Being an essential component of pharmaceutical development, stability studies allow the evaluation of product stability under the influence of various environmental conditions. These include temperature, humidity and light, simulating different climatic zones from around the world. The data from such studies can be used by the client to establish recommended storage conditions, retest periods and shelf life.
ALS offer ICH stability storage and testing programmes for a wide range of APIs, pharmaceuticals, biopharmaceuticals, medical devices, chemicals and cosmetics, whether required for initial product registration and/or Product Quality Review (PQR). Our purpose-built walk-in stability rooms are fully validated to meet GMP regulations and can be utilised for both long term and short-term shelf life studies. All rooms are monitored in real time and our monitoring systems are fully validated and compliant with 21 CFR Part 11 requirements.We operate emergency back-up facilities on site, allowing business continuity and complete peace of mind for our clients.
We can provide a solution tailored to your requirements - storage only or full storage plus testing. Samples can be stored and scheduled for testing or shipped to your chosen location at each time point or as required.
Subtropical and Mediterranean climate
Hot and dry climate
Hot and humid climate
Hot and very humid climate
Stability storage conditions available:-
ALS also offer photostability testing in accordance with ICHQ1B (option 2).