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Stevanato Group, the Italian company that is a world leader in the production of primary packaging for the pharmaceutical industry, announced today that it can now boast of having obtained the prestigious ISO15378:2006 certification for the Pharma division, following an audit performed by the SQS certification agency on October 14th. It had already completed ISO9001 certification for all of its factories, which is issued to organizations whose management system pursues the objective of meeting customer needs and expectations.

ISO15378:2006 certification concerns the department for production of sterile and non-sterile syringes in particular, which qualifies as one of the most advanced in the world. This recognition applies the same quality management system requirements as the ISO9001 schema, which guard the entire process, from customer order management to post-sales service, including design, by completing such requirements with good manufacturing practices (GMPs) applicable to packaging. This is a significant step forward in the Group's process of becoming a pharmaceutical company.

This result shows increasing evidence that there is a robust system guaranteeing that processes are developed according to pharmaceutical criteria, thus strengthening the relationship between Stevanato Group and its customers. It also demonstrates the validity of the Group's approach, which has always been oriented towards emphasizing quality in the organization of the production process.

"The application of GMP principles in the production and control of primary packaging materials for medicinal products is of vital importance for the safety of patients who use medicinal products and pharmaceuticals," said Sergio Stevanato, the Group's Chairman, "because there exists a risk of contamination caused by direct contact of the product with the packaging material. The application of GMP principles for pharmaceutical packaging materials guarantees that requirements conform with and satisfy legal provisions, as well as those of the pharmaceutical sector for medicines."

After obtaining this new certification, Stevanato Group's line has shown that it can assure centralized quality management while protecting the proper application of existing procedures, allowing a coordinated flow of process phases in compliance with the most rigorous standards required by the market.