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摘自微信号：GMPNotes 2016-04-30
不管你爱他、恨他，还是咋地，Continuous Production就这样粉墨登场了！！
亲，还记得GMP上面关于“批”的定义么？ “经一个或若干加工过程生产的、具有预期均一质量和特性的一定数量的原辅料、包装材料或成品。”。
这里，米国FDA已经正式批准位于波多黎各的杨森公司，在生产其600mg的地瑞拉韦片剂时，可以采用连续生产工艺（Continuous Manufacturing）。 从行业内开始有“连续生产”的概念，到业内高手们探索实践，直到今天的正式商业化运营过程中采用连续生产工艺，走过的历程让人唏嘘。
我们伟大、光荣而又正确的***，还有20年，可以实现么？
详细新闻，请参考如下内容：
FDA Approves Tablet Production on Janssen Continuous Manufacturing Line
FDA approved an update in the manufacturing of Prezista (darunavir) using a continuous manufacturing line at Janssen Supply Chain’s facility in Puerto Rico. Apr 12, 2016 By Pharmaceutical Technology Editors
With the April 8, 2016 FDA approval of an update in the manufacturing of PREZISTA (darunavir) 600 mg tablets, Janssen Supply Chain (JSC) can now produce tablets on a continuous manufacturing production line at its manufacturing facility in Gurabo, Puerto Rico. The use of continuous manufacturing to replace the existing batch manufacturing process is a result of a five-year partnership with Rutgers University and the University of Puerto Rico to develop a process that integrates all manufacturing steps (weighing, milling, blending, compression, and coating) into one single line. 2016年4月8日，杨森公司在波多黎各工厂迎来了一大喜讯：FDA批准了该公司可以采用连续生产线制造地瑞拉韦600mg片剂。在同美国罗格斯大学和波多黎各大学经过了为期5年的合作研究，开发出了一套单一生产线，整合了所有步骤的连续生产线，替代原有的“批生产方式”。（注：包括称量、研磨、混合压片和包衣）
Janssen collaborated with researchers in the Engineering Research Center for Structured Organic Particulate Systems (C-SOPS) to develop a full-scale continuous manufacturing direct-compaction production line at the Rutgers facility for testing, and the continuous manufacturing line at JSC’s facility was built using the design (1). In May, 2015, JSC expanded its partnership with C-SOPS to support ongoing continuous manufacturing research (2).
As part of the Janssen Pharmaceutical Companies of Johnson & Johnson, JSC is responsible for supplying medicines to markets around the world by connecting global supply to meet regional and local demand. “JSC continues to strengthen its plant capabilities and processes with optimal resource allocation and reduced complexity in manufacturing procedures in order to accelerate the ability to anticipate and respond to customer needs. By incorporating one of the industry’s first full production-scale continuous direct compression solid oral dosage manufacturing facilities in Puerto Rico, JSC will reduce manufacturing and testing cycle time, reduce waste and environmental impact, and lower process risk, all while maintaining existing product quality,” the company stated in an announcement. Continuous manufacturing reduced a two-week production timeline to a one-day production timeline and allows continuous monitoring of quality, says the company.
The team is also investigating applications of continuous-manufacturing techniques in manufacturing other pharmaceutical therapies, which could lead to reduced scale-up time and eventually shorter time-to-market for other Janssen medicines. With the integration of continuous manufacturing, Janssen and J&J aim to “manufacture 70% of highest-volume products using continuous manufacturing within eight years, increase yield by reducing waste by 33%, and reduce manufacturing and testing cycle time by 80%” (3). | 
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发表于 2018-11-12 08:37:39
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