AGC Pharma Chemicals Europe is an international contract development and manufacturing organisation (CDMO), with sites in Spain and Japan, is dedicated to the manufacture of active pharmaceutical ingredients (APIs). At the current plant there is one of the largest installations in Spain of control system based on PCS 7 and Simatic Batch. But the production part was based on paper, mainly causing a great job of checking the documentation, increasing the possibility of errors due manually entering the production data, lacks with the Data Integrity and also delays in reviewing and launching batches. To optimize processes, increase productivity without reducing quality, requires maximum automation in manufacturing as well as paperless manufacturing. The digitization of manufacturing in conjunction with production are the challenges proposed to meet this project

The Digitalization Road Map of AGC Pharma Chemicals Europe is based on the digital transformation of production operations and manufacturing guidelines. It has consisted of the first phase in two main points:

• Automation: Modernization and migration of the control system based on SIMATIC PCS7 with a complex architecture of 3 interconnected networks that communicate more than 50 PLC’s (AS-41x), 25 redundant servers and 40 operator terminals. As the plant has only been shut down for 15 days a year, this has meant replicating, simulating and migrating the plant in parallel before commissioning. It took 2 years to migrate the whole plant.
• Electronic Batch Record: Electronic batch record, is one of the key elements of the Digitalization Road Map of AGC Pharma Chemicals Europe, and it is aiming the operational excellence in manufacturing operations while ensuring a robust quality system supported by full compliant data integrity  (cGMP 21 CFR Part 11 and GMP Annex 11) and continuous monitoring of quality critical parameter. 

In AGC Pharma Chemicals Europe Electronic Batch Record implements paperless solution for manufacturing, removing paper based Batch records. It is based on integrating both, Manufacturing Execution System (OpCenter Execution Pharma) and Distributed Control System (SIMATIC PCS 7) layer, and therefore linking production execution and management. It connects more than 80 production equipments and >4000 tags for real time parameters extraction. With this new system the electronic batch record is documented digitally: 

• No manual entries are required 
• Critical parameters are continuously monitored in the DCS 
• Operator's interface is easy to follow  
• Barcode scanner system, for material reconciliation securities 
• The Batch review process implements "revision by exclusion" philosophy