Together with key organizations within the ISPE DACH framework, Werum IT 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.
“Holistic Production Control Strategy” deals with the question of how ICH guidelines can be implemented into pharmaceutical production considering the enhanced technical capabilities of Industrie 4.0. Experts are working on a best practice methodology to show pharma manufacturers how submission documents from process development can be moved to commercial production via technology transfer and scale-up. In this context, MES such as Werum’s PAS-X can assure a flexible and robust production control strategy design and execution, meeting quality and compliance requirements.
The global ISPE GAMP “Data Integrity” SIG is working on the creation of a Good Practice Guide for practical implementation of data integrity in all holistic production control strategy areas. Werum is leading the MES chapter for this guide.