FDA 发布 Q13 原料药和制剂连续制造指南最终版
Q13 Continuous Manufacturing of Drug Substances and Drug Products
FDA 发布 Q13 原料药和制剂连续制造指南最终版，文件标注为 2023 年 3 月定稿。该指南基于现有 ICH 质量指南，说明连续制造在开发、实施、运行与生命周期管理中的科学与监管考量，并澄清连续制造相关概念。文件编号为 FDA-2021-D-1047，由 CDER 发布。
该最终指南说明连续制造在开发、实施与生命周期管理中的科学与监管考量，可用于了解 FDA 对连续制造的监管定位。
GUIDANCE DOCUMENT
Q13 Continuous Manufacturing of Drug Substances and Drug Products Guidance for Industry March 2023
Final Level 1 Guidance
- Docket Number:
- FDA-2021-D-1047
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance describes scientific and regulatory considerations for the development, implementation, operation, and lifecycle management of continuous manufacturing (CM). Building on existing International Council for Harmonization (ICH) Quality guidances, this guidance provides clarification on CM concepts and describes scientific approaches and regulatory considerations specific to CM of drug substances and drug products.
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-2021-D-1047.
来源：FDA Pharmaceutical Quality Documents · fda.gov