The World Health Organization (WHEREsuspended its approval process Russian vaccine Sputnik-V because the quality standards were not met in one of the factories where the vaccine is produced, said on Thursday the vice president of the Pan-American Health Organization (PAHO) Xarbas Barbosa (Jarbas Barbosa).
“This process was suspended because during an inspection at one of the factories where the Russian Sputnik-V vaccine is produced, it was found that not “Good manufacturing practices are observed in it,” he pointed out.
Good manufacturing practice (GMP) is a system that guarantees the manufacture of the product based on the quality standards.
In order for the WHO to approve the coronavirus vaccine for emergency use, the manufacturer should to confirm that these specifications are met at the factory, as transmitted by ΑΠΕ ΜΠΕ.
Therefore, the manufacturer of Sputnik-V must inform the WHO that the omissions have been eliminated and after that the factory will be re-inspected.
It is noted that in mid-June the WHO experts carried out inspection in a unit of “Farmastandart-UfaVita” in which the Sputnik-V vaccine is produced.
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