Abstract
Every step of the development process of a veterinary product results in an improvement of its quality, efficacy, and safety until the process of optimization is completed resulting in the final product. It is judicious to generate information on the stability of the product throughout the entire development and scale-up process. Three major stages in the development of a drug product can be identified from a stability viewpoint: the initial development stage, in which the stability studies are designed to provide an insight into potential stability issues relating to the product; the pilot batch stage, in which the stability studies confirm that the process can be operated on a large scale to manufacture batches within specification and with uniform properties; the final product full scale manufacture stage, in which the stability studies are designed to provide on-going information which supports the shelf. This chapter discuses the aspects of stability test programs for the assessment of drug product which falls within the latter two stages of product development.