Regarding the article “Anvisa granted certifications of good practices to Chinese pharmaceutical company Sinovac”, published by the Metrópoles website, Anvisa brings the following clarifications and corrections:
Initially, it should be clarified that the Certificate of Good Manufacturing Practices (CBPF) is a document issued by Anvisa attesting that a certain manufacturing site (place of manufacture) and production line of the drug complies with Good Manufacturing Practices. Thus, it is not possible to correlate or extend the good practices of a medicine production plant to another manufacturing site, even if it is the same medicine.
The certification process for good manufacturing practices is a complex technical act, involving everything from the verification of facilities and equipment and the qualification of employees to quality assurance and risk assessment of each production step for the final release of the input. pharmaceutical and finished product. For this reason, Anvisa and other health authorities in the world evaluate and consider good manufacturing practices by plant and production line.
The General Management of Sanitary Inspection and Inspection (GGFIS) of Anvisa clarifies, in response to the news entitled “Anvisa granted certifications of good practices to Chinese pharmaceutical Sinovac”, published by Metrópoles this Thursday, October 22, that the Agency does has issued, to date, no certification related to the place of manufacture of the Coronavac vaccine, manufactured by Sinovac Biotech.
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Additionally, it informs that it has been making every effort in relation to possible future vaccine suppliers to Brazil, in terms of assessing manufacturing conditions, with a view to granting in the future, when the complete and necessary assessment is made, the Certificate of Good Manufacturing Practices for the plant of the active pharmaceutical ingredient and the vaccine against Covid-19.
Finally, Anvisa maintains its commitment to the Brazilian State to act in favor of access to products with quality, efficiency and safety.