FDA发布原料药GMP指南Q7最终版
Q7 Good Manufacturing Practice Guidance for Active Pharmaceutical Ingredients
FDA发布《Q7原料药药品生产质量管理规范指南》最终版，文件编号FDA-1995-D-0288，由生物制品评价与研究中心和药品评价与研究中心发布。该指南就质量管理体系下的原料药生产提供GMP指导，旨在帮助确保原料药具备其标示的质量和纯度特性。公众可按21 CFR 10.115(g)(5)在线或书面提交意见。
材料说明该最终指南适用于质量管理体系下的原料药生产，并列出文件编号与意见提交途径。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-1995-D-0288
- Issued by:
-
Guidance Issuing Office
Center for Biologics Evaluation and Research
Center for Drug Evaluation and Research
This document is intended to provide guidance regarding good manufacturing practice (GMP) for the manufacturing of active pharmaceutical ingredients (APIs) under an appropriate system for managing quality. It is also intended to help ensure that APIs meet the quality and purity characteristics that they purport, or are represented, to possess.
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-1995-D-0288.
来源：FDA Pharmaceutical Quality Documents · fda.gov