FDA发布ANDA药品杂质行业指南最终版（FDA-2010-D-0584）
ANDAs: Impurities in Drug Products
FDA发布行业指南《ANDAs：药品中的杂质》最终版，Docket编号FDA-2010-D-0584，由CDER签发，文件标注为2010年11月。指南就ANDA申报者在提交时，针对药品中列为降解产物的杂质，应在报告、鉴定和界定方面纳入哪些CMC信息给出建议。文件说明可随时就该指南提交评论，书面评论须注明其案卷编号FDA-2010-D-0584。
文件说明ANDA申报中降解产物类杂质的报告、鉴定与界定应包含哪些CMC信息，便于读者定位需核对的内容。
GUIDANCE DOCUMENT
ANDAs: Impurities in Drug Products Guidance for Industry November 2010
Final
- Docket Number:
- FDA-2010-D-0584
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations on what chemistry, manufacturing, and controls (CMC) information sponsors should include regarding the reporting, identification, and qualification of impurities that are classified as degradation products in drug products when submitting.
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-2010-D-0584.
来源：FDA Pharmaceutical Quality Documents · fda.gov