ICH Steering Committee Withdraws ICH Q1 F Guideline

GMP News No. 761

GMP News
18 July 2006
 

ICH Steering Committee Withdraws ICH Q1 F Guideline

 
After discussions with the World Health Organisation (WHO) and regional harmonisation initiatives the ICH Steering Committee has withdrawn its Q1 F Guideline "Stability Data Package for Registration Applications in Climatic Zones III and IV". This Guideline "described harmonised global stability testing requirements in order to facilitate access to medicines by reducing the number of different storage conditions."

As the Committee's explanation points out, several countries in the mentioned climatic zones conducted new calculations and "expressed their wish to include a larger safety margin for medicinal products to be marketed in their region than foreseen in ICH Q1F."

The entire explanation for the withdrawal you can read here:
http://www.ich.org/LOB/media/MEDIA3124.pdf

 

Stability testing is also in the centre of the European Conference Stability Testing for Drug Substances and Drug Products, organised from 24-25 October 2006 in Berlin by Concept Heidelberg on behalf of the European Compliance Academy (ECA).

Representatives from authorities as well as from the industry will inform you about the newest developments and practical aspects.

 
Prepared by:
Wolfgang Heimes
On behalf of the European Compliance Academy
  

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