Valencian Institute of Microbiology
(I V A M I)

Stability testing of Pharmaceutical products based on ICH Guide (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use).

Test with the Certificate of Good Laboratory Practices (GLPs). 

The objective of a stability study is to establish, based on the analysis of a minimum of three batches of the pharmaceutical product, a period of reanalysis or shelf life, as well as the storage instructions indicated on the label applicable to all future batches, manufactured and packaged under similar circumstances.

There are three types of stability tests: accelerated, intermediate and long-term. A formal stability study should consist of accelerated and long-term stability tests.

Accelerated stability tests are studies designed to increase the rate of chemical degradation or physical change of a drug product through the use of storage conditions. Depending on how the product is to be stored, there are different analysis conditions, described below.

In this test, the parameters to be determined will be analyzed at least at the beginning of the test, in the middle of the period (3 months) and at the end (6 months).

When there is no significant change in the accelerated condition, the useful life will depend on the nature of the long-term and accelerated data. In the event of a significant change in the accelerated condition, the useful life will depend on the results of the stability tests at the intermediate condition, as well as at the long-term condition.

Intermediate stability tests are studies conducted at 30°C/65% RH and designed to moderately increase the rate of chemical degradation or physical changes of a drug product intended for long-term storage at 25°C. If the long-term stability test is performed at the same temperature (30ºC), this test does not apply.

In this test, the parameters to be determined will be analyzed at least at the beginning of the test, in the middle of the period (3 months) and at the end (6 months).

Long-term stability tests are stability studies under recommended storage conditions for the proposed (or approved) shelf life for labeling. 

Because the climate is different in all the countries of the world, the ICH for studies of stability at room temperature, divides the world's climate into five different zones. These stability study 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 pharmaceuticals. The following are the ICH stability conditions for these zones.

In this test, the parameters to be analyzed will be determined, at the beginning, every 3 months the first year, every 6 months the second year and annually in subsequent years.

However, the ICH Guidelines indicate that if the products have active substances whose viability has been demonstrated, the trial period could be reduced to 6 months.