Temperature and Humidity requirement [Study Per­for­mance]

posted by ElMaestro  – Denmark, 2012-11-20 09:01 (4556 d 12:19 ago) – Posting: # 9557
Views: 4,059

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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