ВОЗ проверил производство вакцины в Уфе, как и ожидалось "кадры подкачали"
Identified concerns with the integrity of data and test results of microbiological and
environmental monitoring during the manufacturing and quality control activities of Gam-
COVID-Vac.
2. Identified concerns with the implementation of an appropriate Environmental Monitoring
Program to monitor and control the aseptic operation and filling of Gam-COVID-Vac.
3. Identified concerns with the full traceability, identification and the history of the Gam-
COVID-Vac batches and the Drug Substances of Component I and Component II
manufactured at the inspection site, through the SAP system used.
4. Identified concerns with the implementation of adequate measures to mitigate the risks of
cross contamination.
5. Identified concerns with adequate filling lines and gowning of aseptic operators to ensure
the required sterility assurance level of aseptically filled Gam-COVID-Vac be supported.
6. Identified concerns with appropriate sterile filtration validation of Gam-COVID-Vac.