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]
CONFIDENTIALITY STATEMENT: The information contained in this message may be privileged and confidential. It is intended only for the use of the individual named above. If you are not the intended recipient, you are hereby notified that any dissemination, distribution or copying of this message is prohibited. If you have received this message in error, please advise the sender by reply e-mail, and delete this message and any attachments.
=================================
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
|
