Analytical approaches to ensure product quality -- AAPS Joint Face-to-Face Meeting of the Stability, the Pharmaceutical Impurities, and the CMC Statistics Focus Groups, April 6th, 2016 in Gaithersburg, MD

Abstract

Abstract An AAPS joint face-to-face meeting was held on April 6th, 2016 at MedImmune, Gaithersburg, MD. The meeting was organized by members of the Steering Committees of the Stability Focus Group, the Pharmaceutical Impurities Focus Group and the Chemistry, Manufacturing and Controls (CMC) Statistics Focus Group. Twenty two subject-matter-experts (SME) from the Industry and the Food & Drug Administration (FDA) participated as discussion facilitators or discussion leaders. The total participants reached 65 people representing various sizes of pharmaceutical companies. Four contemporary technical topics on analytical approaches to ensure product quality were selected to be discussed and shared information: (1) Approaches to set release limits and managing method variability; (2) Ensure product quality through lifecycle management; (3) Best practices for predictive stability programs; and (4) ICH Guideline M7 and mutagenic impurities. The purpose of the meeting was to share the best practices in the industry related to the topics; therefore, it is not intended for the participants to reach a consensus on the key issues discussed. This paper summarizes the discussions in the meeting.

Keywords

• Drug Substance
• Release Limit
• Life Cycle Management
• Product Lifecycle Management
• Stability Profile