The Brazilian National Health Surveillance Agency (Anvisa) starts an inspection of Sinovac and AstraZeneca factories for the COVID

By Rafael Bitencourt, Valor – Brasília 11/19/2020 08h49

Laboratories are involved in the race to develop vaccines against covid-19 and maintain agreements with Fiocruz and Instituto Butantan.

The Brazilian National Health Surveillance Agency (Anvisa) foresees the certification of the factories of the Sinovac and AstraZeneca laboratories, involved in the race for the development of vaccines against covid-19, between December 2020 and January 2021, informed the general manager of health inspection and inspection, Ronaldo Lucio Ponciano. The laboratories have agreements with the Oswaldo Cruz Foundation (Fiocruz) and the Butantan Institute, respectively, so that doses of vaccines can be purchased and produced, after formal registration in Brazil.

Ponciano made a presentation to journalists about the international inspection procedures carried out by agency technicians to certify vaccine factories. In practice, the supervisory body is responsible for verifying that the production units meet the requirements related to international good practices.

The agency’s technician ensured that Brazilian standards are in “pari passu” with health control authorities recognized for their high level of excellence in the world, who operate in countries such as Japan, Australia, New Zealand and Malaysia. To date, Anvisa’s inspection team has carried out 43 such procedures in other countries in the past two years, as reported by the manager of the Brazilian agency. It is considered a “risk matrix” with an analysis of ten different factors. Last week, an inspection team landed in China for inspection at the Chinese laboratory Sinovac factory. With costs covered by the manufacturer involved in the research, Anvisa technicians perform isolation in a hotel, to follow the 14-day quarantine rules applied to foreigners. All were subjected to more than one test for covid-19.
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The technical team is made up of Anvisa career employees, who had to complete 80 hours of training and a minimum number of inspections in the training phase to take up the role. “In their luggage, they have over 400 international inspections carried out. So they are qualified and experienced inspectors, ”said Ponciano. The Anvisa technician informed that, when arriving at a production unit, the team will not check the infrastructure conditions, such as “ceiling” or “wall”. For example, water for pharmaceutical purposes will be checked, an item that consumes a minimum of three pages of the report. Ponciano said that the history of inspections carried out by Anvisa points to a failure rate (“rejection”) of 4% to 20%, depending on the country. He informed that, when completing the work, the answer is not immediate. In the following three business days, Anvisa will deliver a type of communication to the manufacturer, with the list of non-conformities categorized as “minor”, “major” or “critical”. The laboratory must answer whether it agrees or not and make the necessary adjustments to the production unit to obtain the certificate.

One of the measures was to eliminate two stages of the approval rite, the regulatory impact analysis and the public consultation. In the same vein, the agency adopted the “continuous submission” process. Thus, technical information is sent as generated by the companies. It will not be necessary to gather all the documents to be presented together, as in the usual procedure. The decisions, made by the board, consider “urgency and seriousness” characterized by a situation of “imminent health risk and the need for immediate action”, according to a statement released. This content was originally published in Valor PRO, Valor’s real-time information service.