Validation test
(USP/EP inhibition or enhancement test)
This test is used to demonstrate that the product does not interfere with the LAL assay. This test is performed at a dilution that is at or below the Maximum Valid Dilution (MVD) for that product. The MVD is determined by the endotoxin limit for the product. Validation is required for all finished products that are parenteral or intrathecal. The test method should be validated using three lots of the finished product before the Release Test is used to release product. The procedure is also used to demonstrate that the assay is valid when used to test raw or in-process materials.