FDA adopts ICH guidance on continuous manufacturing

2023-03-02

After completing all four steps of the ICH’s guideline process, the FDA joined with its European regulatory colleagues in adopting this latest quality-related guideline on continuous manufacturing, known as Q13. The 42-page guidance , which has been in the works since 2018, clarifies continuous manufacturing concepts, describes the various scientific approaches that can be used, and presents regulatory considerations specific to this type of manufacturing for both drug substances and finished products. ICH noted that the guidance focuses on continuous manufacturing systems where two or more unit operations are directly connected, as well as guidance on the development, operation and management of continuous manufacturing systems. Drugmakers initially sought tweaks to the ICH guidance in Dec. 2021, with some seeking more clarity on how it would align with prior FDA draft guidance. An FDA spokesperson told Endpoints that this latest ICH guidance should be read in tandem with other FDA guidance on continuous manufacturing. According to a report from US Pharmacopeia, continuous manufacturing is implemented by several larger pharmas and does have advantages in boosting output, increasing efficiency and reducing environmental impact. However, there are high startup costs with implementing the process, USP said.

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