Europe’s drug regulator is auditing the manufacturing site of the Serum Institute of India (SII), a source with knowledge of the matter has said, a necessary step before AstraZeneca’s Covid-19 vaccine made there can be exported to the bloc, Reuters reported.

The precise reason for the audit of SII’s manufacturing processes and facilities was not clear, but a green light would mean the drug could be exported to the European Union, the source said, declining to be identified because the review is confidential.

“You have to look at all the steps of production. The process right now is in a phase of virtual contacts and data requests,” he said. “No need for an in-person visit if the data are convincing.”