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Risk-Based CMC Review Proposals: Issues and Challenges

Risk-Based CMC Review Proposals: Issues and Challenges. Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA. Desired State. Product quality and performance achieved and assured by design of effective and efficient manufacturing processes

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Risk-Based CMC Review Proposals: Issues and Challenges

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  1. Risk-Based CMC Review Proposals:Issues and Challenges Moheb M. Nasr, Ph.D. Acting Director Office of New Drug Chemistry (ONDC) OPS, CDER, FDA Advisory Committee For Pharmaceutical Sciences (ACPS), October 22, 2003

  2. Desired State • Product quality and performance achieved and assured by design of effective and efficient manufacturing processes • Product specifications based on mechanistic understanding of how formulation and process factors impact product performance • Continuous “real time” assurance of quality • Regulatory policies tailored to recognize the level of scientific knowledge supporting product applications, process validation, and process capability Advisory Committee For Pharmaceutical Sciences (ACPS), October 22, 2003

  3. Issues and Challenges • Risk-Based CMC Proposal • Evolved over the last few years • Good efforts and forward thinking • Multi-Tiered (product and/or process specific) • Product Quality (PQ) for the 21st Century Initiative • Multifaceted and much bigger Initiative • Integrated CMC and GMP Assessment • Quality by Design (QbD)/Pharmaceutical Development as a mean to delineate risk and regulatory scrutiny • New and proposed approaches • Interim Specification • Post approval comparability protocols/Custom SUPAC • Next Steps • Does Risk-Based CMC Proposal fit into the new PQ Initiative? • How can we integrate this proposal (1st tear) into the PQ initiative? Advisory Committee For Pharmaceutical Sciences (ACPS), October 22, 2003

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