Brazilian regulator grants GMP certification to Bharat Biotech’s Covaxin facilities | India News

Brazilian regulator grants GMP certification to Bharat Biotech's Covaxin facilities |  India News

HYDERABAD: Less than a week after Brazil’s health regulator gave the green light to the “exceptional importation” of 4 million doses of Bharat BiotechCovid-19 jab Covaxin, has now granted Certification from Good manufacturing practices (GMP) to the company’s vaccine manufacturing facilities, as well as its biological inputs, paving the way for full exports of Covaxin to Brazil.
Brazilian regulator Anvisa (Agência Nacional de Vigilância Sanitária) granted GMP certifications on Wednesday in video resolutions RE2248 and RE2249, according to a loosely translated version of Anvisa’s announcement.
Certifications are for the plant involved in manufacturing the finish. vaccine, Covaxin, in Hyderabad, as well as the active pharmaceutical ingredient in the vaccine, the Anvisa website said.
“The CBPF (Goom Manufacturing Practices Certification), valid for two years, was issued after the company made the adjustments related to the non-conformities detected in the inspection carried out by the Agencytechnicians in the period from March 1 to 5 of this year, ”said Anvisa.
The Brazilian regulator also emphasized that the issuance of these certifications should not be confused with the deliberate exceptional importation by the Collegiate Council of Anvisa in the extraordinary meeting of June 4 and that the last actions were different.
“Certification is not a prerequisite for applications for authorization of emergency use of vaccines against Covid-19, nor for exceptional importation. In these cases, a verification of the minimum GMP, quality, safety and efficacy requirements and compliance with legal criteria is carried out. The certification is, in fact, a prerequisite for the registration of the vaccine and encompasses a deeper and more complete analysis of all the requirements of the Resolution of the Collegiate Council (RDC) 301/2019 ”, said Anvisa.
In March this year, Anvisa had rejected the first import request from the Brazilian Ministry of Health, after which the ministry approached Anvisa again at the end of May.
At the end of May, Bharat Biotech also submitted two applications to Anvisa to obtain the approval of GMP certifications for the Covaxin production line, as well as its biological input.
At the end of March, Anvisa had refused to grant GMP certification to the company’s facilities, citing non-compliance with GMP standards based on observations from its inspectors who visited the Genome Valley facility in Hyderabad in the first week of March.


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