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The National Sanitary Surveillance Agency (Anvisa) ended this Monday (30) the first working day that aims to verify the Good Manufacturing Practices of the CoronaVac vaccine, by the Chinese pharmaceutical company Sinovac.
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On this first day of inspection, the team verified the points of the company’s pharmaceutical quality management system, such as risk management, document management and a validation master plan.
“In addition, the technical requirements of the Seed and Cell Banks (viral particles and host cells used in the manufacture of the vaccine) were verified, as well as another part of the team dedicated to the verification of the technical requirements applicable to the Sampling Procedures. raw material. , Qualification of suppliers, Lot numbering system and Qualification of transport ”, completed the agency, in a note.
According to Anvisa, the activity began at 9:30 pm yesterday and ended around 7:00 am on Monday. Inspectors’ working hours are extended until Friday (4).
CoronaVac, produced by the Sinovac company in association with the Butantan Institute, is undergoing phase 3 testing in Brazil.
The agency also reported that it has completed the process of adhering to the Pharmaceutical Inspection Cooperation Scheme (PIC / S). With this, Anvisa becomes the 54th member of the international initiative for pharmaceutical inspection, a kind of international recognition for the excellence of inspections in Good Manufacturing Practices for medicines and pharmaceutical supplies for human use.
The process started in 2014. In 2019, Anvisa received PIC / S inspectors, members of the Health Agencies in the United Kingdom, Portugal, Malta and Hong Kong. PIC / s was created in the early 1970s by the European Free Trade Association (EFTA). Until 1995, the group was restricted to European members.
Anvisa will inspect Oxford and CoronaVac vaccine production
On November 23, Gustavo Mendes, the drug manager of the National Health Surveillance Agency (Anvisa), informed the News that the agency would inspect the production of vaccines against Covid-19 produced by the University of Oxford, in the United Kingdom, and by the Sinovac company, in China, at the end of November.
“We are with inspectors in China to inspect both the Chinese company that will manufacture the CoronaVac vaccine and the company that will manufacture the supplies for the Oxford vaccine. The forecast is that on the 30th the inspection will begin in these factories”, said. Mendes.
