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December 2003

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Subject:
From:
Stanley Alekman <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 29 Dec 2003 14:46:02 EST
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In a message dated 12/23/03 6:34:51 PM Central Standard Time,
[log in to unmask] writes:
would like to receive some advices about setting alert and action levels
for environmental monitoring program in an injectable department.

Which statistical approach do you apply (normal distribution, negative
exponential distribution, ...) ? Do you set different levels for each
location (very difficult to manage, I guess) or you consider all the data
from the same grade locations ?
Francesco,

By action and alert limits, do you want to identify the naturally occurring
limits in your specific environment? By natural, I mean identify those limits
that prevail as the environment is presently constituted. Or do you mean
regulatory limits?

Stan Alekman

Let charm be thy spear, wit thine armor.

Stanley L. Alekman PhD
Pharmaceutical Consultant
S.L. Alekman Associates, Inc.
Inverness, Illinois
847-358-6975
[log in to unmask]

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