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December 2003


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"Fry, Robert A [USPGM/0924]" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Thu, 18 Dec 2003 12:43:28 -0500
text/plain (48 lines)

Does anyone know of any requirements to conduct additional sterility testing
in response to lot related routine microbiological environmental monitoring
action level incidents?   It has been a common practice at the Kalamazoo
site to conduct 2X sterility testing for all EM actions that occur in Class
100 areas.   I wrote up a justification to eliminate this practice since the
increase in samples by 2X is statistically insignificant in detecting low
levels of contamination.  Our colleges here at Pfizer are not aware of any
contemporary, regulatory, or compendial requirements or environmental
monitoring guidance documents that recommend 2X sterility testing when
environmental monitoring action levels are reached.  I just want to find out
what everyone else is doing.

Rob Fry
Lab Supervisor
Pfizer Kalamazoo Drug Products (KDP) Quality Operations
Microbiological Support

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