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November 1998

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Subject:
From:
Peter Holman <[log in to unmask]>
Reply To:
Date:
Mon, 30 Nov 1998 10:09:20 -0700
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Davin-

 Thank you, and yes you are correct - The USP will hold weight in a court
of law, and your 'in-house' method may not.

 Interestingly enough, FDA uses the BAM - The FDA's 'in house' validated
methods, but USP is the referee test.

 As is true with GMP's in general - these are minimum - one can always go
beyond and push the envelope - note the recent posting about automated
methods. If everyone was always afraid to challenge what is in the
USP/BAM... then these alternate methods would not be gaining the ground
that they have been.

 This is getting away from the Media Fill discussion, so I'll end here.

     Peter


On Nov 28, 11:53am, [log in to unmask] wrote:
> Subject: Re: [PMFLIST] Media Fill Incubation Temperature
> In a message dated 11/24/1998 5:24:35 PM Pacific Standard Time,
> [log in to unmask] writes:
>
> <<
>   You seem to be of the opinion that one may never use 'in house'
>  validated methods.
>
>   This is not true. >>
>
> Ok, technically you are not wrong, but you are playing with fire . . .
>
> You place your company at risk,...


--
Peter T. Holman
Genentech, Inc.
Corporate Compliance


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