Pioneering Electronic Batch Record Implementation in Spain
Maria Grahm, Vice President, Vertical Management Pharma, Siemens
In the northeast of Spain, AGC Pharma Chemicals is committed to manufacturing active pharmaceutical ingredients (APIs) and intermediates. Siemens has supported AGC to become the first Spanish pharma company to successfully integrate an Electronic Batch Record (eBR) system with a Distributed Control System (DCS) in Spain.
As a part of AGC Inc., AGC Pharma Chemicals is a full-service contract development and manufacturing organization (CDMO), offering innovative solutions to its customers, from early clinical phases through to commercial manufacturing.
A roadmap for Digital Transformation
The AGC Pharma Chemicals site in Barcelona is a manufacture and development plant that has one of the largest installations of an automated control system in Spain. It uses the Siemens Distributed Control System (DCS), Simatic PCS 7, as well as the automated batch recipe functionality in Simatic Batch. The challenge for AGC Pharma Chemicals has been that the production facility also relied heavily on paper-based processes, meaning that there was always a lot of effort to check the large amounts of documentation that were being generated. In addition, the manual entry of data was rather buggy: additional checks were needed. In order to improve processes and increase productivity without reducing quality, AGC Pharma Chemicals looked to optimize automation and enable paperless manufacturing with automate batch records.
“One aspect of our AGC Pharma Chemicals roadmap for digitalization was the challenge to successfully implement the Electronic Batch Record (eBR) and connect it to the Distributed Control System (DCS),” says Nina Mikadze, Systems and Compliance Manager at AGC Pharma Chemicals. Here, AGC Pharma Chemicals works together with its long-standing partner Siemens.
Completely digitalized manufacturing guides
The Siemens' software solution, Opcenter Execution Pharma, which is a paperless MES system for the pharmaceutical industry, has been used to enable this digital transformation of production operations. The Opcenter Execution Pharma software is a manufacturing execution system that seamlessly integrates with the automationsystem (DCS). It has enabled AGC Pharma Chemicals to streamline processes and operations while remaining in full compliance with regulations. Thanks to this integration with the plant’s existing DCS system, SIMATIC PCS 7, the AGC facility has gone beyond the ‘paper on glass’ concept, completely digitalizing their manufacturing guides, which in turn provides support and instruction to operators to do the right thing at the right time. They are the first pharma company in Spain to implement the integrated Siemens solution.
Automation and Electronic Batch Record
The first phase of the AGC digitalization project for the digital transformation of the production operations and the manufacturing guidelines consisted of two main steps.
Firstly, the automation. A modernization and migration of the SIMATIC PCS 7 control system was required. There is a complex architecture of three networks that communicate to more than 50 controllers, 25 server pairs and 40 operator stations. The plant operates 24 hours a day, seven days a week with two short shutdowns per year. This meant replicating, simulating, and migrating the different systems in parallel before commissioning, and so it took two years to migrate the four sites within the plant.
The second step was the introduction of the Electronic Batch Record, one of the key elements of the digitalization roadmap of AGC Pharma Chemicals. The implementation of eBR has brought operational excellence in manufacturing operations. It covers material receipt dispensing, production execution and batch review. The system enables the monitoring of critical process parameters and quality attributes. In addition, it fully complies with pharma regulations on the management of data and data integrity (cGMP 21 CFR Part 11 and GMP Annex 11).
Control, quality, and safety
The DCS connects more than 80 different pieces of production equipment and extracts more than 4,000 data tags in real time. These are recorded in the eBR system, which then becomes a digital documentation of all of the production steps and all of the relevant information.
According to Nina Mikadze, “One of the main advantages of eBR is the integration between the control system and the MES system that brings the control data directly into the manufacturing guides in real time. As a result, more than 530 manual entries from operators have been removed, ensuring data integrity, and simplifying the process. Additionally, the flow of materials is controlled by bar codes, bringing even more value in quality and safety.
Critical parameters are continuously monitored in the DCS, and the operator interface is easy to use and intuitive. In addition, the review by exception philosophy has been implemented thanks to the ability to add automatic checks to the system that alert users in real time and can block the process, if necessary.”
AGC Pharma Chemicals Europe in Barcelona has been working together with Siemens in automation for more than 20 years. Thanks to this successful collaboration, Siemens has been chosen as the partner for the digitalization of manufacturing guides. The integration between the control system and the manufacturing guides has been a key factor in the decision.
Author Bio
Maria Grahm is Vice President of Vertical Management Pharma at Siemens, leading the pharmaceutical business since March 2024. With a background in electrical engineering from Uppsala University, she brings over a decade of leadership experience in industrial automation and digital transformation. Maria previously led Digital Industry Process Automation for Sweden and the Nordics and held key roles at ÅF Food & Pharma. She has also served on international boards including PiiA and Swensk Automation, driving cross-industry collaboration and innovation.
