FDA发布《ANDAs：原料药中的杂质》最终版行业指南
ANDAs: Impurities in Drug Substances
FDA 发布最终版行业指南《ANDAs：原料药中的杂质》，对化学合成原料药杂质在 CMC 资料中的报告、鉴定与界定提出修订建议。指南适用于原始 ANDA、包括 II 型 DMF 的药物主文件，以及涉及原料药合成或工艺变更的 ANDA 补充申请。文件还给出建立原料药杂质可接受标准的建议，案卷编号为 FDA-1998-D-0021，发布时间为 2009 年 7 月。
该最终指南更新了化学合成原料药杂质在 CMC 资料中报告、鉴定与界定方面的建议，并涉及杂质可接受标准的建立。
GUIDANCE DOCUMENT
ANDAs: Impurities in Drug Substances Guidance for Industry July 2009
Final
- Docket Number:
- FDA-1998-D-0021
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides revised recommendations on what chemistry, manufacturing, and controls (CMC) information to include regarding the reporting, identification, and qualification of impurities in drug substances produced by chemical synthesis when submitting:
- Original abbreviated new drug applications (ANDAs)
- Drug master files (DMFs) including type II DMFs
- ANDA supplements for changes in the synthesis or processing of a drug substance
The guidance also provides recommendations for establishing acceptance criteria for impurities in drug substances.
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-1998-D-0021.
来源：FDA Pharmaceutical Quality Documents · fda.gov