Taking No Risks Total Quality Management Ensures Smooth Packaging of Pharmaceutical

Author / Editor: Holeger Frank / Dominik Stephan

Materials, machinery and men – these three factors 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 risk minimization. Here’s an overview of how Sanner meets these standards by implementing a quality management system tailored to the specific needs of the pharmaceutical industry.

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G250 capsule lid transfer wheel
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(Picture: MG2 S.r.l.)

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 the entire production process. A defect in the packaging, such as a malfunctioning child-proof cap, can have drastic 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 consistently high quality of packaging products. Consequently, the complete production process is subject to strict criteria in order to ensure that defective packaging does not end up in the hands of patients.

Process–Oriented Manufacturing

As a company specializing in the development and production of high-quality plastic packaging and components for pharmaceutical, medical and healthcare products, Sanner uses a specially designed quality management system to meet industry requirements. The Sanner Excellence System (SESy) defines groupwide standards, methods and procedures. It includes continuous production monitoring and regular quality checks along with complete documentation of all business processes and compliance with ISO standards and GMP guidelines.

The company 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

The entire process environment at the organization 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. “We consistently focus on the product. All of our work processes are linked to and derived from its production,” explains Head-Quality Management, Sanner, Volker Reichstein. “This ensures that our products meet the highest quality standards in line with different customer requirements,” he adds.

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