ICH Steering Committee Withdraws ICH Q1 F Guideline

GMP News No. 761

GMP News
18 July 2006

ICH Steering Committee Withdraws ICHQ1 F Guideline

After discussions with the World Health Organisation (WHO) and regionalharmonisation initiatives the ICH Steering Committee has withdrawn its Q1F Guideline "Stability Data Package for Registration Applications inClimatic Zones III and IV". This Guideline "described harmonisedglobal stability testing requirements in order to facilitate access tomedicines by reducing the number of different storage conditions."

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



Stability testing is also in the centre of the European Conference StabilityTesting for Drug Substances and Drug Products, organised from24-25 October 2006 in Berlin by Concept Heidelberg on behalf of theEuropean Compliance Academy (ECA).

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

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


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