PMFLIST Archives

September 2012

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:
Scott Sutton <[log in to unmask]>
Reply To:
The Pharmaceutical Microbiology Forum Email List <[log in to unmask]>
Date:
Fri, 14 Sep 2012 13:33:35 -0400
Content-Type:
text/plain
Parts/Attachments:
text/plain (176 lines)
Ramchandra,

Sure - I did CMC filings for many years in ophthalmics and continue to
consult in this area - let me take a try at this question.

My personal believes at what are appropriate were published in the article
In-use Shelf-Life Testing-What Data are Required and When?; with Brian
Matthews and Danny Dunn. Regulatory Affairs Journal   9:728-733. 1998.
http://bit.ly/SlcTxc

However, the relevant guidance document is from EMEA Note for Guidance on
In-Use Stability Testing of Human Medicinal Products - it can be downloaded
at
http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/20
09/09/WC500003475.pdf

Basically, you do a "simulated" dispensing and check for sterility (TAMC) at
the end.    I would recommend doing intermediate counts on the individual
samples as well.

Let me know if you need more info

Scott
=========
Scott Sutton, Ph.D.
Microbiology Network, Inc.
Consultation and training in contamination control & lab operations 
http://www.microbiol.org
+ 585-594-8273 (office)
+1 585-298-0767 (global cell)
[log in to unmask]
Twitter - @microbiologynet







-----Original Message-----
From: The Pharmaceutical Microbiology Forum Email List
[mailto:[log in to unmask]] On Behalf Of Ramchandra Tallu
Sent: Friday, September 14, 2012 4:19 AM
To: [log in to unmask]
Subject: [PMFLIST] In-use stability testing
Importance: High

Dear Forum Members,

 

We are designing in-use stability study protocol for one of our Eye Drop
formulation product.  

 

In this regard I am referring EMEA guide "NOTE FOR GUIDANCE ON IN-USE
STABILITY TESTING OF HUMAN MEDICINAL PRODUCTS" dated 1 March 2001.

As per this guide, appropriate physical, chemical and microbial properties
of the product susceptible to change during use should be monitored. 

 

My question is which test parameters are studied during in-use stability
testing for microbial properties and at what interval?  The product is
sterile and to be used within 28days after opening. 

 

Share your valuable comments.

 

 

Regards,

Ramchandra

 


Disclaimer :-

"The Information in this Dossier/email is proprietary, confidential and
  legally privileged. It is intended solely for the Addressee. Access to
  this Dossier/email by anyone else is unauthorized. If you are not the
  intended recipient, any action taken or omitted to be taken in reliance
  on it, in any form of reproduction, dissemination, copying, disclosure,
  modification, distribution and/or publication of this Dossier/Email is
  strictly prohibited. If you receive this Dossier/Email in error, please
  notify us immediately by telephone on 022-30451500/30451200. Please also
  destroy and
  delete the message immediately from your computer".

WARNING: - "Computer viruses may be transmitted via email. The recipient
  should check this email and any attachments for the presence of viruses.
  The company accepts no liability for any damage caused by any virus
  transmitted by this email."
** Message has been scanned by Emergic MailServ **


------------------
The PMFList (http://microbiol.org/PMFList_info.htm) is operated from The
Microbiology Network (http://microbiol.org) and supported by our sponsors
(http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

EMD Millipore -  http://bit.ly/Udi4CP

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

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

Veltek Associates, Inc - http://www.sterile.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://microbiol.org/PMFList_info.htm) is operated from
The Microbiology Network (http://microbiol.org) and supported by
our sponsors (http://microbiol.org/sponsor.htm) 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.

Accugenix - http://www.accugenix.com

American Type Culture Collection - http://www.atcc.org

BD Diagnostic Systems - http://www.bd.com/ds/

Biolog - http://www.biolog.com

Biomerieux - http://industry.biomerieux-usa.com

EMD Millipore -  http://bit.ly/Udi4CP

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

Pall - http://www.pall.com

NovaTek International - http://www.ntint.com

Rapid Micro Biosystems - http://www.rapidmicrobio.com  (formerly GPS)

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

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