Inšpekčná správa zverejnená na stránke WHO ku Sputnik V a kontrole jeho výrobných procesom (v jednej konkrétnej fabrike, vyrába sa na viacerých miestach)
https://extranet.who.int/pqweb/sites/de ... 2021_0.pdf
Following the inspection of Open Joint-Stock Company Pharmstandard - Ufa Vitamin Plant, (28 Khudayberdina str, Ufa, Republic of Bashkortostan, 450077, Russia) (hereinafter, the “manufacturer”), during the period from 31 May to 4 June 2021, WHO’s PQT Inspection Team (WHO/PQT/INS) reported the following preliminary findings:
1. 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 ofGam-COVID-Vac.