Marc,

So you can predict what changes will be made, what will be eliminated, and
what new elements will be added. Even the FDA microbiologists who wrote the
draft Guidance have no idea how it will finally read after the compliance
and legal groups work their magic.

The prudent course of action is to wait for the final version to be
published.

Tony

On Wed, May 10, 2023 at 9:36 PM Marc Glogovsky <[log in to unmask]>
wrote:

> Tony,
>
> I disagree.  That draft represents their thinking at the time of draft
> publication (before public comment).  If you look back historically at the
> agencies publications almost all of them have the same tone in the final
> publication as they did in the draft, albeit with additional clarifications
> based on industry/individual feedback.
>
> Sincerely,
>
> Marc Glogovsky, MS, S.M. (NRCM)
> Business Unit Manager - Microbiology Consulting
> 609.432.1314
>
> valsource.com<https://www.valsource.com/>
>
> From: The Pharmaceutical Microbiology Forum Email List <
> [log in to unmask]> on behalf of Tony Cundell <
> [log in to unmask]>
> Date: Wednesday, May 10, 2023 at 3:45 PM
> To: [log in to unmask] <
> [log in to unmask]>
> Subject: Re: [PMFLIST] specification of settled plate of non sterile solid
> dosage manufacturing
> Tim,
>
> You should not cite a draft FDA Guidance for Industry as it is not an
> official document and if published may significantly change based on
> industry comments or internal legal review and it could even be withdrawn.
>
> Tony
>
> On Wed, May 10, 2023 at 1:00 PM Timothy Cser <
> [log in to unmask]> wrote:
>
> > Hi Lim Forng.  USP 1115 does a good job of talking about EM in
> non-sterile
> > manufacturing.  There are no charts like there are in aseptic
> manufacturing
> > so you'll need to create your alert/action levels based on product,
> > patient, MFG design, etc.  There are other resources out there as well.
> > Here's one from the FDA: https://www.fda.gov/media/152527/download
> >
> >
> > Sincerely,
> >
> >
> >
> > Tim Cser
> >
> > 916-759-1401
> >
> > MilliporeSigma
> >
> > ________________________________
> > From: The Pharmaceutical Microbiology Forum Email List <
> > [log in to unmask]> on behalf of Lim Foong Choo <
> > [log in to unmask]>
> > Sent: Wednesday, May 10, 2023 4:47:24 AM
> > To: [log in to unmask] <
> > [log in to unmask]>
> > Subject: [PMFLIST] specification of settled plate of non sterile solid
> > dosage manufacturing
> >
> > [WARNING - EXTERNAL EMAIL] Do not open links or attachments unless you
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> > Dear PMF members,
> >
> >
> >
> > What is the specification of settled plate (cfu/plate/4 hours)
> > specification
> > of non-sterile manufacturing facility ?
> >
> > Shall I know the references ?
> >
> >
> >
> >
> >
> >
> >
> > Regards,
> >
> >
> >
> > Lim
> >
> >
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> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
>
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-- 
Tony Cundell, Ph. D.
Consulting Microbiologist
Email: [log in to unmask]
Phone: 914 725-3947
Cell: 914 841-0074

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