New ICH Guidelines on Stability Testing

GMP News No. 184

GMP News
03 April 2002
 

 New ICH Guidelines on Stability Testing

 
In February 2002, two new ICH Guidelines on the topic of stability testing were published. They can now be commented.

Q1E Draft Consensus Guideline -Evaluation of Stability Data

Q1F Draft Consensus Guideline
Stability Data Package for Registration in Climatic Zones III and IV

Both new Drafts refer to the revised ICH Guideline Q1A(R) – "Stability Testing of New Drug Substances and Products." The Guideline "Evaluation of Stability Data" describes when and how an extrapolation of the data can be undertaken in order to establish the re-test period for a drug substance or the shelf life for a drug product beyond the observed range itself, based on the data resulting from the long-term stability testing. 

The Guideline on stability testing for Climatic Zone III and IV takes up a proposal made by WHO and now defines not only storage conditions for stability testing relevant for the ICH tripartite regions (Europe, USA, Japan), but also completes the recommendations for the standardisation of the storage conditions for the Climatic Zones III (dry-hot) and IV (very hot/humid). For these Climatic Zones, the following standard conditions are recommended:

  • Long-term testing: 30°C / 65% RH
  • Accelerated conditions: 40°C / 75% RH

This means that the "accelerated conditions" remain the same as in the Q1A(R) Guideline and only the "long-term storage conditions" have to be modified. Please find the ICH Guidelines at: www.ich.org.

Author: 
Dr Günter Brendelberger
CONCEPT HEIDELBERG 



Update:
Please find the latest GMP News and Guidelines on this topic here.

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