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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