Different Climatic Zone in World and their Stability Storage & Testing Conditions

 

The same drug and drug products may behave differently in worldwide based on their climatic zone. As we know in some of country there is temperature and humidity conditions are different based on their establishment according to north and south poles. The temperature and humidity conditions are changed also according to weather.

According to ICH guideline ICH Q1A (R2) the world is divided in 5 climatic zones (mainly in 4 zones). The temperature and humidity conditions of these zones are as below:

Zone	Climate
Zone I	Temperate Zone
Zone II	Mediterranean/ Subtropical zone
Zone III	Hot Dry Zone
Zone IVa	Hot Humid/ Tropical zone
Zone IVb	Hot/ Higher humid

 

 Based on the climatic condition of the country, the stability study of drug and drug product is being performed.

Stability Studies:

As per ICH guideline “Stability Testing of New Drug Substance and Product” Q1A (R2), Stability study to be performed for Long term, Intermediate storage condition and Accelerated storage conditions. For long term the testing frequency to be performed on quarterly basis for first year, after first year the testing frequency to be done on each 6 months till 2^nd year. After 2^nd year, the testing frequency for long term should be done on annually basis throughout the proposed re-test period.

For Accelerated storage condition, the testing frequency to be done minimum of 3 time point i.e. at 0 month 3 month and 6 month. Based on requirement, the 4^th time point can be also done on additional samples.

Based on ICH guideline, for all climatic zones in world, the required stability storage conditions and minimum time point required for data submission are given below. This information is collected from ICH Q1A (R2) and ICH Q1F (Annex 10). An alternative storage condition can be used based on packaging of drug product, if justified.

Long Term Stability Testing Conditions

Climatic Zone	Temperature	Humidity	Minimum time period covered
Zone I	21°C ± 2°C	45% RH ± 5% RH	12 Months
Zone II	25°C ± 2°C	60% RH ± 5% RH	12 Months
Zone III	30°C ± 2°C	35% RH ± 5% RH	12 Months
Zone IVa	30°C ± 2°C	65% RH ± 5% RH	12 Months
Zone IVb	30°C ± 2°C	70% RH ± 5% RH	12 Months
Refrigerated	5°C ± 3°C	Not Applicable	12 Months
Frozen	-20°C ± 5°C	Not Applicable	12 Months

 

 

Accelerated Stability Testing Conditions

Study	Temperature	Humidity	Minimum time period covered
Accelerated (Drug product for Ambient condition)	40°C ± 2°C	75% RH ± 5% RH	6 Months
Accelerated ( Drug product for Refrigerated condition)*	25°C ± 2°C or 30°C ± 2°C or 30°C ± 2°C	60% RH ± 5% RH or 65% RH ± 5% RH or 75% RH ± 5% RH	6 Months
Accelerated ( Drug product for Frozen condition)	5°C ± 3°C	Not Applicable	6 Months

*Whether accelerated stability studies are performed at 25 °C ± 2 °C/60% RH ± 5% RH or 30 °C ± 2 °C/65% RH ± 5% RH or 30 °C ± 2 °C/75% RH ± 5% RH is based on a risk-based evaluation. Testing at a more severe accelerated condition can be an alternative to the storage condition at 25 °C/60% RH or 30 °C/65% RH.

Intermediate Stability Testing Conditions

Study	Temperature	Humidity	Minimum time period covered
Intermediate**	30°C ± 2°C	65% RH ± 5% RH	6 Months

 ** Where 30°C ± 2°C/ 65% RH ± 5% RH is the long term stability condition in that case intermediate study not required.

If long-term studies are conducted at 25°C ± 2°C/60% RH ± 5% RH and “significant change” occurs at any time during 6 months’ testing at the accelerated storage condition, additional testing at the intermediate storage condition should be conducted and evaluated against significant change criteria. The initial application should include a minimum of 6 months’ data from a 12-month study at the intermediate storage condition.

Categorization of Countries based on Climatic Zone:

Based on climatic zone, the world is classified in 5 zones. The distribution of zone to all countries is tabulated below:-

Classification of Country based on Climatic Zone
Country Name	Climatic Zone	Allocated Zone
Afghanistan	I, II	II
Albania	II	II
Algeria	II, III	II
Andorra	II	II
Angola	II, IV	II
Argentina	II	II
Armenia	I, II	II
Australia	I, II, III, IVa	II
Austria	I, II	II
Azerbaijan	I, II	II
Bahamas	II, IVa	IVa
Bahrain	IVa	IVa
Bangladesh	IVa	IVa
Barbados	IVb	IVb
Belarus	I	I
Belgium	I	I
Belize	IVa	IVa
Benin	IVa	IVa
Bhutan	II	II
Bolivia	I, II, IVb	IVb
Bosnia and Herzegovina	I, II	II
Botswana	III	III
Brazil	II, IVb	IVb
Brunei	IVa	IVa
Bulgaria	I, II	II
Burkina Faso	IVa	IVa
Burundi	IVa	IVa
Côte d'Ivoire	IVb	IVb
Cambodia	IVa	IVa
Cameroon	IVb	IVb
Canada	I	I
Central African Republic	IVb	IVb
Chad	III, IVa	III
Chile	I, II	II
China	I, II, IVa	II
Colombia	IVb	IVb
Comoros	IVa	IVa
Congo (Congo-Brazzaville)	II, IVa	IVa
Costa Rica	IVa	IVa
Croatia	I, II	II
Cuba	IVb	IVb
Cyprus	II	II
Democratic Republic of the Congo	IVa	IVa
Denmark	I	I
Ecuador	I, II, IVa	IVa
Egypt	II, III	II
El Salvador	IVa	IVa
Ethiopia	II, IVa	IVa
Fiji	IVa	IVa
Finland	I, II	II
France	I, II	II
Gabon	IVa	IVa
Gambia	IVa	IVa
Georgia	I, II	II
Germany	I	I
Ghana	IVb	IVb
Greece	II, IVa	II
Grenada	IVa	IVa
Guatemala	IVa	IVa
Guinea	IVa	IVa
Guyana	IVb	IVb
Haiti	IVa	IVa
Honduras	II, IVa	IVa
Hong Kong	IVa	IVa
Hungary	I, II	II
Iceland	I	I
India	III, IVb	IVb
Indonesia	IVb	IVb
Iran	I, II, IVa	II
Iraq	II, III, IVa	III
Ireland	I, II	II
Israel	II, III	II
Italy	I, II	II
Ivory Coast	IVa	IVa
Jamaica	IVa	IVa
Japan	I, II, IVa	II
Jordan	II, III	III
Kampuchea	IVa	IVa
Kazakhstan	I, II	II
Kenya	II, IVa	IVa
Kuwait	IVa	IVa
Laos	IVb	IVb
Lebanon	II	II
Liberia	IVa	IVa
Libya	II, III	II
Madagascar	II, IVa	IVa
Malawi	II, IVa	IVa
Malaysia	II, IVb	IVb
Maldives	IVa	IVa
Mali	III, IVa	IVa
Malta	II	II
Marshall Islands	IVa	IVa
Mauritania	IVa	IVa
Mexico	II, IVa	II
Morocco	II, IVa	IVa
Mozambique	IVb	IVb
Myanmar (formerly Burma)	IVb	IVb
Namibia	II	II
Nepal	II	II
Netherlands	I, II	II
New Zealand	I, II	II
Nicaragua	IVa	IVa
Niger	III, IVa	IVa
Nigeria	IVb	IVb
Oman	IVa	IVa
Pakistan	II, III, IVa	IVa
Panama	IVb	IVb
Papua New Guinea	IVa	IVa
Paraguay	IVa	IVa
Peru	IVb	IVb
Philippines	IVb	IVb
Poland	I, II	II
Portugal	I, II	II
Qatar	IVa	IVa
Remaining Eastern European Nations	I	I
Remaining Northern and Central European Nations	I	I
Romania	I	I
Russia	I	I
Rwanda	II	II
Samoa	IVa	IVa
Saudi Arabia	II, III, IVa	IVa
Senegal	IVa	IVa
Sierra Leone	IVb	IVb
Singapore	IVb	IVb
Solomon Islands	IVa	IVa
Somalia	IVa	IVa
South Africa	II	II
Spain	I, II	II
Sri Lanka	IVa	IVa
Sudan	III, IVb	IVb
Suriname	IVa	IVa
Sweden	I	I
Switzerland	I	I
Syria	II	II
Tajikistan	I, II	II
Tanzania	II, IVb	IVb
Thailand	IVb	IVb
Togo	IVb	IVb
Tonga	II, IVa	IVa
Tunisia	II	II
Turkey	I, II	II
Turkmenistan	I, II	II
Uganda	IVa	IVa
Ukraine	I, II	II
United Arab Emirates	IVa	IVa
United Kingdom	I, II, III, IVa	II
United States of America	I, II, III, IVa	II
Uzbekistan	I, II	II
Venezuela	II, IVb	IVb
Vietnam	IVb	IVb
Yemen	II, IVa	IVa
Zaire	II, IVa	IVa
Zambia	II	II
Zimbabwe	IVb	IVb

• Tweet
• Share
• Share
• Share
• Share

About Author

Abhishek Singh is the author of Pharma technical support. He is pharmaceutical professionals, having experience of more than 12 years in Quality.

Related Post