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July 1999

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Subject:
From:
Jeff Werner <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Thu, 8 Jul 1999 18:47:11 -0400
Content-Type:
text/plain
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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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