Filtered By: Topstories
News

FDA to inspect Sputnik V plant in Russia, pending GMP certification


A team from the Philippines’ Food and Drug Administration is scheduled to fly to Russia next week to inspect the Sputnik V vaccine manufacturing plant of the Gamaleya Institute as part of regulatory hurdles needed for an applicant for emergency use authorization (EUA) in the country.

In an interview on "Dobol B TV," FDA director-general Eric Domingo said that the visit to Russia is being planned in coordination with the Department of Foreign Affairs and the Russian Embassy to the Philippines.

Domingo said a site inspection will be needed if Sputnik V’s manufacturer fails to submit a good manufacturing practice (GMP) certification from regulatory bodies in other countries.

“If that [GMP certification] will take long, the other thing we can do is inspect their plant and manufacturing process to ensure they comply with our standards,” the FDA chief said in Filipino.

Domingo explained why Sputnik V has to be inspected physically while other vaccines with EUA in the country such as Pfizer, AstraZeneca, and Sinovac did not undergo a plant inspection.

“They submitted certification of inspection from other partner countries. If that’s the case, we accept it. If Sputnik V submits a [GMP] certification, there is no need for inspection,” he said.

“If they don’t have GMP certification, we have to inspect it ourselves. The flight to Russia is scheduled next week,” he added. —LBG, GMA News

LOADING CONTENT