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July 1999

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Subject:
From:
Tony & Roz Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Sat, 17 Jul 1999 16:09:11 -0400
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Holly,

The FDA Stability guide allows for the use of chemical assay when the
preservative effectiveness is demonstrated at the lower shelf specification.

A reasonable approach would be to demonstrate effectiveness at the 50, 75
and 100% of the label claim and limt the AET to the first three production
batches at 3, 12 and 24 months.

Tony Cundell

At 03:31 PM 7/16/99 -0700, you wrote:
>    Colleagues,
>    For those of you performing Antimicrobial Effectiveness Testing, I'd
like to
>    take a poll:
>
>    Do you perform AET on each product?
>    Or do you allow the results for one product to represent other products
with
>    equivalent matrices?
>    Have you had any discussion with FDA on this issue?
>
>    Any info on the subject would be appreciated!
>
>    Holly Erickson
>    Chiron Corporation
>
>
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