This is a deviation, after initiating deviation proceed for analysis and compare the result of subsequent stability test point to evaluate the impact.
Regards,
Nitin
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Nilesh Shah
Sent: Saturday, August 17, 2013 10:17 AM
To: [log in to unmask]
Subject: [PSDGLIST] Missed stability sample time point
Dear Members,
Sample pulled from stability chamber on pull date (condition 40/75),time point 1 month and sample were stored at room temperature 25/60,the test to be performed was preservative efficacy test, but the sample was not sent for analysis.After completion of 2nd month it has been realized that we miss the sample.What will be the impact assessment as how it impact on the results if you have any scientific justification and what is the action plan?
Thank you in advance for your thoughts on this matter.
Thanks and regards,
Nilesh Shah
Asst.Manager-Microbiology
SGS LSS
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Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
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High quality controlled environmental walk-in rooms and reach-in chambers
Full installation, validation and spare parts also available
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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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