I have been looking for a resource to address in more detail how to
handle failures encountered in stability intervals.  All the guidance
documents focus on new products but do not really address how to handle
existing product annual studies.  Does anyone know of any sources which
could be used as hard reference materials?

Steven Louer, ASQ-CQE
Quality Assurance Engineer
Covidien



=================================
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