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July 2019

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Subject:
From:
Stan Alekman <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Tue, 30 Jul 2019 21:37:18 +0000
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John,

https://ispe.org/search?search_api_fulltext=stability+chambers
Stan Alekman
Please send me your email address. I am working on a methodology to identify out of trend limits for products on stability that I would like your opinion.
Regards,Stan [log in to unmask]
In a message dated 7/30/2019 11:22:38 AM Eastern Standard Time, [log in to unmask] writes:
Thank you Stan,

Would you have a reference for the ISPE report?  I can do a little sleuthing as well.

Regards,

John

-----Original Message-----
From: Pharmaceutical Stability Discussion Group <[log in to unmask]> On Behalf Of Stan Alekman
Sent: Tuesday, July 23, 2019 11:05 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] Remapping Poll question

Hi John,

In the absence of specific regulatory guidance, I suggest the following.

Consider an IQ/OQ/PQ approach to remapping / requalification using a risk based schedule for the three elements. 
Perform an IQ whenever something has changed regarding the installation in the area where the chamber operates (e.g., power supply, external room environmental control, additional equipment added, etc.). Consult the vendor on latest information re installation requirements and best practice for same.
Perform an OQ whenever something has changed regarding the operation of the chamber to confirm the original OQ. Consult the vendor on latest information re operating requirements and best practices re same.
Perform a PQ + remapping based on an annual review of chamber performance including deviations. Independent of this review, have a full remapping requirement ata  fixed interval, say every three years.
I believe ISPE has published a report on this subject.
Regards,Stan Alekman



In a message dated 6/26/2019 9:06:59 PM Eastern Standard Time, [log in to unmask] writes:
Hello Stability Fans,

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

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

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

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

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