FDA 发布 Q4B 附件 14 细菌内毒素检查法通则最终指南
Q4B Annex 14: Bacterial Endotoxins Test General Chapter
FDA 发布 Q4B 附件 14《细菌内毒素检查法通则》最终指南，文件编号 FDA-2010-D-0343，由 CDER 与 CBER 共同签发。该附件是 Q4B 系列文件之一，说明 Q4B 专家工作组对选定药典文本的评估与建议，以促进其在 ICH 区域内被监管机构互认，从而避免行业重复检验。指南可通过在线或书面方式随时提交意见。
材料说明 Q4B 附件 14 就细菌内毒素检查法通则给出评估与互认建议，可帮助读者了解 ICH 区域避免重复检验的安排。
GUIDANCE DOCUMENT
Final
- Docket Number:
- FDA-2010-D-0343
- 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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All written comments should be identified with this document's docket number: FDA-2010-D-0343.
来源：FDA Pharmaceutical Quality Documents · fda.gov