Good morning everyone,
I am linking for a reference how to handle storage conditions excursions in stability study, can anyone please help?
Thank you & best regards
Mohab
Sent from my iPhone
> On 12 Feb 2021, at 20:10, Michael Barron <[log in to unmask]> wrote:
>
> Hi Sharon,
>
> I am not aware of any FDA or ICH Guidance that specifies anything "tighter" than your stated policy/procedure. As long as you are following your SOP, then it is likely you are compliant with FDA/GMP requirements.
>
> Check the Quality Agreement between your companies to ensure your QA has not agreed to something outside the scope of your SOP. If not, then I would ask your customer to provide documentation supporting their position.
>
> That said, if there are specific scientific concerns about a certain formulation/dosage form/package, you may need to tighten it up contractually with your customer.
>
> Best regards,
> Michael
>
> Michael Barron
> Office: 910.338.5767
> [log in to unmask]
>
> Quality Chemical Laboratories, LLC
> Wilmington, NC 28405
> www.qualitychemlabs.com
>
> -----Original Message-----
> From: Pharmaceutical Stability Discussion Group [mailto:[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] | www.lifecore.com<http://www.lifecore.com>
>
>
> [http://www.lifecore.com/wp-content/uploads/2017/10/LifecoreLogo_Color.png]
>
>
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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.
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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
>
> =================================
> 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.
>
> ------------------
> 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
=================================
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.
------------------
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
|
