Quality Considerations for Continuous Manufacturing

Guidance for Industry – DRAFT GUIDANCE – pdf download at the end of the text.

This guidance document is being distributed for comment purposes only.

Development and Applications of a Material Library for Pharmaceutical Continuous Manufacturing of Solid Dosage Forms

Comments and suggestions regarding this draft document should be submitted within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit electronic comments to https://www.regulations.gov. Submit written comments to the Dockets Management Staff (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. All comments should be identified with the docket number listed in the notice of availability when published in the Federal Register.

For questions regarding this draft document, contact (CDER) Sau L. Lee at 301-796-2905

Download draft guidance here: quality-considerations-for-continuous-manufacturing_1551719839.pdf

continuous manufacturing