March 2013


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Pharmaceutical Stability Discussion Group <[log in to unmask]>
Wed, 13 Mar 2013 17:56:32 -0700
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Hi there,

I would like to seek your opinion/advice on the stability studies on
commercial lots that will be used for post-approval clinical studies.
Is it required that those lots be put into stability studies?  Or the
stability data from an annual batch lot sufficient since they are
manufactured in  the same way?

Also, only one annual batch is required to be placed in stability
program per FDA. But there is no requirement on which lot should be. I
would appreciate if you could share with your experience on this. Do
you usually put your first commercial lot into stabiilty program as
your annual batch?


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