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Subject:
From:
Tony Cundell <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 9 Jul 2020 10:03:21 -0400
Content-Type:
text/plain
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text/plain (112 lines)
Devendra,

This level of detail is not included in USP <1111> as the drug substance
may be used in a sterile drug product or different non-sterile dosage
forms. The recommendation may be viewed as a default microbiological
specification and the drug manufacturer based on a risk analysis would need
to set an appropriate specification or refer to the specification in the
USP monograph for the material.

Tony

On Thu, Jul 9, 2020 at 9:49 AM Devendra Badgujar <
[log in to unmask]> wrote:

> Dear Forum members,
>
> As per the USP <1111> the microbiological quality requirement for the drug
> substances (API) is only TAMC & TYMC,  there is no any requirement mention
> for specified microorganisms.
> I have question, it is required to perform the test for specified
> microorganism for drug substance (API) which are use either in non-sterile
> formulation and sterile drug preparation?
> I want to  know across industry practice.  Any ref. for specified
> microorganism for drug substance?
>
>
> Thank's  & Regard's
> Devendra Badgujar
> 356
> 7016823393
> 9586331571
>
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> Steris - http://www.sterislifesciences.com/
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> Charles River Laboratories -
> https://www2.criver.com/l/60962/2020-03-27/h6jqv6
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> Veltek Associates, Inc - http://www.sterile.com
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> Microbiologics, Inc. - http://www.microbiologics.com
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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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The PMFList is supported by our sponsors as a service to the scientific community.

Please take a second to visit our sponsors' web sites and say thank you for their support of this service.
If your company would be interested in sponsoring this community, please contact [log in to unmask]



Steris - http://www.sterislifesciences.com/

Charles River Laboratories - https://www2.criver.com/l/60962/2020-03-27/h6jqv6

Veltek Associates, Inc - http://www.sterile.com

Microbiologics, Inc. - http://www.microbiologics.com

BD Industrial Media - http://www.bd.com/ds/

Associates of Cape Cod, Inc. - http://www.acciusa.com/


=================================
The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of the PMF or the sponsors of the list.

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