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Session 10: Q12 Updates
Session Chair(s)
M. Scott Furness, PhD
Deputy Director, Office of New Drug Products, OPQ, CDER
FDA, United States
The ICH Q12 Guidance entitled “Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management” was published on May 30, 2018. The 34 page draft aims to help facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceutical drug substances and drug products. The document also features a decision tree on established conditions for manufacturing and control, noting when notification or prior approval is necessary based on the level of potential risk of a proposed change. This session is intended to summarize the latest updates of the guidance and its associated concepts.
Speaker(s)
Speaker
Ashley Boam, MS
FDA, United States
Director, Office of Policy for Pharmaceutical Quality, OPQ, CDER