The purpose of stability testing is to ensure that the product maintains its characteristics throughout its shelf life when stored under reasonably foreseeable storage conditions. The information that is derived after conducting a stability test ensures that unstable products will never be produced or marketed.
Stability is a necessity according to Annex I of Regulation (EC) 1223/2009.
Apart from the product stability another very important asset that needs to be taken into consideration before placing a product on the market is the product-immediate container compatibility.
Since there are no set rules on how to conduct a test the conditions of the market, the type of the product, the type of the container, the normal storage conditions etc should be taken into consideration when establishing a stability protocol.
Answers to the below questions will be given:
• How do I choose my Stability Test protocol?
• Do I always need a Stability Test or are there alternatives?
• Do I always need to run Stability Test with a certified lab?