FDA 发布 Q4B 附件 4B(R1) 最终指南，涵盖非无菌产品指定微生物检查

Q4B Annex 4B(R1): Microbiological Examination of Nonsterile Products: Tests for Specified Microorganisms General Chapter

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FDA 发布 Q4B 附件 4B(R1) 最终指南，涉及非无菌产品指定微生物检查的相关药典通则。该附件属 Q4B 系列，由 Q4B 专家工作组对选定药典文本作出评估与建议，以便在 ICH 地区被监管机构认可为可互换使用，从而避免行业重复检验。文件编号为 FDA-2008-D-0398，由 CBER 和 CDER 发布，页面标注更新日期为 2017 年 9 月 18 日，公众可随时就该指南提交意见。

正文

GUIDANCE DOCUMENT

Final

Docket Number:

FDA-2008-D-0398

Issued by:

Guidance Issuing Office

Center for Biologics Evaluation and Research

Center for Drug Evaluation and Research

[updated 9/18/2017]

This annex is one in a series of guidance documents that describe the evaluations and recommendations by the Q4B Expert Working Group (EWG) of selected pharmacopoeial texts to facilitate their recognition by regulatory authorities for use as interchangeable in the ICH regions. Implementation of the Q4B annexes is intended to avoid redundant testing by industry. For general information on the Q4B process, the reader is referred to the core guidance Q4B Evaluation and Recommendation of Pharmacopoeial Texts for Use in the ICH Regions.

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All written comments should be identified with this document's docket number: FDA-2008-D-0398.