The production of biologicals is subject to strict governmental regulations. These are drawn up in current good manufacturing practices (cGMP), a.o. by the U.S. Food and Drug Administration. To implement cGMP in a production facility, plant automation becomes an essential tool. For this purpose Manufacturing Execution Systems (MES) have been developed that control all operations inside a production facility. The introduction of these recipe-driven control systems that follow ISA S88 standards for batch processes has made it possible to implement cGMP regulations in the control strategy of biological production processes. Next to this, an MES offers additional features such as stock management, planning and routing tools, process-dependent control, implementation of software sensors and predictive models, application of historical data and on-line statistical techniques for trend analysis and detection of instrumentation failures. This paper focuses on the development of new production strategies in which cGMP guidelines are an essential part.
展开▼
机译：生物制剂的生产必须遵守严格的政府法规。这些是根据目前的良好生产规范（cGMP）制定的。由美国食品药品监督管理局（U.S. Food and Drug Administration）提供。为了在生产设施中实施cGMP，工厂自动化成为必不可少的工具。为此，已经开发了制造执行系统（MES），用于控制生产设施内的所有操作。这些遵循ISA S88标准的针对批次过程的配方驱动控制系统的引入，使在生物生产过程的控制策略中实施cGMP法规成为可能。除此之外，MES还提供其他功能，例如库存管理，计划和路由工具，与过程有关的控制，软件传感器和预测模型的实现，历史数据的应用以及用于趋势分析和检测仪器故障的在线统计技术。本文重点研究新的生产策略，其中cGMP准则是必不可少的部分。
展开▼
