Draft Guidance for Industry Quality Considerations for Continuous Manufacturing
This draft guidance encourages applicants to adopt specific or unique scientific and regulatory considerations for continuous manufacturing. The continuous manufacturing is an intergrated process that consists of a series of two or more unit operations. These considerations include process dynamics, batch definition, control strategy, pharmaceutical quality system, scale-up, stability and bridging of existing batch manufacturing to continuous manufacturing.
This emerging technology would provide potential benefits to both industry and patients. For example: using an integrated process with fewer steps, supporting an enhanced development approach i.e., quality by design (QbD) , use of process analytical technology (PAT), models enabling real-time product quality monitoring, providing flexible operation to allow scale-up, scale-down and scale-out to accomodate changing supply demands techniques would enable industrialists to reduce drug product quality issues and improve availability of quality medicines to patients.
For details please refer to the link provided below: