What is meant by lot release and what are the steps involved?
Because of the complex manufacturing process for most biological products, each lot undergoes thorough testing by the manufacturer. The manufacturer performs specific tests as specified in their license application. The manufacturer submits samples of each licensed vaccine lot and the results of their own tests for potency, safety, and sterility to the Agency. The manufacturer may not distribute a lot of the product into interstate commerce until CBER releases it. All vaccines are subject to lot release. The lot release program is part of FDA’s multi-part strategy that helps assure biological product safety by providing a quality control check on product specifications.
