Sanner GmbH, a manufacturer of plastic packaging components for pharmaceutical, medical and healthcare products, has successfully completed certification according to DIN EN ISO 15378:2007 quality standards at its Bensheim plant.
By complying with this ISO standard, Sanner has demonstrated that, as one of the pioneers in the industry, its quality management and manufacturing meet the latest requirements for primary packaging of medicinal products.
The three-day certification audit conducted by TÜV Rheinland LGA Products GmbH took place in mid-August following several weeks of preparation by Sanner employees. Valid for three years and reviewed annually, the certification confirms that Sanner has successfully implemented the guidelines required to meet the ISO 15378 standard. "This certification demonstrates compliance with one of the top international standards that place high demands on quality management and the end-to-end production process for primary packaging of medicinal products," explains Sanner Managing Director Holger Frank. "It also confirms that we offer our customers the best possible operational processes for safe production of high-quality packaging materials for the pharmaceutical industry. This makes our company one of the industry leaders."
The principle of maintaining high quality standards is firmly anchored in the Sanner corporate structure. As plastic specialists, Sanner has integrated a comprehensive internal quality management system along with the "20 Keys" benchmark program to analyze and continuously optimize quality across the entire process chain. Process reliability is also enhanced by regularly scheduled employee training. "High quality standards are not something we just talk about at Sanner. We live and breathe quality in our daily operations," says Frank explaining the company's principle. "We conduct regular in-house audits and use open, transparent lines of communication to identify areas for improvement. This helps us optimize our work processes and increase customer satisfaction."
As a complete quality assurance system for pharmaceutical packaging, ISO 15378 combines the general requirements of DIN EN ISO 9001:2008 with the industry-specific guidelines for Good Manufacturing Practice (GMP). It covers the entire process from design to manufacturing and delivery.
In addition to the recent certification, the entire Sanner Group complies with ISO 9001 and is also certified according to DIN EN ISO 13485:2003 at the Bensheim plant. Holger Frank: "We follow the 'Made in Germany' principle. Our aim is to meet the same high quality standards at all of our manufacturing facilities."
Sanner successfully certified to ISO 15378