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October 2016

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Subject:
From:
"Gray, Philip" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Thu, 27 Oct 2016 18:58:37 +0000
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Hello All,

Can someone please provide information on the following questions, and a guidance reference, if possible.

What are the stability study sample orientation expectations (upright/inverted) for liquid parenteral drug products?  Are upright and inverted studies expected for the registration batch(es), process validation batches, and on-going annual commitments?

What are the stability study sample orientation expectations (upright/inverted) for liquids stored in semi-permeable container?  Are upright and inverted studies expected for the registration batch(es), process validation batches, and on-going annual commitments?


Thank you in advance,
Phil Gray



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