Regulatory Open Forum

This message was posted by a user wishing to remain anonymous

Hello,

We are currently sponsoring phase I study in the US. We are presently doing concurrent stability studies on the Drug Product.

My question is that how can we assign the Retest Date / Expiration Date? 

For example, we store our IP at -70 degrees for long-term storage. We will ship the IP to the sites using dry ice, but the site will store the IP at -20 degrees. We have stability data for 6 months at -20 degrees. Can we use 6 months as the shelf life of the IP we will ship to the sites? 

Thank you.

I would say that if you have data that support the fact that the product remains acceptable for 6 months at -20C and you are shipping on dry ice and the site will store at -20C, then you could reasonably claim and label as 6 months at -20C.  You might need to ensure that you have no excursions from that temperature during the shipping of the product but I think you would be within reason to label in this way.

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Victor Mencarelli
Global Director Regulatory Affairs
MelvilleNY
United States
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Original Message:
Sent: 21-May-2022 15:50
From: Anonymous Member
Subject: Assign Expiration Date / Retest Date for IP during phase I study (FDA)

This message was posted by a user wishing to remain anonymous

Hello,

We are currently sponsoring phase I study in the US. We are presently doing concurrent stability studies on the Drug Product.

My question is that how can we assign the Retest Date / Expiration Date?

For example, we store our IP at -70 degrees for long-term storage. We will ship the IP to the sites using dry ice, but the site will store the IP at -20 degrees. We have stability data for 6 months at -20 degrees. Can we use 6 months as the shelf life of the IP we will ship to the sites?

Thank you.