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December 2003

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From:
"Fry, Robert A [USPGM/0924]" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 29 Dec 2003 11:02:17 -0500
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Francesco,

PDA Technical Bulletin No. 13 "Fundamentals of a Microbiological
Environmental Monitoring Program" has some good information regarding the
setting of EM alert and action levels.  I would not use normal distribution
for microbiological data since it does not follow normal distribution
especially in the Grade A and B areas.  Some companies use 95% cut-off for
alerts and 99% for actions.  This usually works in Grade C and D areas, but
not in Grades A and B since a majority of the counts are zero.


The alert levels at Pfizer Kalamazoo Drug Products are going to be set using
95% cut-off for alerts and a risk factor for action levels.  The risk factor
is based on the type of the classification.   For example, if the 95%
cut-off for surface monitoring in the Grade B areas comes out to 2 cfu then
the action level will be derived by multiplying 2 cfu by the risk factor.
If the risk factor was 2, then your action level would 4 cfu/plate. There is
a stipulation that does not allow the action level to exceed the compendial
or corporate quality standard action level.   To answer question below, we
do consider all the data from the same grade locations.   You are right
about Grades A and B in regards to statistical data.  We are going that
route, but there is not much of a gap between the alert and action level
since a majority of the data is zero.  You would react to 1 cfu for the
alert level for this type of data.

I presented this risk factor approach at the 2003 Spring PDA Conference in
Orlando.  There was good reception to his type of approach, but the only
uncertain area is how do you come up with the risk factors and how do you
defend them.  That is something people have to determine based on the
processes in each companies facility that is being evaluated.

If you have any questions, please contact me via phone.

Rob Fry
Lab Supervisor
Pfizer Kalamazoo Drug Products (KDP) Quality Operations
Microbiological Support
269-833-5685

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]]On Behalf Of Boschi, Francesco
Sent: Friday, December 19, 2003 1:46 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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