FDA 发布 PAT 最终指南，阐述创新药品开发、生产与质量保证框架

PAT—A Framework for Innovative Pharmaceutical Development, Manufacturing, and Quality Assurance

AI 导读

FDA 发布最终指南《PAT—创新药品开发、生产与质量保证框架》（编号 FDA-2003-D-0032），提出鼓励自愿研发和实施过程分析技术的监管框架。该指南由兽药中心、监管事务办公室和药品评价与研究中心共同发布。指南说明公众可随时就任何指南提交意见，书面意见需注明本文件编号并寄至 Dockets Management。

推荐理由

材料为 FDA 正式发布的指南，说明以过程分析技术支持创新药品开发、生产与质量保证的自愿性监管框架。

正文 · 原文

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2003-D-0032

Issued by:

Guidance Issuing Office

Center for Veterinary Medicine

Office of Regulatory Affairs

Center for Drug Evaluation and Research

This guidance is intended to describe a regulatory framework (Process Analytical Technology, PAT) that will encourage the voluntary development and implementation of innovative pharmaceutical development, manufacturing, and quality assurance. Working with existing regulations, the Agency has developed an innovative approach for helping the pharmaceutical industry address anticipated technical and regulatory issues and questions.

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-2003-D-0032.