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March 2017

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Pharmaceutical Stability Discussion Group <[log in to unmask]>
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Sun, 19 Mar 2017 01:17:57 -0400
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Hello Jing: 
Typically in US, each product would have one set of specifications.  According to ICH Q6, "specifications, i.e., those tests, procedures, and acceptance criteria that play a major role in assuring the quality of the new drug substance and new drug product at release and during shelf life."  So as you stated, it's an easy question.  The answer is straight forward: the specs applied to the Drug Product at any time during the life of the lot (i.e. at release, during shelf life, and until expiry).  
Some countries may require a tighter specs at release, if they think it's necessary to warrant the product continue to maintain its quality until its expiry. In many cases, different specs of release and stability may suggest product is not stable, thus different control levels are necessary.
If you are in the consumer health area, then it's the specs that you register for your products. Expiry in this area may a little more different than the regular Rx product, depending on what type of products you are working with.  
For some reason, I have the feeling that your question is not as simple, ....  I'll be happy to clarify further if needed.
Kim-



-------------------------------------------
Kim Huynh-Ba
Executive Director and CEO
PHARMALYTIK LLC
302-731-9959
[log in to unmask]




-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Tony Cundell
Sent: Friday, March 17, 2017 5:28 PM
To: [log in to unmask]
Subject: Re: [PSDGLIST] interpretation of specifications

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
>
>
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--
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.

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