Non-Compliance with GMP at Sputnik Site Found – WHO

    Sputnik GMP practices are in question as WHO reported today, it has found non-compliance with Good Manufacturing Practices at one manufacturing site: Open Joint-Stock Company Pharmstandard – Ufa Vitamin Plant (Republic of Bashkortostan, Russia)

    Under the WHO Emergency Use Listing (EUL) Procedure, WHO has so far carried out 9 inspections of the Sputnik V vaccine clinical trial and manufacturing sites – 5 clinical trial sites were inspected jointly with EMA for Good Clinical Practices, and 4 manufacturing sites were inspected for Good Manufacturing Practices (2 inspected jointly with EMA)

    Full report of Sputnik GMP non-compliance – WHO

    Findings from the other manufacturing sites of the Sputnik V vaccine that WHO has inspected are still being assessed but they have not raised similar concerns

    Subject to certain requirements being met, WHO will continue to assess Sputnik V vaccines from different manufacturing sites and will publish decisions on their EUL status when all the data are available and the review is concluded

    Any vaccine that is proven to be safe, efficacious and quality assured, and otherwise meets the requirements set forth in the EUL Procedure, will be granted an EUL recommendation

    The EUL assessment process aims to contribute to addressing growing vaccine inequity to controlling the COVID-19 pandemic.

    Summary of the Sputnik site Inspection findings by WHO

    1. Identified concerns with the integrity of data and test results of microbiological and

    environmental monitoring during the manufacturing and quality control activities of GamCOVID-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 GamCOVID-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.


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