By: Thomas O’Connor, Sr. Chemical Engineer, US FDA
FDA is committed to supporting and enabling pharmaceutical innovation and modernization as part of the Agency’s mission to protect and promote public health. FDA recognizes that continuous manufacturing is an emerging technology that can enable pharmaceutical modernization and deliver potential benefits to both industry and patients. Continuous manufacturing can improve pharmaceutical manufacturing by, for example, using an integrated process with fewer steps and shorter processing times; requiring a smaller equipment footprint; supporting an enhanced development approach (e.g., quality by design (QbD) and use of process analytical technology (PAT) and models); enabling real-time product quality monitoring; and providing flexible operation to allow scale-up, scale-down, and scale-out to accommodate changing supply demands.
FDA has gained experience with continuous pharmaceutical manufacturing through discussions with academia and industry at public workshops, early dialogue with sponsors through the Emerging Technology Program, externally funded and internal research, and the review and approval of five drug applications utilizing continuous manufacturing to date. Currently, the bulk of the FDA’s experience has been with continuous manufacturing of small molecule, solid oral drug products, which is the scope of the recently published draft guidance on Quality Considerations for Continuous Manufacturing.
This guidance focuses on scientific and regulatory considerations that are specific or unique to continuous manufacturing. These considerations include process dynamics, batch definition, control strategy, pharmaceutical quality system, scale-up, stability, and bridging of existing batch manufacturing to continuous manufacturing. The intent of guidance is to foster wider adoption of continuous manufacturing by providing clarity to sponsors, and by serving as a foundation for international harmonization (i.e. ICH Q13). FDA will continue to engage and work with stakeholders as we move forward recognizing that the modernization of pharmaceutical manufacturing technology is a mutually beneficial approach to increase manufacturing efficiency, improve overall drug quality, avoid shortages, and prepare for future challenges.
View the on-demand webinar to learn how continuous manufacturing can improve pharmaceutical manufacturing by:
- Using an integrated process with fewer steps and shorter processing times
- Requiring a smaller equipment footprint
- Supporting an enhanced development approach (e.g., quality by design (QbD) and use of process analytical technology (PAT) and models)
- Enabling real-time product quality monitoring
- Providing flexible operation to allow scale-up, scale-down, and scale-out to accommodate changing supply demands