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 ================================= 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.