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New Storage Requirements for "Intermediate Conditions"
In December 2002, the Committee for Proprietary Medicinal Products
(CPMP) accepted the Note for Guidance titled "Stability Testing of
Existing Active Substances and Related Finished Products" with the
number "CPMP/QWP/122/02, corr."
The revision of this Guideline was necessary
in order to ensure the correspondence between its requirements and those
of the following Guidelines:
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Note for Guidance on Stability Data Package for Registration in
Climatic Zones III and IV
(CPMP/ICH/421/02)
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Note for Guidance on Stability Testing of New Drug Substances and
Products
(CPMP/ICH/2736/99 corr)
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Common Technical Document
(CPMP/ICH/2287/99)
As a consequence, the relative humidity had
to be changed from 30°C/60% RH to 30°C/65%
RH at storage under "intermediate conditions."
From now on, stability data that have been
generated using these storage conditions are accepted within the EU. In
addition, data generated in stability studies are recognised in case the
relative humidity has been altered during the study in order to comply
with the current requirements, provided that the respective storage
conditions and the date of alteration of the conditions are clearly
documented and indicated in the application file.
The complete Guideline, which represents a
revision of the original Guideline CPMP/QWP/556/96, can be found on the
Internet at:
http://www.emea.eu.int/pdfs/human/qwp/012202en.pdf
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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