Contract Manufacturing Arrangements for Drugs: Quality Agreements | |||
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분류 | GMP, Guidance | 조회 | 3295 |
발행년도 | 2013 | 등록일 | 2015-10-02 |
출처 | FDA (바로가기) | ||
This guidance describes our current thinking on defining, establishing, and documenting the responsibilities of each party (or all parties) involved in the contract manufacturing of drugs subject to Current Good Manufacturing Practice (CGMP).
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이전글 | ACR Guidance Document on MR Safe Practices:2013 |
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다음글 | Heparin for Drug and Medical Device Use: Monitoring Crude |