ANVISA has denied a certificate for good manufacturing practices to Bharat Biotech as it did not meet its manufacturing standards.
A team of five inspectors had visited the production facility in India to inspect and verify the technical details of the vaccine to be supplied. The team raised some issues related to the manufacturing plant and mentioned in the report that the Bharat Biotech laboratory did not meet Current Good Manufacturing Practice (CGMP) requirements and also cited a lack of safety data and documentation. The certification request was rejected as the company did not produce all the required documents, and different non-conformities were found.
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