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Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC

Friday, 08 January 2021
16:03
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Independent batch release testing of COVID-19 (coronavirus) vaccines by the NIBSC
The National Institute for Biological Standards and Control will carry out independent testing in the UK for any potential COVID-19 vaccines.

As is the case for current, licensed vaccines, the quality of each batch of any potential COVID-19 vaccine will be evaluated by an independent laboratory. The independent laboratory will also carry out a thorough review of the manufacturer batch documentation that describes the production process and quality control testing performed by the company.

In the UK, this independent testing is performed by the National Institute for Biological Standards and Control (NIBSC), an expert centre of the Medicines and Healthcare products Regulatory Agency (MHRA).

Before any batch can be released for deployment, the NIBSC will issue a certificate confirming that the independent testing has been performed and that the batch is compliant with the relevant specifications for the product.

See the NIBSC’s statement on independent batch testing of COVID-19 Vaccine AstraZeneca.

Further information on independent batch release testing.

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