The quality policy of AS KEVELT is implemented through a comprehensive Quality Management System. All of our staff is accountable for ensuring product quality and patient safety. All workers have the appropriate education, training skills and experience to carry out their work competently, in accordance with applicable regulatory requirements and AS KEVELT policies and procedures.
Our Quality Control laboratories support production requirements. This includes testing of raw materials, in-process controls, final product release and control of sanitation conditions of working environment. The spectrum of analytical options includes common wet-chemical and physical methods (identity testing as well as assays and impurity profiles), UV-VIS, FT IR and HPLC. Microbiological (bioburden, sterility) and bacterial endotoxins testing is performed as well.
AS KEVELT manufacturing site of sterile medicinal products is Good Manufacturing Practice (GMP) certified since 2003.
AS KEVELT was certified with the GMP certificate of the Russian Federation in 2019.