Stability and stress testing are essential analyses for pharmaceutical development and production and are used to determine the shelf life of a drug. In this case, an analysis is performed to determine whether the pharmaceutical formulation complies with the defined specifications after storage and transport.
For this purpose, samples are taken of the materials and they are stored under controlled conditions (for example, temperature, brightness, humidity) for the duration of the testing. At specified time points during the testing, samples with be retrieved from the various conditions and tested according to a predefined quality control plan. Furthermore, primary products and substances can be analyzed to test stability.
The stability and stress tests are performed in accordance with GMP (Good Manufacturing Practice) guidelines and in accordance with the international standards based on the “International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use” (ICH).
A summary of stability and stress testing:
as needed, storage of the stability and stress samples under controlled conditions