China’s Sinovac one step closer to vaccine approval in Brazil after being issued Good Manufacturing Practices certification

▲Quality inspectors on Sinovac vaccine production lines use digital technology platforms to monitor the quality and efficiency of vaccine packaging on Sunday. Photos: Li Hao/GT

Brazil’s National Health Surveillance Agency (Anvisa) on Monday issued a Good Manufacturing Practices (GMP) certification to Chinese vaccine producer Sinovac for manufacturing a biological active pharmaceutical ingredient and for its sterile production line. 

The certificate was issued after Anvisa on December 16 sent a technical team to China to inspect Sinoavac’s CoronaVac vaccine factory and concluded its evaluation this weekend, Anvisa said in a statement on Monday.

The completed step is one of the prerequisites for continuing both the registration process for Sinovac’s vaccine and an eventual request for authorization for emergency use of the vaccine that will be presented to Anvisa. It is also part of the agency’s continuous efforts to make vaccines available to the population with quality, safety and efficacy in the shortest possible time, according to the announcement. 

GMP is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in any pharmaceutical production that cannot be eliminated through testing the final product, according to the International Society for Pharmaceutical Engineering.

The CoronaVac vaccine is under Phase III clinical trials in Brazil’s Sao Paulo state.

Joao Doria, the governor of Sao Paulo state, has announced that data from the trials will be released on December 23 and he expects the state to begin inoculating residents in January.

Global Times

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