FDA 发布 Q4B 附件 3(R1) 微粒污染检查亚可见微粒通则最终指南
Q4B Annex 3(R1): Test for Particulate Contamination: Subvisible Particles General Chapter
FDA 发布 Q4B 附件 3(R1) 最终指南，针对微粒污染检查中的亚可见微粒通则。该附件由 Q4B 专家工作组对选取的药典文本作出评估与建议，以便在 ICH 地区被监管机构承认可互换使用，实施意在避免行业重复检验。文件编号为 FDA-2007-D-0306，由 CBER 与 CDER 发布。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2007-D-0306
- 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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Dockets Management
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All written comments should be identified with this document's docket number: FDA-2007-D-0306.
来源：FDA Pharmaceutical Quality Documents · fda.gov