Materials, machinery, and people pose the highest risk in pharmaceutical packaging production. This is why pharmaceutical industry suppliers are required to comply with exacting standards when it comes to product safety, hygiene and minimizing risks. Sanner Gmbh meets these standards by implementing a quality management system tailored to the specific needs of the pharmaceutical industry. This guarantees smooth production processes, complete traceability, and maximum product protection, and minimal risk for patients.
Packaging requirements in the pharmaceutical industry are more stringent and complex than in any other sector. This applies to the packaging itself as well as to the entire production process. A defect in the packaging, such as a malfunctioning childproof cap, can have dramatic consequences. For this reason, pharmaceutical industry suppliers are obligated to comply with applicable ISO standards and hygiene regulations, and to produce in accordance with "Good Manufacturing Practices" (GMP). Pharmaceutical manufacturers expect suppliers to implement trouble-free processes along with applied risk management to guarantee the consistently high quality of packaging products. Consequently, the complete production process is subject to strict criteria to ensure that defective packaging does not end up in the hands of patients.
Process-oriented manufacturing organization
As a company specializing in the development and production of plastic packaging and components for pharmaceutical, medical, and healthcare products, Sanner uses a specially designed quality management system to meet pharmaceutical industry requirements. The Sanner Excellence System (SESy) defines group-wide standards, methods, and procedures. These include continuous production monitoring and regular quality checks, along with complete documentation of all business processes and compliance with ISO standards and GMP guidelines.
Sanner uses the SAP-linked Guardus Manufacturing Execution System (MES) to ensure seamless quality and production control across the entire manufacturing process, from incoming materials to outgoing products. All relevant customer and product data is stored in a database that documents the entire production workflow. This includes all manufacturing steps and measures, such as material receipt, quality checks, and administrative processes.
The path to a perfect product
At Sanner, the entire process environment focuses on the product and its manufacturing chain. The advantage lies in the comprehensive organization of all operations, instead of being tied to specific departments. The strong product focus along the entire supply chain enables thorough root-cause analysis. During the product development phase, Sanner already pays close attention to potential risks in production. They 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
With 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.
OTIF levels and complaint rate are integrated to rigorously control and validate processes: 98% of all deliveries arrive at their destination on time without any missing parts. The complaint rate is less than one per 10 million parts supplied. If, despite stringent quality control, a product defect does occur, Sanner can determine the cause using a predefined complaint management system that covers the entire production cycle. Problems in the system are seen as an opportunity for sustainable improvement.
A defined "change control" process is used to handle modifications in material or other new framework conditions.
Assuring quality, breathing life into processes
To improve processes company-wide on a long-term basis, Sanner uses the “20 Keys” management method. This holistic approach compares and describes a company's actual and target status based on 20 fields of action, identifies needs for improvement and integrates them into existing workflows. Instead of treating quality management as a static issue, Sanner sees it as a process in constant motion.
