Management tools for the evaluation of compliance and costs in the production of chemical–pharmaceutical companies

Abstract

Due to the stringent and increasingly demanding Good Manufacturing Practice (GMP) and customer requirements, companies within the chemical–pharmaceutical sector share the enormous challenge of evaluating and measuring compliance and costs. The need for implementing a compliance measuring tool for production was identified within the Schering AG and activities were undertaken. The established compliance evaluation system and the first model for a compliance cost system proved to be well-structured and suitable for the production. Consequently, the systems can be adapted by other areas and chemical–pharmaceutical companies and may even be expanded to other areas, such as Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). Copyright © 2005 John Wiley & Sons, Ltd.