Release testing

The set of specification tests a lot must pass before release, covering identity, assay or potency, purity, safety and the other attributes in the specification. For a product sold in Japan, the tests and limits that count are the ones written in the specifications and test methods section of the Japanese marketing approval. Expect a Japanese customer to compare your certificate of analysis with that text rather than with your internal specification. For cell therapy products with very short shelf lives, some results, such as sterility, may only be available after shipment, and the release plan must say in advance how such results are handled. Validated rapid methods are often used to shorten the wait.