Guidelines for independent lot release of vaccines by regulatory authorities

The lot release of vaccines by regulatory authorities is part of the regulation of vaccines and involves the independent assessment of each lot of a licensed vaccine before it is released on to the market. This assessment is based, as a minimum, on the review of manufacturers’ summary protocols. It may be supplemented by other documents such as the release certificate from the responsible national regulatory authority (NRA) or national control laboratory (NCL) and, in some circumstances, by testing that is independent of the manufacturers’ quality- control testing.