Dear PSDG members,
I am curious what requirement other companies have in place for stability study initiation windows? Is there a requirement to initiate the study within a certain time frame after date of manufacture? Are there examples in which the study must be initiated within a certain time frame based on the data of initiation of release testing (for studies that utilize release data as T=0 results on stability)? Thank you in advance for your feedback!
Scientist I, Product Quality Technical Services
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Nelson Labs - http://www.nelsonlabs.com
Nelson Labs is the industry-leading provider of global lab testing and expert consulting services.
Nelson Labs performs microbiological and analytical laboratory tests across the medical device, pharmaceutical and tissue industries.
ScienTek - http://www.iStability.com/
Provides iStability - Web browser based software for stability management,
reporting, testing/data management, statistical data analysis, and more.
Avista Pharma Solutions - http://www.avistapharma.com/
Comprehensive testing and CMC services organization
Analytical and Microbiology support to early stage API and drug product development and manufacturing.
BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
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Cincinnati Sub-Zero - http://www.cszindustrial.com/
Provides a large selection of environmental chambers from benchtop, reach in to walk-in
rooms along with chambers for freeze/thaw, temperature cycling applications.