From January 14 to January 18, 2019, experts from the Cuban regulatory authority CECMED have been conducting the final GMP audit.
It should be remembered that the final audit was preceded by intense work carried out by specialists from the MECHNIKOV Institute in December.
Thus, from December 3 to 7, 2018, the MFT (Media Fill Test [esp. Media Fill Test]) was bottled. It is a test of the simulation of the filling of the vials that represents a critical stage in the control and validation of aseptic processes to confirm the sterility of the production facilities. During the three-series MFT, the sterility and microbiological purity of the filling process has been demonstrated.
After filling, samples were taken from the primary container to carry out their control. The results obtained from December 17 to 21, 2018 determined the absence of endotoxins and the microbiological purity (sterility) of the samples from the three MFT series.
Similarly, from December 16 to 18, 2018, a validation series of the vaccine for the prevention of influenza was completed (<em> in bulk </em>, the vaccine was previously delivered by the IICVSSP). The results of the quality control of the filling of the validation series that we obtained in early January 2019 determined the absence of endotoxins and the microbiological purity (sterility).