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June 2020

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Subject:
From:
Stephen Langille <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 12 Jun 2020 12:09:12 -0400
Content-Type:
text/plain
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text/plain (137 lines)
Mike,

The answer is dependent upon the microbiological risk of the non-sterile
product that is the subject of clinical trials.  FDA guidance documents for
phase 1 clinical trials and phase 2/3 clinical trials don't require the
submission extensive microbiological test results for non-sterile products.
Products with low water activity generally aren't required to establish
specifications until marketing, although the development of those
specifications and supporting test methods during later clinical trials is
prudent.  Aqueous products prepared and held for extended periods of time
prior to use in the clinical trial, even phase 1 trials, may require
microbial enumeration and/or preservative effectiveness testing to ensure
that the microbiological quality of the product is acceptable.

Best,

Steve Langille
[log in to unmask]

-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> On Behalf Of Michael Barton
Sent: Friday, June 12, 2020 4:09 AM
To: [log in to unmask]
Subject: Re: [PMFLIST] Method suitability for phase 1 - non-sterile product

Hi,
does anyone have any information to support this. Im really struggling to
find information during these earlier phases.

Aanyone who works in these earlier phases or consultants and have any detail
they can share would be really appreciated.

Thanks Mike
________________________________
From: The Pharmaceutical Microbiology Forum Email List
<[log in to unmask]> on behalf of Michael Barton
<[log in to unmask]>
Sent: 02 June 2020 15:37
To: [log in to unmask]
<[log in to unmask]>
Subject: [PMFLIST] Method suitability for phase 1 - non-sterile product

Hi All,
during the early phases of product development and up to clinical trials
where it is intended to test a product to <61> & <62> to what extent does
the method need to be assessed/validated and  suitability performed?

Thanks
Mike.

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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/


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The nature of this service is to provide a medium for communication.  The
specific statements and endorsements of individuals participating in the
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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.

------------------
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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