ABSTRACT
The goal of a pharmaceutical product development program is to successfully register and launch a drug product in global markets. Stability data are also used to build a knowledge base describing the chemical and physical attributes of the product and what environmental factors. Stability testing for product registration is one area covered by International Conference on Harmonisation guidance documents. Stability testing begins as part of the initial characterization of a potential new molecular entity. This early experimental work provides information on the chemical stability properties of the compound and is used to assess promising compounds for product development. Temperature excursion/cycling studies are done to study the effects of short-term temperature excursions that a drug product may experience during shipping, distribution, and storage. A verification of stability during shipping can be done by either modeling the shipping routes or sending samples through the shipping process. Interactions between the container closure system and the product could impact quality and stability.
