ICH Stability Storage

We specialise in the simulation of environmental conditions and provide a trusted outsourced environmental testing service in our multi-point validated chambers which are traceable to UKAS and NPL via their chilled mirror unit.

Moreover, we can help with incorporation of stability studies during all stages of the drug product life cycle; from early stage of the product development to late-stage follow-up stabilities. We can take anything from a small 50L one off study up to any size of trial and accommodate any specific tailored requirements.

For added safety, all our stored items are validated and continually monitored in our temperature and humidity-controlled chambers, that have backup emergency systems in place to protect the integrity of your samples at all times.

What are ICH Stability Storage according to Q1A Guidelines?

The international Council for Harmonisation of Technical Requirements for Pharaceutical Use (ICH) defines Q1A ICH Stability Testing guidleines as “The purpose of stability testing is to provide evidence on how the quality of a drug
substance or drug product varies with time under the influence of a variety of
environmental factors such as temperature, humidity, and light, and to establish a
re-test period for the drug substance or a shelf life for the drug product and
recommended storage conditions.” ¹

“The choice of test conditions defined in this guideline is based on an analysis of the
effects of climatic conditions in the three regions of the EC, Japan and the United
States. The mean kinetic temperature in any part of the world can be derived from
climatic data, and the world can be divided into four climatic zones, I-IV. This
guideline addresses climatic zones I and II. The principle has been established that
stability information generated in any one of the three regions of the EC, Japan and
the United States would be mutually acceptable to the other two regions, provided
the information is consistent with this guideline and the labeling is in accord with
national/regional requirements.” ¹

What are Q1A ICH Stability Storage Conditions?

Drug products should in general be evaluated under storage conditions as outlined by the ICH Harmonised Tripartie Guidelines ‘Stability Testing of New Drug Substances and Products’ and sample storage conditions and lengths chosen should be sufficient to include storage time and environment, transportation and use.¹ General ICH Stability Testing examples are given in the ICH Guidelines as:

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Study	Storage Condition	Minimum Time Period Covered by Data at Submission
Long Term*	25°C ± 2°C/60% RH ± 5% RH or 30°C ± 2°C/65% RH ± 5% RH	12 months
Intermediate*	30°C ± 2°C/65% RH ± 5% RH	6 months
Accelerated	40°C ± 2°C/75% RH ± 5% RH	6 months

Where alternative storage conditions have been justified and required Sampled can provide customized environments to enable your storage conditions according to ICH Stability Storage guidelines.