Manufacturing and Production

Stability Studies and Shelf Life Determination for Medicines

A shelf life is a commitment that a medicine will still meet specification years after it left the factory, made on the strength of data collected before it was ever sold. This course covers generating data that supports the claim. Delegates work through the purpose of stability testing and the difference between long term, intermediate and accelerated conditions. Climatic zones are addressed directly, since much of this region falls into the hottest and most humid zone and data generated for temperate markets does not transfer. Study design follows: batch selection, container closure, orientation, bracketing and matrixing. Testing schedules and the attributes that must be followed are covered. Stability indicating methods are addressed, including forced degradation and specificity. Data evaluation and shelf life extrapolation are covered with their statistical basis and their limits. Ongoing stability programmes and post approval commitments follow. Out of specification and out of trend results are addressed. The course closes on storage statements and on transport excursions.