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| Current Good Manufacturing Practice - Interim Guidance for Human Drug Compounding Outsourcing Facilities Under Section 503B of the FD&C Act | |||
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| 분류 | GMP, Guidance | 조회 | 3495 |
| 발행년도 | 2014 | 등록일 | 2015-10-02 |
| 출처 | FDA (바로가기) | ||
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This interim guidance describes FDA’s expectations regarding compliance with current good manufacturing practice (CGMP) requirements for facilities that compound human drugs and register with FDA as outsourcing facilities under section 503B of the Federal Food, Drug, and Cosmetic Act (FD&C Act).
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 이전글 |
Guidance for Industry: Pyrogen and Endotoxins Testing: Questions and Answers |
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 다음글 |
Current Good Manufacturing Practice Requirements for Combination Products |
