Annual Stability

Annual Stability is a regulatory requirement for all licensed products. The purpose of an Annual Stability study is to monitor the quality of a product under its storage conditions over its shelf life. We test one batch per year of product manufactured in every strength, as well as every primary packaging type to meet the annual stability regulation.

BCM Analytical Services

BCM Analytical Services monitor and maintain annual stability programs.We do this for many customers across a variety of products and pack types. We have a range of ICH stability chambers set at controlled temperatures and humidity. These are fully monitored both internally and externally. We do this to ensure that stability trials fulfil all regulatory and GMP requirements.

ALSO SEE:   STABILITY STUDIES   STORAGE   SPECIALIST STUDIES