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July 2018

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Subject:
From:
"Carenini, Stefano" <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 18 Jul 2018 16:43:06 +0000
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text/plain
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Dear Sloan,

In our company we have 90 days from manufacture to store the samples. If samples are older, then an assessment is required since we will store and test beyond expiry.
Release data can be used as T0 if they are not older than 90days, otherwise T0 has to be repeated.

Best regards
Stefano


Stefano Carenini
Product Stability Management Head
Pharmanalytica SA
Via Balestra
CH-6600 Locarno
SWITZERLAND

Phone 	+41 91 7599145
Fax 	+41 91 7599100
Mobile 	+41795364553
[log in to unmask]
www.novartis.com


-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Jessica Sloan
Sent: Mittwoch, 18. Juli 2018 18:19
To: [log in to unmask]
Subject: [PSDGLIST] Stability Study Initiation Requirements

Dear PSDG members,

I am curious what requirement other companies have in place for stability study initiation windows?  Is there a requirement to initiate the study within a certain time frame after date of manufacture?  Are there examples in which the study must be initiated within a certain time frame based on the data of initiation of release testing (for studies that utilize release data as T=0 results on stability)?  Thank you in advance for your feedback!


Kind Regards,

Jessica Sloan
Scientist I, Product Quality Technical Services

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Nelson Labs - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.nelsonlabs.com&d=DwIDaQ&c=ZbgFmJjg4pdtrnL2HUJUDw&r=1yACjvN7r43Y-rgBDqnKDCalg4VS1JROLmtXC53G_to&m=sdDWAIVx21tlDBW8fOWwSBJrxP0c2WpMsBKqun41ZK0&s=XCOoy7uUzXWQYy9k7Zf2rhHJVzGUnnbMj2A_jRBF4a8&e=
    Nelson Labs is the industry-leading provider of global lab testing and expert consulting services.
    Nelson Labs performs microbiological and analytical laboratory tests across the medical device, pharmaceutical and tissue industries.

ScienTek - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.iStability.com_&d=DwIDaQ&c=ZbgFmJjg4pdtrnL2HUJUDw&r=1yACjvN7r43Y-rgBDqnKDCalg4VS1JROLmtXC53G_to&m=sdDWAIVx21tlDBW8fOWwSBJrxP0c2WpMsBKqun41ZK0&s=FcAbiIwPEU4fMiRNK6Uq17Bixd-DXOlNp_LE9GwAgMQ&e=
   Provides iStability - Web browser based software for stability management,
   reporting, testing/data management, statistical data analysis, and more.

Avista Pharma Solutions - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.avistapharma.com_&d=DwIDaQ&c=ZbgFmJjg4pdtrnL2HUJUDw&r=1yACjvN7r43Y-rgBDqnKDCalg4VS1JROLmtXC53G_to&m=sdDWAIVx21tlDBW8fOWwSBJrxP0c2WpMsBKqun41ZK0&s=dW1bzSWQiQSfk_yIDQpl7H8wftloqx_mQ_DH9wJ2z6Q&e=
   Comprehensive testing and CMC services organization
   Analytical and Microbiology support to early stage API and drug product development and manufacturing.

BahnsonEnvironmental Specialties - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.eschambers.com_&d=DwIDaQ&c=ZbgFmJjg4pdtrnL2HUJUDw&r=1yACjvN7r43Y-rgBDqnKDCalg4VS1JROLmtXC53G_to&m=sdDWAIVx21tlDBW8fOWwSBJrxP0c2WpMsBKqun41ZK0&s=s73g_Z5ymVnGqDthAAHAMf_xMflU8-IZefxYf5DeLlU&e=
   Manufacturer of Quality Stability Chambers, Warm & Cold Rooms, Freezers and
   Ultra Low Storage Chambers with Complete Validation, Maintenance & Calibration

Cincinnati Sub-Zero - https://urldefense.proofpoint.com/v2/url?u=http-3A__www.cszindustrial.com_&d=DwIDaQ&c=ZbgFmJjg4pdtrnL2HUJUDw&r=1yACjvN7r43Y-rgBDqnKDCalg4VS1JROLmtXC53G_to&m=sdDWAIVx21tlDBW8fOWwSBJrxP0c2WpMsBKqun41ZK0&s=kQKL5KSYxA7qAChX5_3GdU3jKGInUwix2yfrMUZ87NA&e=
    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.


Nelson Labs - http://www.nelsonlabs.com
    Nelson Labs is the industry-leading provider of global lab testing and expert consulting services.
    Nelson Labs performs microbiological and analytical laboratory tests across the medical device, pharmaceutical and tissue industries.

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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