This article is describing about the climatic zones for stability testing and countrywise classification of climatic zone as per ICH, WHO guideline.

1.0 What is Climatic Zone?

A climatic zone is an area decided by their long-term weather condition. Factor consider for the climatic zone classification is temperature, water vapour, air, light, longitude, latitude.

There are different types of climates all over the world. This climate is affected on us as well as the other objects. Mainly some factors like temperature, moisture (humidity), light, air etc. which are responsible to change or alter the Physical, Chemical, Microbiological, Therapeutic and Toxicological characteristics of the drugs.

2.0 Climatic Zones for Stability Testing:

Grimm W. is the person who divided countries and decided the stability conditions as per the climatic zones. He divided climatic zone into four parts and mentioned about that storage conditions in the “Drugs made in German”. All ICH, EMEA, WHO guidelines accepted their storage condition and country wise climatic zone classification.

ICH (International Council on Harmonization) and WHO climatic zones for stability testing  classified as per below:

Zones	Name	Acceptance Criteria (Mean annual temperature / Mean annual water vapour pressure)
I	Temperate Zone	≤ 15°C / ≤ 11 hPa (hPa – Hectopascal)
II	Subtropical and Mediterranean Zone	> 15 to 22°C / > 11 to 18 hPa
III	Hot and dry zone	> 22°C / ≤ 15 hPa
IVA	Hot and humid Zone	> 22°C / > 15 to 27 hPa
IVB	Hot and Very Humid Zone	> 22°C / > 27 hPa

Zone IV (hot and humid) is divided into two parts IVA and IVB. Zone IVA (30°C/65% RH) is a standard long-term stability testing condition and If zone IVB (30°C / 75% RH) is justifiable then perform long-term stability testing with this condition.

3.0 Stability Condition:

India is a major exporter of pharmaceutical medicine all over the world. Hence, drugs should be able to survive or maintain their physical, chemical, therapeutical state in that specific climatic zone condition. Therefore, in the country where drugs is to be given, it is necessary to do a stability study as per the climatic zone condition of that country. On the basis of that stability, data exporters decide the shelf life of that drug. That stability data will be stored by that exporter.

Stability study should be conducted as per below stability conditions during submission of data to that regulatory bodies:

Long Term Stability Testing

Intermediate Stability Testing

Accelerated Stability Testing

If 30°C ± 2°C / 65% ± 5% RH and 30°C ± 2°C / 75% ± 5% is not long-term condition for the drug then only intermediate stability testing required. Hence, zone IVA and IVB not required intermediate testing.

4.0 Climatic Zones for Stability Classification according to Countries:

Grimm W. divided the countries as per climatic zone and decided the stability testing classification.

Classification of country as per the climatic zone:

Country	Climatic Zone	Assigned Climatic Zone
Afghanistan	I, II	II
Algeria	II, III	II (a)
Angola	II, IV	II
Argentina	II	II
Armenia	I, II	II (a)
Australia	I, II, III, IVA	II
Azerbaijan	I, II	II
Bahrain	IVA	IVA
Bangladesh	IVA	IVA
Barbados	IVB	IVB
Belize	IVA	IVA
Benin	IVA	IVA
Bolivia	I, II, IVB	II (a)
Botswana	III	III
Brazil	II, IVB	IVB
Bulgaria	I, II	II
Burkina Faso	IVA	IVA
Burundi	IVA	IVA
Cameroon	IVB	IVB
Canada	I	I
Cayman Islands	II	II
Central African Republic	IVB	IVB
Chad	III, IVA	III
Chile	I, II	II
China	I, II, IVA	II (a)
Colombia	IVB	IVB
Democratic Republic of the Congo (Zaire)	II, IVA	IVA
Congo, Republic of the	II, IVA	IVA
Costa Rica	IVA	IVA
Cuba	IVB	IVB
Denmark	I	I
Dominican Republic	IVA	IVA
Ecuador	I, II, IVA	IVA
Egypt	II, III	II (a)
El Salvador	IVA	IVA
Ethiopia	II, IVA	IVA
Fiji	IVA	IVA
France	I, II	II
Gabon	IVA	IVA
Gambia	IVA	IVA
Georgia	I, II	II
Germany	I	I
Ghana	IVB	IVB
Greece	II, IVA	II
Guatemala	IVA	IVA
Guyana	IVB	IVB
Haiti	IVA	IVA
Honduras	II, IVA	IVA
Hong Kong	IVA	IVA
India	III, IVB	IVB
Indonesia	IVB	IVB
Iran	I, II, IVA	II (a)
Iraq	II, III, IVA	III
Israel	II, III	II (a)
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
Korea	I, II	II
Kuwait	IVA	IVA
Kyrgyzstan	I, II	II
Laos	IVB	IVB
Lebanon	II	II
Liberia	IVA	IVA
Libya	II, III	II (a)
Madagascar	II, IVA	IVA
Malawi	II, IVA	IVA
Malaysia	II, IVB	IVB
Maldives	IVA	IVA
Mali	III, IVA	IVA
Marshall Islands	IVA	IVA
Mauritania	IVA	IVA
Mexico	II, IVA	II (a)
Morocco	II, III	II (a)
Mozambique	IVB	IVB
Myanmar	IVB	IVB
Namibia	II	II
Nepal	II	II
New Caledonia	II, IVA	IVA
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
Portugal	I, II	II
Puerto Rico	IVA	IVA
Qatar	IVA	IVA
Remaining Eastern European Nation	I	I
Remaining Northern and Central European Nation	I	I
Remaining southern European Nations	II	II
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
Society Island	IVA	IVA
Somalia	IVA	IVA
South Africa	II	II
Spain	I, II	II
Sri Lanka	IVA	IVA
Sudan	III, IV	IV
Syria	II	II
Taiwan	IVB	IVB
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
United Arab Emirates	IVA	IVA
United States	I, II, III, IVA	II (b)
Uruguay	II	II
Uzbekistan	I, II	II
Venezuela	II, IVB	IVB
Vietnam	IVB	IVB
Yemen	II, IVA	IVA
Zambia	II	II
Zimbabwe	IVB	IVB

In above table mentioned Climatic zone II (a) and II (b). This case is especially for zone II.

In which meaning of (a) and (b) as per below:

(a) Storage directions recommended

(b) Storage Conditions Mandatory

More Articles:

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How to minimize the risk of Data Integrity

Example of deviation

References:

1.0 ICH Q1 (R2) “Stability Testing of New Drug Substances and Products”

2.0 WHO “Stability Testing of Active Pharmaceutical Ingredients and Pharmaceutical Products”

3.0 Grimm W. “Drugs Made in Germany 36, 3, 99-103 (1993)”

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