Maximize Data for Post Approval Changes

Abstract

During the life of a drug product, it is almost certain that at some point, changes will be made, for example to the manufacturing process, the API material, or the formulation. For each change, it is necessary to demonstrate the acceptability of the proposed change, in order to prove that the specified change does not have an adverse effect on the product. The type of change will determine what type of stability data will be required to support it and to understand the impact on the stability profile of the drug product. An appropriate stability design must be developed to understand the impact of the change on the stability profile of the drug product and to demonstrate the acceptability of the proposed change. The type of change will dictate the amount of data needed and the type of regulatory reporting required. Guidance documents provide direction on the reporting category for different types of changes. For a proposed study design or data package that is different from the guidance documents, it is best to discuss the proposal with the regulatory agency first to obtain their opinion. This presentation will review the various reporting categories and provide stability strategies to support some specific types of changes, including some case examples of stability designs that have been conducted.