PMFLIST Archives

October 2019

PMFLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show HTML 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:
"Dr. Michael J. Miller" <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Tue, 1 Oct 2019 11:10:13 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (129 lines)
Any deviation from the compendial assay requires validation to show the alternative method is equivalent to the existing method. Regards, Michael 

 

From: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]> on behalf of "Rabia Begum (Manager Microbiology)" <[log in to unmask]>
Reply-To: The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date: Tuesday, October 1, 2019 at 10:34 AM
To: <[log in to unmask]>
Subject: Re: [PMFLIST] Modification in Microbial examination test for Non-sterile products

 

Dear Members,

I have a query regarding alternate microbiological methods. For non-sterile product testing if we use TSB in place of Buffered peptone for preparation of 1:10 dilution. Does this modification classify in alternate method or it can be still consider as Pharmacopeial method?

 

Your expert opinion is required for the compliance of Pharmacopeial requirement.

 

With regards,

Rabia Begum

Quality Control Department

 

 

“Please consider your environmental responsibility before printing this e-mail or its attachments”

Disclaimer: “This message (including attachment) is intended solely for the use of the individual or entity whom it is addressed and may contain information that is confidential or privileged. If you are not the intended recipient of this message, you are hereby notified that any use, dissemination, distribution or reproduction of this message is prohibited and that, you must not take any action in reliance on it. E-mail transmission cannot be guaranteed to be secure or error-free as information could be intercepted, corrupted, lost, destroyed, arrived incomplete or contain viruses; therefore Getz Pharma (Private) Limited cannot accept legal responsibility for the contents of this message. If you have received this communication in error, please notify the sender or Getz Pharma (Private) Limited at [log in to unmask] immediately and destroy the original message.”

 

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

The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from

The Microbiology Network (http://microbiologynetwork.com) and 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]

 

 

 

Science Advisory Board https://www.scienceboard.net/

 

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

 

Charles River Laboratories - http://www.criver.com/

 

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

 

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

 

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

 

Boston Analytical http://www.bostonanalytical.com/

 

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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

 


------------------
The PMFList (http://microbiologynetwork.com/pmflist.asp) is operated from
The Microbiology Network (http://microbiologynetwork.com) and 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]



Science Advisory Board https://www.scienceboard.net/

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

Charles River Laboratories - http://www.criver.com/

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

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

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

Boston Analytical http://www.bostonanalytical.com/

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 Microbiology Network, Inc., the PMF, or the sponsors of the list.

ATOM RSS1 RSS2