Members: I was wondering what industry practice is for performing LAL validation testing for raw materials. The USP, EP, or FDA Guidelines are specific for finished product testing. Therefore, I am curious to know whether folks perform a compendial gel clot inhibition / enhancement test for raw materials, with 3 lots being tested for one LAL vendor and just 1 lot for a backup LAL vendor. If you also use a second method such as kinetic, do you also repeat the testing with another 3/1 lots? If you do not perform I/E testing on raw materials, do you rely on just the positive product control? If so, have you encountered any issues from inspectors during audits? Thanks in advance for any information. Regards, Jeff_Werner @biogen.com V-P, PMF ------------------ The PMFList (http://microbiol.org/PMFList_info.htm) is operated from The Microbiology Network (http://microbiol.org) and supported by our sponsors (http://microbiol.org/sponsor.htm) as a service to the scientific community.