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ICH “Points to Consider” Part Two on Implementing Q8-10 Addresses Models, Design Space and Process Validation

ICH has released the second half of its “Points to Consider” (PTC) on implementing Q8-10 with advice on: ● the use of models ● development of design space as part of the control strategy, and ● the use of process validation and continuous verification strategies....

FDA’s ONDQA Bolsters its QbD Review Effectiveness

FDA is continuing to refine its quality-by-design (QbD ) review framework by creating QbD “CMC lead” and “liaison” positions within the Office of New Drug Quality Assessment (ONDQA), instituting an internal database of QbD application elements for use by reviewers, and increasing collaborative research between ONDQA and academia on QbD-focused topics....

Current Staffing Levels at China’s SFDA May Hinder QbD Submissions; Investigational-Stage Changes and Timelines Also at Issue

International pharma is expressing concern that the ability to put ICH Q8-10 principles into practice in China is hampered by the significant limitations in its current review manpower....

China’s CMC Harmonization Efforts Provide Opportunities for Industry Input

The China State Food and Drug Administration (SFDA) initiative to adopt selected international guidelines offers significant opportunities for industry to work closely with the agency to help it move toward a more science and risk-based approach to its CMC review process in line with the ICH model, industry regulatory experts are stressing....

Divergent Global Change Filing Requirements Present Continuous Improvement Roadblocks, Experts Stress at ICH Q10 Conference

The power of the advancing pharmaceutical quality systems to manage change and drive continuous improvement is being hampered by the disharmony and inflexibility of the CMC filing requirements across the globe, prominent industry and regulatory experts reemphasized at a quality systems/ICH Q10 conference in Arlington, Virginia in early October....

ICH “Points to Consider” on Implementing Q8-10 Addresses Control Strategy Development and Filing

ICH’s newly-released “Points to Consider” (PTC) on implementing Q8-10 underscores the need for QbD-based marketing applications to provide a scientific justification for the proposed control strategy, including enough information, clearly enough organized, for regulators to understand how the firm developed it....

Control Strategy is Nexus for QbD Regulatory Paradigm, US and EU Regulators Affirm

CMC review policy makers in the US and Europe are focusing increasing attention on the control strategy as the nexus for the advancing pharmaceutical quality-by-design regulatory paradigm....

Pfizer Finds QbD a “Large Value Proposition,” VP Migliaccio Tells DIA Annual Meeting

Pfizer’s assessment of its data on the impact of implementing quality by design indicates that QbD is “a very large value proposition,” Global Manufacturing Network Performance Senior VP Gerald Migliaccio reported at DIA’s Annual Meeting in Washington, D.C. on June 16....

QbD is Changing the Quality Regulatory Landscape in the US and EU

The quality regulatory initiatives underway as the new decade begins show the strong imprint of ICH Q8-10 at both the agency and international levels. The May 2010 issue of International Pharmaceutical Quality (IPQ) provides an in-depth analysis of how quality by design and the new Q8-10 paradigm is transforming the quality regulatory landscape....

Novo Nordisk QbD Initiative Gaining Traction Faster Than Anticipated

Novo Nordisk’s broad-reaching quality-by-design (QbD) initiative for protein development is gaining traction faster than the company had anticipated, fueled by buy-in from top management and the production department....
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