FDA 发布符合 21 CFR 211.110 考量的指南草案
Considerations for Complying with 21 CFR 211.110
FDA 发布指南草案，说明符合 21 CFR 211.110 要求以确保批次均匀性和药品完整性的考量，该文件为草案、不供实施，案卷编号 FDA-2024-D-5374。草案还讨论采用先进制造生产的药品相关质量考量，以及生产商如何将工艺模型纳入商业生产控制策略。指南由 CDER、CBER 和 CVM 发布，公众可随时在线或书面提交意见。
草案拟说明符合 21 CFR 211.110 以确保批次均匀性的考量，并覆盖先进制造与工艺模型纳入控制策略的相关内容。
GUIDANCE DOCUMENT
Draft Level 1 Guidance
Not for implementation. Contains non-binding recommendations.
- Docket Number:
- FDA-2024-D-5374
- Issued by:
-
Guidance Issuing Office
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.
Submit Comments
You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))
If unable to submit comments online, please mail written comments to:
Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All written comments should be identified with this document's docket number: FDA-2024-D-5374.
来源：FDA Pharmaceutical Quality Documents · fda.gov