PMFLIST Archives

July 2020

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
Mike Villa <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Mon, 20 Jul 2020 16:51:22 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (85 lines)
Hello Kristen,
I believe the USP indicates that a repeat with different neutralizers, larger solution of product to diluent, etc are all acceptable next steps. 
Until you have validated that you can neutralize the product, you can’t move forward with PET. 

Mike

> On Jul 20, 2020, at 3:34 PM, Kristen Peters <[log in to unmask]> wrote:
> 
> All - does anyone know what the USP recommends if the suitability test
> fails using neutralizing agents? What is the next step, can we proceed with
> the PET/AET on the product?
> 
> Kristen Peters
> General Manager
> Advanced Laboratories, Inc. North Carolina
> 919-989-7793 <(919)%20989-7793> (NC Lab, FDA Reg #10560615298)
> 919-989-9226 <(919)%20989-9226>(Fax)
> 
> www.advancedlabsinc.com
> 
> *If you liked our service, please tell a friend.  If you didn’t, please
> tell us!*
> 
> ISO/IEC 17025:2017 Accredited  |   UT Lab FDA Registration # 14353128308  |
> NC Lab FDA Registration # 10560615298
> 
> CONFIDENTIALITY NOTICE
> 
> The information contained in this e-mail correspondence is intended solely
> for the use of the individual or entity to which it is addressed, and may
> contain information that is PRIVILEGED and CONFIDENTIAL. If you are not the
> intended recipient, you are hereby notified that any disclosure,
> duplication, distribution or the taking of any action in reliance upon this
> correspondence is strictly prohibited. If you received this correspondence
> in error, please notify the sender by phone, fax, or e-mail and destroy any
> and all copies of the correspondence. Thank you.
> 
> ------------------
> 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.

ATOM RSS1 RSS2