The CDMO company, AGC Pharma Chemicals Europe, based in Spain, participates in the SIEMENS Neo Era Event with a talk about digitalization as a reference in implementing the electronic batch record, being a pioneer in the pharma-chemical industry.
Nina Mikadze, responsible for the industrial network, automation, and compliance, shared with the Pharmaceutical Industry at the SIEMENS Neo Era Event the experience of implementing the SIEMENS Op center Execution Pharma Electronic Batch Record AGC Pharma Chemicals Europe a CDMO digital reference with this system.
This project has been key in implementing the Electronic Batch Record (eBR) completely connected to the Distributed Control System (DCS), one of the largest network in Spain, with 20 thousand process objects tags, as one of the businesses’ primary site digitalization projects and the first CDMO in Spain to do so.
This complete communication overpasses the paper on glass concept by automatically extracting the process data and synchronizing with the batch record. It provides real-time production execution, continuous monitoring and alerts of critical parameters whilst ensuring compliance requirement fulfilment and data integrity (cGMP Annex 11 and cGMP 21 CFR Part 11).
“It isn’t just about digitizing separate processes. It is about studying all processes, directly or indirectly, associated with manufacturing operations to efficiently redesign and optimize them to increase production efficiency, reduce manual human input, offer information availability, and ensure data integrity fulfilling compliance requirements.”
AGC Pharma Chemicals Europe continues following their strategic digital transformation roadmap towards industry 5.0!
