Revision of the EMEA Guideline on Stability Testing of Existing Active Substances and Related Finished Products

GMP News No. 288

GMP News
15 February 2003
 

Revision of the EMEA Guideline on Stability Testing
of Existing Active Substances and Related Finished Products

 
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:

  • Note for Guidance on Stability Data Package for Registration in 
    Climatic Zones III and IV
    (CPMP/ICH/421/02)
  • Note for Guidance on Stability Testing of New Drug Substances and Products
    (CPMP/ICH/2736/99 corr)
  • 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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