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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