FDA无菌生产指南中英文对照版技术方案.doc

Translated from / 译自： Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — 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规范(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  Guidance for Industry Sterile Drug Products Produced by Aseptic Processing — Current Good Manufacturing Practice Additional copies are available from: Office of Training and C