Laboratory for Product and Process Development, National Institute of Public Health and the Environment, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands.
Cytotechnology. 1997 Jan;23(1-3):19-28. doi: 10.1023/A:1007923820231.
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.
生物制品的生产受到严格的政府法规的限制。这些法规是根据现行良好生产规范（cGMP）制定的，例如由美国食品和药物管理局制定。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 批处理标准的配方驱动控制系统的引入，使得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 还提供了其他功能，例如库存管理、计划和路线工具、与过程相关的控制、软件传感器和预测模型的实现、历史数据的应用以及在线统计技术用于趋势分析和检测仪器故障。本文重点介绍了新的生产策略的开发，其中 cGMP 指南是一个重要组成部分。
