FDA Draft Guidance on 'Quality Considerations for Continuous Manufacturing'
On February 27, 2019, FDA issued a Draft Guidance on Quality Considerations for Continuous Manufacturing.
This draft guidance applies to the development and implementation of continuous manufacturing for small molecule, solid oral drug products regulated by CDER and submitted as NDAs, ANDAs, supplemental NDAs, and ANDAs.
Benefits of continuous manufacturing include shorter processing times thanks to the use of an integrated process with fewer steps, application of QbD principles and process analytical technology application, real-time product quality monitoring, process scalability, batch-to-batch consistency, etc. which collectively may lead to reduced risks of drug shortages and reduced need for some post-approval regulatory submission.