PSDGLIST Archives

November 2021

PSDGLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Barron, Michael" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 9 Nov 2021 19:37:20 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (179 lines)
I concur with Tony's remarks, especially the part about doing what's in your current SOP :)



If you are looking to streamline labeling then, with sample traceability as your guiding principle and mistake-proofing the process your goal, the most fundamental info for an individual stability sample label to remove any doubt about its identity is:

*         Drug name and strength

*         Lot #

*         Timepoint and storage condition, plus orientation if relevant.

o   You can assign meaning to abbreviations in your SOP to save label space

o   e.g. 6m, 25/60, Inv (or Up, or Hz)



I don't think you need a protocol #, set-date, or pull date on each individual sample label.  Those meta data can be recorded elsewhere in your protocol/inventory documentation.  Not sure I understand what you mean by lab ID so can't comment on that.



I like your idea of having lab storage/handling conditions referenced for the lab but perhaps that can be included somewhere else in the project documentation which the analyst is required to read?  If wanted on the label then abbreviate: e.g. RT, 5C, -20C, -70C



Michael Barron



-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Mazzeo, Tony
Sent: Tuesday, November 9, 2021 9:09 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] sample labels



There is no regulatory requirement for what is on the sample label.  You just need a system that is under control.

You need to be able to track your samples through the pulling testing and reporting process and ensure there is enough information to prevent mix ups. Auditors will be looking for sample custody control for the stability samples.  You could probably do that with a single sample code on the label if you had the infrastructure support for it. And of course, whatever is in your SOPs, you need to do that.



-----Original Message-----

From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Sharon Blaha Ph.D.

Sent: Wednesday, November 3, 2021 11:34 AM

To: [log in to unmask]

Subject: [PSDGLIST] sample labels



[Use CAUTION when opening links/attachments]



Is there any requirement about what information has to be on a stability sample label that is pulled and submitted to the lab for testing?



We include a lab ID, Time point, storage condition/orientation, and lab storage requirements as well as the date pulled.  This is in addition to the study labels that include the Lot number, protocol, initiation date and protocol storage condition (orientation if applicable).  Pull date is traceable to the lab ID.



With our containers getting smaller, so have the labels we can fit on the containers, I'm wondering if the date the sample is pulled is really necessary if we have the time point and ID.



Sharon Blaha



Sharon Blaha Ph.D.  |  Stability Manager Lifecore Biomedical, LLC

3515 Lyman Blvd

Chaska, MN  55318

Direct: 952-368-6235

[log in to unmask] | https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.lifecore.com%2F&amp;data=04%7C01%7Ctony.mazzeo%40BMS.COM%7C1feb7d5a7d234ed5424f08d9a32af859%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637720227228568272%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=bS1EKiQ7cW2AWxXsNcJXnTBqmjNUVOLiv7sbOHEU4sA%3D&amp;reserved=0<https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.lifecore.com%2F&amp;data=04%7C01%7Ctony.mazzeo%40BMS.COM%7C1feb7d5a7d234ed5424f08d9a32af859%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637720227228568272%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=bS1EKiQ7cW2AWxXsNcJXnTBqmjNUVOLiv7sbOHEU4sA%3D&amp;reserved=0>





[https://nam02.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.lifecore.com%2Fwp-content%2Fuploads%2F2017%2F10%2FLifecoreLogo_Color.png&amp;data=04%7C01%7Ctony.mazzeo%40BMS.COM%7C1feb7d5a7d234ed5424f08d9a32af859%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637720227228568272%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=r3wstHEKp5X1htvq90ESlXpFcPVO%2F2%2B21P8pcWVxPms%3D&amp;reserved=0]





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 (https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fmicrobiol.org%2Fpsdglist.htm&amp;data=04%7C01%7Ctony.mazzeo%40BMS.COM%7C1feb7d5a7d234ed5424f08d9a32af859%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637720227228568272%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=WIDUkSU2Y87jPWYhg5JiOwdkZ8ozpR4rvIBm7zVZQeM%3D&amp;reserved=0) is operated from The Microbiology Network (https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.microbiol.org%2F&amp;data=04%7C01%7Ctony.mazzeo%40BMS.COM%7C1feb7d5a7d234ed5424f08d9a32af859%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637720227228568272%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=NFG9u6t867WmRLGF4teUWjdLLk%2B5oWOK2UD2MMrwPEE%3D&amp;reserved=0) 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 - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.istability.com%2F&amp;data=04%7C01%7Ctony.mazzeo%40BMS.COM%7C1feb7d5a7d234ed5424f08d9a32af859%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637720227228568272%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=OCxyI3U0G8HB6clLnmk6hX8zqcIqwrBH66kDB2U%2FuCM%3D&amp;reserved=0

   Provides iStability - Web browser based software for stability management,

   reporting, testing/data management, statistical data analysis, and more.



BahnsonEnvironmental Specialties - https://nam02.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.eschambers.com%2F&amp;data=04%7C01%7Ctony.mazzeo%40BMS.COM%7C1feb7d5a7d234ed5424f08d9a32af859%7C71e34cb83a564fd5a2594acadab6e4ac%7C0%7C0%7C637720227228578267%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C1000&amp;sdata=RRF1VmUbNt6zjG2LkMWb8c1l8iEo9w56miGj1Hru3dA%3D&amp;reserved=0

   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and

   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

________________________________

This message (including any attachments) may contain confidential, proprietary, privileged and/or private information. The information is intended to be for the use of the individual or entity designated above. If you are not the intended recipient of this message, please notify the sender immediately, and delete the message and any attachments. Any disclosure, reproduction, distribution or other use of this message or any attachments by an individual or entity other than the intended recipient is prohibited.



=================================

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

ATOM RSS1 RSS2