I work for a Molecular Diagnostics company in which we manufacture assay
reagents which contain preservatives.  Currently we perform
Antimicrobial Effectiveness testing for our marketed annual monitoring
stability lots.  However, we are exploring the option of eliminating
this testing for stability.  I wanted see what the practice was for
other companies.  Is Antimicrobial Effectiveness Testing required for
all molecular diagnostic assay reagents on stability which contain
preservative?  Has anyone successfully justified not doing this testing,
and if so, what was the justification?  Any thoughts would be greatly
appreciated.
Thanks,

Kevin Detweiler
QC Stability
Gen-Probe Inc

=================================
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.

Environmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers and
   Provider of Complete Validation & Calibration Services


Calvex, LLC - http://www.calvex.net
   Validation and Calibration Services

Veriteq Instruments - http://www.veriteq.com/
   Environmental Monitoring, Alarming, Reporting & Validation