Hi,
I would always go for option 1 for a BLA or NDA submission. There are obvious risks if you go for option 2 as you mentioned below--i.e. if you find an issue with your method during validation later on.
If your product is in Phase1/ Phase 2 clinical trials you need the methods at the minimum qualified --if not validated. By Phase 3 clinical trials you need to get your methods validated. During BLA/NDA submission you methods should be fully validated.
Regards
Shilpa
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Laugen, Harald (GE Healthcare)
Sent: Monday, January 27, 2014 9:32 AM
To: [log in to unmask]
Subject: [PSDGLIST] ICH validation of stability indicating methods
Dear All,
I have a query regarding when you would perform the ICH validation of stability indicating methods for both drug substance and drug product.
According to ICH Q1A (R2) the analytical procedures should be fully validated and stability indicating. When would you perform the ICH validation of your stability indicating methods:
1. Before the 0 months sampling point for the primary batches
or
2. Before submission, i.e. for the 12 months sampling point (you would then risk to re-start you stability study if there was an issue during ICH validation)
Thanks for your input here.
Best regards,
Harald
Harald Laugen
Manager, Dept. of Stability Studies
GE Healthcare
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BahnsonEnvironmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
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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.
=================================
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.
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