According to ICH guidelines the world is divided into four different climatic zones and the climatic zones are decided on the basis of climate of the region.
The world has different climate in the different region and the stability study of the drug product shall be perform according to climatic zones.
The long term, Intermediate and Accelerated condition is decided based on the temperature of the region.
stability climatic Zones of the world/ ICH Stability climatic zones:
ICH stability zones and their types: Zone 4 has devided into 2 zones as per climatic condition.
|Types of World climatic zones||Names of world climatic zones|
|Zone-III||Hot dry zone|
|Zone-IV a||Hot humid/tropical zone|
|Zone-IV b||Hot/very humidity|
According to temperature and humidity impact can be observed on the pharmaceutical drug product. Temperature and humanity has critical role for the degradation of the drug product and generation of impurities in the drug product or drug substance.
To study the impact of different climatic zones ICH has devided into four stability climatic zones basis on their temperature and humidity.
Long term stability condition as per ICH:
Long term stability condition is differs as climatic zone change, it is differs as per temperature and humidity. Likewise Intermediate and Accelerated condition also differs.
In some of the countries Intermediate stability condition is considered as long term testing condition.
stability Climatic zones of the world and their temperature condition:
Long term stability testing is varies as climatic zone are changed. It is also known as Stability conditions.
|Stability climatic zone||Zone temperature|
|Zone I||21℃ +/-2℃ & 45% RH +/- 5% RH|
|Zone-II||25℃ +/-2℃ & 60% RH +/- 5% RH|
|Zone-III||30℃ +/-2℃ & 35% RH +/- 5% RH|
|Zone-IV a||30℃ +/-2℃ & 65% RH +/- 5% RH|
|Zone-IV b||30℃ +/-2℃ & 75% RH +/- 5% RH|
|Refrigerated||5℃ +/- 3℃ & No humidity|
|Froozen||-15℃ +/- 5℃ & No humidity|
Accelerated and intermediate stability testing condition:
Accelarated and intermediate stability condition are worst case study. In this study forcefully applying stress condition on drug product.
Accelerated (ACC) conditions are:
For long term condition : 40℃ +/- 2℃ & 75% RH +/- 5% RH is a ACC condition.
For Refrigerated condition : 25℃ +/- 2℃ & 60% RH +/- 5% RH is a ACC condition.
For Frozen condition : 5℃ +/- 3℃ & No humidity is a ACC condition.
Intermidiate stability condition:
Intermediate condition is 30℃ +/- 2℃ & 65% RH +/- 5% RH.
ICH 14 guidelines in pharmaceutical
What is stability testing?
The stability testing is a systematic approach to study the drug product and provide an evidence of the quality of the drug product or drug substance, over time period under the influence of environmental factors such as temperature, humanity and light.
What is long term stability testing?
Long term stability testing is control room temperature (CRT) study. It is perform through out the self life and storage period of drug product or drug substance.
Long term stability testing includes physical, chemical, biological and microbiological studies that provides an evidence of product quality.
The long term stability testing conditions are mention in world stability climatic zone and their temperature conditions.
What is intermediate stability testing?
Intermediate stability testing is a study in between long term and accelerated condition.
If the drug fails to meet the long term condition at any time point, then intermediate condition study can be start to check the quality of the drug product.
Intermediate stability condition is 30℃ +/- 2℃ & 65% RH +/- 5% RH.
In some of the countries intermediate condition is perform as long term testing, in such case intermediate testing is skipped.
What is accelerated (ACC) stability testing?
Accelarared stability testing is stress testing. Accelerated testing is designed to increase the rate of drug degradation by applying stress condition on drug product.
The aim of the ACC testing is to predict the self life of the drug product.
According to storage condition of drug product ACC condition can be defined. It is not same for all conditions.
In below table storage condition and what are the ACC condition of that it is given:
|Storage condition||Accelarated condition|
|CRT/Long term condition||40℃ +/- 2℃ & 75% RH +/- 5%RH|
|Refrigerated condition||25℃ +/- 2℃ & 60% RH +/- 5% RH|
|Freezer condition||5℃ +/- 3℃|
Accelerated stability testing is conducted up to 6 months for all conditions.
ICH Q1 Stability Guideline:
According to the ICH quality guideline, Q1 is the ICH guideline for stability. The ICH Stability guideline includes 6 sub guidelines.
Q1A (R2): Stability testing of new drug substance and product.
Q1B : Photostability testing of new drug substance and drug roduct.
Q1C : Stability testing for new dosage form.
Q1D : Bracketing and matrixing design for stability of new drug product and drug substance.
Q1E : Evaluation of stability data
Q1F : Stability data package for registration application in climatic zone III and IV. (This guideline is withdrawn from Jun 2006.)
As the stability climatic zones of the world are different but for different climatic zone study also change. Different stability condition and different climatic zones are depends on temperature and humidity of the region.
Stability testing is a study to check the quality of drug throughout life of drug product.
Classification of Countries with their climatic zones:
|USA||I, II, III, IVa|
|China||I, II, IVa|
|Japan||I, II, IVa|
|New Zealand||I, II|
|Australia||I, II, III, IVa|
classification of countries
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