From 14 to 18 January 2019, the final GMP audit of the Latin American Institute of Biotechnology MECHNIKOV has been started by the Cuban National Regulatory Authority CECMED.
Let us recall that that the final audit was preceded by intensive work carried out by specialists from MECHNIKOV Institute in December. Thus, the MFT (media fill test) series were carried out from 3 to 7 December 2018.
During the process of making three MFT series, sterility and microbiological purity of the filling process were demonstrated. After vaccine filling process, some samples were taken from the primary package for laboratory control. The results determined the absence of endotoxins and the microbiological purity (sterility) of the samples of the three series of MFT.