The climate is different in all the countries in the world. Stability studies of the pharmaceutical drug should be done according to the climatic conditions of the country. According to the ICH guidelines for stability studies, the climate of the world is divided into five different zones.
ICH Stability Zones
Zone
|
Type of 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 humidity
|
These stability studies zones are created due to the difference in temperature and humidity in different parts of the world. These zones have different ICH stability conditions for pharmaceutical products. Following are ICH stability conditions for these zones.
Related: Significant Change in Pharmaceutical Stability Testing
Related: Significant Change in Pharmaceutical Stability Testing
Long Term Stability Testing Conditions
Climatic Zone
|
Temperature
|
Humidity
|
Minimum Duration
|
Zone I
|
21ºC ± 2ºC
|
45% RH ± 5% RH
|
12 Months
|
Zone II
|
25ºC ± 2ºC
|
60% RH ± 5% RH
|
12 Months
|
Zone III
|
30ºC ± 2ºC
|
35% RH ± 5% RH
|
12 Months
|
Zone IVa
|
30ºC ± 2ºC
|
65% RH ± 5% RH
|
12 Months
|
Zone IVb
|
30ºC ± 2ºC
|
75% RH ± 5% RH
|
12 Months
|
Refrigerated
|
5ºC ± 3ºC
|
No Humidity
|
12 Months
|
Frozen
|
-15ºC ± 5ºC
|
No Humidity
|
12 Months
|
Accelerated and Intermediate Stability Testing Conditions
Climatic Zone
|
Temperature
|
Humidity
|
Minimum Duration
|
Accelerated Ambient
|
40ºC ± 2ºC
|
75% RH ± 5% RH
|
6 Months
|
Accelerated Refrigerated
|
25ºC ± 2ºC
|
60% RH ± 5% RH
|
6 Months
|
Accelerated Frozen
|
5ºC ± 3ºC
|
No Humidity
|
6 Months
|
Intermediate
|
30ºC ± 2ºC
|
65% RH ± 5% RH
|
6 Months
|
Related: List of Current ICH Quality Guidelines
Update: The whole world is divided into 5 groups according to their climatic conditions. Following is the list of countries of different climatic zones for stability studies.
Update: The whole world is divided into 5 groups according to their climatic conditions. Following is the list of countries of different climatic zones for stability studies.
Classification of Countries According to Climate Zones |
||
Country
|
Climatic Zones
|
Assigned To Zone
|
Afghanistan
|
I, II
|
II
|
Algeria
|
II, III
|
II
|
Angola
|
II, IV
|
II
|
Argentina
|
II
|
II
|
Armenia
|
I, II
|
II
|
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
|
IVb
|
Botswana
|
III
|
III
|
Brazil
|
II, IVb
|
IVb
|
Bulgaria
|
I, II
|
II
|
Burkina Faso
|
IVa
|
IVa
|
Burundi
|
IVa
|
IVa
|
Cameroon
|
IVb
|
IVb
|
Canada
|
I
|
I
|
Canary Islands
|
II
|
II
|
Central African Republic
|
IVb
|
IVb
|
Chad
|
III, IVa
|
III
|
Chile
|
I, II
|
II
|
China
|
I, II, IVa
|
II
|
Columbia
|
IVb
|
IVb
|
Congo
|
II, IVa
|
IVa
|
Costa
|
IVa
|
IVa
|
Cuba
|
IVb
|
IVb
|
Dominican Republic
|
IVa
|
IVa
|
Dutch Antilles
|
IVa
|
IVa
|
Ecuador
|
I, II, IVa
|
IVa
|
Egypt
|
II, III
|
II
|
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
|
Guinca
|
IVa
|
IVa
|
Haiti
|
IVa
|
IVa
|
Honduras
|
II, IVa
|
IVa
|
Hong Kong
|
IVa
|
IVa
|
India
|
III, IVb
|
IVb
|
Indonesia
|
IVb
|
IVb
|
Iran
|
I, II, IVa
|
II
|
Iraq
|
II, III, IVa
|
III
|
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
|
Kazakstan
|
I, II
|
II
|
Kenya
|
II, IVa
|
IVa
|
Kirghizia
|
I, II
|
II
|
Korea
|
I, II
|
II
|
Kuwait
|
IVa
|
IVa
|
Laos
|
IVb
|
IVb
|
Lebannon
|
II
|
II
|
Liberia
|
IVa
|
IVa
|
Libya
|
II, III
|
II
|
Madagascar
|
II, IVa
|
IVa
|
Malawi
|
II, IVa
|
IVa
|
Malaysia
|
II, IVb
|
IVb
|
Maldive Islands
|
IVa
|
IVa
|
Mali
|
III, IVa
|
IVa
|
Marshall Islands
|
IVa
|
IVa
|
Mauretania
|
IVa
|
IVa
|
Mexico
|
II, IVa
|
II
|
Morocco
|
II, III
|
II
|
Mozambique
|
IVb
|
IVb
|
Myanmar (Burma)
|
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 Nations
|
I
|
I
|
Remaining Northern and Central European Nations
|
I
|
I
|
Remaining Southern
|
II
|
II
|
European Nations
|
||
Rumania
|
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 Islands
|
IVa
|
IVa
|
Somalia
|
IVa
|
IVa
|
South Africa
|
II
|
II
|
Spain
|
I, II
|
II
|
Sri Lanka
|
IVa
|
IVa
|
Sudan
|
III, IV
|
IV
|
Syria
|
II
|
II
|
Tadzhikistan
|
I, II
|
II
|
Taiwan
|
IV
|
IV
|
Tanzania
|
II, IVb
|
IVb
|
Thailand
|
IVb
|
IVb
|
Togo
|
IVb
|
IVb
|
Tonga
|
II, IVa
|
IVa
|
Tunisia
|
II
|
II
|
Turkey
|
I, II
|
II
|
Turkmenia
|
I, II
|
II
|
Uganda
|
IVa
|
IVa
|
United Arab Emirates
|
IVa
|
IVa
|
Uruguay
|
II
|
II
|
United States
|
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
|
The above data given basic clarity, Thank you sir.
ReplyDeleteOn what basis shelf life of the drug and drug products are desited.
ReplyDeleteWhat are the minimum requirements for opening small scale osd plant ?
ReplyDeleteGood information sir
ReplyDeleteTHANK YOU FOR THE INFORMATION, IT'S SO USEFUL
ReplyDeleteMinimum Zone ivb stability batches required for Malaysia registration.2 or 3
ReplyDeleteWhat is the source for the assigned climatic zone in the table? I am mostly interested of countries with several climatic zones but assigned II e.g. China and Australia. What does the "assigned" climatic zone mean and when is it used? To my understanding its up to the different authorities but both China and Australia usually want more data than for Climate zone II.
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