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November 1998

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Subject:
From:
"Davin C. Enigl" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Mail List <[log in to unmask]>
Date:
Tue, 24 Nov 1998 10:16:31 EST
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In a message dated 11/23/1998 4:17:01 PM Pacific Standard Time,
[log in to unmask] writes:

<< How do you think FDA microbiologists would handle validation data (using C.
 albicans and A. niger) that showed adequate recovery with the 30-35C
 incubation first followed by 20-25C? >>

I my opinion, they (and I would agree with them) would say:  You got lucky
this time, but in general, you are violating standard methods procedures and
are therefore noncompliant with already validated methods.  It sounds to me
like someone is trying to circumvent the method in order to save time and
money -- to heck with the USP method validations and standard methods
protocols.

Davin C. Enigl,
Regulatory Compliance Microbiologist
[log in to unmask]


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