Hi,
I am working on a generic product where the RLD was approved many years ago using terminal sterilization. R&D has discovered the heat from TS increases the potential for nitrosamine and another impurity formation. Has anyone proposed aseptic processing in an ANDA using the data gathered on a batch tested pre and post TS to show the impact as justification? Does it need a controlled correspondence or will it be ok to just include the data and proceed with the aseptic processing for the exhibit batches?
Thanks,
Lisa
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Lisa Apolis, RAC
Apolis Regulatory Consulting
Georgia, USA
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