Together with key organizations within the ISPE DACH framework, Werum Solutions promotes the foundation of the Special Interest Group (SIG) “Pharma 4.0”. The goal is to provide best practice implementation methodologies, approaches and practical examples to apply new Industrie 4.0 technologies in pharmaceutical and biopharmaceutical production environments according to the current GMP and ICH guidelines. Divided into subgroups, experts are currently evaluating the topics “Plug & Produce” and “Holistic Production Control Strategy”.
In the “Plug & Produce” subgroup, Werum is contributing to the development of an integration standard which connects the ISA S95 levels 3 and 2, each vertically and horizontally, supporting an open message oriented communication concept based on common standards like OPC-UA. The standard has to meet all GxP-specific requirements, e.g. for data integrity, and needs to allow a simplified implementation and lifecycle approach for pharmaceutical manufacturing equipment. Werum’s new standardized messaged-based interface constitutes the technical basis for the Plug & Produce solution.