title: Current good manufacturing practice in plant automation of biological production processes.
abstract: 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.
authors.affiliation: Laboratory for Product and Process Development, National Institute of Public Health and the Environment, P.O. Box 1, 3720 BA, Bilthoven, The Netherlands.
authors.forename: R C
authors.initials: RC
authors.lastname: Dorresteijn
authors.forename: G
authors.initials: G
authors.lastname: Wieten
authors.forename: P T
authors.initials: PT
authors.lastname: van Santen
authors.forename: M C
authors.initials: MC
authors.lastname: Philippi
authors.forename: C D
authors.initials: CD
authors.lastname: de Gooijer
authors.forename: J
authors.initials: J
authors.lastname: Tramper
authors.forename: E C
authors.initials: EC
authors.lastname: Beuvery