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Username Post: Temperature Monitoring        (Topic#3301)
Timothy.QA 
Beginner
Posts: 6
Timothy.QA
05-10-06 05:56 AM - Post#3406    


Hi my boss said that all non-clinical test (sera) samples need to be stored with a temperature monitoring system in place (e.g. Rees). Where in the GLPs does it state that?







 
mjgregor 
Beginner
Posts: 22

06-01-06 12:16 PM - Post#3440    

    In response to Timothy.QA

Hello Timothy,

A good resouce to find what is required by the regulations is my company site, which has a fully searchable regualtion and warning letter tool. Please check out the link in my signature and register. I will contact you to discuss.

Best regards,
Michael J. Gregor
President/CEO, Compliance Gurus Inc.
800.381.6859 Corporate Office
978.363.5453 Fax
mgregor@compliancegurus.com
http://www.compliancegurus.com/








 
aheck 
Beginner
Posts: 2

07-19-06 07:55 AM - Post#3515    

    In response to mjgregor

Tim,

58.63,
the data generated when you sample the sera must be 'assessed' in light of the storage system. your GLP assay is validated under certain conditions, deviations from those conditions may affect the outcome.
AL







 
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