FDA发布终版指南，说明CMC上市后生产变更如何在年报中记录
CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports
FDA发布终版指南，列出可在年报中记录的CMC上市后生产变更类型，面向NDA和ANDA持有人。指南针对FDA认定对产品质量产生不利影响的可能性很小的变更。文件编号为FDA-2010-D-0283，FDA说明可随时就该指南提交意见。
该终版指南列出可在年报中记录的CMC上市后生产变更类别，便于NDA和ANDA持有人核对变更记录路径。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2010-D-0283
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
This guidance provides recommendations to holders of new drug applications (NDAs) and abbreviated new drug applications (ANDAs) regarding the types of changes to be documented in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes that we have determined will likely have a minimal potential to have an adverse effect on product quality and, therefore, should be documented by applicants in an annual report.
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-0283.
来源：FDA Pharmaceutical Quality Documents · fda.gov