent unit with seven employees on 4 November 2002 led by dr. Janko Žmitek (also formerly LEK employee). The connection with the D06 was still maintained until the end of 2008, where, as occasional task holders, participated in Dr. Mirko Prošek., Ph.D. Andrej Šmidovnik, Ph.D. Alenka Golc Wondra, Ph.D. Breda Simonovska, Ph.D. Irena Vovk and Dr. Mitja Križman. On August 31, 2008 Alenka Golc-Wondra took over the management of the department until 01.04.2014, when the role of manager for shorter period was taken by Maja Gričar Lokar, Ph.D., then from 18.06. 2014 the Head of CVTA position was taken by Samo Andrenšek, Ph.D. (also former LEK employee).

At the time of its establishment in 2012, it moved from the premises of D06 to basement space of 140 m2, and then in 2015, with EU co-financing (European Regional Development Fund; 1.8 million €), managed to obtain funds for the renovation of the entire east wing of the premises on the second floor in the old building of National Institute of Chemistry (NIC). The renovation enabled the expansion of the CVTA from approx. 140 to approx. 450 sq. m. It could therefore be said that in the old building, through the involvement of CVTA, NIC acquired a total of approximately 600 sq. m of surface area for its operation. In addition, in 2014, CVTA also completed the construction of a modern fireproof GMP archive in the basement of Pregl Research Center. This investment was absolutely necessary to ensure the continuation of data integrity requirements. The value of all investments in 2014 and 2015 amounted to almost 1.9 million €.

CVTA specializes in Good Manufacturing and Laboratory Practice (GMP and GLP) and operates exclusively with market services. Customer demand led CVTA to introduce two other segments in the GMP environment, from 2012 onwards departments D04 and D05 and in 2017 D15 (NMR center) joined CVTA with its activities. In 2018, the CVTA took over GMP activities and also the activities related to ISO 17025:2017 standard and metrology activities connected to Metrology Bureau of the Republic of Slovenia (MIRS) successfully finished in 2019 while D05 was merged with D09.

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