Hello Justin:
From what you quoted, it makes perfect sense. Some companies may take the manufacturing date as the start date of a study (I don't recommend), and you don't tell me if that is the case or not. As example, it may be at least a month from manufacturing date to the time samples show up in the lab for initial testing and may be another month for testing to be done. So if that is the case, your samples are already 2 month old, before you can place it on the intermediate/accelerated chamber. So the 6mo in 40/75 may be actually equivalent to 2mo at RT and 4mo acc. And you'd vastly underestimate the rate of degradation at these elevated temperature and humidity.
That is the reason I'd never recommend to use manufacturing date as study start date, and we should all know the risk of using release data as time zero for accelerated condition/intermediate condition.
So now, my curiosity is that if "The date the samples are placed in the stability chamber is considered the beginning of the study.", then do you have different dates for pulling the RT and Intermediate/acc samples then? This would be tough to batch testing, wouldn't it?
All the bests, and please stay safe.
Kim
-----------------------------------------
Kim Huynh-Ba
[log in to unmask]
Managing Director | PHARMALYTIK Consulting | Newark DE
Adjunct Faculty | RAQA Program | Temple University | School of Pharmacy | Philadelphia PA
Adjunct Faculty | Chemistry Department | Illinois Institute of Technology | Chicago IL
Council of Expert | Chair of Chemical Medicines IV | U.S. Pharmacopeia | Rockville MD
-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Justin Morell
Sent: Tuesday, June 9, 2020 4:40 PM
To: [log in to unmask]
Subject: [PSDGLIST] Accelerated and Intermediate studies and release (T=0) testing
Good afternoon all,
I am currently evaluating my stability program SOPs and I noticed a requirement that I do not fully understand. The requirement is written as, “Do not place sample on accelerated or intermediate stability until initial testing has been completed. The date the samples are placed in the stability chamber is considered the beginning of the study.”
The second sentence makes perfect sense, since these are shorter studies with special challenge conditions, you would not want to “short” the studies in any way. However, the 1st sentence is what I do not fully understand. Why not place the samples on stability as soon as you can get them? Is there any benefit to waiting until the results of the initial testing is completed?
I can think of only one benefit: if there were to be a failure in the time zero testing that was confirmed OOS, then the studies would have to be cancelled and all the samples removed from the chamber and disposed of. Although, that may seem like a hassle, it is not that big of a deal for the size of typical studies for my company. It is a reasonable risk. We do not expect testing failures at time zero or we would not begin process validation. I have checked the following guidance documents: 21 CFR 211.166; EudraLex Chapter 6, Sections 6.26 – 6.36; HC guidance regulations C.02.027 and C.02.028; ICH Q1A(r2); ICH Q1E, WHO technical report series No. 953. I have found nothing to indicate that is something agencies suggest to do.
Thanks in advance for our consideration and I hope you have a great day 😊.
Regards,
Justin 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.
------------------
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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