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October 1999

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Subject:
From:
Steven G Richter <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 5 Oct 1999 11:57:03 -0400
Content-Type:
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Dear Ms. Spears,

The FDA guideline indicates that each lot has to be tested prior to
release.  The interpretation of a lot is considered as important as testing
the product.   The lot is determined by a manufacturing schedule.  However,
in terms of LAL, one has to determine lot size based on components and
manufacturing time tables for the product.    For example, If  a LAL
critical component lot number changes for a manufacturing lot, then the
manufacturing lot should change or additional LAL samples should be culled.
 Critical LAL components would be components that have a propensitiy to
contain endotoxin such as water washed products, extrusion products,
natural components or  parts that have a endotoxin history.  In any
situation, one should have an SOP that determines lot size based on these
issues.

We hightly recommend component testing for endotoxin prior to acceptance
into the production area.

Sincerely,

Steven G. Richter Ph.D.
President and Scientific Director
MicroTest Laboratories,Inc.
www.microtestlabs.com
[log in to unmask]


Steven G. Richter Ph.D.
Microtest Laboratories, Inc.
http://www.microtestlabs.com
[log in to unmask]


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