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June 2020

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Subject:
From:
Donald English <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Thu, 11 Jun 2020 18:31:50 -0400
Content-Type:
text/plain
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text/plain (79 lines)
Dear Helga,  

USP Chapter 51 should not be used as a routine Quality Control release test.  For Quality Control testing of production batches, you can do either qualitative confirmation of preservatives in a batch or to fo quantification of the preservative levels to confirm the presence of preservatives.

USP Chapter 51 is done during product development and during real-time stability testing of production batches for confirmation of shelf-life.

Regards,
Don

Donald J. English Microbiological Quality Consulting LLC
Florham Park, New Jersey 07932


Sent from my iPhone

> On Jun 11, 2020, at 4:47 PM, Helga Rivas <[log in to unmask]> wrote:
> 
> ´╗┐Dear Forum Members
> 
> 
> 
> Does the antimicrobial efficacy test <51> need to be done during product
> development? Or is it taken as a criterion for batch to batch release?
> Where can I find this premise in detail?
> 
> 
> Thanks
> 
> 
> Helga
> 
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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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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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