Hey Tina!
No, I can echo the other responses, as I have not run into this requirement before. You may want to ask where this is written as a requirement. It may be a practice the consultant ran into, but this does not make it a requirement.
From a guidance perspective, the link below has the FDA guidance for the CMC section of Annual Reports, which includes a stability data table template. This is probably the most detailed example of a stability data table found in any guidance, and it does NOT include the chamber number.
https://www.fda.gov/downloads/drugs/guidancecomplianceregulatoryinformation/guidances/ucm070565.pdf
Thank you!
Jing
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of INGHAM Tina
Sent: Monday, June 05, 2017 4:36 PM
To: [log in to unmask]
Subject: [EXTERNAL] [PSDGLIST] Question - Stability data tables - chamber reference
Hello,
We have a Quality Consultant on site, and she is suggesting that we should reference the chamber number on the commercial stability data table.
We currently do not reference the chamber on the data table. We would trace the chamber through the inventory.
Can you please tell me, do you have the chamber number listed on your submitted data tables?
Thank you,
Tina Ingham
Unither Manufacturing
Manager, Stability Laboratory and QC Support
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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
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
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.
=================================
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.
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
Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration
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.
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