Brazil regulator grants GMP certification to Bharat Biotechs Covaxin facilities
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HYDERABAD: Less than every week after Brazil’s well being regulator green-lighted the “exceptional import” of four million doses of Bharat Biotech’s Covid-19 jab Covaxin, it has now granted certification of Good Manufacturing Practices (GMP) to the corporate’s vaccine-manufacturing facility in addition to its organic enter, paving the best way for full-fledged exports of Covaxin to Brazil.
Brazilian regulator Anvisa (Agência Nacional de Vigilância Sanitária) granted the GMP certifications on Wednesday vide resolutions RE2248 and RE2249, based on a loosely translated model of Anvisa’s announcement.
The certifications are for the plant concerned within the manufacture of the completed vaccine, Covaxin, at Hyderabad in addition to the energetic pharmaceutical ingredient of the vaccine, the Anvisa web site stated.
“The CBPF (Certification of Goom Manufacturing Practices), legitimate for 2 years, was issued after the corporate made the changes associated to non-conformities detected within the inspection carried out by the Agency‘s technicians within the interval from 1st to March 5 this yr,” Anvisa stated.
The Brazilian regulator additionally emphasised that the issuance of those certifications shouldn’t be confused with the distinctive importation deliberated by the Collegiate Board of Anvisa on the extraordinary assembly of on June four and that the most recent actions had been totally different.
“Certification is not a prerequisite for applications for authorisation of emergency use of vaccines against Covid-19, nor for exceptional importation. In these cases, a verification of the minimum requirements of GMP, quality, safety and efficacy and compliance with legal criteria is carried out. Certification is, indeed, a prerequisite for the registration of the vaccine and encompasses a more in-depth and complete analysis of all the requirements of the Collegiate Board Resolution (RDC) 301/2019,” Anvisa stated.
In March this yr, Anvisa had turned down the primary import request of the Brazilian well being ministry following which the ministry approached Anvisa once more in May finish.
In May finish, Bharat Biotech too submitted two purposes to Anvisa in search of approval for GMP certifications forCovaxin’s manufacturing line in addition to its organic enter.
In March finish, Anvisa had refused to grant GMP certification to the corporate’s amenities citing non-compliance with GMP requirements based mostly on observations by its inspectors that visited the Genome Valley facility in Hyderabad within the first week of March.


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