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Classification of Countries according to Climatic Zones

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Classification of Countries according to Climatic Zones

This article gives the classification of various countries according to their climatic zones.

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Description

Introduction

Stability studies give the shelf life of the drug or the product. It also outlines the storage condition for the drug substance. Hence it is crucial to know the storage conditions. Given the different climatic conditions in the world, climatic zones are defined and classified.

Classification of Climatic Zones

Climatic zones are defined and given by WHO – World Health Organization in 2009.

Criteria for classification – Mean Annual temperature measured in open air, Mean annual Partial pressure of water

Climatic zone

Condition

Criteria

I

Temperate Climate

≤15oC / 11 hPa

II

Subtropical and Mediterranean Climate

15 to 22oC / > 11 to 18 hPa

III

Hot and dry climate

> 22o C / ≤15 hPa

IV (CZ IV a, CZ IVb)

Hot and humid Climate (CZ IV a)

> 22o C / >15 to 27 hPa

Hot and very humid climate (CZ IV b)

> 22o C / > 27 hPa

Long term conditions for stability data

WHO and ICH guidelines

Long term testing conditions

(Temp/Humidity)

Testing conditions

Climatic Zones

Long term Stability testing which could be realized in order to cover all climatic zones

21oC/ 45% RH

Long term

I

250C/ 60% RH

25oC/ 60% RH

Long term

I and II

30oC/ 35% RH

Long term

III

30oC/ 65% RH

30oC/ 65% RH

Intermediate

Long term

I and II

IV a

30oC/ 75% RH

Long term

IV b

30oC/ 75% RH

 

  • Stability requirements for Climatic zones I and II are well established and defined in ICH guidelines Q1A,
  • Stability requirements for climatic zones III and IV are not properly outlined due to divergences in its stability requirements so no global harmonization on long term conditions was reached.

Classification of countries according to climatic zones

Region

Zone I and II countries

Zone III and IV countries

Europe

All countries

--

America

Argentina, Bolivia, Chile, Canada,

Mexico, Peru, Uruguay, USA

Barbados, Belize, Brazil, Costa Rica, Dominican Republic,

Ecuador, El Salvador, Guatemala, Guyana, Haita,

Honduras, Jamaica, Columbia, Cuba, Nicaragua, Dutch

Antilles, Panama, Paraguay, Puerto Rico, Venezuela. All

of these countries are assigned to CZ IV.

Asia

Afghanistan, Armenia,

Azerbaijan, China, Georgia, Iran,

Israel, Japan, Kazakstan,

Kirghizia, Korea, Lebanon, Nepal,

Syria, Tadzhikistan, Turkey,

Turkmenia, Uzbekistan

Bahrain, Bangladesh, Hong Kong, India, Indonesia, Iraq

(III), Jordan (III), Kampuchea, Qatar, Kuwait, Laos,

Malaysia, Maldive Islands, Myanmar, Oman, Pakistan,

Philippines, Saudi Arabia, Singapore, Sri Lanka, Taiwan,

Thailand, United Arab Emirates, Vietnam, Yemen

Africa

Egypt, Algeria, Tunesia, Libya,

Morocco, Namibia, Ruanda,

South Africa, Tunesia, Zambia,

Zimbabwe.

 

Angola, Ethiopia, Benin, Botswana (III), Burkino Faso,

Burundi, Djibouti, Ivory Coast, Gabon, Gambia, Ghana,

Guinea, Cameroon, Kenya, Longo, Liberia, Madagascar,

Malawi, Mali, Mauritania, Mozambique, Niger, Nigeria,

Senegal, Sierra Leone, Somalia, Sudan, Tanzania, Togo,

Chad (III), Uganda, Zaire, Central African Republic.

Australian/

oceanic

Australia, New Zealand.

Figi. Society Islands, Marshall Islands, New Caledonia,

Papua-New Guinea, Samoa, Tonga.

Tags

Climatic zones, stability requirements,testing conditions,long term stability, temperate climate, subtropical and mediterranean climate, hot and dry climate, hot and humid climate

References

eudrac.de

ipapharma.org

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