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December 2003

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Subject:
From:
Katarina Mihailovic <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 24 Dec 2003 11:00:03 +0100
Content-Type:
text/plain
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text/plain (94 lines)
Dear Francesco,

I use normal distribution approach for class D and set alert level at 2
st.dev. + mean, and action level at 3 st.dev. + mean!
For class C alert level is set at 2 st.dev. and action at 3 st.dev. I
use poisson distribution approach for class C, B and A.
For class A and B I use GMP limits as action limits, meaning 1 for class
A and 5 for B. 

I hope this helps,

Katarina Mihailovic, BSc.Biochem.spec. 
Hemofarm AD

-----Original Message-----
From: Boschi, Francesco [mailto:[log in to unmask]] 
Sent: Friday, December 19, 2003 7:46 PM
To: [log in to unmask]
Subject: [PMFLIST] Setting statistical alert and action levels

Dear list,
I 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 ? Are you required to set statistically
levels
for all classes (for grade A and probably B it does not sound very
meaningful ...) ?

Thanks,
Francesco


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