FDA 发布 Q4B 附件 12 分析筛分通则最终指南
Q4B Annex 12: Analytical Sieving General Chapter
FDA 发布 Q4B 附件 12 分析筛分通则最终指南，文件编号 FDA-2009-D-0579，由 CDER 与 CBER 发布。该附件属 Q4B 系列，说明 Q4B 专家工作组对部分药典文本的评估与建议，以便其在 ICH 区域被监管机构认可为可互换使用。FDA 称实施 Q4B 附件旨在避免行业重复检验，并说明可就任何指南随时提交意见。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2009-D-0579
- Issued by:
-
Guidance Issuing Office
Center for Drug Evaluation and Research
Center for Biologics Evaluation and Research
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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Food and Drug Administration
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All written comments should be identified with this document's docket number: FDA-2009-D-0579.
来源：FDA Pharmaceutical Quality Documents · fda.gov