Hi Phil,
Typically, the testing window is 30 days from pull date.  A few references
for you to consider:
1. I've written this into the Stability Handbook, published in 2008.  And
I've learned that this have been used to respond many observations
worldwide, as well as to establish many SOPs.  
Handbook of Stability Testing for Pharmaceutical Products: Regulations,
Methodologies and Best Practices, published by Springer, 2008.
2. The latest draft of the WHO on stability testing, issued for comments in
January 2017 has included 30-days timeline for testing.  However, there is
no specific regulatory reference for 5c and -20C conditions.  
3. The latest draft of ANVISA for stability testing also include a timeframe
for testing.
4. and of course, the industry practice of 30 days from pull date is very
well known.
However, the above are for a general consideration and fairly stable
product. If you have a specific products such as vaccines or biologics,
waiting 30days to complete the testing may not be a good idea, especially
for the earlier timepoints even that you store in the same conditions.
All the bests, 
Kim.


-------------------------------------------
Kim Huynh-Ba
Executive Director
PHARMALYTIK LLC
[log in to unmask]



-----Original Message-----
From: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] On Behalf Of Gray, Philip
Sent: Monday, June 19, 2017 6:33 AM
To: [log in to unmask]
Subject: [PSDGLIST] Testing Start-by date

Hello,

Can anyone point me to a regulatory reference for testing within a certain
time frame after samples are pulled from the chamber?  Specifically 5C and
-20C  where the samples are pulled then held at the designated temperature
(5C samples held at 5C, -20C samples are held at -20C) until testing starts?
If there is no reference, what is the practice at your company?

Thank you in advance,
Phil Gray

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BahnsonEnvironmental Specialties - http://www.eschambers.com/
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   Ultra Low Storage Chambers with Complete Validation, Maintenance &
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Cincinnati Sub-Zero - http://www.cszindustrial.com/
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reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling
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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.


Avista Pharma Solutions - http://www.avistapharma.com/
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.


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

Cincinnati Sub-Zero - http://www.cszindustrial.com/
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.