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,
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