FDA 发布 CDER 药品质量相关自愿性共识标准认可计划最终指南

CDER’s Program for the Recognition of Voluntary Consensus Standards Related to Pharmaceutical Quality

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FDA 发布最终指南 FDA-2018-D-4417，说明 CDER 将公开一份药品质量相关已认可自愿性共识标准的完整清单。指南称 FDA 参与制定并使用此类技术标准，用于开发和评估剂型性能、检测方法、生产实践、产品标准、科学方案、成分规格和药品标签等。指南同时说明公众可随时按 21 CFR 10.115(g)(5) 在线或书面提交意见，书面意见须标注该文件编号。

推荐理由

材料说明 CDER 将公开已认可的自愿性共识标准清单，并列出这些标准在剂型、检测方法与生产实践中的用途，便于读者了解该计划的定位。

正文 · 原文

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2018-D-4417

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance describes a program at FDA’s Center for Drug Evaluation and Research (CDER) to make public a comprehensive listing of recognized voluntary consensus standards related to pharmaceutical quality. FDA’s participation in the development and use of technical voluntary consensus standards has been integral to the execution of FDA’s mission. For example, FDA has used such standards to develop and/or evaluate performance characteristics of dosage forms, testing methodologies, manufacturing practices, product standards, scientific protocols, ingredient specifications, labeling of drug products, and other technical or policy criteria.

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-2018-D-4417.