PSDGLIST Archives

April 2014

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Subject:
From:
Qasem Abu Shaqra <[log in to unmask]>
Reply To:
Pharmaceutical Stability Discussion Group <[log in to unmask]>
Date:
Wed, 23 Apr 2014 19:01:03 +0300
Content-Type:
text/plain
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text/plain (55 lines)
Dear Claudia
Actual shelf life stability study files are kept as long as manufacturers keep on producing the product studied. It is a major important document that regulatory inspectors ask about particularly in case of deviation or complaints regardless the time of registration. We encountered this situation 13 years after one of our products was registered and launched into the market. For sure It can not be compared with the batch file which you can terminate a period after the expiry date is reached.
Qasem Abu Shaqra  
 
> Date: Wed, 23 Apr 2014 07:01:39 -0300
> From: [log in to unmask]
> Subject: [PSDGLIST] Time that documentation must be kept for stability studies
> To: [log in to unmask]
> 
> Dear people:
> Somebody knows if there any recommendation for the period in which the 
> stability studies, must be kept stored?
> Thanks
> Claudia
> 
> -- 
> Este mensaje y sus adjuntos es confidencial y su divulgación se encuentra prohibida por la ley. Si el mensaje no fuera dirigido a usted por favor tenga a bien notificar dicha circunstancia respondiendo a esta misma dirección.
> This message and its attachments are confidential and privileged communication and its disclosure is legally forbidden. If you are not the intended recipient, please notify us by reply.
> 
> =================================
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> ------------------
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> 
> 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
> 
> 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
> 
> Hardy Diagnostics - http://www.HardyDiagnostics.com
>     Provides a complete selection of laboratory and microbiology supplies
>     for the clinical, industrial, and molecular biology research communities.
 		 	   		  
=================================
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.

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

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

Hardy Diagnostics - http://www.HardyDiagnostics.com
    Provides a complete selection of laboratory and microbiology supplies
    for the clinical, industrial, and molecular biology research communities.

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