Climatic Zones for Stability Studies : Pharmaguideline

Online GMP Courses with Certificate

ENROLL

Climatic Zones for Stability Studies

Know different climatic zones by ICH in the world for stability conditions including Temperate, Mediterranean / subtropical, Hot dry, Hot humid / tropical and hot & higher humidity zones.
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

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.

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





Ankur Choudhary is India's first professional pharmaceutical blogger, author and founder of pharmaguideline.com, a widely-read pharmaceutical blog since 2008. Sign-up for the free email updates for your daily dose of pharmaceutical tips.
.moc.enilediugamrahp@ofni :liamENeed Help: Ask Question


14 comments: Post Yours! Read Comment Policy ▼

  1. The above data given basic clarity, Thank you sir.

    ReplyDelete
  2. What are the references for this data??

    ReplyDelete
    Replies
    1. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guidelines/Quality/Q1F/Stability_Guideline_WHO.pdf

      Delete
  3. Taiwan is zone IV. So what condition apply when conduct stability study in Taiwan (IVA or IVB)? Thank you

    ReplyDelete
  4. On what basis shelf life of the drug and drug products are desited.

    ReplyDelete
  5. What are the minimum requirements for opening small scale osd plant ?

    ReplyDelete
  6. Good information sir

    ReplyDelete
  7. THANK YOU FOR THE INFORMATION, IT'S SO USEFUL

    ReplyDelete
  8. Minimum Zone ivb stability batches required for Malaysia registration.2 or 3

    ReplyDelete
  9. It's very useful basic

    ReplyDelete
  10. This comment has been removed by the author.

    ReplyDelete
  11. What 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.

    ReplyDelete

Please don't spam. Comments having links would not be published.


Popular Categories

QA SOPs QC SOPs Micro SOPs HVAC Production SOPs Stores SOPs Checklists Maintenance SOPs HPLC Sterile GLP Validation Protocols Water System GDP Regulatory Maintenance Calibration Warning Letters Education B.Pharmacy
Online Courses


Follow Pharmaguideline


DOCUMENTS

PHARMACEUTICAL DOCUMENTS




Editable Pharmaceutical Documents in MS-Word Format. Ready to use SOPs, Protocols, Master Plans, Manuals and more...

View


adsbypg


Recent Posts