Global S&T Development Trend Analysis Platform of Resources and Environment
DOI | 10.17226/26009 |
Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations | |
National Academies of Sciences, Engineering, and Medicine | |
2021-02-24 | |
出版年 | 2021 |
国家 | 美国 |
领域 | 资源环境 |
英文摘要 | In 2002, the U.S. Food and Drug Administration (FDA) launched the Pharmaceutical Quality for the 21st Century Initiative to encourage adoption of innovative technologies that would lead to an agile, flexible pharmaceutical manufacturing sector. The goal was to encourage a transition to manufacturing processes and approaches that could produce high-quality drugs reliably without extensive regulatory oversight. Much progress has been made toward that goal as the industry has developed and advanced new technologies, but more progress is required as recent natural disasters and the coronavirus pandemic have revealed vulnerabilities in supply chains and highlighted the need to modernize pharmaceutical manufacturing further. At the request of the FDA Center for Drug Evaluation and Research (CDER), Innovations in Pharmaceutical Manufacturing on the Horizon identifies emerging technologies - such as product technologies, manufacturing processes, control and testing strategies, and platform technologies - that have the potential to advance pharmaceutical quality and modernize pharmaceutical manufacturing for products regulated by CDER. This report describes many innovations to modernize the manufacture of drug substances and drug products, to advance new control approaches, and to develop integrated, flexible, and distributed manufacturing networks within 5-10 years. |
URL | 查看原文 |
来源平台 | National Academies Press |
引用统计 | |
文献类型 | 科技报告 |
条目标识符 | http://119.78.100.173/C666/handle/2XK7JSWQ/317147 |
专题 | 资源环境科学 |
推荐引用方式 GB/T 7714 | National Academies of Sciences, Engineering, and Medicine. Innovations in Pharmaceutical Manufacturing on the Horizon: Technical Challenges, Regulatory Issues, and Recommendations,2021. |
条目包含的文件 | 条目无相关文件。 |
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