PSDGLIST Archives

March 2017

PSDGLIST@LISTS.MICROBIOLOGYNETWORK.COM

Options: Use Monospaced Font
Show Text Part by Default
Show All Mail Headers

Message: [<< First] [< Prev] [Next >] [Last >>]
Topic: [<< First] [< Prev] [Next >] [Last >>]
Author: [<< First] [< Prev] [Next >] [Last >>]

Print Reply
Subject:
From:
"Liu, Jian" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Fri, 17 Mar 2017 23:33:03 +0000
Content-Type:
text/plain
Parts/Attachments:
text/plain (94 lines)
Hi Jing,

It may be helpful with the following information for the answers:

1. Verify internally if there is only one specification for a specific test.  Some companies may have separate specifications for Assay and stability.
2. Confirm with regulatory affair department how the specifications were specified in the submissions to regulatory agencies, for lot release or stability, or both.
3. Check which geographic regions specifications are applied.  For the same test, there may be different specifications for different geographic region, e.g. specifications for the US and European may be different.  

After confirming the information above, you may clearly indicate application of specifications (lot release, stability or geographic region) in the appropriate internal documents, such as product or quality specifications, C of As, stability protocols, test methods, etc.

Hope this helps.

Best,

Jian Liu, Ph.D.
Sr. Staff Scientist
Abbott Vascular
[log in to unmask]




-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Capucao, Jing [MCCUS]
Sent: Friday, March 17, 2017 7:46 AM
To: [log in to unmask]
Subject: [PSDGLIST] interpretation of specifications

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.

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

ATOM RSS1 RSS2