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June 2013

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Subject:
From:
Mike Koenig <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 6 Jun 2013 15:12:01 +0000
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It sounds like you have a combination product?  

If you are regulated as a drug, and you have an OOS in a stability study that can't be attributed to laboratory error, you are required to file a field alert report within 3 days if the batch is on the market.  

Mike



-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Stephanie DelPaine
Sent: Wednesday, June 05, 2013 11:35 AM
To: [log in to unmask]
Subject: [PSDGLIST] Annual Monitoring Stability

Hi All,
I was wondering what happens if you have an OOS on annual monitoring stability.   I know that you would launch an investigation, but what happens to the product line? Do you continue to sell the product?  Do the combo device and drug worlds have different procedures?
Thanks in advance for your response.

Steph


Stephanie Del Paine, Ph.D.
Regulatory Scientist
COOK/MED Institute, Inc.
1 Geddes Way
West Lafayette, IN 47906
Ph.   765.463.7537  (x-1192)
Fx.   765.497.0641
Cell  765.586.9348

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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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