Institute of Good Manufacturing Practices India®

WHO ‘identifies issues’ at Sputnik V vaccine manufacturing plant in Moscow

The WHO (World Health Organization) uncovered some problems at a Sputnik V vaccine filling site in Moscow related to the implementing an appropriate Environmental Monitoring Program to monitor and control the aseptic operation and filling of Gam-COVID-Vac. 

The agency published a review report of its initial findings, reporting approximately six concerns observed during its visit to the Pharmstandard Ufa Vitamin Plant in Ufa, southern Russia, from May 31 to June 4.

The WHO inspectors also identified issues with traceability and identification of new batches of the vaccine, data integrity, and testing from monitoring during manufacturing and quality control. 

The Sputnik V vaccine, manufactured by the Gamaleya Institute and the Russian Direct Investment Fund (RDIF), is waiting for approval from WHO.