Stability Testing (or shelf life testing) is the major segment of pharmaceutical testing that Precision supports. This precise temperature and humidity storage allow manufacturers to accurately predict expiration dates for their drug substances and products as well as recommended storage conditions prior to usage. Our cGMP validated facility has been designed to meet Zones I-IV global submission requirements, providing you with the most accurate stability data possible.
Companies utilize our full suite of stability storage rooms and chambers that allow testing at the following recommended ICH conditions:
- Long-Term and Intermediate storage conditions of 25°C | 40%Rh, 25°C | 60%Rh, 30°C | 65%Rh, 30°C | 75%Rh
- Accelerated storage conditions of 40°C| not more than (NMT) 25%Rh, 40°C | 75%Rh
- Refrigerated and Freezer storage conditions of 2°C – 8°C (5°C), -20°C, and -80°C
The International Conference on Harmonization (ICH) guidelines Q1A(R2) defines the stability data needed for a new drug substance or product. It is integral to the registration process of United States, EU, and Japan and the systematic approach to stability evaluation.
Our standard SOPs direct the proper mapping and validation procedures to insure that all products stored at Precision fall with in the proper range of conditions specified by ICH.