Office of Pharmaceutical Science, Center for Drug Evaluation and Research, U.S. Food and Drug Administration, Building 51, Room 4166, 10903 New Hampshire Avenue, Silver Spring, Maryland 20993-0002, USA.
AAPS PharmSciTech. 2010 Sep;11(3):1482-4. doi: 10.1208/s12249-010-9503-z. Epub 2010 Sep 16.
For several decades, the FDA has undertaken many initiatives to improve the quality and safety of sterile drug products. In recent years, efforts have also been undertaken to accelerate the rate for application approval by adding earlier involvement of microbiology reviewers in drug development. Product and manufacturing process development, as well as safe use and product design, are among the elements of enhanced technical involvement. An overview of the product quality microbiology aspects for sterile drugs is provided.
几十年来，FDA 采取了许多举措来提高无菌药品的质量和安全性。近年来，还通过让微生物学审查员更早地参与药物开发，来加快申请批准的速度。加强技术参与的内容包括产品和制造工艺的开发以及安全使用和产品设计。本文概述了无菌药品的产品质量微生物学方面的内容。
