FDA发布眼科局部给药产品质量考量指南草案并征求意见

Quality Considerations for Topical Ophthalmic Drug Products

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FDA发布《眼科局部给药产品质量考量》指南草案，就微生物、可见颗粒物、可提取物与浸出物及杂质降解产物、稳定性等提出建议。草案为Level 1指南，标注不适用于实施，属非约束性建议，并载明编号FDA-2023-D-4177，可随时提交意见。文件还将体外释放或溶出试验列为部分眼科剂型的可选质量控制策略，并涵盖容器密封系统的设计、给药与分装特征。

推荐理由

草案列出眼用局部给药产品在微生物、颗粒物、可提取物与浸出物及稳定性方面的质量考量，可供核对适用范围。

正文 · 原文

GUIDANCE DOCUMENT

Draft Level 1 Guidance

Not for implementation. Contains non-binding recommendations.

Docket Number:

FDA-2023-D-4177

Issued by:

Guidance Issuing Office

Center for Drug Evaluation and Research

This guidance discusses certain quality considerations for ophthalmic drug products (i.e., gels, ointments, creams, and liquid formulations such as solutions, suspensions, and emulsions) intended for topical delivery in and around the eye. Specifically, the guidance discusses:

Microbiological considerations.
Approaches to evaluating visible particulate matter, extractables and leachables, and impurities and degradation products.
Use of in vitro drug release/dissolution testing as an optional quality control strategy for certain ophthalmic dosage forms.
Recommendations for design, delivery, and dispensing features of container closure systems (CCSs).
Recommendations for stability studies.

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-2023-D-4177.