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He began the presentation by defining pharmaceutical quality as an assurance that every dose of a drug is safe, effective, and free of contamination and defects. Then, he elaborated on four key themes: innovation in a changing world, challenges and opportunities within that endeavor, importance of advanced manufacturing, and regulatory framework.
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Motivation for the Study Innovation in pharmaceutical manufacturing will require the identification of ways to fulfill the desire for an agile, flexible manufacturing sector that can produce high-quality drugs reliably without extensive regulatory oversight. Statement of Task • Identify emerging technologies that have the potential to advance pharmaceutical quality and modernize manu facturing for CDER-regulated products, • Describe technical and regulatory issues associated with innovations, and • Recommend how to overcome regulatory issues to facilitate adoption of novel technologies.
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CDER should examine internal practices to increase technical fluency among its scientists through such actions as evaluating priorities in hiring and retention practices and ensuring that staff development plans support continuous education on innovative technologies. • Advance innovative mechanisms for evaluating technology outside product approvals.
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FDA will continue to approve evaluating technology outside product applications based on drug products approvals • ETP currently offers a non-product specific track that allows feedback on a proposed emerging technology • Through ETP, OPQ has adopted risk-based approaches to streamline implementation of technologies over multiple products using the existing regulatory framework • OPQ will streamline, when possible, the regulatory approaches for implementing a new technology as post approval changes Increase external engagement to facilitate • Consortia can apply to ETP to discuss and receive recommendations from ETP innovation and increase awareness of • ETP 2.0 plans to update its website readiness of CDER to evaluate innovative • OPQ already supports extramural research and training in advanced manufacturing technology Additional opportunities under consideration: • Create ways to improve knowledge transfer from intramural and extramural research to aid quality assessment of new technologies • Offer more training opportunities to assessor and investigators Expand leadership role in global regulatory • OPQ currently works with ICH to develop guidelines on: harmonization efforts • Continuous Manufacturing of Drug Substances and Drug Products (ICH 13) a • Analytical Procedure Validation and Development (ICH Q2(R2)
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Settimi listed process intensification, advanced process control and automation, and modular systems as innovative technologies identified in the 2021 National Academies report that met all three criteria. "These will have a path forward for adoption or commercialization because there is a tangible business impact," said Settimi.
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Direct Sponsor Interaction The first major mechanism was direct sponsor interaction, where GSK would build relations with agencies through existing programs. Arden listed the following domestic and international platforms as examples: ETP or ETT, CBER, Advanced Technologies Team, Center for Devices Innovation Group, European Medicines Agency's (EMA's)
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Ransohoff, Co-Head of the Biologicals Franchise at Resilience, Dolores Hernan, Chemical Manufacturing Control Regulatory Specialist at EMA, Malcolm Barratt-Johnson, Managing Director at PharmaMedic Consultancy Ltd., and Mike Hourigan, Founder and Managing Director at Horizon Controls Group and Founder and President at International Academy of Automation Engineering, all spoke on this topic. Ransohoff stated that one of the biggest challenges to deploying innovative technologies is in the perception of risk.
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When asked about regulatory risks in business decisions related to innovations in manufacturing processes, some audience members highlighted protracted regulatory reviews, whereas others highlighted either clarity and consistency in the evaluation of residual risk to product quality or satisfying regulatory requirements across different geographic areas. POSSIBLE SOLUTIONS AND ACTIONS In session four, speakers shared viewpoints on possible actions that can be taken by stakeholders to introduce innovative technologies in pharmaceutical manufacturing.
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Additionally, training CDER and ORA staff in innovative technologies at CDER's Research Manufacturing Pilot Plant are actions taking place. Finally, collaborating with stakeholders outside of CDER is also an activity FDA is conducting to improve regulatory oversight of advanced manufacturing.
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Reklaitis referenced Muzzio and Kelvin Lee's talks, where the impetus for moving technology forward should be focused on the patient's interest. Rogers stated that while there is significant effort within FDA to enable new technologies, a misalignment between the pharmaceutical manufacturing community's incentives and FDA is evident.
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Q3. What is the business case to support advanced manufacturing?
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In the end, he emphasized the importance for different stakeholders to come together and work toward a common goal of using advanced manufacturing to deliver safe products. He said, "Let's take what we've learned and use manufacturing innovation to give patients and consumers more confidence and better quality in their next dose of medicine that they take." DISCLAIMER: This Proceedings of a Workshop -- in Brief was prepared by Linda Nhon as a factual summary of what occurred at the workshop.
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