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February 2020

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Subject:
From:
Justin Morell <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 25 Feb 2020 22:09:12 +0000
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Pharmaceutical stability professionals,

For stability studies on commercial drug products (at Long-Term conditions), when is the appropriate date to begin counting days until the first stability pull interval.  I have an SOP that instructs me to use the Date of Manufacture as the study start date for Long-Term stability studies.  For accelerated or intermediate conditions, however, the SOP instructs me to use the date the samples were placed into the chamber as the study start date.  To clarify my question I will present a scenario:

A commercial batch of drug product has a Date of Manufacture of 01Jan20.  Due to scheduling constraints in the manufacturing unit, the batch was not labeled and inspected until 28Jan20.  Samples for stability were delivered to the stability personnel and the stability samples were placed into the stability chamber on 01Feb20.  During all this time, the drug product is stored under controlled room temperature conditions and Long-Term stability conditions are 25C +/- 2C & 60% RH +/- 5% RH.  For this scenario, what would be the appropriate 3-months pull date?  Should it be 01Apr20 or should it be 01May20?

I'm curious to see if my SOP is acceptable as written since it is reflective of the commercial process or if it needs to be updated to use the date the sample are placed into the chamber as the study start date.

Thanks for your consideration of this scenario.

J. Morell
Stability Coordinator


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