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March 2017

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Subject:
From:
Claudia Talamona <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Mon, 20 Mar 2017 15:46:07 -0300
Content-Type:
text/plain
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We have approved products with both specifications: 
For release, and for stability, and its ok.
Claudia

-----Mensaje original-----
De: Pharmaceutical Stability Discussion Group
[mailto:[log in to unmask]] En nombre de Narayan
Enviado el: sábado, 18 de marzo de 2017 15:08
Para: [log in to unmask]
Asunto: Re: [PSDGLIST] interpretation of specifications

If you have not specified (I am assuming in an approved FDA application ) a
specification for release and stability separately, then it applies for both
the same specs! However, if you do have separate specifications for release
and stability internally but you just did not submit it in the application
and the application got it approved that way, then I would submit a CBE-30
and get it corrected as soon as possible. 
Hope this helps!
NR
GRSAonline.com
Regulatory Affairs.

Sent from my iPhone

> On Mar 17, 2017, at 5:28 PM, Tony Cundell <[log in to unmask]> wrote:
> 
> Jing these would be shelf-life specifications. If the potency or 
> moisture levels changes significantly you would want tighter release 
> specifications Tony
> 
> On Fri, Mar 17, 2017 at 10:46 AM, Capucao, Jing [MCCUS] < 
> [log in to unmask]> wrote:
> 
>> Dear Folks,
>> This should be an easy one so please let me know your thoughts!
>> 
>> If you have acceptance criteria or specifications that are not 
>> indicated as either "for release only" or "for stability only", for
example:
>> 
>> Active Assay: 90.0-110.0%
>> Unspecified Degradation Products: Not More Than 0.2%
>> Moisture: Maximum 5%
>> 
>> Do the specifications apply:
>> 
>> A: for both release and stability?
>> B: for stability only?
>> C: other, please specify...
>> 
>> Thank you in advance for your responses!
>> Jing
>> 
>> 
>> Jing Capucao, Ph. D.
>> R&D Stability Manager
>> Johnson & Johnson Consumer Inc.
>> [log in to unmask]
>> 215-273-2441
>> 
>> 
>> =================================
>> 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.
>> 
>> 
>> 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.
>> 
> 
> 
> 
> --
> Tony Cundell, Ph. D.
> Consulting Microbiologist
> Email: [log in to unmask]
> Phone: 914 725-3947
> Cell: 914 841-0074
> 
> =================================
> 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.
> 
> 
> 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.


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.


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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