Pharma production goes paperless
The pharma industry, propelled by novel therapies and tech, is rapidly advancing. AGC Pharma Chemicals in Spain, a drug development and manufacturing service provider, transformed its production operations with a paperless manufacturing execution system.
AGC Pharma Chemicals: Digital Transformation
Drug manufacturers prioritize quality. AGC Pharma Chemicals, a CDMO in Spain and Japan, does R&D and manufacturing. They previously used error-prone manual documentation for quality/process control, which was slow. Rapid growth led AGC to partner with Siemens for digitalization, moving from paper-based production to maintain standards and profitability.
No downtime for digitalization
The first order of business was to upgrade the entire production operating system to the Simatic PCS 7 distributed control system (DCS). The four sites that make up AGC’s Barcelona plant run continuously 24/7, allowing only for two short shutdowns a year. This means that the migration team had to replicate, simulate, and migrate the entire architecture – comprising three networks, 50 controllers and 40 operator stations – while the system was up and running.
The second phase of the transformation saw the introduction of the Simatic Batch electronic batch record (eBR), the lynchpin of AGC Pharma Chemicals’ digitalization effort. eBRs contain data on the operators, processes, equipment, and supplies; they prove whether all the steps needed to produce each batch of a product were handled properly. Implementing the eBR also meant that AGC met FDA regulations on the management of data and data integrity.
Paperless release of the charges: Employee in AGC's plant in Barcelona
Quality first: an AGC Pharma Chemicals employee scans the raw materials in the warehouse.
GC Pharma Chemicals’ facility in Barcelona, Spain, is the first FDA registered site in Europe for AGC
“One of the main advantages of eBRs is the integration between the control system and the MES system that brings the control data directly into the manufacturing guides in real time,” says Nina Mikadze, systems and compliance manager at AGC Pharma Chemicals. “As a result, more than 530 manual entries from operators have been removed, ensuring data integrity, and simplifying the process.”
The DCS connects more than 80 different production equipment that extract more than 4,000 data tags, which are then recorded in the eBR. This gives the manufacturer a complete digital documentation of all its production steps. Data transparency is crucial for quality control and benefits AGC, its customers, and the people who consume the medicine they produce. It is critical for the industry to maintain data integrity across all production stages while also delivering on speed and flexibility in material and product manufacture.
January 2023