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Session 8A: Process Validation/Continuous Verification for APIs: Challenges and Potential Benefits
Session Chair(s)
Jean-Louis Robert, PHD
Former CHMP/CVMP QWP Chair, Luxembourg
A major element of the new paradigm in pharmaceutical quality, besides science and risk management, is the life cycle approach as described in ICH Q10. Continuous verification strategies form the basis for handling life cycle maintenance. These strategies can enable continuous improvement and process optimization by continuously collecting information, allowing for better scientific understanding of both process and product. The session will present the regulatory expectation for process validation and process verification. Two drug substance examples, chemical and bio, will highlight the benefit of continuous verification strategies compared to traditional process validation.
Speaker(s)
Jean-Louis Robert, PHD
Former CHMP/CVMP QWP Chair, Luxembourg
Process Validation/Process Verification: A Regulatory Perspective
Thomas Gervais, PHD
Associate Director, Process Life Cycle Management, Bristol-Myers Squibb, United States
A Risk-Based Approach to Process Validation Using QRM Principles and Practices
Kevin Seibert, PHD, MS
Engineering Fellow, Synthetic Molecule Design and Development, Eli Lilly and Company, United States
Process Validation and Continuous Verification; Leveraging Process Models for the Manufacture of a Small Molecule Semi-Continuous Process
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