PMFLIST Archives

May 2018

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:
ganesh chaudhari <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Wed, 30 May 2018 08:12:10 +0530
Content-Type:
text/plain
Parts/Attachments:
text/plain (108 lines)
Regulatory says must revalidate the product if ,either
1). Vendor/Manufacturer get changed.
2)Formulation get changed.
So it is basically the second category which force that revalidation should
be done.

Regards,
Ganesh Chaudhari

On May 29, 2018 9:41 PM, "Voigt, Thomas" <[log in to unmask]> wrote:

Good Morning,

For a product formulation, they want to remove one of the excipients (Boric
Acid).  It will be the same API concentration and all of the other
excipients, just minus the boric acid.  Would you have to repeat micro
validation testing (B/F, E/I, and bioburden qualification)?   Would you
consider the formulation with the boric acid as almost a worst case?  Sorry
I am used to seeing something being added to the formulation not removed.

Thanks,
Thomas


This e-mail communication (including any attachments) contains information
from Emergent BioSolutions or its affiliates that is confidential and may
be privileged. The information contained herein is intended only for the
use of the addressee(s) named above. If you are not the intended recipient
(or the agent responsible to deliver it to the intended recipient), you are
hereby notified that any dissemination, distribution, use, or copying of
this communication is strictly prohibited. If you have received this e-mail
in error, please immediately reply to sender, delete the message and
destroy all copies of it. If you have questions, please email
[log in to unmask] Thank you.

------------------
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]

Sartorius https://promotions.sartorius.com/real-heroes

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

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

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

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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - 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]

Sartorius https://promotions.sartorius.com/real-heroes

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

Avista Pharma Solutions  http://www.avistapharma.com

MilliporeSigma  http://www.emdmillipore.com/

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

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

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

Nelson Labs - http://www.nelsonlabs.com

BD Diagnostic Systems - 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