Question:  Has anyone ever backdated the study initiation date to be the
DOM?  Even when the manufacturing process is not a continuous process?
Kim:  You don't backdate the study initiation date.  You assigned the SID
date as manufacturing date. 

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?
Kim:  You stop the study at expiration. Regulations do not require you to
conduct stability past expiry.

Best regards, 
Kim.


-----------------------------------------
Kim Huynh-Ba
[log in to unmask]
302-607-5324 (cell)
Managing Director | PHARMALYTIK LLC | Newark DE

Adjunct Faculty | RAQA Program | Temple University | School of Pharmacy |
Philadelphia PA
Adjunct Professor | Chemistry Department | Illinois Institute of Technology
| Chicago IL
Council of Expert | Chair of Chemical Medicines IV | U.S. Pharmacopeia |
Rockville MD
https://www.linkedin.com/in/kimhuynhba

-----Original Message-----
From: Pharmaceutical Stability Discussion Group
<[log in to unmask]> On Behalf Of Sharon L. Blaha
Sent: Thursday, February 4, 2021 10:54 AM
To: [log in to unmask]
Subject: [PSDGLIST] Study initiation date question

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
[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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The nature of this service is to provide a medium for communication.  The specific statements and endorsements of individuals participating in the discussions are not necessarily those of The Microbiology Network, Inc., the PSDG, or the sponsors of the list.

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The PSDGList (http://microbiol.org/psdglist.htm) is operated from The Microbiology Network (http://www.microbiol.org) and supported by our sponsors as a service to the scientific community.   Please take a second to visit our sponsors' web sites and say thank you for their support of this service.


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