Dear Yoshida,
I am frequent reader of FDA policy change and have close contacts with the interactive groups of policy makers. I never saw such announcement or any warning letter citing the reference of mean KT. Please share the info if someone have better idea about this.
Regards
Afsar Shaikh
Manager- Regulatory Affairs
-----Original Message-----
From: Pharmaceutical Stability Discussion Group [mailto:[log in to unmask]] On Behalf Of Hidetoshi Yoshida
Sent: 23 February 2012 15:58
To: [log in to unmask]
Subject: [PSDGLIST] mean kinetic temperature
According to the following website, when stability studies, calculating mean kinetic temperature has been recently mandated by the FDA.
http://www.basinc.com/services/stability.html
Does anyone know the specific regulation document for this?
Does anyone know the background for the enforcement?
Best regards,
HIDETOSHI YOSHIDA
NAGANO SCIENCE CO.,LTD.
==========================================+
1-10 Amashinmachi , Takatsukishi , Osaka
569-1106 , JAPAN
TEL:(+81)726818800 FAX:(+81)726848528
==========================================+
=================================
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.
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
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
DISCLAIMER:
The information contained in this email communication is intended only for the personal and confidential use of the designated recipient named above. This message may be an attorney-client communication, and as such is privileged and confidential. If the reader of this message is not the intended recipient, you are hereby notified that you have received this communication in error, and that any review, dissemination, distribution, or copying of the message is strictly prohibited. If you have received this transmission in error, please destroy this transmission and notify Glenmark Pharmaceuticals Limited immediately by telephone and/or send an email to [log in to unmask]
=================================
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.
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
Environmental Specialties - http://www.eschambers.com/
Manufacturer of Quality Stability Chambers and
Provider of Complete Validation & Calibration Services
|
