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April 2000

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Subject:
From:
"Lee, Lucy" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 25 Apr 2000 08:33:47 -0400
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I agree with Tony's approach.  It certainly is a common approach as numerous
clients have asked us to repeat the preparatory testing, sometimes in
triplicate but most often it is not.

> -----Original Message-----
> From: Anthony Cundell [SMTP:[log in to unmask]]
> Sent: Monday, April 24, 2000 8:56 AM
> To:   [log in to unmask]
> Subject:      Re: [PMFLIST] Comparative Testing
>
> Tina,
>
> Since almost all the products to be tested will the transferred ML Test
> contain no bioburden we decided to get the receiving lab to repeat some
> elements of the preparatory testing to qualify the test.
>
> Tony Cundell
> Wyeth-Ayerst Pharmaceuticals
>
> >>> Tina Kramer <[log in to unmask]> 04/20 11:50 AM >>>
> For those of you who have been involved with the transfer of products from
> one
> manufacturing and testing site to another via the PAC-ATLS (Postapproval
> Changes--Analytical Testing Laboratory Sites) guidelines....have you
> performed
> comparative testing for Microbial Limits Testing between the two
> laboratories
> involved.  Is comparative testing necessary for the transfer of Microbial
> limit
> methods?  If so, how have you determined acceptance criteria for the
> comparison?
> For example, what if one lab recovers an organism that the other lab does
> not
> recover, even if the presence of that organism does not result in an OOS
> result?
> What if both labs get different, but passing total aerobic count results?
> Due
> to the variability and the fact that organisms may not be evenly
> distributed
> throughout a batch, how do you determine how much variability would be
> acceptable?  Any insight would be appreciated!
>
> Tina Kramer
> Teva Pharmaceuticals USA
>
>
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