There are several different types of stability programs throughout the drug product life cycle, starting with the determination of the stability of the new drug, and proceeding through to the confirmation of the expiry date of the marketed batches as predicted by the development programs. Most of these programs generate data only very slowly and thus usually need to be carefully managed because of the cost benefit factors involved. Since products can change either because of imposed change control (e.g. for regulatory, quality or fiscal reasons) or external imposition (e.g. a supplier does not inform the firm of a change), it is usually necessary for many of the stability programs to be continuous in fulfilling the ultimate objective of always knowing the dating for the drug product with a high degree of confidence. This course discusses in detail the elements of the different types of developmental and market product programs and how they can be designed and operated. Because stability programs usually rapidly become expensive, particular attention is given as to how the principles of risk management can be applied to minimize cost.

The topics in this course include the following:

• Objectives & basic approaches of stability testing

• Stability testing throughout the product life cycle

• Regulatory aspects: FDA, ICH, EU, Health Canada & USP

• Meaning of Mean Kinetic temperature

• Stability test methodology including updating & validation • Stability protocols

• Program cost optimization & incorporating risk management

• Detailed aspects of developmental programs

• Detailed aspects of market batch programs

• Role of Change Control

• Statistical analysis of stability data

• Handling the retain program

• Treatment of OOS and OOT data & situations

• Policy/SOP aspects