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February 2021

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Subject:
From:
"Sharon L. Blaha" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 10 Feb 2021 16:38:52 +0000
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In the Handbook of Stability... it discusses general operating procedures for Stability programs, and mentions that the industry standard for sample throughput is 30 days, but that some samples may need to be tested more quickly to prevent degradation.

Our sample testing window for samples stored <12M (to cover accelerated storage conditions) is within two weeks of the pull date (not including data review), or at a minimum, testing should be initiated within two weeks of the pull date and completed (including data review) within 30 days of the pull date.  Samples are stored at the long term storage condition while awaiting testing.  The lab operates on a FIFO testing schedule. Testing that is initiated after 2 weeks is treated as a procedural deviation and evaluated for impact.

We have a client that is saying that this is not compliant with ICH and FDA guidelines.


a)      Is there an ICH or FDA guidance that defines a testing window for stability studies?

b)     Do people test accelerated samples faster (separately) than other storage conditions?

The Handbook also mentions that if there is a significant change under accelerated storage, that the intermediate condition should be tested immediately.


c)      What is the practice in terms of an intermediate condition being tested 'immediately" when a significant change or OOS is identified?

Sharon Blaha

Sharon Blaha  |  Stability Manager
Lifecore Biomedical, LLC
3515 Lyman Blvd
Chaska, MN  55318
Direct: 952-368-6235
[log in to unmask] | www.lifecore.com<http://www.lifecore.com>


[http://www.lifecore.com/wp-content/uploads/2017/10/LifecoreLogo_Color.png]


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ScienTek - http://www.iStability.com/
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

BahnsonEnvironmental Specialties - http://www.eschambers.com/
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

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