Bharat Biotech's COVID-19 vaccine Covaxin has received Good Manufacturing Practices (GMP) compliance certificate from Hungary, the vaccine maker said on Thursday in a tweet.
"Another milestone in our account as COVAXIN receives GMP certificate from Hungary. This marks the 1st EUDRAGDMP compliance certificate received by Bharat Biotech from European regulatories," the tweet said.
The approval was received from the National Institute of Pharmacy and Nutrition Hungary certifying the GMP for the manufacture of Covaxin.
With this approval, Bharat Biotech achieved another significant milestone in innovating and manufacturing vaccines at global quality standards and moving forward in the ongoing fight against the COVID-19 pandemic, read Bharat Biotech statement.
The certificate of GMP is now listed on the EudraGMDP database, which is the database of the European Community of manufacturing authorizations and certificates of the good manufacturing practice.
Bharat Biotech intends to submit documentation for emergency use authorisation to several additional countries worldwide, the company said.
"With this approval Bharat Biotech has achieved another significant milestone in innovating and manufacturing vaccines at Global quality standards and moving forward in the ongoing fight against the COVID-19 pandemic," the note said.
The recognition compliments the firm's commitment of driving world class innovation and being a frontrunner in the research and development of vaccines, it added.
What is a GMP certificate?
Good manufacturing practice (GMP) is a system for ensuring that products are consistently produced and controlled according to quality standards. It is designed to minimize the risks involved in pharmaceutical production that cannot be eliminated through testing the final product.
According to World Health Organization's (WHO) website, GMP covers all aspects of production; from the starting materials, premises and equipment to the training and personal hygiene of staff. Detailed, written procedures are essential for each process that could affect the quality of the finished product.
(With inputs from ANI and PTI)