The ICH (International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals) is the pharmaceutical industry’s regulatory authority in the EU, Japan, and the US. Their document, “Q1A (R2) Stability Testing of New Drug Substances and Products”, is the most current revision used by the industry to conduct stability studies.
Purpose of Stability Testing
Stability Testing provides data that help assess a drug product’s stability and shelf life. The Q1A (R2) guidelines offer test parameters and durations for long-term, intermediate, and accelerated studies that can be used for drug products or combination devices.
Per Q1A (R2), “The purpose of stability testing is to provide evidence on how the quality of a drug substance or product varies with time under the influence of a variety of environmental factors, such as temperature, humidity, and light, and to establish a retest period for the drug substance or a shelf life for the drug product and recommended storage conditions.”
ICH Stability Testing
Three environmental conditions are used in the testing:
+25⁰C, 60%RH (Long-term)
+30⁰C, 65%RH (Long-term or intermediate)
+40⁰C, 75%RH (Accelerated)
The minimum recommended time is based on the storage condition. For example, the shortest duration is 6 months for an Accelerated study (+40⁰C, 75%RH), and 12 months for a Long-Term (+25⁰C, 60%RH).
WESTPAK has the stability chambers, facilities, experience, and package test capability that companies need to achieve compliance for their pharmaceutical products and packaging. In addition, custom storage conditions are available to satisfy unique, proprietary requirements.
ICH Q1A (R2)
(13) Stability Environmental Chambers with a variety of temperature and humidity levels
(65) Temperature and Humidity Chambers