Climatic Zones For Stability Studies

The drug products are tested under various environmental conditions to collect data regarding the stability of drug products.

Pharmaceutical drug products are stored under various ranges of temperature & humidity & are tested to check the safety & efficacy of that drug product after a specified period of time.

The temperature & humidity of all the countries is not the same. That is why the ICH has divided the whole world into various climatic zones.

Importance Of Climatic

Stability zones play an important role in collecting stability data of a drug product.

• One must have to collect stability data of new drug products according to the climatic zone of the country where it is going to be registered.
• For export of a drug product in a specific country we must collect stability data according to the zone of that country.
• Storage conditions for various pharmaceutical drug products are determined by testing the product in various climatic conditions.

Climatic Zones For Stability Studies

The world is divided into four climatic zones & zone IV is further subdivided into two zones which are IVa & IVb so by adding by division we have 5 ICH climatic zones.

The numbering of climatic zones for stability studies is given below,

• Zone I
• Zone II
• Zone III
• Zone IVa 
• Zone IVb
  
  
  
  
  

The names of above mentioned climatic zones are given below

Zone	Zone Name/Climate
Zone I	Temperate
Zone II	Mediterranean/ Subtropical
Zone III	Hot Dry
Zone IVa	Hot Humid/Tropical
Zone IVb	Hot Higher Humidity

Following are the long-term stability study conditions for above mentioned ICH stability zones

Long-Term Stability Studies

 

Zone	Temperature	Humidity	Minimum time at submission
Zone I	21°C ± 2%	45% RH ±5%	12 Month
Zone II	25 °C± 2%	60% RH ±5%	12 Month
Zone III	30 °C± 2%	35% RH ±5%	12 Month
Zone IVa	30 °C± 2%	65% RH ±5%	12 Month
Zone IVb	30 °C± 2%	75% RH ±5%	12 Month

Countries According To Climatic Zones

Following is the division of main countries according to their climatic zones

Name	Zone
UK	Zone I
North Europe
Germany
Russia
Canada

 

Name	Zone
USA	Zone II
China
Iran
Japan
Australia

 

Name	Zone
Iraq	Zone III
Jordan
Botswana

 

Name	Zone
Pakistan	Zone IV
India
Bangladesh
Omam
EUE
Indonesia

Also Read

1. Potency calculation of Active pharmaceutical Ingredient.
2. Why Do We Use Three Batches For Validation