January 2025
Docket Number: FDA-2024-D-5374
Issued by: Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
Center for Veterinary Medicine
This guidance, when finalized, will describe considerations for complying with the requirements in 21 CFR 211.110 to ensure batch uniformity and drug product integrity. In addition, this guidance discusses related quality considerations for drug products that are manufactured using advanced manufacturing. It also discusses how manufacturers can incorporate process models into commercial manufacturing control strategies.
Posted in Drugs, FDA and USDA Regulatory Update.