One of FDA’s major goals is to modernize the regulation of pharmaceutical manufacturing and enhance product quality. As part of its comprehensive approach to quality oversight across the drug product lifecycle, CDER conducts research to support the development of scientific standards and policies related to quality, safety, and effectiveness of human drug products.
Product quality research studies help to address unresolved regulatory science questions and prepare the organization for emerging science issues and technologies. Results from this research have directly informed review decisions, impacted or revised agency guidance and policies, and protected the public health by ensuring that high-quality products reach the American people.
Below are a few examples of the many product quality research programs supported by CDER.
Drug shortages and product recalls are commonly related to shortcomings in product or facility quality including the utilization of outdated technologies and equipment. CDER places great emphasis on improvements in manufacturing technologies and on research in emerging manufacturing technologies. Continuous manufacturing, a process in which the finished drug product is produced in a continuous stream rather than step-wise in batches, has great potential for bringing agility, flexibility, and robustness to the manufacture of pharmaceuticals.
CDER initiated a project in partnership with collaborators from Rutgers University and the University of Massachusetts Lowell to develop a simulation and modeling platform for continuous pharmaceutical manufacturing processes. Research using this platform will aid in the science- and risk-based review and inspection of integrated continuous manufacturing processes and control strategies. The platform will help to:
- identify critical material attributes and process parameters using sensitivity analysis
- facilitate real-time release testing
- enable the implementation of new advance process control approaches
- facilitate the evaluation of risk mitigation approaches
A project aiming to demonstrate the implementation of advanced process control (e.g., feedforward model predictive control) for continuous flow reactors has been initiated through an external collaboration.
- Lee, SL. et al. “Modernizing Pharmaceutical Manufacturing: from Batch to Continuous Production.” Journal of Pharmaceutical Innovation. 2015.
- Escotet-Espinoza, MS. et al. “Flowsheet Models Modernize Pharmaceutical Manufacturing Design and Risk Assessment.” Pharmaceutical Technology. 2015.