FDA无菌生产指南-中英文对照版.docx

Translated from译/自： Guidance for Industry Sterile Drug Products Produced by Aseptic Processig Current Good Manufacturing Practice 行业指南 无菌加工生产的无菌药品 —现行的生产质量管理标准 (cGMP 〕 U.S. Department of Health and Human Services Food and Drug Administration Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER) Office of Regulatory Affairs (ORA) September 2004 Pharmaceutical CGMPs 学习文档 仅供参考 学习文档 仅供参考 Guidance for Industry Sterile Drug Products Produced by Aseptic Processig Current Good Manufacturing Practice Additional copies are available from: Office of Train