Center for Validation Technologies and Analytics
KEY ACTIVITES
- Development and optimization of analytical methodologies (UV-VIS, HPLC, U(H)PLC, GC-FID/TCD/MS, dissolution tests, ICP-MS, ICP-OES, IC, NMR, He-pycnometry)
- Studies of accelerated atability (UV-VIS, HPLC, U(H)PLC, GC-FID/TCD/MS)
- Validation and transfer of analytical methods for GMP-analyses (UV-VIS, HPLC, U(H)PLC, GC-FID/TCD/MS, dissolution tests, ICP-MS, ICP-OES, IC, NMR, He-pycnometry)
- Quali- and quantitative analyses of products using validated analytical procedures within GMP environment (system), issuing of cartificates of conformity.
CVTA pursues the goals of implementing analytical support for industry partners by developing, optimizing and validating analytical procedures. We also perform regular analyses of samples of ingredients for the production of active pharmaceutical compounds, green (OTC) medicines and samples of other pharmaceutical products. All procedures at CVTA are carried out in accordance to the guidelines on good-manufacturing-practice (GMP) and we are holders of the JAZMP GMP certificate, which is renewed during audits every three years. GMP certification allows us to work with industry partners who work to be done under GMP conditions. CVTA maintains, develops and supports the quality system for NIC. CVTA also oversees GMP news published by regulatory authorities (European Pharmacopoeia, US Pharmacopoeia, ...) and implements them into the GMP system. CVTA also manages the GMP system for other NIC departments and labs and also educates NIC departments that wish to join GMP system. As part of our work, we also train highly qualified staff who, due to their specific work within the GMP environment, are easily employed as experts in the (especially pharmaceutical) industry.