For your GMP stability chambers, how often do you re-map your
>chambers (assuming no major changes have been made to the system). If
>you do not routinely remap just say 'do not remap'?
Response: once in 3 years
2. Do you have a strategy for placing probes at a worst-case location?
Response: Yes
3. Are you routinely audited by European authorities or European
Qualified Person?
Response: No
Thanks
Shashi Raju
Director -Quality Control
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Mazzeo (R&D), Tony
Sent: Tuesday, October 08, 2013 2:07 PM
To: [log in to unmask]
Subject: [PSDGLIST] FW: stability chamber re-mapping - poll
>
>Hi stabilitarians,
>
>I've asked this question a few years back and believe the regulatory
>environment regarding the subject has changed some, so I am polling again.
>You can respond to me directly at [log in to unmask] and I will
>publish the poll results at a later date.
>
>1. For your GMP stability chambers, how often do you re-map your
>chambers (assuming no major changes have been made to the system). If
>you do not routinely remap just say 'do not remap'?
>
>
>2. Do you have a strategy for placing probes at a worst-case location?
>
>
>3. Are you routinely audited by European authorities or European
>Qualified Person?
>
>
>Thanks
>Tony
>
>
>
>Anthony R. Mazzeo, Ph.D.
>Senior Principal Scientist
>Analytical and Bioanalytical Development Pharmaceutical Development
>Department
>
>Bristol-Myers Squibb Company
>1 Squibb Drive
>New Brunswick, New Jersey 08903-0191
>USA
>
>Ph: 732-227-7044
>[log in to unmask]
>
>
>
>
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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.
=================================
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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