PSDGLIST Archives

May 2013

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Subject:
From:
"Kolbush, Renee" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 2 May 2013 21:48:43 +0000
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1) We are now storing liquid / cream products horizontally for the annual stability program
2) We are now storing liquid / cream retains horizontally 
3) Yes, we just received the 483 observation from the FDA for not storing our annual batch program horizontally even though we had supportive data from the pre-market studies in the horizontal orientation to show no effect.    We deal with non-registered products (monographs) so approval of stability protocols is not applicable to our operation.  

Renee Kolbush
Novartis Consumer Health, Inc.


-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of [log in to unmask]
Sent: Thursday, May 02, 2013 9:25 AM
To: [log in to unmask]
Subject: [PSDGLIST] storing liquid products horizontally (or inverted)

Hi everyone,

We have recently heard that companies have been receiving audit observations for not storing liquid products horizontally (or inverted) for their annual lots (even if accelerated pre-marketed studies were performed horizontally and the submission storing only upright was approved by the FDA).  I have three questions:


(1)    How many companies are storing liquid products horizontally (or inverted) for their annual stability programs?

(2)    Are any companies storing their liquid product retention samples horizontally or inverted?

(3)    Has anyone received an audit observation for not storing horizontally?


Thanks!

Tina

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    Provides a complete selection of laboratory and microbiology supplies
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=================================
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 PSDG, or the sponsors of the list.

------------------
The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) 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.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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