Hi Harald:

Q1A (R2) requires that procedures should be fully validated and stability
indicating to test any sample of primary batches.
So option 2 is not acceptable.

All the bests, 

Kim Huynh-Ba
Executive Director
[log in to unmask]

-----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


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

Thanks for your input here.

Best regards,

Harald Laugen
Manager, Dept. of Stability Studies
GE Healthcare

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