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July 1999

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The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Fri, 9 Jul 1999 07:10:57 -0500
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        Where I have worked in the past, all pharmaceutical RM's are fully
qualified by I/E testing, and the limits, if none are established, are
determined "additively" (by considering the final product limit and what
contribution each raw material could make towards that total limit)- this has
been a SERIOUS pain sometimes, particularly with lipids and such, and calls for
some real inventiveness i test methodology- but, we have been audited for this
approach, by many agencies, domestic and foreign, and all found it acceptable.
M.Carroll ([log in to unmask])

______________________________ Reply Separator _________________________________
Subject: [PMFLIST] Inhibition/Enhancement LAL testing for Raw materia
Author:  <[log in to unmask]> at INTERNET-MAIL
Date:    7/8/99 6:47 PM


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


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