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Risk-based CMC Review and Quality Assessment: How Well is it Working?
Monday, November 12
2:00 pm – 4:30 pm
Symposium
ACPE #073-999-07-558-L04
Risk based regulatory scrutiny, based on risk-based CMC review, is associated with the level of scientific understanding of product composition and manufacturing process. In the current review system, product quality and performance are primarily established and confirmed by end product testing. The present review system places little or no scrutiny on how the design of an effective manufacturing process, drug product specifications and acceptance criteria are adequate to ensure product quality. With the introduction of Quality-by-Design principles and Process Analytical Technologies in manufacturing processes, companies can better assess and monitor critical drug product attributes and product performance. Since the FDA moved to a risk based CMC review in 2004, several companies have gained considerable experience via the FDA pilot program for review of CMC information. This symposium is intended to discuss both Agency and Industry perspectives from the risk based CMC review practices and any learnings from the FDA pilot program. In addition, a review of the QbD principles in dosage form development and how these can streamline drug product review practices will be the subject of this discussion.
Moderators
Sanjay Sehgal, Ph.D.
Wyeth Pharmaceuticals
Robert Bell, Ph.D.
Drug & Biotechnology Development, LLC
Risk-based Pharmaceutical Quality Assessment: An FDA Perspective
Moheb M. Nasr, Ph.D.
U.S. Food and Drug Administration
FDA Proposal for Risk Based Regulatory Quality Assessment: Approaches to Managing Regulatory Uncertainties
Ajaz Hussain, Ph.D.
Sandoz
Risk-based Pharmaceutical Quality Assessment – An Industry Perspective
Jeffrey J. Blumenstein, Ph.D.
Pfizer, Inc.