PMFLIST Archives

November 1998

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Subject:
From:
Peter Holman <[log in to unmask]>
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Date:
Tue, 24 Nov 1998 15:16:03 -0700
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Davin -

 You seem to be of the opinion that one may never use 'in house'
validated methods.

 This is not true.  One may choose to use published 'standard methods' as
you put it, but one is always free to use other methods provided that
there is supportive validation.

 You mention the USP specifically - The above concept holds true for both
general information chapters in the USP (>1000) and official compendial
chapters in the USP (<1000), provided that you can show your method(s)
to be equivalent or better than the published method.

 If you would like to discuss in more detail the implications of using
non-compendial methods we can, but I won't get into it in this e-mail.

   Peter

---
To everyone in the group -

 I'm glad to be back in the loop. And Laura did find me.

Peter
---

---
Peter T. Holman
Corporate Compliance
Genentech, Inc.
(All comments are mine - not Genentech's.)



On Nov 24, 10:16am, Davin C. Enigl wrote:
> Subject: Re: [PMFLIST] Media Fill Incubation Temperature
> 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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>
>
>-- End of excerpt from Davin C. Enigl


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