FDA发布药用与医疗器械用肝素粗品质量监测最终指南
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality
FDA发布最终行业指南，提示粗品肝素存在污染风险，涉及原料药生产商、制剂与医疗器械生产商及分装商等。该指南为2013年6月定稿版本，文件编号FDA-2012-D-0083，由兽药中心、药品评价与研究中心和器械与放射健康中心共同发布。指南说明可按21 CFR 10.115(g)(5)随时提交意见，书面意见需标注该文件编号。
该定稿指南提示粗品肝素存在污染风险，并列出原料药、制剂与医疗器械生产商、分装商等需要关注的对象。
GUIDANCE DOCUMENT
Heparin for Drug and Medical Device Use: Monitoring Crude Heparin for Quality Guidance for Industry June 2013
Final
- Docket Number:
- FDA-2012-D-0083
- Issued by:
-
Guidance Issuing Office
Center for Veterinary Medicine
Center for Drug Evaluation and Research
Center for Devices and Radiological Health
This guidance is intended to alert manufacturers of active pharmaceutical ingredients (APIs), pharmaceutical and medical device manufacturers of finished products, repackers, and others to the potential risk of crude heparin contamination.
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-2012-D-0083.
来源：FDA Pharmaceutical Quality Documents · fda.gov