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.



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