Hello Justin!
You should have an SOP which is state what is the date of production, when should be the release and when is a zero-time for the stability storage program.
A stability storage program starts from the date samples are placed in a stability oven according to a QA-approved protocol. The protocol should state in advance what are the pull dates and these start from the date of placing the samples in the oven. The 3 month is therefore 01May20.
You write "I have an SOP that instructs me to use the Date of Manufacture as the study start date for Long-Term stability studies.". According to EU GMP, the date of production of batch is defines as the date that the first step is performed involving combining the active ingredient with other ingredients. This is usually done in the plant (shop floor). How can this be a start of a stability study??? Samples need to be incubated under constant and controlled temp and humidity. In my opinion, your SOP should be re-considered.
Raphy Bar
BR Consulting
__________________
Raphael (Raphy) Bar, Ph.D.
BR Consulting
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Michael Barron
Sent: Wednesday, February 26, 2020 8:28 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Stability Study Start Dates
Hi Justin,
I agree generally that either approach is acceptable as long as it is your written procedure that you follow. Remember, the stability studies are establishing your Expiry Period; 2 year, 3 year, etc. Your Expiration Date applied to any given batch is based on the manufacturing date.
Best regards,
Michael Barron
Quality Chemical Laboratories
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Sarah DeBoer
Sent: Wednesday, February 26, 2020 10:38 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Stability Study Start Dates
Hi Justin,
I have had stability studies start both ways for CRT. The 01Apr20 date would be the accurate 3 month date for CRT storage, but the 01May20 date would provide a worse case, especially toward the end of the study. Your SOP is appropriate, and I would argue either approach is acceptable.
Hope this helps,
Sarah DeBoerQC/Stability Lab CoordinatorVelesco Pharmaceutical Services Sarah M. DeBoer
On Wednesday, February 26, 2020, 09:59:31 AM EST, Justin Morell <[log in to unmask]> wrote:
Pharmaceutical stability professionals,
For stability studies on commercial drug products (at Long-Term conditions), when is the appropriate date to begin counting days until the first stability pull interval. I have an SOP that instructs me to use the Date of Manufacture as the study start date for Long-Term stability studies. For accelerated or intermediate conditions, however, the SOP instructs me to use the date the samples were placed into the chamber as the study start date. To clarify my question I will present a scenario:
A commercial batch of drug product has a Date of Manufacture of 01Jan20. Due to scheduling constraints in the manufacturing unit, the batch was not labeled and inspected until 28Jan20. Samples for stability were delivered to the stability personnel and the stability samples were placed into the stability chamber on 01Feb20. During all this time, the drug product is stored under controlled room temperature conditions and Long-Term stability conditions are 25°C +/- 2°C & 60% RH +/- 5% RH. For this scenario, what would be the appropriate 3-months pull date? Should it be 01Apr20 or should it be 01May20?
I'm curious to see if my SOP is acceptable as written since it is reflective of the commercial process or if it needs to be updated to use the date the sample are placed into the chamber as the study start date.
Thanks for your consideration of this scenario.
J. Morell
Stability Coordinator
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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
=================================
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
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