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ICH的原料药gmp规范英文版.pdf


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\\CDS018\CDERGUID\ for IndustryQ7A Good ManufacturingPractice Guidance for ActivePharmaceutical . Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)August 2001ICHGuidance for IndustryQ7A Good ManufacturingPractice Guidance for ActivePharmaceutical IngredientsAdditional copies are available from:Office of Training municationsDivision munications ManagementDrug Information Branch, HFD-2105600 Fishers LaneRockville, MD 20857(Tel) 301-827-4573() r/guidance/ Office munication, Training andManufacturers Assistance, HFM-40Center for Biologics Evaluation and Research Food and Drug Administration1401 Rockville Pike, Rockville, MD 20852-: r/: 1-888-CBERFAX or 301-827-3844Mail: the Voice Information System at 800-835-4709 or 301-827-. Department of Health and Human ServicesFood and Drug AdministrationCenter for Drug Evaluation and Research (CDER)Center for Biologics Evaluation and Research (CBER)August 2001ICHiTable Of ContentsI. INTRODUCTION (1)........................................................................................................... 1A. Objective ().................................................................................................................................1B. Regulatory Applicability ().......................................................................................................2C. Scope ().......................................................................................................................................2II. QUALITY MANAGEMENT (2) ......................................................................................... 5A. Principles ()................................................................................................................................5B. Responsibilities of the Quality Uni

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  • 时间2016-10-28