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| Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers | |||
|---|---|---|---|
| 분류 | GMP, Guidance | 조회 | 2838 |
| 발행년도 | 2012 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This guidance provides recommendations for biological product, drug, and device firms on FDA’s current thinking concerning the testing recommendations and acceptance criteria in the United States Pharmacopeia (USP) Chapter <85> Bacterial Endotoxins Test, USP Chapter <161> Transfusion and Infusion Assemblies and Similar Medical Devices, and the Association for the Advancement of Medical Instrumentation (AAMI) ST72:2002/R2010, Bacterial Endotoxins—Test Methodologies, Routine Monitoring, and Alternatives to Batch Testing (AAMI ST72).
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