ISO 15378:2011 specifies needs for a quality management system where an organization requirements to demonstrate its ability to provide primary packaging materials for medicinal products, which constantly meet client needs, including regulatory necessities and International Standards applicable to primary packaging materials.
ISO 15378:2011 is an application standard for the design, manufacture and provide of primary packaging materials for medicinal products. It is also applicable for certification purposes.
Benefits of ISO 15378:2011
