Draft Guidance - Quality Considerations for Continuous Manufacturing

FDA is announcing the availability of a draft guidance for industry entitled Quality Considerations for Continuous Manufacturing.  This guidance provides information regarding FDA’s current thinking on the quality considerations for continuous manufacturing of small molecule, solid oral drug products that are regulated by the Center for Drug Evaluation and Research (CDER).  The guidance describes several key quality considerations and provides recommendations for how applicants should address these considerations in new drug applications (NDAs), abbreviated new drug applications (ANDAs), and supplemental NDAs and ANDAs, for small molecule, solid oral drug products that are produced via a continuous manufacturing process.  

FDA invites general comments to the docket on the quality considerations described in the draft guidance, including comments on control strategy, facility, and process validation considerations for continuous manufacturing of small molecule, solid oral drug products.  In addition to comments on the guidance generally, FDA is requesting comments and related supporting information on the following topics: 

 

(1) data storage and handling from process analytical technology systems

(2) potential approaches for situations where direct attribute measurement is not possible (e.g., low dose compounds)

(3) contract manufacturers employing continuous manufacturing, 

(4) risk-based reporting of routine model maintenance and updates, and 

(5) statistical approaches using large samples (e.g., Large N).  

FDA is seeking public comment on topics for potential inclusion in the final guidance or additional guidance and any other alternative approaches.  In addition to this guidance, pharmaceutical manufacturers with product-specific continuous manufacturing questions may submit a proposal to the Emerging Technology Program.