PSDGLIST Archives

August 2015

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Subject:
From:
Mitchell Cyran <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 31 Jul 2015 13:12:31 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (169 lines)
No--
Accelerated data is only used to support a shelf life up to 2 years.
Extending the expiration date anything past 2 years needs to be supported by real-time data only.

Mitchell E. Cyran
Stability Coordinator
Sancilio & Company, Inc. (SCI)

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Radwan Almofti
Sent: Tuesday, July 28, 2015 11:10 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] setting expiration dates from extrapolated data question

Just to ensure that we are following you guys properly, the extrapolation for a 4th or 5th year if you have a 3rd  or 4th year in long term data is acceptable provided you have accelerated stability studies to cover the 4th or 5th year, right?

Thanks,
Radwan

-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Forenzo, Patrick
Sent: Thursday, July 23, 2015 11:39 AM
To: [log in to unmask]
Subject: Re: [PSDGLIST] setting expiration dates from extrapolated data question

I don't see the attachment, but ICH Q1E does not have this limitation, so yes as long as all requirements are met 24M gets you 36 - 36M gets you 48 etc. - as long as the samples are on stability to confirm the propose SL


Patrick Forenzo
Senior Fellow / Stability Expert
Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, NJ 07936-1080
USA

Phone   +1  862 7786690
Cell        + 1  201 7047992
Fax     +1  973 7812019
[log in to unmask]
www.novartis.com


-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Katrina Elia
Sent: Friday, July 17, 2015 5:40 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] setting expiration dates from extrapolated data question

Hi all,

I would like to get your opinions of how you interpret the section on Evaluation of stability data to establish retest period/shelf life in the attached article, "stability testing of active pharmaceutical ingredients (API) on page 4 of 6. Specifically the  verbiage on extrapolation of data verse the chart right below those 2 paragraphs.

"the extrapolation retest period may be up to twice, but should not be more that 12 months beyond the period covered by real time data, ....' Verses the chart for in section 01 wording. "Accelerated (6 months OK) long term (36 months OK) Y=x No extrapolation beyond 36 months"

My question is can you extrapolation for a 4th or 5th year if you have a 3rd  or 4th year in long term data?

Thank you for your interpretation
Katrina






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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

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.



This email and its attachments are confidential, subject to copyright and may be legally privileged. If they have come to you in error you should take no action based upon the contents nor should you copy or show them to anyone. Please delete the email and its attachments and inform [log in to unmask] Any views or opinions expressed are those of the author and do not necessarily represent those of SPI Pharma, Inc.

Security: Internet email is not a completely secure medium; please note this when considering the content of your message.

Viruses: We take precautions to ensure email is free of viruses but cannot make a guarantee. Accordingly we advise scanning all email and attachments.

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

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

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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

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

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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

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

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.
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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.

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

Stability Environments, Inc., an affiliate of Solar Light Company, Inc. - http://www.StabilityEnvironments.com
   High quality controlled environmental walk-in rooms and reach-in chambers
   Full installation, validation and spare parts also available

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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