The pharmaceutical industry is primarily confronted with high international and local regulatory challenges, which are understood as Good Manufacturing Process (GMP). These include in particular the traceability of products along the entire value chain and closely comprehensive control loops. The result is a high documentation effort, which is often paper-based. Comprehensive digital data for further analyses and process improvements are therefore not available.
An increasing digitalization of production processes simplifies the fulfillment of transparency requirements. This allows the data to be used for further analysis and associated process improvements. The Industrie 4.0 Maturity Center was significantly involved in the development of the Pharma 4.0 model of ISPE. This adapted version of the Industrie 4.0 Maturity Index specifically addresses the challenges and needs of the pharmaceutical industry.