New Climatic Zones For Stability Testing

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

Climatic zones for stability, long term stability testing condition

Intermediate Stability Testing

Climatic zones for stability, Intermediate stability testing condition

Accelerated Stability Testing

Climatic zones for stability, Accelerated stability testing condition

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:

What is ALCOA+

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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