February 2021


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"Sharon L. Blaha" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 4 Feb 2021 15:53:54 +0000
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We have products that go through formulation (addition of API), then are sent out for terminal sterilization, then come back and go through packaging.  Some of the overall manufacturing process can take 2-3 months.   We define out study initiation date as the date the stability samples are placed in the stability chambers.  We get samples from the finished package for our stability studies.

Question:  Has anyone ever backdated the study initiation date to be the DOM?  Even when the manufacturing process is not a continuous process?

How do you address an issue if you have a study that goes beyond the batches expiry, and the product is not stable enough to meet shelf life specs several months past its expiry?

Sharon Blaha

Sharon Blaha  |  Stability Manager
Lifecore Biomedical, LLC
3515 Lyman Blvd
Chaska, MN  55318
Direct: 952-368-6235
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