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The National Health Surveillance Agency (Anvisa) rejected the request for Certification of Good Manufacturing Practices for Medicines by Bharat Biotech, manufacturer of Covaxin, a vaccine against Covid-19.
This step is a prerequisite for drug manufacturers to receive authorization for emergency use of the immunizer or definitive registration. The inspection at the Indian factory was carried out by the Brazilian agency in early March.
The Ministry of Health presented to Anvisa, on Monday (22), the request for authorization to import 20 million doses of Covaxin from India, where the immunizer has authorization for emergency use.
The agency’s decision, signed by the general manager of Inspection and Sanitary Inspection, Ana Carolina Moreira Marino Araújo, was published in this Tuesday (30) edition of Union Official Gazette.
Considering the non-compliance with the requirements of Good Practices in the Manufacture of Medicines, or the non-compliance of the request procedures submitted for analysis, recommended in the current legislation, it is resolved: Art. 1 Deny the Request (s) Certification of Good Manufacturing Practices for Medicines of the company (s) listed in the ANNEX ”, says the resolution.
The certification request was made by the Brazilian company Precis – Comercialização de Medicamentos Ltda for the Bharat factory in the state of Telangana, India.
In the justification presented by Anvisa, the breach of three articles of the Resolution of the Collegiate Board of Directors (RDC) 69/2014 of the agency was presented, which refer to the documents that must be presented in the process, the specifications that must be established for intermediaries and active pharmaceutical supplies and the validation of the pharmacopoeial methods used by the company.
Five articles of Anvisa’s Normative Instruction (IN) 36/2019 must be adopted, dealing with critical parameters of the operating process that affect product quality, methods used for sterilization and measures to avoid the risk of new contamination of the products. , process to ensure the complete inactivation of the living organism, among other problems.
The agency’s decision also cites the violation of three articles provided for in EN 35/2019: 108, 154 and 158. They refer to the monitoring of bioburden, about the time required to filter a known volume of the bulk solution and determine that the filter should not affect the product.
Finally, the resolution also included non-compliance with article 94 of EN 47/2019, which establishes that “all analytical methods, used in qualification, validation or cleaning, must also be validated with the appropriate detection and quantification limits. “.
