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July 2019

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Subject:
From:
Nick Maynard <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 9 Jul 2019 18:39:51 +0000
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I audit laboratories including stability services, so I've seen some variety. I most commonly see annual re-qualification (including at least partial mapping, though not always as many test points as IOQ, and usually at least a door open recovery test), sometimes other periods like 2 or rarely 3 years. One of the more interesting ones I saw was annual for new devices, then, upon passing 3 annuals, reduced to once every 3 years, and if ever a failing qualification, increased to annual again until 3 successes. Of course always qualify before and after any major change, such as movement of device.



Nicklaus Maynard  |  Compliance and Regulatory Affairs Specialist
140 Front Ave SW  |  Grand Rapids, MI 49504
O: 616.678.2400 x 326  |  [log in to unmask] 




-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of John O'Neill
Sent: Tuesday, June 25, 2019 9:34 AM
To: [log in to unmask]
Subject: [PSDGLIST] Remapping Poll question

Hello Stability Fans,  

I have a poll question:  There are a lot of variations on how Stabilitarians approach re-qualification of stability chambers (re-validation and re-mapping included in this question, though their definitions will vary by company). Guidance input is to re-map/etc. every 2 to 3 years and at any point when there is a significant change (equipment location, settings, parts, loading pattern, etc.) but as an industry, we seem to practice the scheduled re-mapping/etc. timing range from "as necessary" to every 5 years, to continuous remapping/etc.  I'm interested in what list server readers practice for scheduled intervals and what justifications they record for their practice. 

John O'Neill

Nagano Science


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The PSDGList (https://linkprotect.cudasvc.com/url?a=http%3a%2f%2fmicrobiol.org%2fpsdglist.htm&c=E,1,c79yB5ttQK_jmXtJ1WX5r_4d6c1tbFmizH0Fj4dSlUx_CgUO6JsOV_6E-PCldse9TH-bcYNiax1gGMQvEX_k-TbQWfRq36r3yOzw50WSh6HW&typo=1) is operated from The Microbiology Network (https://linkprotect.cudasvc.com/url?a=http%3a%2f%2fwww.microbiol.org&c=E,1,U_nFVBAcD7fGc5PokOFMmzNQiAVLLUUYFugMcuogNH_1S8eFaUF5gZhKkTrCfeKB6PrkQVO1B5HZc6424UsVZoYz8_XbuJSnk0578KzkfnEteSG67xRQUOA4iw,,&typo=1) 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://linkprotect.cudasvc.com/url?a=http%3a%2f%2fwww.iStability.com%2f&c=E,1,xxIw-4UxS_eThF3R0rdV-Ohaj-C4cGdBgMK_duRXN1mtGWsRILluCczkwyvTxr5Ar5tmqovmKIJUjZqksVEnzLTVgUJ6zpvSOUWm8nNNVnA3dmHX1n6Ah7Q,&typo=1
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

Avista Pharma Solutions - https://linkprotect.cudasvc.com/url?a=http%3a%2f%2fwww.avistapharma.com%2f&c=E,1,n3szXTANVB3wBYSFk_ve79w-eB81Q95bZoNV0UjXeDjwkTnFqzlLscDqmiTIqeVR675vxaNqFzOBIxIsfuUBjhKS4OSde12uKED_vrn7JWux6a32fSaaGw,,&typo=1
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.

BahnsonEnvironmental Specialties - https://linkprotect.cudasvc.com/url?a=http%3a%2f%2fwww.eschambers.com%2f&c=E,1,taEGIn4CgNmJoJXQq1LVk5ABqBFXmLTHXyjuX1sRY-_ACkmyiXohKODjc-otlGMvIqVbOsziNPH0vjdoVdnFYGXB4zUnjxKqxvuMJNMTt5wnxOHlUxOy2l8T&typo=1
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - https://linkprotect.cudasvc.com/url?a=http%3a%2f%2fwww.cszindustrial.com%2f&c=E,1,ZXjWkr3eDbMhLl-Z5J04jUfTBIG6DA853pU1uZlIe3nxmIS2DTqo_kVGdrtKjJEgGiJp00_JqQXj9O-9es1W1sR2lniPRbJVQJPKECthm4dH&typo=1
    Provides a large selection of environmental chambers from benchtop, reach in to walk-in
    rooms along with chambers for freeze/thaw, temperature cycling applications.

=================================
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.

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.

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