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.

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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.

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.”

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.

This solutionoriented approach is a key benefit for customers like HemoCue AB. “We have been working successfully with Sanner for many years,” confirms Asa Sjöstrand from HemoCue, Sweden. “We were especially impressed by the company’s expertise and the service mentality of Sanner specialists. They took our requests seriously and responded immediately with satisfactory solutions,” Sjöstrand adds.

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, the company sees it as a process in constant motion.

“We don’t just talk about processes at Sanner, we breathe life into them. This is the key to continuously improving quality and supplying customers with reliable products that minimize risk and maximize patient safety. These are the factors that make Sanner an ideal partner for the pharmaceutical industry,” Reichstein concludes.

* The author is the Chief Executive Officer of Sanner GmbH

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