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Chemistry, Manufacturing, and Controls …

Guidance for Industry: Analytical Procedures and Method Validation GU042A ggmmppeeyyee www.gmpeye.co.kr 4 FOR NDAs, ANDAs, BLAs, AND PLAs) A. 공정서 미수재 분석 절차(Noncompendial Analytical Procedures) 1. 밸리데이션 특성 항목(Validation Characteristics) 2.

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