I would like to know how others handle these issues, I've broken them down into 2 parts:
* How many data points (or minimum time, e.g. 12 months) do you require before you trend individual studies. We are wondering this as at less than 12 months for some tests, the 95% confidence interval can be pretty wide.
* When you encounter a trend that shows the 95% confidence interval crosses before your expiry, but you are still well within spec., what type of action do you take? Do you add an interim time point to monitor (and show diligence) or wait until the next time point (which might be 12 months away)? I should add that this test method can have some variability, so this isn't unprecedented for us to see and we don't expect the product to go out of spec. looking at historical data.
Any input would be beneficial. I'll summarize the responses and publish.
LIMS Administrator, Quality Control Laboratory Support
</pre>This e-mail communication (including any attachments) contains information from Emergent BioSolutions or its affiliates that is confidential and may be privileged. The information contained herein is intended only for the use of the addressee(s) named above. If you are not the intended recipient (or the agent responsible to deliver it to the intended recipient), you are hereby notified that any dissemination, distribution, use, or copying of this communication is strictly prohibited. If you have received this e-mail in error, please immediately reply to sender, delete the message and destroy all copies of it. If you have questions, please email [log in to unmask] Thank you.
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.