The FDA has purchased a GEA ConsiGma™ 1 OSD development unit, which is housed in the CDER/OPQ (Office of Pharmaceutical Quality). The GEA ConsiGma™ 1 will be an important asset for continuous manufacturing research within the OPQ Office of Testing and Research and Emerging Technologies Team.
The FDA/CDER/OPQ mission is to ensure that safe, effective, high quality drugs are available for the American public. Established in 2015, OPQ encourages and supports development and adoption of emerging technology to modernize pharmaceutical development and manufacturing.
In development, scientist and engineers need to investigate the capability of their processes and develop strategies to avoid or manage the effects variability from various sources. The GEA ConsiGma™ 1 enables development of granules following QbD principles via fast DOE approaches with controlled continuous operation, providing an opportunity to explore a wider range of process parameters with less product and less time. The result is much better process understanding in a shorter time and with lower costs.