In February this year 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.
Both Guidelines can be downloaded from
the ICH website at
http://www.ifpma.org/ich5q.html
Author:
Dr Günter Brendelberger
CONCEPT HEIDELBERG
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