Promens Firenze leads the way in Italy

19.01.2009

Promens Firenze, a member of Promens packaging division has become the first company in Italy to receive an ISO 15378 certification.

ISO 15378 specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide primary packaging materials for medicinal products, which consistently meet customer requirements, including regulatory requirements and International Standards applicable to primary packaging materials.

Developed with the participation of pharmaceutical sector experts, ISO 15378 incorporates in a single document the quality management requirements of ISO 9001 together with the Principles of Good Manufacturing Practice (GMP) for the design, manufacturing and supply of primary packaging materials for medicinal products.

Good Manufacturing Practices (GMP) relate to quality control and quality assurance enabling companies in the pharmaceutical sector to minimize or eliminate instances of contamination, mix-ups, and errors. This in turn, protects the customer from purchasing a product which is ineffective or even dangerous. Until introduction of ISO 15378, however, there was no applicable guideline or rule for primary packaging materials, which contain, seal or are used for dose application and have direct contact with the medicinal product.

The ISO 15378 standard is therefore of vital importance to the pharmaceutical industry and its suppliers of pharmaceutical primary packaging materials, such as Promens. It provides the pharmaceutical industry with an internationally recognized management tool to improve patient safety.

In 2006 Promens was also the first company in France to receive the ISO 15378 certification when three of its packaging plants, Bellignat, Geovreisset and L’Aigle were certified by AFAQ AFNOR along with two other norms, ISO 13485* and ISO 9001.

*The ISO 13485 is based on the ISO 9001, with dedicated needs for medical devices.