anky1212
☆    

India,
2012-11-20 08:42
(4964 d 18:48 ago)

Posting: # 9555
Views: 6,092
 

 Temperature and Humidity requirement [Study Per­for­mance]

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Hello to all,

What should be the ideal temperature and humidity requirement to store investigational product in pharmacy?

Also, give range for temperature and humidity in pharmacy area.

Thanks & Regards,
Ankur Patel
 
ElMaestro
★★★

Denmark,
2012-11-20 09:01
(4964 d 18:28 ago)

@ anky1212
Posting: # 9557
Views: 4,914
 

 Temperature and Humidity requirement

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Hello Ankur,

❝ What should be the ideal temperature and humidity requirement to store investigational product in pharmacy?


The ideal temperature/rh is whatever complies with the Sponsor's storage requirements and this varies from IMP to IMP. These will always be specified in writing since it is a GCP obligation, see e.g. clauses 5.13.2 and 5.14.3 of ICH E6.
—
Pass or fail!
ElMaestro
 
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