February 2021


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Kim Huynh-Ba <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Thu, 11 Feb 2021 17:03:59 -0500
text/plain (72 lines)
Dear Sharon:
It looks like you need to chat with the Handbook of Stability Editor, and the author of that chapter. 😊
Please connect with me at [log in to unmask] and we can discuss this further. For other, feel free to share your practices.

Also, a 6-part Annual Pharmaceutical Stability Training program will start in March, if you are interested.  I cover most of the information in the Stability Handbook with new updates.  You can select a session or the complete series.

All the bests, 
Kim Huynh-Ba

Kim Huynh-Ba, MS, PMP, FAAPS
[log in to unmask]
Managing Director | PHARMALYTIK Consulting | Newark DELAWARE

Adjunct Faculty | RAQA Program | Temple University | School of Pharmacy | Philadelphia PA
Adjunct Faculty | Chemistry Department | Illinois Institute of Technology | Chicago IL
Council of Expert | Chair of Chemical Medicines IV | U.S. Pharmacopeia | Rockville MD

-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Sharon L. Blaha
Sent: Wednesday, February 10, 2021 11:39 AM
To: [log in to unmask]
Subject: [PSDGLIST] Sample Testing Turnaround

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] |<>


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