Climatic Zone and Stability Study Conditions as per ICH Guidelines

The climatic condition changes as we move across the globe, which means that the climatic condition is different in a different part of the world. Now since the stability of pharmaceutical product is influenced by climatic conditions, the stability study of the pharmaceutical product needs to be studied keeping in mind the climatic conditions of the country. As per ICH guidelines for stability studies, the climate of the world is divided into four different zones (Zone I, II, III, IV.). Zone IV is further divided into two, zone IV A and zone IV B.

ICH stability zone:

Stability ZonesClimatic Condition
Zone ITemperate Zone
Zone IIMediterranean /Sub-tropical Zone
Zone IIIHot Dry Zone
Zone IV AHot Humid Tropical Zone
Zone IV BHot/Higher Humidity

As the climatic zones are differentiated based on the temperature and humidity of different part of the world. ICH has defined different stability condition for studies as per the Stability zone. The stability study condition for Drug Product is mentioned below:

Long Term Stability Testing Conditions
Stability ZoneTemperatureHumidityMinimum Duration
Zone I21°C ± 2°C45 %RH ± 5 % RH12 Months
Zone II25°C ± 2°C60 %RH ± 5 % RH12 Months
Zone III30°C ± 2°C35 %RH ± 5 % RH12 Months
Zone IV A30°C ± 2°C65 %RH ± 5 % RH12 Months
Zone IV B30°C ± 2°C75 %RH ± 5 % RH12 Months

Intermediate and Accelerated Stability Testing Condition:

StudyStorage conditionMinimum Duration
Intermediate30°C ± 2°C/65% RH ± 5% RH6 Months
Accelerated40°C ± 2°C/75% RH ± 5% RH6 months

For the Drug Productintended for storage in a refrigerator:

StudyStorage ConditionMinimum Duration
Long Term 5°C ± 3°C12 months
Accelerated25°C ± 2°C/60% RH ± 5% RH6 months

For the Drug Product intended for storage in a freezer:

StudyStorage ConditionMinimum Duration
Long Term-15°C ± 5°C/ No Humidity12 months
Accelerated5°C ± 3°C/No Humidity6 months

A successful stability study establishes the shelf-life of the drug product, the retest period of a drug substance, and appropriate storage conditions. A successful stability study must also ensure that patients receive safe and effective medicine.

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