Taking No Risks

Total Quality Management Ensures Smooth Packaging of Pharmaceutical

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The strong product focus along the entire supply chain enables thorough root-cause analysis. During the product development phase, close attention is paid to potential risks in production. The risks are quantified and appropriate measures are taken to minimize the risk for patients. This results in a consistent process with the lowest possible error rate and a safe product supplied to the customer.

Complete Traceability Minimizes Risks

Thanks to technical data embedding, the MES system meets the highest standards for end-to-end traceability and production control across the entire supply chain, down to each individual packaging unit. When raw materials are ordered, the ERP system forwards part numbers and supplier information to Guardus MES. “We document all production steps and quality checks in the manufacturing process,” says Reichstein. “This enables us to subsequently determine how each product was manufactured and which raw materials were processed.”

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On-time and in-full (OTIF) levels and complaint rates prove that the firm integrates rigorously controlled and validated processes: 98 per cent of all deliveries arrive at their destination on time without any missing parts. The complaint rate is less than one per ten million parts supplied. If, despite stringent quality control, a product defect does occur, the cause can be determined using a predefined complaint management system that covers the entire production cycle.

There are no Problems - Only Opportunities

Problems in the system are seen as an opportunity for sustainable improvement. “Our MES system gives us instant access to all the data. This enables us to immediately respond to requests and actively intervene if necessary. We carefully analyze the problem and develop a long-term solution,” avers Reichstein.

Michael Kuhs from Analyticon Biotechnologies AG states, “We were impressed by the way Sanner reacted immediately to our complaint. The changes made in the production process now give us even more product safety and quality.” A defined ‘change control’ process is used to handle modifications in material or other new framework conditions.

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